Study Comparing Doses Of An Experimental Glucocorticoid C... | NCT01393639 | Trialant
NCT01393639
Sponsor
Pfizer
Status
Completed
Last Update Posted
Sep 4, 2024Actual
Enrollment
323Actual
Phase
Phase 2
Conditions
Rheumatoid Arthritis
Interventions
PF-04171327
PF-04171327
PF-04171327
PF-04171327
prednisone
prednisone
placebo
Countries
United States
Bulgaria
Colombia
Czechia
Germany
Hungary
India
Malaysia
Mexico
Poland
Romania
Russia
Serbia
Slovakia
South Africa
South Korea
Spain
Ukraine
Protocol Section
Identification Module
NCT ID
NCT01393639
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
A9391010
Secondary IDs
ID
Type
Description
Link
2010-023782-22
EudraCT Number
Brief Title
Study Comparing Doses Of An Experimental Glucocorticoid Compound To Prednisone And Placebo In Rheumatoid Arthritis
Official Title
A PHASE 2, RANDOMIZED, DOUBLE BLIND ASSESSMENT OF EFFICACY AND SAFETY OF PF 04171327(1, 5, 10, 15 MG DOSE, DAILY) COMPARED TO 5 MG AND 10 MG PREDNISONE DAILY AND PLACEBO DAILY IN SUBJECTS WITH RHEUMATOID ARTHRITIS OVER AN 8 WEEK PERIOD FOLLOWED BY A 4 WEEK PERIOD OF TAPERING OF STUDY DRUG.
Acronym
Not provided
Organization
PfizerINDUSTRY
Status Module
Record Verification Date
Aug 2024
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Sep 27, 2011Actual
Primary Completion Date
Jun 3, 2014Actual
Completion Date
Jun 9, 2014Actual
First Submitted Date
Jun 13, 2011
First Submission Date that Met QC Criteria
Jul 11, 2011
First Posted Date
Jul 13, 2011Estimated
Results Waived
Not provided
Results First Submitted Date
Jan 12, 2023
Results First Submitted that Met QC Criteria
Aug 12, 2024
Results First Posted Date
Sep 4, 2024Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Dec 12, 2018
Certification/Extension First Submitted that Passed QC Review
Dec 12, 2018
Certification/Extension First Posted Date
Dec 14, 2018Actual
Last Update Submitted Date
Aug 12, 2024
Last Update Posted Date
Sep 4, 2024Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
PfizerINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of this study is to compare the safety and efficacy of multiple doses of PF-04171327, an experimental glucocorticoid drug, to prednisone at 5 mg or 10 mg and placebo in the treatment of rheumatoid arthritis. All subjects will also be receiving background treatment of methotrexate for their rheumatoid arthritis. Study medication will be given for eight weeks followed by a 4 week period during which the dose of study medication will be gradually reduced. The efficacy of the study medications will be determined by assessing severity of the rheumatoid arthritis during the study and safety will be determined by adverse event reporting, laboratory tests and biomarker analysis.
Detailed Description
Not provided
Conditions Module
Conditions
Rheumatoid Arthritis
Keywords
treatment of rheumatoid arthritis
treatment of RA
patients on methotrexate for rheumatoid arthritis
prednisone for rheumatoid arthritis
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
323Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
PF-04171327 1 mg QD
Experimental
Drug: PF-04171327
PF-04171327 5 mg QD
Experimental
Drug: PF-04171327
PF-04171327 10 mg QD
Experimental
Drug: PF-04171327
PF-04171327 15 mg QD
Experimental
Drug: PF-04171327
prednisone 5 mg QD
Active Comparator
Drug: prednisone
prednisone 10 mg QD
Active Comparator
Other: prednisone
placebo
Placebo Comparator
Other: placebo
Interventions
Name
Type
Description
Arm Group Labels
Other Names
PF-04171327
Drug
1 mg tablet once daily (QD) for 8 weeks
PF-04171327 1 mg QD
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percentage of Participants Achieving a 20% Improvement in American College of Rheumatology (ACR) Criteria at Week 8
ACR20 response: greater than or equal to (≥) 20 percent (%) improvement in tender joint count; ≥ 20% improvement in swollen joint count; and ≥ 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP).
Week 8
Mean Percent Change From Baseline in 0 Hour Procollagen Type 1 N Terminal Propeptide (P1NP) at Week 8 (Comparisons to Prednisone 5 mg)
Change from baseline in P1NP at week 8 is presented in this outcome measure.
Week 8
Mean Percent Change From Baseline in 0 Hour Urinary N Telopeptide/Urinary Creatinine (uNTx/uCr) at Week 8 (Comparisons to Prednisone 5 mg)
Change from baseline in uNTx/uCr at week 8 is presented in this outcome measure.
Week 8
Secondary Outcomes
Measure
Description
Time Frame
Percentage of Participants Achieving ACR20 Response at Weeks 2, 4, and 12 (Comparisons to Placebo, and Prednisone 10 mg)
ACR20 response: greater than or equal to (≥) 90 percent (%) improvement in tender or swollen joint counts and 90% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Subjects must have documented rheumatoid arthritis with a duration of at least 3 months as determined by the investigator using standardly accepted criteria, must have been receiving methotrexate for at least 3 months to treat their rheumatoid arthritis, and must be free of any signs or symptoms of infection.
Exclusion Criteria:
Subjects cannot enter the study if they have recently received treatment with certain medications which might interfere with study medications;
subjects cannot enter if they have abnormalities in certain blood tests, history of cancer, recent bone fracture or other significant conditions.
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
Participants enrolled who had documented rheumatoid arthritis with a duration of at least 3 months as determined by the investigator using standardly accepted criteria, had received methotrexate for at least 3 months to treat their rheumatoid arthritis, and were free of any signs or symptoms of infection.
Recruitment Details
This multi-center, randomized, double-blind, parallel-group, active and placebo-controlled study randomized 323 participants in at 73 centers. An additional 34 centers had no screening activities, but received study medication; and an additional 17 centers had at least 1 participant screened, but did not randomize any participants.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
PF-04171327 1 mg
Participants received PF-04171327 1 mg Once daily (QD) for 8 weeks. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.
FG001
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
1
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Canada
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Double
Masking Description
Not provided
Who Masked
ParticipantInvestigator
PF-04171327
Drug
5 mg tablet once daily (QD) for 8 weeks
PF-04171327 5 mg QD
PF-04171327
Drug
10 mg tablet once daily (QD) for 8 weeks
PF-04171327 10 mg QD
PF-04171327
Drug
15 mg tablet once daily (QD) for 8 weeks
PF-04171327 15 mg QD
prednisone
Drug
5 mg capsule once daily for 8 weeks
prednisone 5 mg QD
prednisone
Other
10 mg capsule once daily for 8 weeks
prednisone 10 mg QD
placebo
Other
placebo (tablet or capsule) once daily (QD) for 8 weeks
placebo
Weeks 2, 4, and 12 (taper period)
Percentage of Participants Achieving ACR50 Response at Weeks 2, 4, 6, 8 and 12 (Comparisons to Placebo, and Prednisone 10 mg)
ACR50 response: greater than or equal to (≥) 50 percent (%) improvement in tender or swollen joint counts and 50% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit.
Weeks 2, 4, 6, 8, and 12 (taper period)
Percentage of Participants Achieving ACR70 Response at Weeks 2, 4, 6, 8 and 12 (Comparisons to Placebo, and Prednisone 10 mg)
ACR70 response: greater than or equal to (≥) 70 percent (%) improvement in tender or swollen joint counts and 70% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) subject's assessment of disease activity, 3) subject's assessment of pain, 4) subject's assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit.
Weeks 2, 4, 6, 8, and 12 (taper period)
Change From Baseline in Tender-Joint Counts at Weeks 2, 4, 6, 8 (Comparisons to Placebo, and Prednisone 10 mg)
Twenty-eight tender/painful joint count included the following joints: shoulders, elbows, wrists, metacarpophalangeal joints, proximal interphalangeal joints, and knees. Artificial joints were not assessed. These joints were assessed by a joint assessor, who was blinded to the participant's safety data, previous efficacy data and treatment randomization, to determine the number of joints that were considered tender or painful, and swollen.
Weeks 2, 4, 6, and 8
Change From Baseline in Tender-Joint Counts at Week 12 (Descriptive Statistics)
Twenty-eight tender/painful joint count included the following joints: shoulders, elbows, wrists, metacarpophalangeal joints, proximal interphalangeal joints, and knees. Artificial joints were not assessed. These joints were assessed by a joint assessor, who was blinded to the participant's safety data, previous efficacy data and treatment randomization, to determine the number of joints that were considered tender or painful, and swollen.
Week 12
Change From Baseline in Swollen-Joint Counts at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg)
Twenty-eight tender/painful joint count included the following joints: shoulders, elbows, wrists, metacarpophalangeal joints, proximal interphalangeal joints, and knees. Artificial joints were not assessed. These joints were assessed by a joint assessor, who was blinded to the participant's safety data, previous efficacy data and treatment randomization, to determine the number of joints that were considered tender or painful, and swollen.
Weeks 2, 4, 6, and 8
Change From Baseline in Swollen-Joint Counts at Week 12 (Descriptive Statistics)
Twenty-eight tender/painful joint count included the following joints: shoulders, elbows, wrists, metacarpophalangeal joints, proximal interphalangeal joints, and knees. Artificial joints were not assessed. These joints were assessed by a joint assessor, who was blinded to the participant's safety data, previous efficacy data and treatment randomization, to determine the number of joints that were considered tender or painful, and swollen.
Week 12
Change From Baseline in C Reactive Protein (CRP) at Weeks 2, 4, 6, and 8 (Comparisons to Placebo and Prednisone 10 mg)
The CRP was collected at each applicable clinic visit and analyzed by a central laboratory. In order to assist with the data clean-up at the end of the study, the CRP results were unblinded to the sponsor at the time of the last subject's last visit. All statistics presented below are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Weeks 2, 4, 6, and 8
Change From Baseline of CRP at Week 12 (Descriptive Statistics)
The CRP was collected at each applicable clinic visit and analyzed by a central laboratory. In order to assist with the data clean-up at the end of the study, the CRP results were unblinded to the sponsor at the time of the last subject's last visit.
Week 12
Change From Baseline in Patient Global Assessment of Arthritis at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg)
Participants answered the following question, "Considering all the ways your arthritis affects you, how are you feeling today?" The subject's response was recorded using a 100 mm Visual Analog Scale (VAS), where 0 mm = no pain and 100 mm = most severe pain.
Weeks 2, 4, 6, and 8
Change From Baseline in Patient Global Assessment of Arthritis at Week 12 (Descriptive Statistics)
Participants answered the following question, "Considering all the ways your arthritis affects you, how are you feeling today?" The subject's response was recorded using a 100 mm Visual Analog Scale (VAS), where 0 mm = no pain and 100 mm = most severe pain.
Week 12
Change From Baseline in Physician Global Assessment of Arthritis at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg)
The investigator assessed how the participant's overall arthritis appears at the time of the visit. This was an evaluation based on the participant's disease signs, functional capacity and physical examination, and was independent of the Patient's Global Assessment of Arthritis. The investigator's response was recorded using a 100 mm VAS, where 0 mm = no pain and 100 mm = most severe pain.
Weeks 2, 4, 6, and 8
Change From Baseline in Physician Global Assessment of Arthritis at Week 12 (Descriptive Statistics)
The investigator assessed how the participant's overall arthritis appears at the time of the visit. This was an evaluation based on the participant's disease signs, functional capacity and physical examination, and was independent of the Patient's Global Assessment of Arthritis. The investigator's response was recorded using a 100 mm VAS, where 0 mm = no pain and 100 mm = most severe pain.
Week 12
Change From Baseline in Pain VAS at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg)
Participants assessed the severity of their arthritis pain using a 100 mm VAS placing a mark on the scale between 0 (no pain) and 100 (most severe pain), which corresponds to the magnitude of their pain.
Weeks 2, 4, 6, and 8
Change From Baseline in Pain VAS at Week 12 (Descriptive Statistics)
Participants assessed the severity of their arthritis pain using a 100 mm VAS placing a mark on the scale between 0 (no pain) and 100 (most severe pain), which corresponds to the magnitude of their pain.
Week 12
Change From Baseline in HAQ-DI at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg)
Health Assessment Questionnaire-Disability Index (HAQ-DI): participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.
Weeks 2, 4, 6, and 8
Change From Baseline in HAQ-DI at Week 12 (Descriptive Statistics)
Health Assessment Questionnaire-Disability Index (HAQ-DI): participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.
Week 12
Change From Baseline in Disease Activity Score (DAS) 28-3 CRP at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg)
DAS28-3 (CRP) was calculated from the SJC and TJC using the 28 joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) <= 3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (CRP) <2.6 = remission.
Weeks 2, 4, 6, and 8
Change From Baseline in DAS 28-3 CRP at Week 12 (Descriptive Statistics)
DAS28-3 (CRP) was calculated from the SJC and TJC using the 28 joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) <= 3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (CRP) <2.6 = remission.
Week 12
Change From Baseline in DAS28-4(CRP) at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg)
DAS28-4 (CRP) was calculated from the SJC and TJC using the 28 joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) <= 3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (CRP) <2.6 = remission. All statistics presented below are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Weeks 2, 4, 6, and 8
Change From Baseline in DAS28-4(CRP) at Week 12 (Descriptive Statistics)
DAS28-4 (CRP) was calculated from the SJC and TJC using the 28 joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) <= 3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (CRP) <2.6 = remission.
Week 12
Change From Baseline in SF-36v2 Mental Component Scores at Weeks 4 and 8 (Comparisons to Placebo, and Prednisone 10 mg)
The 36 item Short Form Health Survey (SF-36) (Versions 2, acute version) is a 36 item generic health status measure. It measures 8 general health concepts: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. These concepts can also be summarized as physical component score (PCS) and mental component score (MCS). The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). This questionnaire was completed by the participant prior to any procedures being performed at the visit, if possible. The form was then checked by site staff for completeness.
Weeks 4 and 8
Change From Baseline in SF-36v2 Mental Component Scores at Week 12 (Descriptive Statistics)
The 36 item Short Form Health Survey (SF-36) (Versions 2, acute version) is a 36 item generic health status measure. It measures 8 general health concepts: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. These concepts can also be summarized as physical component score (PCS) and mental component score (MCS). The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). This questionnaire was completed by the participant prior to any procedures being performed at the visit, if possible. The form was then checked by site staff for completeness.
Week 12
Change From Baseline in SF-36v2 Physical Component Scores at Weeks 4 and 8 (Comparisons to Placebo, and Prednisone 10 mg)
The 36 item Short Form Health Survey (SF-36) (Versions 2, acute version) is a 36 item generic health status measure. It measures 8 general health concepts: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. These concepts can also be summarized as physical component score (PCS) and mental component score (MCS). The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). This questionnaire was completed by the participant prior to any procedures being performed at the visit, if possible. The form was then checked by site staff for completeness.
Weeks 4 and 8
Change From Baseline in SF-36v2 Physical Component Scores at Week 12 (Descriptive Statistics)
The 36 item Short Form Health Survey (SF-36) (Versions 2, acute version) is a 36 item generic health status measure. It measures 8 general health concepts: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. These concepts can also be summarized as physical component score (PCS) and mental component score (MCS). The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). This questionnaire was completed by the participant prior to any procedures being performed at the visit, if possible. The form was then checked by site staff for completeness.
Week 12
San Leandro
California
94578
United States
Javed Rheumatology Associates, Inc.
Newark
Delaware
19713
United States
Allergy, Asthma, Arthritis, and Lung Center
Daytona Beach
Florida
32114
United States
Millennium Research
Ormond Beach
Florida
32174
United States
Alastair C. Kennedy, MD
Vero Beach
Florida
32960
United States
The Center for Arthritis and Rheumatism
Vero Beach
Florida
32960
United States
Arthritis and Osteoporosis Medical Associates, PLLC
Brooklyn
New York
11201
United States
Cincinnati Rheumatic Disease Study Group, Inc.
Cincinnati
Ohio
45219
United States
Altoona Center for Clinical Research
Duncansville
Pennsylvania
16635
United States
Low Country Rheumatology, PA
Charleston
South Carolina
29406
United States
Tricounty Radiology
Charleston
South Carolina
29406
United States
Accurate Clinical Research, Inc.
Houston
Texas
77034
United States
Arthritis Northwest, PLLC
Spokane
Washington
99204
United States
Revmatologichen kabinet, DKTs Sv. Pantaleimon OOD
Pleven
5800
Bulgaria
Revmatologichno Otdelenie, MBAL - Plovdiv
Plovdiv
4000
Bulgaria
MBAL "Sveti Ivan Rilski" Sofia; Klinika po Revmatologia
Sofia
1612
Bulgaria
MBAL Sveti Ivan Rilski Sofia; Klinika po Revmatologia
Sofia
1612
Bulgaria
Hospital Pablo Tobon Uribe
Medellín
Antioquia
Colombia
Reumalab S.A.S
Medellín
Antioquia
Colombia
Centro Integral de Reumatologia e Inmunologia CIREI
Municipal Establishment "City Clinical Hospital #9 n.a. O.I. Minakov", Department of Rheumatology
Odesa
65026
Ukraine
Vinnytsya regional clinical hospital named after M.I. Pyrogova; Department of rheumatology
Vinnytsia
21018
Ukraine
Municipal Institution:"Zaporizhzhya Regional Clinical Hospital",Rheumatology Dep.
Zaporizhzhya
69600
Ukraine
PF-04171327 5 mg
Participants received PF-04171327 5 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.
FG002
PF-04171327 10 mg
Participants received PF-04171327 10 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.
FG003
PF-04171327 15 mg
Participants received PF-04171327 15 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.
FG004
Prednisone 5 mg
Participants received prednisone 5 mg QD for 8 weeks. From week 9 through 10, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every 3 days.
FG005
Prednisone 10 mg
Participants received prednisone 10 mg QD for 8 weeks. After 8 weeks of treatment, participants were tapered off prednisone dosage. From week 9 through 10, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every 3 days.
FG006
Placebo
Participants received placebo QD until week 12.
FG00045 subjects
FG00147 subjects
FG00245 subjects
FG00348 subjects
FG00445 subjects
FG00546 subjects
FG00647 subjects
COMPLETED
FG00042 subjects
FG00140 subjects
FG00244 subjects
FG00343 subjects
FG00444 subjects
FG00544 subjects
FG00639 subjects
NOT COMPLETED
FG0003 subjects
FG0017 subjects
FG0021 subjects
FG0035 subjects
FG0041 subjects
FG0052 subjects
FG0068 subjects
Type
Comment
Reasons
Protocol Violation
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
Other
FG0000 subjects
FG0012 subjects
FG0020 subjects
FG0032 subjects
FG004
Withdrawal by Subject
FG0001 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Medication error without associated AE
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Lost to Follow-up
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Lack of Efficacy
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Adverse Event
FG0002 subjects
FG0013 subjects
FG0021 subjects
FG0032 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
PF-04171327 1 mg
Participants received PF-04171327 1 mg Once daily (QD) for 8 weeks. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.
BG001
PF-04171327 5 mg
Participants received PF-04171327 5 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.
BG002
PF-04171327 10 mg
Participants received PF-04171327 10 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.
BG003
PF-04171327 15 mg
Participants received PF-04171327 15 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.
BG004
Prednisone 5 mg
Participants received prednisone 5 mg QD for 8 weeks. From week 9 through 10, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every 3 days.
BG005
Prednisone 10 mg
Participants received prednisone 10 mg QD for 8 weeks. After 8 weeks of treatment, participants were tapered off prednisone dosage. From week 9 through 10, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every 3 days.
BG006
Placebo
Participants received placebo QD until week 12.
BG007
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00045
BG00147
BG00245
BG00348
BG00445
BG00546
BG00647
BG007323
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG00050.4± 14.2
BG00155.1± 12.1
BG00254.7± 13.1
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00033
BG00138
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Percentage of Participants Achieving a 20% Improvement in American College of Rheumatology (ACR) Criteria at Week 8
ACR20 response: greater than or equal to (≥) 20 percent (%) improvement in tender joint count; ≥ 20% improvement in swollen joint count; and ≥ 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP).
Full Analysis Set (FAS) included all participants who were randomized to the study and received at least one dose of the randomized study drug (PF 04171327, prednisone, or placebo). N= number of participants with observations.
Posted
Number
Percentage of participants
Week 8
ID
Title
Description
OG000
PF-04171327 1 mg
Participants received PF-04171327 1 mg Once daily (QD) for 8 weeks. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.
OG001
PF-04171327 5 mg
Participants received PF-04171327 5 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.
OG002
PF-04171327 10 mg
Participants received PF-04171327 10 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.
OG003
PF-04171327 15 mg
Participants received PF-04171327 15 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.
OG004
Prednisone 5 mg
Participants received prednisone 5 mg QD for 8 weeks. From week 9 through 10, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every 3 days.
OG005
Prednisone 10 mg
Participants received prednisone 10 mg QD for 8 weeks. After 8 weeks of treatment, participants were tapered off prednisone dosage. From week 9 through 10, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every 3 days.
OG006
Placebo
Participants received placebo QD until week 12.
Units
Counts
Participants
OG00045
OG00147
OG00245
OG003
Title
Denominators
Categories
Title
Measurements
OG00047
OG00161
OG00269
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG006
Bayesian 4 Parameter Emax Model Based Estimates are provided.
Mean Difference (Final Values)
10
2-Sided
60
5
15
Superiority criterion versus placebo: Lower bound of 60% credible interval >20%. Non-responder imputation was used to handle dropouts at Week 8.
Superiority or Other (legacy)
Primary
Mean Percent Change From Baseline in 0 Hour Procollagen Type 1 N Terminal Propeptide (P1NP) at Week 8 (Comparisons to Prednisone 5 mg)
Change from baseline in P1NP at week 8 is presented in this outcome measure.
FAS included all participants who were randomized to the study and received at least one dose of the randomized study drug (PF 04171327, prednisone, or placebo). N= number of participants with observations.
Posted
Least Squares Mean
Standard Error
Percent change
Week 8
ID
Title
Description
OG000
PF-04171327 1 mg
Participants received PF-04171327 1 mg Once daily (QD) for 8 weeks. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.
OG001
PF-04171327 5 mg
Participants received PF-04171327 5 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.
OG002
PF-04171327 10 mg
Participants received PF-04171327 10 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.
Primary
Mean Percent Change From Baseline in 0 Hour Urinary N Telopeptide/Urinary Creatinine (uNTx/uCr) at Week 8 (Comparisons to Prednisone 5 mg)
Change from baseline in uNTx/uCr at week 8 is presented in this outcome measure.
FAS included all participants who were randomized to the study and received at least one dose of the randomized study drug (PF 04171327, prednisone, or placebo). N= number of participants with observations.
Posted
Least Squares Mean
Standard Error
Percent change
Week 8
ID
Title
Description
OG000
PF-04171327 1 mg
Participants received PF-04171327 1 mg Once daily (QD) for 8 weeks. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.
OG001
PF-04171327 5 mg
Participants received PF-04171327 5 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.
OG002
PF-04171327 10 mg
Secondary
Percentage of Participants Achieving ACR20 Response at Weeks 2, 4, and 12 (Comparisons to Placebo, and Prednisone 10 mg)
ACR20 response: greater than or equal to (≥) 90 percent (%) improvement in tender or swollen joint counts and 90% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit.
FAS included all participants who were randomized to the study and received at least one dose of the randomized study drug (PF 04171327, prednisone, or placebo). Note, N = number of participants in FAS and n = number of participants with observations in the below table.
Posted
Number
Percentage of Participants
Weeks 2, 4, and 12 (taper period)
ID
Title
Description
OG000
PF-04171327 1 mg
Participants received PF-04171327 1 mg Once daily (QD) for 8 weeks. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.
OG001
PF-04171327 5 mg
Participants received PF-04171327 5 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.
Secondary
Percentage of Participants Achieving ACR50 Response at Weeks 2, 4, 6, 8 and 12 (Comparisons to Placebo, and Prednisone 10 mg)
ACR50 response: greater than or equal to (≥) 50 percent (%) improvement in tender or swollen joint counts and 50% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit.
FAS included all participants who were randomized to the study and received at least one dose of the randomized study drug (PF 04171327, prednisone, or placebo). Note, N = number of participants in FAS and n = number of participants with observations in the below table.
Posted
Number
Percentage of Participants
Weeks 2, 4, 6, 8, and 12 (taper period)
ID
Title
Description
OG000
PF-04171327 1 mg
Participants received PF-04171327 1 mg Once daily (QD) for 8 weeks. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.
OG001
PF-04171327 5 mg
Participants received PF-04171327 5 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.
Secondary
Percentage of Participants Achieving ACR70 Response at Weeks 2, 4, 6, 8 and 12 (Comparisons to Placebo, and Prednisone 10 mg)
ACR70 response: greater than or equal to (≥) 70 percent (%) improvement in tender or swollen joint counts and 70% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) subject's assessment of disease activity, 3) subject's assessment of pain, 4) subject's assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit.
Full analysis set was used. Note, N = number of participants in FAS and n = number of participants with observations in the below table.
Posted
Number
Percentage of Participants
Weeks 2, 4, 6, 8, and 12 (taper period)
ID
Title
Description
OG000
PF-04171327 1 mg
Participants received PF-04171327 1 mg Once daily (QD) for 8 weeks. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.
OG001
PF-04171327 5 mg
Participants received PF-04171327 5 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.
Secondary
Change From Baseline in Tender-Joint Counts at Weeks 2, 4, 6, 8 (Comparisons to Placebo, and Prednisone 10 mg)
Twenty-eight tender/painful joint count included the following joints: shoulders, elbows, wrists, metacarpophalangeal joints, proximal interphalangeal joints, and knees. Artificial joints were not assessed. These joints were assessed by a joint assessor, who was blinded to the participant's safety data, previous efficacy data and treatment randomization, to determine the number of joints that were considered tender or painful, and swollen.
FAS included all participants who were randomized to the study and received at least one dose of the randomized study drug (PF 04171327, prednisone, or placebo). Note, N = number of participants in FAS and n = number of participants with observations in the below table.
Posted
Least Squares Mean
Standard Error
Joints
Weeks 2, 4, 6, and 8
ID
Title
Description
OG000
PF-04171327 1 mg
Participants received PF-04171327 1 mg Once daily (QD) for 8 weeks. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.
OG001
PF-04171327 5 mg
Participants received PF-04171327 5 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.
Secondary
Change From Baseline in Tender-Joint Counts at Week 12 (Descriptive Statistics)
Twenty-eight tender/painful joint count included the following joints: shoulders, elbows, wrists, metacarpophalangeal joints, proximal interphalangeal joints, and knees. Artificial joints were not assessed. These joints were assessed by a joint assessor, who was blinded to the participant's safety data, previous efficacy data and treatment randomization, to determine the number of joints that were considered tender or painful, and swollen.
FAS included all participants who were randomized to the study and received at least one dose of the randomized study drug (PF 04171327, prednisone, or placebo). Note, N = number of participants with observations in the below table.
Posted
Mean
Standard Deviation
Joints
Week 12
ID
Title
Description
OG000
PF-04171327 1 mg
Participants received PF-04171327 1 mg Once daily (QD) for 8 weeks. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.
OG001
PF-04171327 5 mg
Participants received PF-04171327 5 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.
Secondary
Change From Baseline in Swollen-Joint Counts at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg)
Twenty-eight tender/painful joint count included the following joints: shoulders, elbows, wrists, metacarpophalangeal joints, proximal interphalangeal joints, and knees. Artificial joints were not assessed. These joints were assessed by a joint assessor, who was blinded to the participant's safety data, previous efficacy data and treatment randomization, to determine the number of joints that were considered tender or painful, and swollen.
FAS included all participants who were randomized to the study and received at least one dose of the randomized study drug (PF 04171327, prednisone, or placebo). Note, N = number of participants in FAS and n = number of participants with observations in the below table.
Posted
Least Squares Mean
Standard Error
Joints
Weeks 2, 4, 6, and 8
ID
Title
Description
OG000
PF-04171327 1 mg
Participants received PF-04171327 1 mg Once daily (QD) for 8 weeks. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.
OG001
PF-04171327 5 mg
Participants received PF-04171327 5 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.
Secondary
Change From Baseline in Swollen-Joint Counts at Week 12 (Descriptive Statistics)
Twenty-eight tender/painful joint count included the following joints: shoulders, elbows, wrists, metacarpophalangeal joints, proximal interphalangeal joints, and knees. Artificial joints were not assessed. These joints were assessed by a joint assessor, who was blinded to the participant's safety data, previous efficacy data and treatment randomization, to determine the number of joints that were considered tender or painful, and swollen.
FAS included all participants who were randomized to the study and received at least one dose of the randomized study drug (PF 04171327, prednisone, or placebo). Note, N = number of participants with observations in the below table.
Posted
Mean
Standard Deviation
Joints
Week 12
ID
Title
Description
OG000
PF-04171327 1 mg
Participants received PF-04171327 1 mg Once daily (QD) for 8 weeks. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.
OG001
PF-04171327 5 mg
Participants received PF-04171327 5 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.
Secondary
Change From Baseline in C Reactive Protein (CRP) at Weeks 2, 4, 6, and 8 (Comparisons to Placebo and Prednisone 10 mg)
The CRP was collected at each applicable clinic visit and analyzed by a central laboratory. In order to assist with the data clean-up at the end of the study, the CRP results were unblinded to the sponsor at the time of the last subject's last visit. All statistics presented below are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
FAS included all participants who were randomized to the study and received at least one dose of the randomized study drug (PF 04171327, prednisone, or placebo). Note, N = number of participants in FAS and n = number of participants with observations in the below table.
Posted
Least Squares Mean
Standard Error
mg/L
Weeks 2, 4, 6, and 8
ID
Title
Description
OG000
PF-04171327 1 mg
Participants received PF-04171327 1 mg Once daily (QD) for 8 weeks. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.
OG001
PF-04171327 5 mg
Participants received PF-04171327 5 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.
Secondary
Change From Baseline of CRP at Week 12 (Descriptive Statistics)
The CRP was collected at each applicable clinic visit and analyzed by a central laboratory. In order to assist with the data clean-up at the end of the study, the CRP results were unblinded to the sponsor at the time of the last subject's last visit.
FAS included all participants who were randomized to the study and received at least one dose of the randomized study drug (PF 04171327, prednisone, or placebo). Note, N = number of participants with observations in the below table.
Posted
Mean
Standard Deviation
mg/L
Week 12
ID
Title
Description
OG000
PF-04171327 1 mg
Participants received PF-04171327 1 mg Once daily (QD) for 8 weeks. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.
OG001
PF-04171327 5 mg
Participants received PF-04171327 5 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.
OG002
PF-04171327 10 mg
Secondary
Change From Baseline in Patient Global Assessment of Arthritis at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg)
Participants answered the following question, "Considering all the ways your arthritis affects you, how are you feeling today?" The subject's response was recorded using a 100 mm Visual Analog Scale (VAS), where 0 mm = no pain and 100 mm = most severe pain.
FAS included all participants who were randomized to the study and received at least one dose of the randomized study drug (PF 04171327, prednisone, or placebo). Note, N = number of participants in FAS and n = number of participants with observations in the below table.
Posted
Least Squares Mean
Standard Error
mm
Weeks 2, 4, 6, and 8
ID
Title
Description
OG000
PF-04171327 1 mg
Participants received PF-04171327 1 mg Once daily (QD) for 8 weeks. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.
OG001
PF-04171327 5 mg
Participants received PF-04171327 5 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.
Secondary
Change From Baseline in Patient Global Assessment of Arthritis at Week 12 (Descriptive Statistics)
Participants answered the following question, "Considering all the ways your arthritis affects you, how are you feeling today?" The subject's response was recorded using a 100 mm Visual Analog Scale (VAS), where 0 mm = no pain and 100 mm = most severe pain.
FAS included all participants who were randomized to the study and received at least one dose of the randomized study drug (PF 04171327, prednisone, or placebo). Note, N = number of participants with observations in the below table.
Posted
Mean
Standard Deviation
mm
Week 12
ID
Title
Description
OG000
PF-04171327 1 mg
Participants received PF-04171327 1 mg Once daily (QD) for 8 weeks. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.
OG001
PF-04171327 5 mg
Participants received PF-04171327 5 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.
OG002
Secondary
Change From Baseline in Physician Global Assessment of Arthritis at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg)
The investigator assessed how the participant's overall arthritis appears at the time of the visit. This was an evaluation based on the participant's disease signs, functional capacity and physical examination, and was independent of the Patient's Global Assessment of Arthritis. The investigator's response was recorded using a 100 mm VAS, where 0 mm = no pain and 100 mm = most severe pain.
FAS included all participants who were randomized to the study and received at least one dose of the randomized study drug (PF 04171327, prednisone, or placebo). Note, N = number of participants in FAS and n = number of participants with observations in the below table.
Posted
Least Squares Mean
Standard Error
mm
Weeks 2, 4, 6, and 8
ID
Title
Description
OG000
PF-04171327 1 mg
Participants received PF-04171327 1 mg Once daily (QD) for 8 weeks. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.
OG001
PF-04171327 5 mg
Participants received PF-04171327 5 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.
Secondary
Change From Baseline in Physician Global Assessment of Arthritis at Week 12 (Descriptive Statistics)
The investigator assessed how the participant's overall arthritis appears at the time of the visit. This was an evaluation based on the participant's disease signs, functional capacity and physical examination, and was independent of the Patient's Global Assessment of Arthritis. The investigator's response was recorded using a 100 mm VAS, where 0 mm = no pain and 100 mm = most severe pain.
FAS included all participants who were randomized to the study and received at least one dose of the randomized study drug (PF 04171327, prednisone, or placebo). Note, N = number of participants with observations in the below table.
Posted
Mean
Standard Deviation
mm
Week 12
ID
Title
Description
OG000
PF-04171327 1 mg
Participants received PF-04171327 1 mg Once daily (QD) for 8 weeks. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.
OG001
PF-04171327 5 mg
Participants received PF-04171327 5 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.
Secondary
Change From Baseline in Pain VAS at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg)
Participants assessed the severity of their arthritis pain using a 100 mm VAS placing a mark on the scale between 0 (no pain) and 100 (most severe pain), which corresponds to the magnitude of their pain.
FAS included all participants who were randomized to the study and received at least one dose of the randomized study drug (PF 04171327, prednisone, or placebo). Note, N = number of participants in FAS and n = number of participants with observations in the below table.
Posted
Least Squares Mean
Standard Error
mm
Weeks 2, 4, 6, and 8
ID
Title
Description
OG000
PF-04171327 1 mg
Participants received PF-04171327 1 mg Once daily (QD) for 8 weeks. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.
OG001
PF-04171327 5 mg
Participants received PF-04171327 5 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.
OG002
Secondary
Change From Baseline in Pain VAS at Week 12 (Descriptive Statistics)
Participants assessed the severity of their arthritis pain using a 100 mm VAS placing a mark on the scale between 0 (no pain) and 100 (most severe pain), which corresponds to the magnitude of their pain.
FAS included all participants who were randomized to the study and received at least one dose of the randomized study drug (PF 04171327, prednisone, or placebo). Note, N = number of participants with observations in the below table.
Posted
Mean
Standard Deviation
mm
Week 12
ID
Title
Description
OG000
PF-04171327 1 mg
Participants received PF-04171327 1 mg Once daily (QD) for 8 weeks. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.
OG001
PF-04171327 5 mg
Participants received PF-04171327 5 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.
OG002
PF-04171327 10 mg
Secondary
Change From Baseline in HAQ-DI at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg)
Health Assessment Questionnaire-Disability Index (HAQ-DI): participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.
FAS included all participants who were randomized to the study and received at least one dose of the randomized study drug (PF 04171327, prednisone, or placebo). Note, N = number of participants in FAS and n = number of participants with observations in the below table.
Posted
Least Squares Mean
Standard Error
Units on a scale
Weeks 2, 4, 6, and 8
ID
Title
Description
OG000
PF-04171327 1 mg
Participants received PF-04171327 1 mg Once daily (QD) for 8 weeks. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.
OG001
PF-04171327 5 mg
Participants received PF-04171327 5 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.
Secondary
Change From Baseline in HAQ-DI at Week 12 (Descriptive Statistics)
Health Assessment Questionnaire-Disability Index (HAQ-DI): participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.
FAS included all participants who were randomized to the study and received at least one dose of the randomized study drug (PF 04171327, prednisone, or placebo). Note, N = number of participants with observations in the below table.
Posted
Mean
Standard Deviation
Units on a scale
Week 12
ID
Title
Description
OG000
PF-04171327 1 mg
Participants received PF-04171327 1 mg Once daily (QD) for 8 weeks. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.
OG001
PF-04171327 5 mg
Participants received PF-04171327 5 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.
Secondary
Change From Baseline in Disease Activity Score (DAS) 28-3 CRP at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg)
DAS28-3 (CRP) was calculated from the SJC and TJC using the 28 joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) <= 3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (CRP) <2.6 = remission.
FAS included all participants who were randomized to the study and received at least one dose of the randomized study drug (PF 04171327, prednisone, or placebo). Note, N = number of participants in FAS and n = number of participants with observations in the below table.
Posted
Least Squares Mean
Standard Error
Units on a scale
Weeks 2, 4, 6, and 8
ID
Title
Description
OG000
PF-04171327 1 mg
Participants received PF-04171327 1 mg Once daily (QD) for 8 weeks. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.
OG001
PF-04171327 5 mg
Participants received PF-04171327 5 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.
Secondary
Change From Baseline in DAS 28-3 CRP at Week 12 (Descriptive Statistics)
DAS28-3 (CRP) was calculated from the SJC and TJC using the 28 joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) <= 3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (CRP) <2.6 = remission.
FAS included all participants who were randomized to the study and received at least one dose of the randomized study drug (PF 04171327, prednisone, or placebo). Note, N = number of participants with observations in the below table.
Posted
Mean
Standard Deviation
Units on a scale
Week 12
ID
Title
Description
OG000
PF-04171327 1 mg
Participants received PF-04171327 1 mg Once daily (QD) for 8 weeks. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.
OG001
PF-04171327 5 mg
Participants received PF-04171327 5 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.
Secondary
Change From Baseline in DAS28-4(CRP) at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg)
DAS28-4 (CRP) was calculated from the SJC and TJC using the 28 joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) <= 3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (CRP) <2.6 = remission. All statistics presented below are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
FAS included all participants who were randomized to the study and received at least one dose of the randomized study drug (PF 04171327, prednisone, or placebo). Note, N = number of participants in FAS and n = number of participants with observations in the below table.
Posted
Least Squares Mean
Standard Error
Units on a scale
Weeks 2, 4, 6, and 8
ID
Title
Description
OG000
PF-04171327 1 mg
Participants received PF-04171327 1 mg Once daily (QD) for 8 weeks. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.
OG001
PF-04171327 5 mg
Participants received PF-04171327 5 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.
Secondary
Change From Baseline in DAS28-4(CRP) at Week 12 (Descriptive Statistics)
DAS28-4 (CRP) was calculated from the SJC and TJC using the 28 joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) <= 3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (CRP) <2.6 = remission.
FAS included all participants who were randomized to the study and received at least one dose of the randomized study drug (PF 04171327, prednisone, or placebo). Note, N = number of participants with observations in the below table.
Posted
Mean
Standard Deviation
Units on a scale
Week 12
ID
Title
Description
OG000
PF-04171327 1 mg
Participants received PF-04171327 1 mg Once daily (QD) for 8 weeks. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.
OG001
PF-04171327 5 mg
Participants received PF-04171327 5 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.
Secondary
Change From Baseline in SF-36v2 Mental Component Scores at Weeks 4 and 8 (Comparisons to Placebo, and Prednisone 10 mg)
The 36 item Short Form Health Survey (SF-36) (Versions 2, acute version) is a 36 item generic health status measure. It measures 8 general health concepts: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. These concepts can also be summarized as physical component score (PCS) and mental component score (MCS). The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). This questionnaire was completed by the participant prior to any procedures being performed at the visit, if possible. The form was then checked by site staff for completeness.
FAS included all participants who were randomized to the study and received at least one dose of the randomized study drug (PF 04171327, prednisone, or placebo). Note, N = number of participants in FAS and n = number of participants with observations in the below table.
Posted
Least Squares Mean
Standard Error
Units on a scale
Weeks 4 and 8
ID
Title
Description
OG000
PF-04171327 1 mg
Participants received PF-04171327 1 mg Once daily (QD) for 8 weeks. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.
OG001
PF-04171327 5 mg
Secondary
Change From Baseline in SF-36v2 Mental Component Scores at Week 12 (Descriptive Statistics)
The 36 item Short Form Health Survey (SF-36) (Versions 2, acute version) is a 36 item generic health status measure. It measures 8 general health concepts: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. These concepts can also be summarized as physical component score (PCS) and mental component score (MCS). The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). This questionnaire was completed by the participant prior to any procedures being performed at the visit, if possible. The form was then checked by site staff for completeness.
FAS included all participants who were randomized to the study and received at least one dose of the randomized study drug (PF 04171327, prednisone, or placebo). Note, N = number of participants with observations in the below table.
Posted
Mean
Standard Deviation
Units on a scale
Week 12
ID
Title
Description
OG000
PF-04171327 1 mg
Participants received PF-04171327 1 mg Once daily (QD) for 8 weeks. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.
OG001
PF-04171327 5 mg
Participants received PF-04171327 5 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.
Secondary
Change From Baseline in SF-36v2 Physical Component Scores at Weeks 4 and 8 (Comparisons to Placebo, and Prednisone 10 mg)
The 36 item Short Form Health Survey (SF-36) (Versions 2, acute version) is a 36 item generic health status measure. It measures 8 general health concepts: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. These concepts can also be summarized as physical component score (PCS) and mental component score (MCS). The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). This questionnaire was completed by the participant prior to any procedures being performed at the visit, if possible. The form was then checked by site staff for completeness.
FAS included all participants who were randomized to the study and received at least one dose of the randomized study drug (PF 04171327, prednisone, or placebo). Note, N = number of participants in FAS and n = number of participants with observations in the below table.
Posted
Least Squares Mean
Standard Error
Units on a scale
Weeks 4 and 8
ID
Title
Description
OG000
PF-04171327 1 mg
Participants received PF-04171327 1 mg Once daily (QD) for 8 weeks. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.
OG001
PF-04171327 5 mg
Secondary
Change From Baseline in SF-36v2 Physical Component Scores at Week 12 (Descriptive Statistics)
The 36 item Short Form Health Survey (SF-36) (Versions 2, acute version) is a 36 item generic health status measure. It measures 8 general health concepts: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. These concepts can also be summarized as physical component score (PCS) and mental component score (MCS). The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). This questionnaire was completed by the participant prior to any procedures being performed at the visit, if possible. The form was then checked by site staff for completeness.
FAS included all participants who were randomized to the study and received at least one dose of the randomized study drug (PF 04171327, prednisone, or placebo). Note, N = number of participants with observations in the below table.
Posted
Mean
Standard Deviation
Units on a scale
Week 12
ID
Title
Description
OG000
PF-04171327 1 mg
Participants received PF-04171327 1 mg Once daily (QD) for 8 weeks. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.
OG001
PF-04171327 5 mg
Participants received PF-04171327 5 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.
Time Frame
13 weeks
Description
All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
PF-04171327 1 mg
Participants received PF-04171327 1 mg Once daily (QD) for 8 weeks. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.
0
45
20
45
EG001
PF-04171327 5 mg
Participants received PF-04171327 5 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.
1
47
18
47
EG002
PF-04171327 10 mg
Participants received PF-04171327 10 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.
2
45
22
45
EG003
PF-04171327 15 mg
Participants received PF-04171327 15 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.
2
48
16
48
EG004
Prednisone 5 mg
Participants received prednisone 5 mg QD for 8 weeks. From week 9 through 10, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every 3 days.
0
45
16
45
EG005
Prednisone 10 mg
Participants received prednisone 10 mg QD for 8 weeks. After 8 weeks of treatment, participants were tapered off prednisone dosage. From week 9 through 10, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every 3 days.
2
46
19
46
EG006
Placebo
Participants received placebo QD until week 12.
2
47
16
47
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Coronary artery disease
Cardiac disorders
MedDRA (v17.0)
Non-systematic Assessment
EG0000 affected45 at risk
EG0010 affected47 at risk
EG0021 affected45 at risk
EG0030 affected48 at risk
EG0040 affected45 at risk
EG0050 affected46 at risk
EG0060 affected47 at risk
Chest pain
General disorders
MedDRA (v17.0)
Non-systematic Assessment
EG0000 affected45 at risk
EG0010 affected47 at risk
EG0020 affected45 at risk
EG003
Bronchitis
Infections and infestations
MedDRA (v17.0)
Non-systematic Assessment
EG0000 affected45 at risk
EG0010 affected47 at risk
EG0020 affected45 at risk
EG003
Cholecystitis infective
Infections and infestations
MedDRA (v17.0)
Non-systematic Assessment
EG0000 affected45 at risk
EG0010 affected47 at risk
EG0020 affected45 at risk
EG003
Spinal compression fracture
Injury, poisoning and procedural complications
MedDRA (v17.0)
Non-systematic Assessment
EG0000 affected45 at risk
EG0010 affected47 at risk
EG0021 affected45 at risk
EG003
Intervertebral disc protrusion
Musculoskeletal and connective tissue disorders
MedDRA (v17.0)
Non-systematic Assessment
EG0000 affected45 at risk
EG0010 affected47 at risk
EG0020 affected45 at risk
EG003
Rheumatoid arthritis
Musculoskeletal and connective tissue disorders
MedDRA (v17.0)
Non-systematic Assessment
EG0000 affected45 at risk
EG0010 affected47 at risk
EG0020 affected45 at risk
EG003
Glioblastoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (v17.0)
Non-systematic Assessment
EG0000 affected45 at risk
EG0011 affected47 at risk
EG0020 affected45 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA (v17.0)
Non-systematic Assessment
EG0000 affected45 at risk
EG0010 affected47 at risk
EG0020 affected45 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA (v17.0)
Non-systematic Assessment
EG0000 affected45 at risk
EG0010 affected47 at risk
EG0020 affected45 at risk
EG0030 affected48 at risk
EG0041 affected45 at risk
EG0050 affected46 at risk
EG0060 affected47 at risk
Eosinophilia
Blood and lymphatic system disorders
MedDRA (v17.0)
Non-systematic Assessment
EG0001 affected45 at risk
EG0010 affected47 at risk
EG0020 affected45 at risk
EG003
Monocytosis
Blood and lymphatic system disorders
MedDRA (v17.0)
Non-systematic Assessment
EG0000 affected45 at risk
EG0010 affected47 at risk
EG0020 affected45 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA (v17.0)
Non-systematic Assessment
EG0001 affected45 at risk
EG0010 affected47 at risk
EG0020 affected45 at risk
EG003
Bradycardia
Cardiac disorders
MedDRA (v17.0)
Non-systematic Assessment
EG0000 affected45 at risk
EG0011 affected47 at risk
EG0020 affected45 at risk
EG003
Extrasystoles
Cardiac disorders
MedDRA (v17.0)
Non-systematic Assessment
EG0000 affected45 at risk
EG0010 affected47 at risk
EG0020 affected45 at risk
EG003
Sinus bradycardia
Cardiac disorders
MedDRA (v17.0)
Non-systematic Assessment
EG0000 affected45 at risk
EG0010 affected47 at risk
EG0020 affected45 at risk
EG003
Sinus tachycardia
Cardiac disorders
MedDRA (v17.0)
Non-systematic Assessment
EG0000 affected45 at risk
EG0010 affected47 at risk
EG0020 affected45 at risk
EG003
Adrenal insufficiency
Endocrine disorders
MedDRA (v17.0)
Non-systematic Assessment
EG0000 affected45 at risk
EG0010 affected47 at risk
EG0020 affected45 at risk
EG003
Goitre
Endocrine disorders
MedDRA (v17.0)
Non-systematic Assessment
EG0000 affected45 at risk
EG0011 affected47 at risk
EG0020 affected45 at risk
EG003
Astigmatism
Eye disorders
MedDRA (v17.0)
Non-systematic Assessment
EG0000 affected45 at risk
EG0010 affected47 at risk
EG0021 affected45 at risk
EG003
Cataract
Eye disorders
MedDRA (v17.0)
Non-systematic Assessment
EG0000 affected45 at risk
EG0010 affected47 at risk
EG0021 affected45 at risk
EG003
Dry eye
Eye disorders
MedDRA (v17.0)
Non-systematic Assessment
EG0000 affected45 at risk
EG0010 affected47 at risk
EG0021 affected45 at risk
EG003
Presbyopia
Eye disorders
MedDRA (v17.0)
Non-systematic Assessment
EG0000 affected45 at risk
EG0010 affected47 at risk
EG0021 affected45 at risk
EG003
Visual impairment
Eye disorders
MedDRA (v17.0)
Non-systematic Assessment
EG0001 affected45 at risk
EG0010 affected47 at risk
EG0020 affected45 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA (v17.0)
Non-systematic Assessment
EG0000 affected45 at risk
EG0010 affected47 at risk
EG0020 affected45 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA (v17.0)
Non-systematic Assessment
EG0000 affected45 at risk
EG0010 affected47 at risk
EG0022 affected45 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA (v17.0)
Non-systematic Assessment
EG0001 affected45 at risk
EG0010 affected47 at risk
EG0020 affected45 at risk
EG003
Aphthous stomatitis
Gastrointestinal disorders
MedDRA (v17.0)
Non-systematic Assessment
EG0000 affected45 at risk
EG0011 affected47 at risk
EG0020 affected45 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA (v17.0)
Non-systematic Assessment
EG0001 affected45 at risk
EG0010 affected47 at risk
EG0020 affected45 at risk
EG003
Food poisoning
Gastrointestinal disorders
MedDRA (v17.0)
Non-systematic Assessment
EG0000 affected45 at risk
EG0010 affected47 at risk
EG0020 affected45 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA (v17.0)
Non-systematic Assessment
EG0000 affected45 at risk
EG0011 affected47 at risk
EG0020 affected45 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA (v17.0)
Non-systematic Assessment
EG0000 affected45 at risk
EG0011 affected47 at risk
EG0020 affected45 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA (v17.0)
Non-systematic Assessment
EG0000 affected45 at risk
EG0010 affected47 at risk
EG0020 affected45 at risk
EG003
Oral discomfort
Gastrointestinal disorders
MedDRA (v17.0)
Non-systematic Assessment
EG0000 affected45 at risk
EG0010 affected47 at risk
EG0021 affected45 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA (v17.0)
Non-systematic Assessment
EG0000 affected45 at risk
EG0010 affected47 at risk
EG0020 affected45 at risk
EG003
Chest pain
General disorders
MedDRA (v17.0)
Non-systematic Assessment
EG0000 affected45 at risk
EG0010 affected47 at risk
EG0020 affected45 at risk
EG003
Chills
General disorders
MedDRA (v17.0)
Non-systematic Assessment
EG0001 affected45 at risk
EG0010 affected47 at risk
EG0021 affected45 at risk
EG003
Drug ineffective
General disorders
MedDRA (v17.0)
Non-systematic Assessment
EG0001 affected45 at risk
EG0011 affected47 at risk
EG0020 affected45 at risk
EG003
Face oedema
General disorders
MedDRA (v17.0)
Non-systematic Assessment
EG0001 affected45 at risk
EG0010 affected47 at risk
EG0020 affected45 at risk
EG003
Fatigue
General disorders
MedDRA (v17.0)
Non-systematic Assessment
EG0001 affected45 at risk
EG0010 affected47 at risk
EG0020 affected45 at risk
EG003
Feeling hot
General disorders
MedDRA (v17.0)
Non-systematic Assessment
EG0000 affected45 at risk
EG0010 affected47 at risk
EG0021 affected45 at risk
EG003
Local swelling
General disorders
MedDRA (v17.0)
Non-systematic Assessment
EG0000 affected45 at risk
EG0010 affected47 at risk
EG0020 affected45 at risk
EG003
Pyrexia
General disorders
MedDRA (v17.0)
Non-systematic Assessment
EG0000 affected45 at risk
EG0010 affected47 at risk
EG0021 affected45 at risk
EG003
Hepatic steatosis
Hepatobiliary disorders
MedDRA (v17.0)
Non-systematic Assessment
EG0000 affected45 at risk
EG0010 affected47 at risk
EG0021 affected45 at risk
EG003
Abscess bacterial
Infections and infestations
MedDRA (v17.0)
Non-systematic Assessment
EG0000 affected45 at risk
EG0010 affected47 at risk
EG0020 affected45 at risk
EG003
Bronchitis
Infections and infestations
MedDRA (v17.0)
Non-systematic Assessment
EG0000 affected45 at risk
EG0011 affected47 at risk
EG0021 affected45 at risk
EG003
Candida infection
Infections and infestations
MedDRA (v17.0)
Non-systematic Assessment
EG0000 affected45 at risk
EG0010 affected47 at risk
EG0020 affected45 at risk
EG003
Cystitis
Infections and infestations
MedDRA (v17.0)
Non-systematic Assessment
EG0000 affected45 at risk
EG0010 affected47 at risk
EG0020 affected45 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA (v17.0)
Non-systematic Assessment
EG0000 affected45 at risk
EG0010 affected47 at risk
EG0020 affected45 at risk
EG003
Gingivitis
Infections and infestations
MedDRA (v17.0)
Non-systematic Assessment
EG0000 affected45 at risk
EG0011 affected47 at risk
EG0020 affected45 at risk
EG003
Herpes virus infection
Infections and infestations
MedDRA (v17.0)
Non-systematic Assessment
EG0000 affected45 at risk
EG0010 affected47 at risk
EG0020 affected45 at risk
EG003
Influenza
Infections and infestations
MedDRA (v17.0)
Non-systematic Assessment
EG0000 affected45 at risk
EG0010 affected47 at risk
EG0020 affected45 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA (v17.0)
Non-systematic Assessment
EG0001 affected45 at risk
EG0013 affected47 at risk
EG0023 affected45 at risk
EG003
Oral herpes
Infections and infestations
MedDRA (v17.0)
Non-systematic Assessment
EG0000 affected45 at risk
EG0011 affected47 at risk
EG0020 affected45 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA (v17.0)
Non-systematic Assessment
EG0001 affected45 at risk
EG0010 affected47 at risk
EG0020 affected45 at risk
EG003
Pharyngitis bacterial
Infections and infestations
MedDRA (v17.0)
Non-systematic Assessment
EG0001 affected45 at risk
EG0010 affected47 at risk
EG0021 affected45 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA (v17.0)
Non-systematic Assessment
EG0000 affected45 at risk
EG0010 affected47 at risk
EG0021 affected45 at risk
EG003
Respiratory tract infection viral
Infections and infestations
MedDRA (v17.0)
Non-systematic Assessment
EG0000 affected45 at risk
EG0011 affected47 at risk
EG0020 affected45 at risk
EG003
Rhinitis
Infections and infestations
MedDRA (v17.0)
Non-systematic Assessment
EG0001 affected45 at risk
EG0010 affected47 at risk
EG0020 affected45 at risk
EG003
Sinusitis
Infections and infestations
MedDRA (v17.0)
Non-systematic Assessment
EG0000 affected45 at risk
EG0010 affected47 at risk
EG0020 affected45 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA (v17.0)
Non-systematic Assessment
EG0001 affected45 at risk
EG0010 affected47 at risk
EG0023 affected45 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA (v17.0)
Non-systematic Assessment
EG0000 affected45 at risk
EG0010 affected47 at risk
EG0021 affected45 at risk
EG003
Viral infection
Infections and infestations
MedDRA (v17.0)
Non-systematic Assessment
EG0001 affected45 at risk
EG0010 affected47 at risk
EG0020 affected45 at risk
EG003
Viral rhinitis
Infections and infestations
MedDRA (v17.0)
Non-systematic Assessment
EG0000 affected45 at risk
EG0010 affected47 at risk
EG0020 affected45 at risk
EG003
Viral upper respiratory tract infection
Infections and infestations
MedDRA (v17.0)
Non-systematic Assessment
EG0000 affected45 at risk
EG0011 affected47 at risk
EG0021 affected45 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA (v17.0)
Non-systematic Assessment
EG0000 affected45 at risk
EG0010 affected47 at risk
EG0020 affected45 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA (v17.0)
Non-systematic Assessment
EG0000 affected45 at risk
EG0010 affected47 at risk
EG0020 affected45 at risk
EG003
Ligament sprain
Injury, poisoning and procedural complications
MedDRA (v17.0)
Non-systematic Assessment
EG0001 affected45 at risk
EG0010 affected47 at risk
EG0020 affected45 at risk
EG003
Soft tissue injury
Injury, poisoning and procedural complications
MedDRA (v17.0)
Non-systematic Assessment
EG0000 affected45 at risk
EG0010 affected47 at risk
EG0020 affected45 at risk
EG003
Spinal compression fracture
Injury, poisoning and procedural complications
MedDRA (v17.0)
Non-systematic Assessment
EG0000 affected45 at risk
EG0011 affected47 at risk
EG0020 affected45 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA (v17.0)
Non-systematic Assessment
EG0002 affected45 at risk
EG0011 affected47 at risk
EG0024 affected45 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA (v17.0)
Non-systematic Assessment
EG0001 affected45 at risk
EG0011 affected47 at risk
EG0021 affected45 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA (v17.0)
Non-systematic Assessment
EG0000 affected45 at risk
EG0010 affected47 at risk
EG0020 affected45 at risk
EG003
Blood creatine phosphokinase increased
Investigations
MedDRA (v17.0)
Non-systematic Assessment
EG0000 affected45 at risk
EG0010 affected47 at risk
EG0021 affected45 at risk
EG003
Blood creatinine decreased
Investigations
MedDRA (v17.0)
Non-systematic Assessment
EG0000 affected45 at risk
EG0010 affected47 at risk
EG0021 affected45 at risk
EG003
Blood pressure increased
Investigations
MedDRA (v17.0)
Non-systematic Assessment
EG0000 affected45 at risk
EG0010 affected47 at risk
EG0021 affected45 at risk
EG003
Body temperature increased
Investigations
MedDRA (v17.0)
Non-systematic Assessment
EG0000 affected45 at risk
EG0010 affected47 at risk
EG0020 affected45 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA (v17.0)
Non-systematic Assessment
EG0000 affected45 at risk
EG0010 affected47 at risk
EG0021 affected45 at risk
EG003
Weight increased
Investigations
MedDRA (v17.0)
Non-systematic Assessment
EG0000 affected45 at risk
EG0010 affected47 at risk
EG0020 affected45 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA (v17.0)
Non-systematic Assessment
EG0000 affected45 at risk
EG0010 affected47 at risk
EG0020 affected45 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA (v17.0)
Non-systematic Assessment
EG0000 affected45 at risk
EG0010 affected47 at risk
EG0020 affected45 at risk
EG003
Dyslipidaemia
Metabolism and nutrition disorders
MedDRA (v17.0)
Non-systematic Assessment
EG0000 affected45 at risk
EG0010 affected47 at risk
EG0020 affected45 at risk
EG003
Hypercholesterolaemia
Metabolism and nutrition disorders
MedDRA (v17.0)
Non-systematic Assessment
EG0000 affected45 at risk
EG0010 affected47 at risk
EG0021 affected45 at risk
EG003
Hyperuricaemia
Metabolism and nutrition disorders
MedDRA (v17.0)
Non-systematic Assessment
EG0001 affected45 at risk
EG0010 affected47 at risk
EG0020 affected45 at risk
EG003
Polydipsia
Metabolism and nutrition disorders
MedDRA (v17.0)
Non-systematic Assessment
EG0000 affected45 at risk
EG0010 affected47 at risk
EG0021 affected45 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA (v17.0)
Non-systematic Assessment
EG0001 affected45 at risk
EG0011 affected47 at risk
EG0021 affected45 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA (v17.0)
Non-systematic Assessment
EG0001 affected45 at risk
EG0010 affected47 at risk
EG0023 affected45 at risk
EG003
Arthropathy
Musculoskeletal and connective tissue disorders
MedDRA (v17.0)
Non-systematic Assessment
EG0000 affected45 at risk
EG0010 affected47 at risk
EG0020 affected45 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA (v17.0)
Non-systematic Assessment
EG0000 affected45 at risk
EG0010 affected47 at risk
EG0020 affected45 at risk
EG003
Joint swelling
Musculoskeletal and connective tissue disorders
MedDRA (v17.0)
Non-systematic Assessment
EG0000 affected45 at risk
EG0010 affected47 at risk
EG0020 affected45 at risk
EG003
Muscle contracture
Musculoskeletal and connective tissue disorders
MedDRA (v17.0)
Non-systematic Assessment
EG0000 affected45 at risk
EG0011 affected47 at risk
EG0020 affected45 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA (v17.0)
Non-systematic Assessment
EG0000 affected45 at risk
EG0010 affected47 at risk
EG0022 affected45 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA (v17.0)
Non-systematic Assessment
EG0000 affected45 at risk
EG0011 affected47 at risk
EG0020 affected45 at risk
EG003
Pathological fracture
Musculoskeletal and connective tissue disorders
MedDRA (v17.0)
Non-systematic Assessment
EG0000 affected45 at risk
EG0011 affected47 at risk
EG0020 affected45 at risk
EG003
Rheumatoid arthritis
Musculoskeletal and connective tissue disorders
MedDRA (v17.0)
Non-systematic Assessment
EG0001 affected45 at risk
EG0010 affected47 at risk
EG0020 affected45 at risk
EG003
Rheumatoid nodule
Musculoskeletal and connective tissue disorders
MedDRA (v17.0)
Non-systematic Assessment
EG0000 affected45 at risk
EG0011 affected47 at risk
EG0020 affected45 at risk
EG003
Synovial cyst
Musculoskeletal and connective tissue disorders
MedDRA (v17.0)
Non-systematic Assessment
EG0000 affected45 at risk
EG0010 affected47 at risk
EG0020 affected45 at risk
EG003
Tendonitis
Musculoskeletal and connective tissue disorders
MedDRA (v17.0)
Non-systematic Assessment
EG0000 affected45 at risk
EG0010 affected47 at risk
EG0021 affected45 at risk
EG003
Dizziness
Nervous system disorders
MedDRA (v17.0)
Non-systematic Assessment
EG0000 affected45 at risk
EG0010 affected47 at risk
EG0020 affected45 at risk
EG003
Headache
Nervous system disorders
MedDRA (v17.0)
Non-systematic Assessment
EG0001 affected45 at risk
EG0010 affected47 at risk
EG0020 affected45 at risk
EG003
Migraine
Nervous system disorders
MedDRA (v17.0)
Non-systematic Assessment
EG0001 affected45 at risk
EG0010 affected47 at risk
EG0020 affected45 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA (v17.0)
Non-systematic Assessment
EG0000 affected45 at risk
EG0010 affected47 at risk
EG0020 affected45 at risk
EG003
Presyncope
Nervous system disorders
MedDRA (v17.0)
Non-systematic Assessment
EG0000 affected45 at risk
EG0010 affected47 at risk
EG0021 affected45 at risk
EG003
Sciatica
Nervous system disorders
MedDRA (v17.0)
Non-systematic Assessment
EG0000 affected45 at risk
EG0010 affected47 at risk
EG0020 affected45 at risk
EG003
Tremor
Nervous system disorders
MedDRA (v17.0)
Non-systematic Assessment
EG0000 affected45 at risk
EG0010 affected47 at risk
EG0020 affected45 at risk
EG003
Depression
Psychiatric disorders
MedDRA (v17.0)
Non-systematic Assessment
EG0000 affected45 at risk
EG0011 affected47 at risk
EG0020 affected45 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA (v17.0)
Non-systematic Assessment
EG0000 affected45 at risk
EG0010 affected47 at risk
EG0020 affected45 at risk
EG003
Sleep disorder
Psychiatric disorders
MedDRA (v17.0)
Non-systematic Assessment
EG0000 affected45 at risk
EG0011 affected47 at risk
EG0020 affected45 at risk
EG003
Microalbuminuria
Renal and urinary disorders
MedDRA (v17.0)
Non-systematic Assessment
EG0000 affected45 at risk
EG0010 affected47 at risk
EG0020 affected45 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA (v17.0)
Non-systematic Assessment
EG0000 affected45 at risk
EG0010 affected47 at risk
EG0021 affected45 at risk
EG003
Nocturia
Renal and urinary disorders
MedDRA (v17.0)
Non-systematic Assessment
EG0000 affected45 at risk
EG0010 affected47 at risk
EG0021 affected45 at risk
EG003
Polymenorrhoea
Reproductive system and breast disorders
MedDRA (v17.0)
Non-systematic Assessment
EG0000 affected45 at risk
EG0010 affected47 at risk
EG0020 affected45 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA (v17.0)
Non-systematic Assessment
EG0000 affected45 at risk
EG0010 affected47 at risk
EG0021 affected45 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA (v17.0)
Non-systematic Assessment
EG0000 affected45 at risk
EG0010 affected47 at risk
EG0020 affected45 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA (v17.0)
Non-systematic Assessment
EG0001 affected45 at risk
EG0010 affected47 at risk
EG0020 affected45 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA (v17.0)
Non-systematic Assessment
EG0000 affected45 at risk
EG0010 affected47 at risk
EG0020 affected45 at risk
EG003
Respiratory disorder
Respiratory, thoracic and mediastinal disorders
MedDRA (v17.0)
Non-systematic Assessment
EG0000 affected45 at risk
EG0010 affected47 at risk
EG0020 affected45 at risk
EG003
Dermal cyst
Skin and subcutaneous tissue disorders
MedDRA (v17.0)
Non-systematic Assessment
EG0000 affected45 at risk
EG0010 affected47 at risk
EG0020 affected45 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA (v17.0)
Non-systematic Assessment
EG0000 affected45 at risk
EG0011 affected47 at risk
EG0020 affected45 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA (v17.0)
Non-systematic Assessment
EG0000 affected45 at risk
EG0010 affected47 at risk
EG0021 affected45 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA (v17.0)
Non-systematic Assessment
EG0000 affected45 at risk
EG0010 affected47 at risk
EG0020 affected45 at risk
EG003
Knee operation
Surgical and medical procedures
MedDRA (v17.0)
Non-systematic Assessment
EG0001 affected45 at risk
EG0010 affected47 at risk
EG0020 affected45 at risk
EG003
Tooth extraction
Surgical and medical procedures
MedDRA (v17.0)
Non-systematic Assessment
EG0000 affected45 at risk
EG0010 affected47 at risk
EG0020 affected45 at risk
EG003
Flushing
Vascular disorders
MedDRA (v17.0)
Non-systematic Assessment
EG0000 affected45 at risk
EG0010 affected47 at risk
EG0020 affected45 at risk
EG003
Hot flush
Vascular disorders
MedDRA (v17.0)
Non-systematic Assessment
EG0000 affected45 at risk
EG0010 affected47 at risk
EG0020 affected45 at risk
EG003
Hypertension
Vascular disorders
MedDRA (v17.0)
Non-systematic Assessment
EG0000 affected45 at risk
EG0013 affected47 at risk
EG0020 affected45 at risk
EG003
Hypotension
Vascular disorders
MedDRA (v17.0)
Non-systematic Assessment
EG0000 affected45 at risk
EG0011 affected47 at risk
EG0021 affected45 at risk
EG003
Varicose vein
Vascular disorders
MedDRA (v17.0)
Non-systematic Assessment
EG0000 affected45 at risk
EG0010 affected47 at risk
EG0020 affected45 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Point of Contact
Title
Organization
Phone
Extension
Email
Pfizer ClinicalTrials.gov Call Center
Pfizer, Inc.
1-800-718-1021
ClinicalTrials.gov_Inquiries@pfizer.com
ID
Term
D001172
Arthritis, Rheumatoid
Ancestor Terms
ID
Term
D001168
Arthritis
D007592
Joint Diseases
D009140
Musculoskeletal Diseases
D012216
Rheumatic Diseases
D003240
Connective Tissue Diseases
D017437
Skin and Connective Tissue Diseases
D001327
Autoimmune Diseases
D007154
Immune System Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C000615597
fosdagrocorat
D011241
Prednisone
Ancestor Terms
ID
Term
D011244
Pregnadienediols
D011245
Pregnadienes
D011278
Pregnanes
D013256
Steroids
D000072473
Fused-Ring Compounds
D011083
Polycyclic Compounds
Browse Leaves
Not provided
Browse Branches
Not provided
1 subjects
FG0050 subjects
FG0061 subjects
0 subjects
FG0050 subjects
FG0061 subjects
0 subjects
FG0050 subjects
FG0061 subjects
0 subjects
FG0050 subjects
FG0061 subjects
0 subjects
FG0050 subjects
FG0061 subjects
0 subjects
FG0052 subjects
FG0063 subjects
54.0
± 11.1
BG00452.9± 11.2
BG00557.3± 10.7
BG00655.2± 13.2
BG00754.3± 12.3
34
BG00337
BG00439
BG00541
BG00637
BG007259
Male
BG00012
BG0019
BG00211
BG00311
BG0046
BG0055
BG00610
BG00764
48
OG00445
OG00546
OG00647
73
OG00451
OG00571
OG00637
OG001
OG006
Bayesian 4 Parameter Emax Model Based Estimates are provided.
Mean Difference (Final Values)
24
2-Sided
60
18
31
Superiority criterion versus placebo: Lower bound of 60% credible interval >20%. Non-responder imputation was used to handle dropouts at Week 8.
Superiority or Other (legacy)
OG002
OG006
Bayesian 4 Parameter Emax Model Based Estimates are provided.
Mean Difference (Final Values)
32
2-Sided
60
25
39
Superiority criterion versus placebo: Lower bound of 60% credible interval >20%. Non-responder imputation was used to handle dropouts at Week 8.
Superiority or Other (legacy)
OG003
OG006
Bayesian 4 Parameter Emax Model Based Estimates are provided.
Mean Difference (Final Values)
36
2-Sided
60
29
43
Superiority criterion versus placebo: Lower bound of 60% credible interval >20%. Non-responder imputation was used to handle dropouts at Week 8.
Superiority or Other (legacy)
OG004
OG006
Bayesian 4 Parameter Emax Model Based Estimates are provided.
Mean Difference (Final Values)
14
2-Sided
60
6
22
Superiority criterion versus placebo: Lower bound of 60% credible interval >20%. Non-responder imputation was used to handle dropouts at Week 8.
Superiority or Other (legacy)
OG005
OG006
Bayesian 4 Parameter Emax Model Based Estimates are provided.
Mean Difference (Final Values)
34
2-Sided
60
27
42
Superiority criterion versus placebo: Lower bound of 60% credible interval >20%. Non-responder imputation was used to handle dropouts at Week 8.
Superiority or Other (legacy)
OG000
OG005
Bayesian 4 Parameter Emax Model Based Estimates are provided.
Mean Difference (Final Values)
-24
2-Sided
60
-32
-17
Non inferiority criterion versus prednisone 10 mg: Lower bound of 60% credible interval >-5%. Non-responder imputation was used to handle dropouts at Week 8.
Superiority or Other (legacy)
OG001
OG005
Bayesian 4 Parameter Emax Model Based Estimates are provided.
Mean Difference (Final Values)
-10
2-Sided
60
-16
-4
Non inferiority criterion versus prednisone 10 mg: Lower bound of 60% credible interval >-5%. Non-responder imputation was used to handle dropouts at Week 8.
Superiority or Other (legacy)
OG002
OG005
Bayesian 4 Parameter Emax Model Based Estimates are provided.
Mean Difference (Final Values)
-2
2-Sided
60
-9
4
Non inferiority criterion versus prednisone 10 mg: Lower bound of 60% credible interval >-5%. Non-responder imputation was used to handle dropouts at Week 8.
Superiority or Other (legacy)
OG003
OG005
Bayesian 4 Parameter Emax Model Based Estimates are provided.
Mean Difference (Final Values)
1
2-Sided
60
-5
8
Non inferiority criterion versus prednisone 10 mg: Lower bound of 60% credible interval >-5%. Non-responder imputation was used to handle dropouts at Week 8.
Superiority or Other (legacy)
OG003
PF-04171327 15 mg
Participants received PF-04171327 15 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.
OG004
Prednisone 5 mg
Participants received prednisone 5 mg QD for 8 weeks. From week 9 through 10, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every 3 days.
OG005
Prednisone 10 mg
Participants received prednisone 10 mg QD for 8 weeks. After 8 weeks of treatment, participants were tapered off prednisone dosage. From week 9 through 10, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every 3 days.
OG006
Placebo
Participants received placebo QD until week 12.
Units
Counts
Participants
OG00044
OG00142
OG00244
OG00343
OG00443
OG00544
OG00641
Title
Denominators
Categories
Title
Measurements
OG000-3.25± 5.50
OG001-11.60± 5.55
OG002-9.96± 5.49
OG003-16.63± 5.55
OG004-4.89± 5.55
OG005-20.14± 5.50
OG00614.19± 5.56
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG004
Mean Difference (Final Values)
1.64
2-Sided
95
-13.75
17.03
Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used.
Superiority or Other (legacy)
OG001
OG004
Mean Difference (Final Values)
-6.71
2-Sided
90
-22.16
8.75
Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used.
Superiority or Other (legacy)
OG002
OG004
Mean Difference (Final Values)
-5.07
2-Sided
90
-20.45
10.30
Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used.
Superiority or Other (legacy)
OG003
OG004
Mean Difference (Final Values)
-11.74
2-Sided
90
-27.19
3.72
Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used.
Superiority or Other (legacy)
Participants received PF-04171327 10 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.
OG003
PF-04171327 15 mg
Participants received PF-04171327 15 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.
OG004
Prednisone 5 mg
Participants received prednisone 5 mg QD for 8 weeks. From week 9 through 10, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every 3 days.
OG005
Prednisone 10 mg
Participants received prednisone 10 mg QD for 8 weeks. After 8 weeks of treatment, participants were tapered off prednisone dosage. From week 9 through 10, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every 3 days.
OG006
Placebo
Participants received placebo QD until week 12.
Units
Counts
Participants
OG00043
OG00142
OG00243
OG00343
OG00443
OG00543
OG00642
Title
Denominators
Categories
Title
Measurements
OG0006.08± 5.83
OG001-3.78± 5.88
OG0026.96± 5.86
OG00315.57± 5.83
OG0042.74± 5.87
OG005-9.14± 5.83
OG0063.81± 5.88
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG004
Mean Difference (Final Values)
3.34
2-Sided
95
-12.92
19.61
Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used.
Superiority or Other (legacy)
OG001
OG004
Mean Difference (Final Values)
-6.52
2-Sided
90
-22.86
9.81
Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used.
Superiority or Other (legacy)
OG002
OG004
Mean Difference (Final Values)
4.22
2-Sided
90
-12.11
20.55
Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used.
Superiority or Other (legacy)
OG003
OG004
Mean Difference (Final Values)
12.83
2-Sided
90
-3.49
29.15
Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used.
Superiority or Other (legacy)
OG002
PF-04171327 10 mg
Participants received PF-04171327 10 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.
OG003
PF-04171327 15 mg
Participants received PF-04171327 15 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.
OG004
Prednisone 5 mg
Participants received prednisone 5 mg QD for 8 weeks. From week 9 through 10, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every 3 days.
OG005
Prednisone 10 mg
Participants received prednisone 10 mg QD for 8 weeks. After 8 weeks of treatment, participants were tapered off prednisone dosage. From week 9 through 10, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every 3 days.
OG006
Placebo
Participants received placebo QD until week 12.
Units
Counts
Participants
OG00045
OG00147
OG00245
OG00348
OG00445
OG00546
OG00647
Title
Denominators
Categories
Week 2
ParticipantsOG00044
ParticipantsOG00146
ParticipantsOG00245
ParticipantsOG00347
ParticipantsOG00445
ParticipantsOG00546
ParticipantsOG00644
Title
Measurements
OG00031.82± 7.02
OG00132.61± 6.91
OG00240.00± 7.30
OG003
Week 4
ParticipantsOG00045
ParticipantsOG00147
ParticipantsOG00245
ParticipantsOG00347
Week 12
ParticipantsOG00045
ParticipantsOG00147
ParticipantsOG00245
ParticipantsOG00347
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG006
Week 2 analysis presented in this section for comparison to placebo.
Difference in percentage
11.36
2-Sided
95
-6.84
29.56
Non-responder imputation was used to handle dropouts.
Superiority or Other (legacy)
OG001
OG006
Week 2 analysis presented in this section for comparison to placebo.
Difference in percentage
12.15
2-Sided
95
-5.88
30.19
Non-responder imputation was used to handle dropouts.
Superiority or Other (legacy)
OG002
OG006
Week 2 analysis presented in this section for comparison to placebo.
Difference in percentage
19.54
2-Sided
95
0.91
38.17
Non-responder imputation was used to handle dropouts.
Superiority or Other (legacy)
OG003
OG006
Week 2 analysis presented in this section for comparison to placebo.
Difference in percentage
22.09
2-Sided
95
3.60
40.58
Non-responder imputation was used to handle dropouts.
Superiority or Other (legacy)
OG004
OG006
Week 2 analysis presented in this section for comparison to placebo.
Difference in percentage
8.43
2-Sided
95
-9.38
26.25
Non-responder imputation was used to handle dropouts.
Superiority or Other (legacy)
OG005
OG006
Week 2 analysis presented in this section for comparison to placebo.
Difference in percentage
16.50
2-Sided
95
-1.84
34.84
Non-responder imputation was used to handle dropouts.
Superiority or Other (legacy)
OG000
OG006
Week 4 analysis presented in this section for comparison to placebo.
Difference in percentage
-8.88
2-Sided
95
-28.58
10.80
Non-responder imputation was used to handle dropouts.
Superiority or Other (legacy)
OG001
OG006
Week 4 analysis presented in this section for comparison to placebo.
Difference in percentage
15.31
2-Sided
95
-4.85
35.49
Non-responder imputation was used to handle dropouts.
Superiority or Other (legacy)
OG002
OG006
Week 4 analysis presented in this section for comparison to placebo.
Difference in percentage
26.66
2-Sided
95
6.80
46.53
Non-responder imputation was used to handle dropouts.
Superiority or Other (legacy)
OG003
OG006
Week 4 analysis presented in this section for comparison to placebo.
Difference in percentage
13.19
2-Sided
95
-7.01
33.40
Non-responder imputation was used to handle dropouts.
Superiority or Other (legacy)
OG004
OG006
Week 4 analysis presented in this section for comparison to placebo.
Difference in percentage
8.88
2-Sided
95
-11.56
29.33
Non-responder imputation was used to handle dropouts.
Superiority or Other (legacy)
OG005
OG006
Week 4 comparisons presented in this section for comparison to placebo.
Difference in percentage
25.21
2-Sided
95
5.35
45.07
Non-responder imputation was used to handle dropouts.
Superiority or Other (legacy)
OG000
OG006
Week 12 analysis presented in this section for comparison to placebo.
Difference in percentage
2.22
2-Sided
95
-17.40
21.85
Non-responder imputation was used to handle dropouts.
Superiority or Other (legacy)
OG001
OG006
Week 12 analysis presented in this section for comparison to placebo.
Difference in percentage
15.60
2-Sided
95
-4.24
35.45
Non-responder imputation was used to handle dropouts.
Superiority or Other (legacy)
OG002
OG006
Week 12 analysis presented in this section for comparison to placebo.
Difference in percentage
22.22
2-Sided
95
2.20
42.23
Non-responder imputation was used to handle dropouts.
Superiority or Other (legacy)
OG003
OG006
Week 12 analysis presented in this section for comparison to placebo.
Difference in percentage
4.96
2-Sided
95
-14.60
24.53
Non-responder imputation was used to handle dropouts.
Superiority or Other (legacy)
OG004
OG006
Week 12 analysis presented in this section for comparison to placebo.
Difference in percentage
15.55
2-Sided
95
-4.51
35.63
Non-responder imputation was used to handle dropouts.
Superiority or Other (legacy)
OG005
OG006
Week 12 analysis presented in this section for comparison to placebo.
Difference in percentage
23.18
2-Sided
95
3.31
43.06
Non-responder imputation was used to handle dropouts.
Superiority or Other (legacy)
OG000
OG005
Week 2 analysis presented in this section for comparison to prednisone 10 mg.
Difference in percentage
-5.13
2-Sided
95
-24.73
14.45
Non-responder imputation was used to handle dropouts.
Superiority or Other (legacy)
OG001
OG005
Week 2 analysis presented in this section for comparison to prednisone 10 mg.
Difference in percentage
-4.34
2-Sided
95
-23.79
15.09
Non-responder imputation was used to handle dropouts.
Superiority or Other (legacy)
OG002
OG005
Week 2 analysis presented in this section for comparison to prednisone 10 mg.
Difference in percentage
3.04
2-Sided
95
-16.94
23.02
Non-responder imputation was used to handle dropouts.
Superiority or Other (legacy)
OG003
OG005
Week 2 analysis presented in this section for comparison to prednisone 10 mg.
Difference in percentage
5.59
2-Sided
95
-14.26
25.45
Non-responder imputation was used to handle dropouts.
Superiority or Other (legacy)
OG000
OG005
Week 4 analysis presented in this section for comparison to prednisone 10 mg.
Difference in percentage
-34.10
2-Sided
95
-53.40
-14.80
Non-responder imputation was used to handle dropouts.
Superiority or Other (legacy)
OG001
OG005
Week 4 analysis presented in this section for comparison to prednisone 10 mg.
Difference in percentage
-9.89
2-Sided
95
-29.68
9.88
Non-responder imputation was used to handle dropouts.
Superiority or Other (legacy)
OG002
OG005
Week 4 analysis presented in this section for comparison to prednisone 10 mg.
Difference in percentage
1.44
2-Sided
95
-18.02
20.92
Non-responder imputation was used to handle dropouts.
Superiority or Other (legacy)
OG003
OG005
Week 4 analysis presented in this section for comparison to prednisone 10 mg.
Difference in percentage
-12.02
2-Sided
95
-31.84
7.79
Non-responder imputation was used to handle dropouts.
Superiority or Other (legacy)
OG000
OG005
Week 12 analysis presented in this section for comparison to prednisone 10 mg.
Difference in percentage
-20.96
2-Sided
95
-40.98
-0.94
Non-responder imputation was used to handle dropouts.
Superiority or Other (legacy)
OG001
OG005
Week 12 analysis presented in this section for comparison to prednisone 10 mg.
Difference in percentage
-7.58
2-Sided
95
-27.82
12.65
Non-responder imputation was used to handle dropouts.
Superiority or Other (legacy)
OG002
OG005
Week 12 analysis presented in this section for comparison to prednisone 10 mg.
Difference in percentage
-0.96
2-Sided
95
-21.36
19.43
Non-responder imputation was used to handle dropouts.
Superiority or Other (legacy)
OG003
OG005
Week 12 analysis presented in this section for comparison to prednisone 10 mg.
Difference in percentage
-18.22
2-Sided
95
-38.18
1.73
Non-responder imputation was used to handle dropouts.
Superiority or Other (legacy)
OG002
PF-04171327 10 mg
Participants received PF-04171327 10 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.
OG003
PF-04171327 15 mg
Participants received PF-04171327 15 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.
OG004
Prednisone 5 mg
Participants received prednisone 5 mg QD for 8 weeks. From week 9 through 10, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every 3 days.
OG005
Prednisone 10 mg
Participants received prednisone 10 mg QD for 8 weeks. After 8 weeks of treatment, participants were tapered off prednisone dosage. From week 9 through 10, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every 3 days.
OG006
Placebo
Participants received placebo QD until week 12.
Units
Counts
Participants
OG00045
OG00147
OG00245
OG00348
OG00445
OG00546
OG00647
Title
Denominators
Categories
Week 2
ParticipantsOG00044
ParticipantsOG00146
ParticipantsOG00245
ParticipantsOG00347
ParticipantsOG00445
ParticipantsOG00546
ParticipantsOG00644
Title
Measurements
OG0004.55± 3.14
OG0018.70± 4.15
OG0028.89± 4.24
OG003
Week 4
ParticipantsOG00045
ParticipantsOG00147
ParticipantsOG00245
ParticipantsOG00347
Week 6
ParticipantsOG00045
ParticipantsOG00147
ParticipantsOG00245
ParticipantsOG00347
Week 8
ParticipantsOG00045
ParticipantsOG00147
ParticipantsOG00245
ParticipantsOG00347
Week 12
ParticipantsOG00045
ParticipantsOG00147
ParticipantsOG00245
ParticipantsOG00347
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG006
Week 2 analysis presented in this section for comparison to placebo.
Difference in percentage
-2.27
2-Sided
95
-11.93
7.38
Non-responder imputation was used to handle dropouts.
Superiority or Other (legacy)
OG001
OG006
Week 2 analysis presented in this section for comparison to placebo.
Difference in percentage
1.87
2-Sided
95
-9.15
12.91
Non-responder imputation was used to handle dropouts.
Superiority or Other (legacy)
OG002
OG006
Week 2 analysis presented in this section for comparison to placebo.
Difference in percentage
2.07
2-Sided
95
-9.09
13.23
Non-responder imputation was used to handle dropouts.
Superiority or Other (legacy)
OG003
OG006
Week 2 analysis presented in this section for comparison to placebo.
Difference in percentage
18.71
2-Sided
95
4.19
33.23
Non-responder imputation was used to handle dropouts.
Superiority or Other (legacy)
OG004
OG006
Week 2 analysis presented in this section for comparison to placebo.
Difference in percentage
-4.59
2-Sided
95
-13.19
4.00
Non-responder imputation was used to handle dropouts.
Superiority or Other (legacy)
OG005
OG006
Week 2 analysis presented in this section for comparison to placebo.
Difference in percentage
12.74
2-Sided
95
-0.92
26.41
Non-responder imputation was used to handle dropouts.
Superiority or Other (legacy)
OG000
OG006
Week 4 analysis presented in this section for comparison to placebo.
Difference in percentage
-2.22
2-Sided
95
-14.60
10.16
Non-responder imputation was used to handle dropouts.
Superiority or Other (legacy)
OG001
OG006
Week 4 analysis presented in this section for comparison to placebo.
Difference in percentage
12.29
2-Sided
95
-2.90
27.48
Non-responder imputation was used to handle dropouts.
Superiority or Other (legacy)
OG002
OG006
Week 4 analysis presented in this section for comparison to placebo.
Difference in percentage
24.44
2-Sided
95
7.71
41.17
Non-responder imputation was used to handle dropouts.
Superiority or Other (legacy)
OG003
OG006
Week 4 analysis presented in this section for comparison to placebo.
Difference in percentage
16.54
2-Sided
95
0.80
32.29
Non-responder imputation was used to handle dropouts.
Superiority or Other (legacy)
OG004
OG006
Week 4 analysis presented in this section for comparison to placebo.
Difference in percentage
0.0
2-Sided
95
-12.98
12.98
Non-responder imputation was used to handle dropouts.
Superiority or Other (legacy)
OG005
OG006
Week 4 analysis presented in this section for comparison to placebo.
Difference in percentage
19.32
2-Sided
95
3.16
35.48
Non-responder imputation was used to handle dropouts.
Superiority or Other (legacy)
OG000
OG006
Week 6 analysis presented in this section for comparison to placebo.
Difference in percentage
-4.44
2-Sided
95
-18.46
9.57
Non-responder imputation was used to handle dropouts.
Superiority or Other (legacy)
OG001
OG006
Week 6 analysis presented in this section for comparison to placebo.
Difference in percentage
12.10
2-Sided
95
-4.49
28.70
Non-responder imputation was used to handle dropouts.
Superiority or Other (legacy)
OG002
OG006
Week 6 analysis presented in this section for comparison to placebo.
Difference in percentage
24.44
2-Sided
95
6.63
42.24
Non-responder imputation was used to handle dropouts.
Superiority or Other (legacy)
OG003
OG006
Week 6 analysis presented in this section for comparison to placebo.
Difference in percentage
26.99
2-Sided
95
9.33
44.65
Non-responder imputation was used to handle dropouts.
Superiority or Other (legacy)
OG004
OG006
Week 6 analysis presented in this section for comparison to placebo.
Difference in percentage
8.88
2-Sided
95
-7.53
25.31
Non-responder imputation was used to handle dropouts.
Superiority or Other (legacy)
OG005
OG006
Week 6 analysis presented in this section for comparison to placebo.
Difference in percentage
21.40
2-Sided
95
3.88
38.91
Non-responder imputation was used to handle dropouts.
Superiority or Other (legacy)
OG000
OG006
Week 8 analysis presented in this section for comparison to placebo.
Difference in percentage
8.88
2-Sided
95
-6.80
24.57
Non-responder imputation was used to handle dropouts.
Superiority or Other (legacy)
OG001
OG006
Week 8 analysis presented in this section for comparison to placebo.
Difference in percentage
18.58
2-Sided
95
1.96
35.20
Non-responder imputation was used to handle dropouts.
Superiority or Other (legacy)
OG002
OG006
Week 8 analysis presented in this section for comparison to placebo.
Difference in percentage
35.55
2-Sided
95
17.89
53.21
Non-responder imputation was used to handle dropouts.
Superiority or Other (legacy)
OG003
OG006
Week 8 analysis presented in this section for comparison to placebo.
Difference in percentage
29.21
2-Sided
95
11.94
46.49
Non-responder imputation was used to handle dropouts.
Superiority or Other (legacy)
OG004
OG006
Week 8 analysis presented in this section for comparison to placebo.
Difference in percentage
13.33
2-Sided
95
-2.96
29.63
Non-responder imputation was used to handle dropouts.
Superiority or Other (legacy)
OG005
OG006
Week 8 analysis presented in this section for comparison to placebo.
Difference in percentage
32.31
2-Sided
95
14.83
49.80
Non-responder imputation was used to handle dropouts.
Superiority or Other (legacy)
OG000
OG006
Week 12 analysis presented in this section for comparison to placebo.
Difference in percentage
0.00
2-Sided
95
-15.79
15.79
Non-responder imputation was used to handle dropouts.
Superiority or Other (legacy)
OG001
OG006
Week 12 analysis presented in this section for comparison to placebo.
Difference in percentage
3.49
2-Sided
95
-12.67
19.67
Non-responder imputation was used to handle dropouts.
Superiority or Other (legacy)
OG002
OG006
Week 12 analysis presented in this section for comparison to placebo.
Difference in percentage
6.66
2-Sided
95
-10.13
23.47
Non-responder imputation was used to handle dropouts.
Superiority or Other (legacy)
OG003
OG006
Week 12 analysis presented in this section for comparison to placebo.
Difference in percentage
-0.75
2-Sided
95
-16.25
14.74
Non-responder imputation was used to handle dropouts.
Superiority or Other (legacy)
OG004
OG006
Week 12 analysis presented in this section for comparison to placebo.
Difference in percentage
8.88
2-Sided
95
-8.19
25.96
Non-responder imputation was used to handle dropouts.
Superiority or Other (legacy)
OG005
OG006
Week 12 analysis presented in this section for comparison to placebo.
Difference in percentage
6.13
2-Sided
95
-10.50
22.77
Non-responder imputation was used to handle dropouts.
Superiority or Other (legacy)
OG000
OG005
Week 2 analysis presented in this section for comparison to prednisone 10 mg.
Difference in percentage
-15.01
2-Sided
95
-28.03
-2.00
Non-responder imputation was used to handle dropouts.
Superiority or Other (legacy)
OG001
OG005
Week 2 analysis presented in this section for comparison to prednisone 10 mg.
Difference in percentage
-10.86
2-Sided
95
-24.93
3.19
Non-responder imputation was used to handle dropouts.
Superiority or Other (legacy)
OG002
OG005
Week 2 analysis presented in this section for comparison to prednisone 10 mg.
Difference in percentage
-10.67
2-Sided
95
-24.83
3.48
Non-responder imputation was used to handle dropouts.
Superiority or Other (legacy)
OG003
OG005
Week 2 analysis presented in this section for comparison to prednisone 10 mg.
Difference in percentage
5.96
2-Sided
95
-10.96
22.90
Non-responder imputation was used to handle dropouts.
Superiority or Other (legacy)
OG000
OG005
Week 4 analysis presented in this section for comparison to prednisone 10 mg.
Difference in percentage
-21.54
2-Sided
95
-37.22
-5.86
Non-responder imputation was used to handle dropouts.
Superiority or Other (legacy)
OG001
OG005
Week 4 analysis presented in this section for comparison to prednisone 10 mg.
Difference in percentage
-7.03
2-Sided
95
-25.01
10.95
Non-responder imputation was used to handle dropouts.
Superiority or Other (legacy)
OG002
OG005
Week 4 analysis presented in this section for comparison to prednisone 10 mg.
Difference in percentage
5.12
2-Sided
95
-14.17
24.41
Non-responder imputation was used to handle dropouts.
Superiority or Other (legacy)
OG003
OG005
Week 4 analysis presented in this section for comparison to prednisone 10 mg.
Difference in percentage
-2.77
2-Sided
95
-21.22
15.67
Non-responder imputation was used to handle dropouts.
Superiority or Other (legacy)
OG000
OG005
Week 6 analysis presented in this section for comparison to prednisone 10 mg.
Difference in percentage
-25.84
2-Sided
95
-42.54
-9.14
Non-responder imputation was used to handle dropouts.
Superiority or Other (legacy)
OG001
OG005
Week 6 analysis presented in this section for comparison to prednisone 10 mg.
Difference in percentage
-9.29
2-Sided
95
-28.22
9.62
Non-responder imputation was used to handle dropouts.
Superiority or Other (legacy)
OG002
OG005
Week 6 analysis presented in this section for comparison to prednisone 10 mg.
Difference in percentage
3.04
2-Sided
95
-16.94
23.02
Non-responder imputation was used to handle dropouts.
Superiority or Other (legacy)
OG003
OG005
Week 6 analysis presented in this section for comparison to prednisone 10 mg.
Difference in percentage
5.59
2-Sided
95
-14.26
25.45
Non-responder imputation was used to handle dropouts.
Superiority or Other (legacy)
OG000
OG005
Week 8 analysis presented in this section for comparison to prednisone 10 mg.
Difference in percentage
-23.42
2-Sided
95
-42.26
-4.59
Non-responder imputation was used to handle dropouts.
Superiority or Other (legacy)
OG001
OG005
Week 8 analysis presented in this section for comparison to prednisone 10 mg.
Difference in percentage
-13.73
2-Sided
95
-33.35
5.87
Non-responder imputation was used to handle dropouts.
Superiority or Other (legacy)
OG002
OG005
Week 8 analysis presented in this section for comparison to prednisone 10 mg.
Difference in percentage
3.23
2-Sided
95
-17.26
23.74
Non-responder imputation was used to handle dropouts.
Superiority or Other (legacy)
OG003
OG005
Week 8 analysis presented in this section for comparison to prednisone 10 mg.
Difference in percentage
-3.09
2-Sided
95
-23.27
17.07
Non-responder imputation was used to handle dropouts.
Superiority or Other (legacy)
OG000
OG005
Week 12 analysis presented in this section for comparison to prednisone 10 mg.
Difference in percentage
-6.13
2-Sided
95
-22.77
10.50
Non-responder imputation was used to handle dropouts.
Superiority or Other (legacy)
OG001
OG005
Week 12 analysis presented in this section for comparison to prednisone 10 mg.
Difference in percentage
-2.63
2-Sided
95
-19.63
14.35
Non-responder imputation was used to handle dropouts.
Superiority or Other (legacy)
OG002
OG005
Week 12 analysis presented in this section for comparison to prednisone 10 mg.
Difference in percentage
0.53
2-Sided
95
-17.06
18.12
Non-responder imputation was used to handle dropouts.
Superiority or Other (legacy)
OG003
OG005
Week 12 analysis presented in this section for comparison to prednisone 10 mg.
Difference in percentage
-6.89
2-Sided
95
-23.24
9.46
Non-responder imputation was used to handle dropouts.
Superiority or Other (legacy)
OG002
PF-04171327 10 mg
Participants received PF-04171327 10 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.
OG003
PF-04171327 15 mg
Participants received PF-04171327 15 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.
OG004
Prednisone 5 mg
Participants received prednisone 5 mg QD for 8 weeks. From week 9 through 10, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every 3 days.
OG005
Prednisone 10 mg
Participants received prednisone 10 mg QD for 8 weeks. After 8 weeks of treatment, participants were tapered off prednisone dosage. From week 9 through 10, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every 3 days.
OG006
Placebo
Participants received placebo QD until week 12.
Units
Counts
Participants
OG00045
OG00147
OG00245
OG00348
OG00445
OG00546
OG00647
Title
Denominators
Categories
Week 2
ParticipantsOG00044
ParticipantsOG00146
ParticipantsOG00245
ParticipantsOG00347
ParticipantsOG00445
ParticipantsOG00546
ParticipantsOG00644
Title
Measurements
OG0000.0
OG0014.35
OG0022.22
OG003
Week 4
ParticipantsOG00045
ParticipantsOG00147
ParticipantsOG00245
ParticipantsOG00347
Week 6
ParticipantsOG00045
ParticipantsOG00147
ParticipantsOG00245
ParticipantsOG00347
Week 8
ParticipantsOG00045
ParticipantsOG00147
ParticipantsOG00245
ParticipantsOG00347
Week 12
ParticipantsOG00045
ParticipantsOG00147
ParticipantsOG00245
ParticipantsOG00347
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG006
Week 2 analysis presented in this section for comparison to placebo.
Difference in percentage
0.00
2-Sided
95
0.00
0.00
Non-responder imputation was used to handle dropouts.
Superiority or Other (legacy)
OG001
OG006
Week 2 analysis presented in this section for comparison to placebo.
Difference in percentage
4.34
2-Sided
95
-1.54
10.24
Non-responder imputation was used to handle dropouts.
Superiority or Other (legacy)
OG002
OG006
Week 2 analysis presented in this section for comparison to placebo.
Difference in percentage
2.22
2-Sided
95
-2.08
6.52
Non-responder imputation was used to handle dropouts.
Superiority or Other (legacy)
OG003
OG006
Week 2 analysis presented in this section for comparison to placebo.
Difference in percentage
6.38
2-Sided
95
-0.60
13.37
Non-responder imputation was used to handle dropouts.
Superiority or Other (legacy)
OG004
OG006
Week 2 analysis presented in this section for comparison to placebo.
Difference in percentage
2.22
2-Sided
95
-2.08
6.52
Non-responder imputation was used to handle dropouts.
Superiority or Other (legacy)
OG005
OG006
Week 2 analysis presented in this section for comparison to placebo.
Difference in percentage
8.69
2-Sided
95
0.55
16.83
Non-responder imputation was used to handle dropouts.
Superiority or Other (legacy)
OG000
OG006
Week 4 analysis presented in this section for comparison to placebo.
Difference in percentage
0.00
2-Sided
95
0.00
0.00
Non-responder imputation was used to handle dropouts.
Superiority or Other (legacy)
OG001
OG006
Week 4 analysis presented in this section for comparison to placebo.
Difference in percentage
8.51
2-Sided
95
0.53
16.48
Non-responder imputation was used to handle dropouts.
Superiority or Other (legacy)
OG002
OG006
Week 4 analysis presented in this section for comparison to placebo.
Difference in percentage
15.55
2-Sided
95
4.96
26.14
Non-responder imputation was used to handle dropouts.
Superiority or Other (legacy)
OG003
OG006
Week 4 analysis presented in this section for comparison to placebo.
Difference in percentage
17.02
2-Sided
95
6.27
27.76
Non-responder imputation was used to handle dropouts.
Superiority or Other (legacy)
OG004
OG006
Week 4 analysis presented in this section for comparison to placebo.
Difference in percentage
4.44
2-Sided
95
-1.57
10.46
Non-responder imputation was used to handle dropouts.
Superiority or Other (legacy)
OG005
OG006
Week 4 analysis presented in this section for comparison to placebo.
Difference in percentage
15.21
2-Sided
95
4.83
25.59
Non-responder imputation was used to handle dropouts.
Superiority or Other (legacy)
OG000
OG006
Week 6 analysis presented in this section for comparison to placebo.
Difference in percentage
-2.22
2-Sided
95
-9.62
5.18
Non-responder imputation was used to handle dropouts.
Superiority or Other (legacy)
OG001
OG006
Week 6 analysis presented in this section for comparison to placebo.
Difference in percentage
8.32
2-Sided
95
-2.96
19.60
Non-responder imputation was used to handle dropouts.
Superiority or Other (legacy)
OG002
OG006
Week 6 analysis presented in this section for comparison to placebo.
Difference in percentage
8.88
2-Sided
95
-2.72
20.50
Non-responder imputation was used to handle dropouts.
Superiority or Other (legacy)
OG003
OG006
Week 6 analysis presented in this section for comparison to placebo.
Difference in percentage
12.57
2-Sided
95
0.26
24.89
Non-responder imputation was used to handle dropouts.
Superiority or Other (legacy)
OG004
OG006
Week 6 analysis presented in this section for comparison to placebo.
Difference in percentage
2.22
2-Sided
95
-7.23
11.67
Non-responder imputation was used to handle dropouts.
Superiority or Other (legacy)
OG005
OG006
Week 6 analysis presented in this section for comparison to placebo.
Difference in percentage
17.29
2-Sided
95
3.94
30.64
Non-responder imputation was used to handle dropouts.
Superiority or Other (legacy)
OG000
OG006
Week 8 analysis presented in this section for comparison to placebo.
Difference in percentage
-2.22
2-Sided
95
-14.60
10.16
Non-responder imputation was used to handle dropouts.
Superiority or Other (legacy)
OG001
OG006
Week 8 analysis presented in this section for comparison to placebo.
Difference in percentage
5.91
2-Sided
95
-8.22
20.04
Non-responder imputation was used to handle dropouts.
Superiority or Other (legacy)
OG002
OG006
Week 8 analysis presented in this section for comparison to placebo.
Difference in percentage
15.55
2-Sided
95
-0.29
31.40
Non-responder imputation was used to handle dropouts.
Superiority or Other (legacy)
OG003
OG006
Week 8 analysis presented in this section for comparison to placebo.
Difference in percentage
10.16
2-Sided
95
-4.70
25.03
Non-responder imputation was used to handle dropouts.
Superiority or Other (legacy)
OG004
OG006
Week 8 analysis presented in this section for comparison to placebo.
Difference in percentage
-4.44
2-Sided
95
-16.16
7.27
Non-responder imputation was used to handle dropouts.
Superiority or Other (legacy)
OG005
OG006
Week 8 analysis presented in this section for comparison to placebo.
Difference in percentage
14.97
2-Sided
95
-0.68
30.63
Non-responder imputation was used to handle dropouts.
Superiority or Other (legacy)
OG000
OG006
Week 12 analysis presented in this section for comparison to placebo.
Difference in percentage
0.00
2-Sided
95
-10.30
10.30
Non-responder imputation was used to handle dropouts.
Superiority or Other (legacy)
OG001
OG006
Week 12 analysis presented in this section for comparison to placebo.
Difference in percentage
6.09
2-Sided
95
-5.90
18.10
Non-responder imputation was used to handle dropouts.
Superiority or Other (legacy)
OG002
OG006
Week 12 analysis presented in this section for comparison to placebo.
Difference in percentage
0.00
2-Sided
95
-10.30
10.30
Non-responder imputation was used to handle dropouts.
Superiority or Other (legacy)
OG003
OG006
Week 12 analysis presented in this section for comparison to placebo.
Difference in percentage
1.84
2-Sided
95
-8.96
12.64
Non-responder imputation was used to handle dropouts.
Superiority or Other (legacy)
OG004
OG006
Week 12 analysis presented in this section for comparison to placebo.
Difference in percentage
4.44
2-Sided
95
-7.27
16.16
Non-responder imputation was used to handle dropouts.
Superiority or Other (legacy)
OG005
OG006
Week 12 analysis presented in this section for comparison to placebo.
Difference in percentage
4.20
2-Sided
95
-7.37
15.77
Non-responder imputation was used to handle dropouts.
Superiority or Other (legacy)
OG000
OG005
Week 2 analysis presented in this section for comparison to prednisone 10 mg.
Difference in percentage
-8.69
2-Sided
95
-16.83
-0.55
Non-responder imputation was used to handle dropouts.
Superiority or Other (legacy)
OG001
OG005
Week 2 analysis presented in this section for comparison to prednisone 10 mg.
Difference in percentage
-4.34
2-Sided
95
-14.39
5.70
Non-responder imputation was used to handle dropouts.
Superiority or Other (legacy)
OG002
OG005
Week 2 analysis presented in this section for comparison to prednisone 10 mg.
Difference in percentage
-6.47
2-Sided
95
-15.68
2.73
Non-responder imputation was used to handle dropouts.
Superiority or Other (legacy)
OG003
OG005
Week 2 analysis presented in this section for comparison to prednisone 10 mg.
Difference in percentage
-2.31
2-Sided
95
-13.04
8.41
Non-responder imputation was used to handle dropouts.
Superiority or Other (legacy)
OG000
OG005
Week 4 analysis presented in this section for comparison to prednisone 10 mg.
Difference in percentage
-15.21
2-Sided
95
-25.59
-4.83
Non-responder imputation was used to handle dropouts.
Superiority or Other (legacy)
OG001
OG005
Week 4 analysis presented in this section for comparison to prednisone 10 mg.
Difference in percentage
-6.70
2-Sided
95
-19.79
6.38
Non-responder imputation was used to handle dropouts.
Superiority or Other (legacy)
OG002
OG005
Week 4 analysis presented in this section for comparison to prednisone 10 mg.
Difference in percentage
0.33
2-Sided
95
-14.49
15.16
Non-responder imputation was used to handle dropouts.
Superiority or Other (legacy)
OG003
OG005
Week 4 analysis presented in this section for comparison to prednisone 10 mg.
Difference in percentage
1.80
2-Sided
95
-13.13
16.74
Non-responder imputation was used to handle dropouts.
Superiority or Other (legacy)
OG000
OG005
Week 6 analysis presented in this section for comparison to prednisone 10 mg.
Difference in percentage
-19.51
2-Sided
95
-32.19
-6.84
Non-responder imputation was used to handle dropouts.
Superiority or Other (legacy)
OG001
OG005
Week 6 analysis presented in this section for comparison to prednisone 10 mg.
Difference in percentage
-8.97
2-Sided
95
-24.24
6.29
Non-responder imputation was used to handle dropouts.
Superiority or Other (legacy)
OG002
OG005
Week 6 analysis presented in this section for comparison to prednisone 10 mg.
Difference in percentage
-8.40
2-Sided
95
-23.92
7.10
Non-responder imputation was used to handle dropouts.
Superiority or Other (legacy)
OG003
OG005
Week 6 analysis presented in this section for comparison to prednisone 10 mg.
Difference in percentage
-4.71
2-Sided
95
-20.76
11.32
Non-responder imputation was used to handle dropouts.
Superiority or Other (legacy)
OG000
OG005
Week 8 analysis presented in this section for comparison to prednisone 10 mg.
Difference in percentage
-17.19
2-Sided
95
-32.36
-2.02
Non-responder imputation was used to handle dropouts.
Superiority or Other (legacy)
OG001
OG005
Week 8 analysis presented in this section for comparison to prednisone 10 mg.
Difference in percentage
-9.06
2-Sided
95
-25.69
7.56
Non-responder imputation was used to handle dropouts.
Superiority or Other (legacy)
OG002
OG005
Week 8 analysis presented in this section for comparison to prednisone 10 mg.
Difference in percentage
0.57
2-Sided
95
-17.53
18.68
Non-responder imputation was used to handle dropouts.
Superiority or Other (legacy)
OG003
OG005
Week 8 analysis presented in this section for comparison to prednisone 10 mg.
Difference in percentage
-4.81
2-Sided
95
-22.07
12.45
Non-responder imputation was used to handle dropouts.
Superiority or Other (legacy)
OG000
OG005
Week 12 analysis presented in this section for comparison to prednisone 10 mg.
Difference in percentage
-4.20
2-Sided
95
-15.77
7.37
Non-responder imputation was used to handle dropouts.
Superiority or Other (legacy)
OG001
OG005
Week 12 analysis presented in this section for comparison to prednisone 10 mg.
Difference in percentage
1.89
2-Sided
95
-11.21
15.00
Non-responder imputation was used to handle dropouts.
Superiority or Other (legacy)
OG002
OG005
Week 12 analysis presented in this section for comparison to prednisone 10 mg.
Difference in percentage
-4.20
2-Sided
95
-15.77
7.37
Non-responder imputation was used to handle dropouts.
Superiority or Other (legacy)
OG003
OG005
Week 12 analysis presented in this section for comparison to prednisone 10 mg.
Difference in percentage
-2.35
2-Sided
95
-14.38
9.66
Non-responder imputation was used to handle dropouts.
Superiority or Other (legacy)
OG002
PF-04171327 10 mg
Participants received PF-04171327 10 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.
OG003
PF-04171327 15 mg
Participants received PF-04171327 15 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.
OG004
Prednisone 5 mg
Participants received prednisone 5 mg QD for 8 weeks. From week 9 through 10, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every 3 days.
OG005
Prednisone 10 mg
Participants received prednisone 10 mg QD for 8 weeks. After 8 weeks of treatment, participants were tapered off prednisone dosage. From week 9 through 10, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every 3 days.
OG006
Placebo
Participants received placebo QD until week 12.
Units
Counts
Participants
OG00045
OG00147
OG00245
OG00348
OG00445
OG00546
OG00647
Title
Denominators
Categories
Week 2
ParticipantsOG00044
ParticipantsOG00146
ParticipantsOG00245
ParticipantsOG00347
ParticipantsOG00445
ParticipantsOG00546
ParticipantsOG00644
Title
Measurements
OG000-4.08± 0.74
OG001-5.55± 0.72
OG002-4.97± 0.73
OG003
Week 4
ParticipantsOG00045
ParticipantsOG00144
ParticipantsOG00245
ParticipantsOG00345
Week 6
ParticipantsOG00044
ParticipantsOG00142
ParticipantsOG00244
ParticipantsOG00344
Week 8
ParticipantsOG00044
ParticipantsOG00142
ParticipantsOG00244
ParticipantsOG00344
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG006
Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-2.13
2-Sided
95
-4.19
-0.07
Superiority or Other (legacy)
OG001
OG006
Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-3.60
2-Sided
95
-5.63
-1.57
Superiority or Other (legacy)
OG002
OG006
Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-3.02
2-Sided
95
-5.06
-0.97
Superiority or Other (legacy)
OG003
OG006
Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-3.70
2-Sided
95
-5.73
-1.68
Superiority or Other (legacy)
OG004
OG006
Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-1.93
2-Sided
95
-3.97
0.12
Superiority or Other (legacy)
OG005
OG006
Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-3.43
2-Sided
95
-5.46
-1.39
Superiority or Other (legacy)
OG000
OG006
Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-1.81
2-Sided
95
-4.03
0.42
Superiority or Other (legacy)
OG001
OG006
Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-2.83
2-Sided
95
-5.04
-0.62
Superiority or Other (legacy)
OG002
OG006
Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-2.85
2-Sided
95
-5.07
-0.64
Superiority or Other (legacy)
OG003
OG006
Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-2.77
2-Sided
95
-4.98
-0.56
Superiority or Other (legacy)
OG004
OG006
Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-1.63
2-Sided
95
-3.85
0.59
Superiority or Other (legacy)
OG005
OG006
Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-3.27
2-Sided
95
-5.48
-1.06
Superiority or Other (legacy)
OG000
OG006
Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-2.23
2-Sided
95
-4.66
0.20
Superiority or Other (legacy)
OG001
OG006
Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-4.19
2-Sided
95
-6.62
-1.77
Superiority or Other (legacy)
OG002
OG006
Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-3.73
2-Sided
95
-6.15
-1.31
Superiority or Other (legacy)
OG003
OG006
Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-3.68
2-Sided
95
-6.09
-1.26
Superiority or Other (legacy)
OG004
OG006
Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-2.27
2-Sided
95
-4.69
0.16
Superiority or Other (legacy)
OG005
OG006
Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-4.11
2-Sided
95
-6.52
-1.70
Superiority or Other (legacy)
OG000
OG006
Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-2.80
2-Sided
95
-5.34
-0.25
Superiority or Other (legacy)
OG001
OG006
Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-4.38
2-Sided
95
-6.93
-1.83
Superiority or Other (legacy)
OG002
OG006
Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-5.20
2-Sided
95
-7.74
-2.66
Superiority or Other (legacy)
OG003
OG006
Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-4.90
2-Sided
95
-7.43
-2.36
Superiority or Other (legacy)
OG004
OG006
Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-2.74
2-Sided
95
-5.28
-0.20
Superiority or Other (legacy)
OG005
OG006
Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-4.57
2-Sided
95
-7.10
-2.05
Superiority or Other (legacy)
OG000
OG005
Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
1.30
2-Sided
95
-0.73
3.33
Superiority or Other (legacy)
OG001
OG005
Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-0.17
2-Sided
95
-2.18
1.84
Superiority or Other (legacy)
OG002
OG005
Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
0.41
2-Sided
95
-1.61
2.44
Superiority or Other (legacy)
OG003
OG005
Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-0.27
2-Sided
95
-2.27
1.73
Superiority or Other (legacy)
OG000
OG005
Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
1.47
2-Sided
95
-0.74
3.68
Superiority or Other (legacy)
OG001
OG005
Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
0.45
2-Sided
95
-1.76
2.65
Superiority or Other (legacy)
OG002
OG005
Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
0.42
2-Sided
95
-1.79
2.63
Superiority or Other (legacy)
OG003
OG005
Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
0.51
2-Sided
95
-1.69
2.70
Superiority or Other (legacy)
OG000
OG005
Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
1.88
2-Sided
95
-0.53
4.29
Superiority or Other (legacy)
OG001
OG005
Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-0.08
2-Sided
95
-2.50
2.33
Superiority or Other (legacy)
OG002
OG005
Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
0.38
2-Sided
95
-2.03
2.79
Superiority or Other (legacy)
OG003
OG005
Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
0.43
2-Sided
95
-1.97
2.84
Superiority or Other (legacy)
OG000
OG005
Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
1.78
2-Sided
95
-0.75
4.30
Superiority or Other (legacy)
OG001
OG005
Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
0.19
2-Sided
95
-2.34
2.73
Superiority or Other (legacy)
OG002
OG005
Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-0.62
2-Sided
95
-3.14
1.89
Superiority or Other (legacy)
OG003
OG005
Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-0.33
2-Sided
95
-2.84
2.19
Superiority or Other (legacy)
OG002
PF-04171327 10 mg
Participants received PF-04171327 10 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.
OG003
PF-04171327 15 mg
Participants received PF-04171327 15 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.
OG004
Prednisone 5 mg
Participants received prednisone 5 mg QD for 8 weeks. From week 9 through 10, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every 3 days.
OG005
Prednisone 10 mg
Participants received prednisone 10 mg QD for 8 weeks. After 8 weeks of treatment, participants were tapered off prednisone dosage. From week 9 through 10, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every 3 days.
OG006
Placebo
Participants received placebo QD until week 12.
Units
Counts
Participants
OG00044
OG00141
OG00244
OG00343
OG00444
OG00543
OG00641
Title
Denominators
Categories
Title
Measurements
OG000-6.25± 6.77
OG001-7.24± 6.13
OG002-6.16± 6.40
OG003-6.47± 7.54
OG004-7.07± 5.89
OG005-8.16± 4.66
OG006-5.59± 6.67
OG002
PF-04171327 10 mg
Participants received PF-04171327 10 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.
OG003
PF-04171327 15 mg
Participants received PF-04171327 15 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.
OG004
Prednisone 5 mg
Participants received prednisone 5 mg QD for 8 weeks. From week 9 through 10, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every 3 days.
OG005
Prednisone 10 mg
Participants received prednisone 10 mg QD for 8 weeks. After 8 weeks of treatment, participants were tapered off prednisone dosage. From week 9 through 10, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every 3 days.
OG006
Placebo
Participants received placebo QD until week 12.
Units
Counts
Participants
OG00045
OG00147
OG00245
OG00348
OG00445
OG00546
OG00647
Title
Denominators
Categories
Week 2
ParticipantsOG00044
ParticipantsOG00146
ParticipantsOG00245
ParticipantsOG00347
ParticipantsOG00445
ParticipantsOG00546
ParticipantsOG00644
Title
Measurements
OG000-3.42± 0.62
OG001-4.70± 0.61
OG002-4.27± 0.62
OG003
Week 4
ParticipantsOG00045
ParticipantsOG00144
ParticipantsOG00245
ParticipantsOG00345
Week 6
ParticipantsOG00044
ParticipantsOG00142
ParticipantsOG00244
ParticipantsOG00344
Week 8
ParticipantsOG00044
ParticipantsOG00142
ParticipantsOG00244
ParticipantsOG00344
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG006
Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-1.18
2-Sided
95
-2.91
0.56
Superiority or Other (legacy)
OG001
OG006
Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-2.45
2-Sided
95
-4.17
-0.73
Superiority or Other (legacy)
OG002
OG006
Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-2.03
2-Sided
95
-3.76
-0.29
Superiority or Other (legacy)
OG003
OG006
Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-3.11
2-Sided
95
-4.82
-1.40
Superiority or Other (legacy)
OG004
OG006
Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-1.40
2-Sided
95
-3.13
0.33
Superiority or Other (legacy)
OG005
OG006
Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-2.80
2-Sided
95
-4.52
-1.07
Superiority or Other (legacy)
OG000
OG006
Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-1.67
2-Sided
95
-3.63
0.29
Superiority or Other (legacy)
OG001
OG006
Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-1.98
2-Sided
95
-3.94
-0.01
Superiority or Other (legacy)
OG002
OG006
Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-2.07
2-Sided
95
-4.03
-0.11
Superiority or Other (legacy)
OG003
OG006
Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-3.13
2-Sided
95
-5.09
-1.17
Superiority or Other (legacy)
OG004
OG006
Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-1.88
2-Sided
95
-3.85
0.09
Superiority or Other (legacy)
OG005
OG006
Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-2.84
2-Sided
95
-4.79
-0.88
Superiority or Other (legacy)
OG000
OG006
Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-1.32
2-Sided
95
-3.25
0.60
Superiority or Other (legacy)
OG001
OG006
Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-1.97
2-Sided
95
-3.90
-0.04
Superiority or Other (legacy)
OG002
OG006
Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-2.43
2-Sided
95
-4.35
-0.50
Superiority or Other (legacy)
OG003
OG006
Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-2.75
2-Sided
95
-4.66
-0.83
Superiority or Other (legacy)
OG004
OG006
Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-1.96
2-Sided
95
-3.88
-0.03
Superiority or Other (legacy)
OG005
OG006
Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-3.08
2-Sided
95
-5.00
-1.17
Superiority or Other (legacy)
OG000
OG006
Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-1.99
2-Sided
95
-4.20
0.21
Superiority or Other (legacy)
OG001
OG006
Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-2.95
2-Sided
95
-5.17
-0.72
Superiority or Other (legacy)
OG002
OG006
Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-3.44
2-Sided
95
-5.65
-1.23
Superiority or Other (legacy)
OG003
OG006
Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-3.32
2-Sided
95
-5.52
-1.12
Superiority or Other (legacy)
OG004
OG006
Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-2.39
2-Sided
95
-4.60
-0.18
Superiority or Other (legacy)
OG005
OG006
Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-3.87
2-Sided
95
-6.07
-1.68
Superiority or Other (legacy)
OG000
OG005
Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
1.62
2-Sided
95
-0.10
3.34
Superiority or Other (legacy)
OG001
OG005
Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
0.34
2-Sided
95
-1.36
2.05
Superiority or Other (legacy)
OG002
OG005
Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
0.77
2-Sided
95
-0.94
2.48
Superiority or Other (legacy)
OG003
OG005
Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-0.31
2-Sided
95
-2.01
1.38
Superiority or Other (legacy)
OG000
OG005
Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
1.17
2-Sided
95
-0.79
3.12
Superiority or Other (legacy)
OG001
OG005
Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
0.86
2-Sided
95
-1.10
2.82
Superiority or Other (legacy)
OG002
OG005
Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
0.76
2-Sided
95
-1.19
2.72
Superiority or Other (legacy)
OG003
OG005
Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-0.29
2-Sided
95
-2.24
1.66
Superiority or Other (legacy)
OG000
OG005
Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
1.76
2-Sided
95
-0.16
3.67
Superiority or Other (legacy)
OG001
OG005
Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
1.12
2-Sided
95
-0.81
3.04
Superiority or Other (legacy)
OG002
OG005
Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
0.66
2-Sided
95
-1.26
2.57
Superiority or Other (legacy)
OG003
OG005
Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
0.34
2-Sided
95
-1.57
2.25
Superiority or Other (legacy)
OG000
OG005
Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
1.88
2-Sided
95
-0.31
4.07
Superiority or Other (legacy)
OG001
OG005
Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
0.93
2-Sided
95
-1.28
3.13
Superiority or Other (legacy)
OG002
OG005
Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
0.43
2-Sided
95
-1.76
2.62
Superiority or Other (legacy)
OG003
OG005
Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
0.55
2-Sided
95
-1.63
2.74
Superiority or Other (legacy)
OG002
PF-04171327 10 mg
Participants received PF-04171327 10 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.
OG003
PF-04171327 15 mg
Participants received PF-04171327 15 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.
OG004
Prednisone 5 mg
Participants received prednisone 5 mg QD for 8 weeks. From week 9 through 10, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every 3 days.
OG005
Prednisone 10 mg
Participants received prednisone 10 mg QD for 8 weeks. After 8 weeks of treatment, participants were tapered off prednisone dosage. From week 9 through 10, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every 3 days.
OG006
Placebo
Participants received placebo QD until week 12.
Units
Counts
Participants
OG00044
OG00141
OG00244
OG00343
OG00444
OG00543
OG00641
Title
Denominators
Categories
Title
Measurements
OG000-6.20± 6.21
OG001-5.98± 4.81
OG002-5.86± 6.17
OG003-5.58± 6.24
OG004-7.43± 5.82
OG005-7.07± 5.02
OG006-6.17± 5.48
OG002
PF-04171327 10 mg
Participants received PF-04171327 10 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.
OG003
PF-04171327 15 mg
Participants received PF-04171327 15 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.
OG004
Prednisone 5 mg
Participants received prednisone 5 mg QD for 8 weeks. From week 9 through 10, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every 3 days.
OG005
Prednisone 10 mg
Participants received prednisone 10 mg QD for 8 weeks. After 8 weeks of treatment, participants were tapered off prednisone dosage. From week 9 through 10, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every 3 days.
OG006
Placebo
Participants received placebo QD until week 12.
Units
Counts
Participants
OG00045
OG00147
OG00245
OG00348
OG00445
OG00546
OG00647
Title
Denominators
Categories
Week 2
ParticipantsOG00044
ParticipantsOG00146
ParticipantsOG00245
ParticipantsOG00348
ParticipantsOG00445
ParticipantsOG00545
ParticipantsOG00644
Title
Measurements
OG000-7.29± 2.89
OG001-12.95± 2.82
OG002-13.73± 2.87
OG003
Week 4
ParticipantsOG00045
ParticipantsOG00143
ParticipantsOG00243
ParticipantsOG00344
Week 6
ParticipantsOG00044
ParticipantsOG00143
ParticipantsOG00245
ParticipantsOG00344
Week 8
ParticipantsOG00043
ParticipantsOG00142
ParticipantsOG00244
ParticipantsOG00343
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG006
Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-4.49
2-Sided
95
-12.52
3.55
Superiority or Other (legacy)
OG001
OG006
Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-10.15
2-Sided
95
-18.10
-2.20
Superiority or Other (legacy)
OG002
OG006
Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-10.93
2-Sided
95
-18.94
-2.92
Superiority or Other (legacy)
OG003
OG006
Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-16.12
2-Sided
95
-24.01
-8.24
Superiority or Other (legacy)
OG004
OG006
Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-5.45
2-Sided
95
-13.45
2.56
Superiority or Other (legacy)
OG005
OG006
Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-14.10
2-Sided
95
-22.09
-6.11
Superiority or Other (legacy)
OG000
OG006
Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-3.42
2-Sided
95
-11.13
4.29
Superiority or Other (legacy)
OG001
OG006
Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-7.98
2-Sided
95
-15.70
-0.26
Superiority or Other (legacy)
OG002
OG006
Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-5.17
2-Sided
95
-12.93
2.59
Superiority or Other (legacy)
OG003
OG006
Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-10.22
2-Sided
95
-17.90
-2.54
Superiority or Other (legacy)
OG004
OG006
Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
2.43
2-Sided
95
-5.32
10.19
Superiority or Other (legacy)
OG005
OG006
Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-11.14
2-Sided
95
-18.83
-3.45
Superiority or Other (legacy)
OG000
OG006
Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-5.42
2-Sided
95
-12.44
1.59
Superiority or Other (legacy)
OG001
OG006
Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-12.24
2-Sided
95
-19.27
-5.20
Superiority or Other (legacy)
OG002
OG006
Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-9.13
2-Sided
95
-16.11
-2.14
Superiority or Other (legacy)
OG003
OG006
Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-9.88
2-Sided
95
-16.89
-2.88
Superiority or Other (legacy)
OG004
OG006
Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-2.61
2-Sided
95
-9.63
4.40
Superiority or Other (legacy)
OG005
OG006
Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-12.93
2-Sided
95
-19.88
-5.98
Superiority or Other (legacy)
OG000
OG006
Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-3.10
2-Sided
95
-10.03
3.83
Superiority or Other (legacy)
OG001
OG006
Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-10.10
2-Sided
95
-17.06
-3.13
Superiority or Other (legacy)
OG002
OG006
Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-10.67
2-Sided
95
-17.57
-3.77
Superiority or Other (legacy)
OG003
OG006
Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-7.79
2-Sided
95
-14.72
-0.86
Superiority or Other (legacy)
OG004
OG006
Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-3.05
2-Sided
95
-9.98
3.89
Superiority or Other (legacy)
OG005
OG006
Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-13.41
2-Sided
95
-20.27
-6.54
Superiority or Other (legacy)
OG000
OG005
Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
9.61
2-Sided
95
1.62
17.61
Superiority or Other (legacy)
OG001
OG005
Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
3.95
2-Sided
95
-3.96
11.85
Superiority or Other (legacy)
OG002
OG005
Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
3.17
2-Sided
95
-4.80
11.13
Superiority or Other (legacy)
OG003
OG005
Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-2.03
2-Sided
95
-9.86
5.81
Superiority or Other (legacy)
OG000
OG005
Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
7.72
2-Sided
95
0.03
15.42
Superiority or Other (legacy)
OG001
OG005
Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
3.16
2-Sided
95
-4.54
10.87
Superiority or Other (legacy)
OG002
OG005
Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
5.97
2-Sided
95
-1.77
13.71
Superiority or Other (legacy)
OG003
OG005
Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
0.92
2-Sided
95
-6.75
8.59
Superiority or Other (legacy)
OG000
OG005
Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
7.50
2-Sided
95
0.57
14.43
Superiority or Other (legacy)
OG001
OG005
Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
0.69
2-Sided
95
-6.26
7.64
Superiority or Other (legacy)
OG002
OG005
Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
3.80
2-Sided
95
-3.09
10.70
Superiority or Other (legacy)
OG003
OG005
Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
3.05
2-Sided
95
-3.87
9.96
Superiority or Other (legacy)
OG000
OG005
Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
10.31
2-Sided
95
3.43
17.18
Superiority or Other (legacy)
OG001
OG005
Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
3.31
2-Sided
95
-3.59
10.22
Superiority or Other (legacy)
OG002
OG005
Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
2.73
2-Sided
95
-4.10
9.57
Superiority or Other (legacy)
OG003
OG005
Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
5.62
2-Sided
95
-1.25
12.48
Superiority or Other (legacy)
Participants received PF-04171327 10 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.
OG003
PF-04171327 15 mg
Participants received PF-04171327 15 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.
OG004
Prednisone 5 mg
Participants received prednisone 5 mg QD for 8 weeks. From week 9 through 10, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every 3 days.
OG005
Prednisone 10 mg
Participants received prednisone 10 mg QD for 8 weeks. After 8 weeks of treatment, participants were tapered off prednisone dosage. From week 9 through 10, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every 3 days.
OG006
Placebo
Participants received placebo QD until week 12.
Units
Counts
Participants
OG00042
OG00139
OG00243
OG00342
OG00443
OG00542
OG00639
Title
Denominators
Categories
Title
Measurements
OG0000.72± 27.40
OG001-6.24± 23.06
OG002-4.52± 20.35
OG003-0.64± 29.08
OG004-2.90± 16.10
OG005-9.39± 36.10
OG006-4.07± 22.10
OG002
PF-04171327 10 mg
Participants received PF-04171327 10 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.
OG003
PF-04171327 15 mg
Participants received PF-04171327 15 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.
OG004
Prednisone 5 mg
Participants received prednisone 5 mg QD for 8 weeks. From week 9 through 10, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every 3 days.
OG005
Prednisone 10 mg
Participants received prednisone 10 mg QD for 8 weeks. After 8 weeks of treatment, participants were tapered off prednisone dosage. From week 9 through 10, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every 3 days.
OG006
Placebo
Participants received placebo QD until week 12.
Units
Counts
Participants
OG00045
OG00147
OG00245
OG00348
OG00445
OG00546
OG00647
Title
Denominators
Categories
Week 2
ParticipantsOG00044
ParticipantsOG00146
ParticipantsOG00245
ParticipantsOG00347
ParticipantsOG00445
ParticipantsOG00545
ParticipantsOG00644
Title
Measurements
OG000-10.24± 2.85
OG001-18.77± 2.79
OG002-24.72± 2.83
OG003
Week 4
ParticipantsOG00045
ParticipantsOG00144
ParticipantsOG00244
ParticipantsOG00345
Week 6
ParticipantsOG00043
ParticipantsOG00142
ParticipantsOG00244
ParticipantsOG00344
Week 8
ParticipantsOG00044
ParticipantsOG00142
ParticipantsOG00244
ParticipantsOG00344
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG006
Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
0.38
2-Sided
95
-7.56
8.31
Superiority or Other (legacy)
OG001
OG006
Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-8.15
2-Sided
95
-16.01
-0.30
Superiority or Other (legacy)
OG002
OG006
Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-14.10
2-Sided
95
-22.01
-6.20
Superiority or Other (legacy)
OG003
OG006
Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-11.88
2-Sided
95
-19.70
-4.06
Superiority or Other (legacy)
OG004
OG006
Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
0.58
2-Sided
95
-7.33
8.48
Superiority or Other (legacy)
OG005
OG006
Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-12.89
2-Sided
95
-20.80
-4.98
Superiority or Other (legacy)
OG000
OG006
Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-0.37
2-Sided
95
-9.31
8.58
Superiority or Other (legacy)
OG001
OG006
Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-9.48
2-Sided
95
-18.43
-0.53
Superiority or Other (legacy)
OG002
OG006
Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-13.42
2-Sided
95
-22.39
-4.44
Superiority or Other (legacy)
OG003
OG006
Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-8.58
2-Sided
95
-17.48
0.33
Superiority or Other (legacy)
OG004
OG006
Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-2.60
2-Sided
95
-11.57
6.38
Superiority or Other (legacy)
OG005
OG006
Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-13.75
2-Sided
95
-22.73
-4.78
Superiority or Other (legacy)
OG000
OG006
Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-0.22
2-Sided
95
-9.32
8.88
Superiority or Other (legacy)
OG001
OG006
Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-12.28
2-Sided
95
-21.39
-3.17
Superiority or Other (legacy)
OG002
OG006
Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-16.44
2-Sided
95
-25.53
-7.36
Superiority or Other (legacy)
OG003
OG006
Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-9.38
2-Sided
95
-18.42
-0.34
Superiority or Other (legacy)
OG004
OG006
Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-4.52
2-Sided
95
-13.61
4.57
Superiority or Other (legacy)
OG005
OG006
Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-13.78
2-Sided
95
-22.87
-4.69
Superiority or Other (legacy)
OG000
OG006
Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
1.85
2-Sided
95
-7.90
11.60
Superiority or Other (legacy)
OG001
OG006
Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-10.72
2-Sided
95
-20.51
-0.93
Superiority or Other (legacy)
OG002
OG006
Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-18.52
2-Sided
95
-28.28
-8.77
Superiority or Other (legacy)
OG003
OG006
Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-12.96
2-Sided
95
-22.67
-3.25
Superiority or Other (legacy)
OG004
OG006
Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-7.46
2-Sided
95
-17.21
2.30
Superiority or Other (legacy)
OG005
OG006
Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-16.24
2-Sided
95
-26.00
-6.48
Superiority or Other (legacy)
OG000
OG005
Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
13.27
2-Sided
95
5.34
21.20
Superiority or Other (legacy)
OG001
OG005
Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
4.74
2-Sided
95
-3.12
12.59
Superiority or Other (legacy)
OG002
OG005
Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-1.21
2-Sided
95
-9.10
6.68
Superiority or Other (legacy)
OG003
OG005
Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
1.01
2-Sided
95
-6.79
8.81
Superiority or Other (legacy)
OG000
OG005
Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
13.39
2-Sided
95
4.39
22.38
Superiority or Other (legacy)
OG001
OG005
Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
4.27
2-Sided
95
-4.73
13.27
Superiority or Other (legacy)
OG002
OG005
Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
0.34
2-Sided
95
-8.68
9.35
Superiority or Other (legacy)
OG003
OG005
Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
5.18
2-Sided
95
-3.77
14.12
Superiority or Other (legacy)
OG000
OG005
Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
13.56
2-Sided
95
4.44
22.68
Superiority or Other (legacy)
OG001
OG005
Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
1.50
2-Sided
95
-7.64
10.64
Superiority or Other (legacy)
OG002
OG005
Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-2.66
2-Sided
95
-11.76
6.44
Superiority or Other (legacy)
OG003
OG005
Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
4.41
2-Sided
95
-4.65
13.46
Superiority or Other (legacy)
OG000
OG005
Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
18.09
2-Sided
95
8.34
27.84
Superiority or Other (legacy)
OG001
OG005
Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
5.52
2-Sided
95
-4.27
15.32
Superiority or Other (legacy)
OG002
OG005
Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-2.28
2-Sided
95
-12.03
7.46
Superiority or Other (legacy)
OG003
OG005
Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
3.28
2-Sided
95
-6.42
12.98
Superiority or Other (legacy)
PF-04171327 10 mg
Participants received PF-04171327 10 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.
OG003
PF-04171327 15 mg
Participants received PF-04171327 15 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.
OG004
Prednisone 5 mg
Participants received prednisone 5 mg QD for 8 weeks. From week 9 through 10, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every 3 days.
OG005
Prednisone 10 mg
Participants received prednisone 10 mg QD for 8 weeks. After 8 weeks of treatment, participants were tapered off prednisone dosage. From week 9 through 10, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every 3 days.
OG006
Placebo
Participants received placebo QD until week 12.
Units
Counts
Participants
OG00044
OG00141
OG00244
OG00343
OG00444
OG00542
OG00641
Title
Denominators
Categories
Title
Measurements
OG000-14.54± 27.33
OG001-22.26± 26.11
OG002-18.10± 25.35
OG003-16.74± 31.57
OG004-19.24± 29.32
OG005-25.29± 29.20
OG006-17.90± 23.14
OG002
PF-04171327 10 mg
Participants received PF-04171327 10 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.
OG003
PF-04171327 15 mg
Participants received PF-04171327 15 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.
OG004
Prednisone 5 mg
Participants received prednisone 5 mg QD for 8 weeks. From week 9 through 10, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every 3 days.
OG005
Prednisone 10 mg
Participants received prednisone 10 mg QD for 8 weeks. After 8 weeks of treatment, participants were tapered off prednisone dosage. From week 9 through 10, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every 3 days.
OG006
Placebo
Participants received placebo QD until week 12.
Units
Counts
Participants
OG00045
OG00147
OG00245
OG00348
OG00445
OG00546
OG00647
Title
Denominators
Categories
Week 2
ParticipantsOG00043
ParticipantsOG00146
ParticipantsOG00245
ParticipantsOG00347
ParticipantsOG00445
ParticipantsOG00545
ParticipantsOG00644
Title
Measurements
OG000-16.35± 2.53
OG001-21.74± 2.45
OG002-22.14± 2.48
OG003
Week 4
ParticipantsOG00043
ParticipantsOG00144
ParticipantsOG00244
ParticipantsOG00345
Week 6
ParticipantsOG00043
ParticipantsOG00142
ParticipantsOG00244
ParticipantsOG00344
Week 8
ParticipantsOG00043
ParticipantsOG00142
ParticipantsOG00244
ParticipantsOG00344
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG006
Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-7.06
2-Sided
95
-14.07
-0.06
Superiority or Other (legacy)
OG001
OG006
Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-12.45
2-Sided
95
-19.34
-5.56
Superiority or Other (legacy)
OG002
OG006
Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-12.85
2-Sided
95
-19.79
-5.91
Superiority or Other (legacy)
OG003
OG006
Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-15.92
2-Sided
95
-22.79
-9.06
Superiority or Other (legacy)
OG004
OG006
Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-3.95
2-Sided
95
-10.89
2.99
Superiority or Other (legacy)
OG005
OG006
Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-13.51
2-Sided
95
-20.44
-6.57
Superiority or Other (legacy)
OG000
OG006
Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-7.25
2-Sided
95
-14.65
0.16
Superiority or Other (legacy)
OG001
OG006
Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-12.03
2-Sided
95
-19.38
-4.68
Superiority or Other (legacy)
OG002
OG006
Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-15.72
2-Sided
95
-23.10
-8.35
Superiority or Other (legacy)
OG003
OG006
Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-13.95
2-Sided
95
-21.27
-6.63
Superiority or Other (legacy)
OG004
OG006
Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-5.94
2-Sided
95
-13.31
1.43
Superiority or Other (legacy)
OG005
OG006
Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-16.16
2-Sided
95
-23.54
-8.79
Superiority or Other (legacy)
OG000
OG006
Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-6.09
2-Sided
95
-13.50
1.32
Superiority or Other (legacy)
OG001
OG006
Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-13.06
2-Sided
95
-20.46
-5.65
Superiority or Other (legacy)
OG002
OG006
Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-15.31
2-Sided
95
-22.69
-7.93
Superiority or Other (legacy)
OG003
OG006
Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-13.31
2-Sided
95
-20.66
-5.96
Superiority or Other (legacy)
OG004
OG006
Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-9.06
2-Sided
95
-16.44
-1.68
Superiority or Other (legacy)
OG005
OG006
Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-14.44
2-Sided
95
-21.82
-7.06
Superiority or Other (legacy)
OG000
OG006
Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-4.72
2-Sided
95
-12.53
3.09
Superiority or Other (legacy)
OG001
OG006
Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-12.40
2-Sided
95
-20.21
-4.59
Superiority or Other (legacy)
OG002
OG006
Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-16.48
2-Sided
95
-24.25
-8.71
Superiority or Other (legacy)
OG003
OG006
Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-12.19
2-Sided
95
-19.94
-4.44
Superiority or Other (legacy)
OG004
OG006
Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-7.73
2-Sided
95
-15.50
0.04
Superiority or Other (legacy)
OG005
OG006
Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-13.98
2-Sided
95
-21.75
-6.21
Superiority or Other (legacy)
OG000
OG005
Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
6.45
2-Sided
95
-0.53
13.42
Superiority or Other (legacy)
OG001
OG005
Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
1.06
2-Sided
95
-5.81
7.92
Superiority or Other (legacy)
OG002
OG005
Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
0.66
2-Sided
95
-6.25
7.57
Superiority or Other (legacy)
OG003
OG005
Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-2.42
2-Sided
95
-9.26
4.42
Superiority or Other (legacy)
OG000
OG005
Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
8.91
2-Sided
95
1.48
16.35
Superiority or Other (legacy)
OG001
OG005
Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
4.13
2-Sided
95
-3.24
11.51
Superiority or Other (legacy)
OG002
OG005
Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
0.44
2-Sided
95
-6.96
7.84
Superiority or Other (legacy)
OG003
OG005
Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
2.21
2-Sided
95
-5.14
9.56
Superiority or Other (legacy)
OG000
OG005
Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
8.35
2-Sided
95
0.92
15.77
Superiority or Other (legacy)
OG001
OG005
Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
1.38
2-Sided
95
-6.03
8.80
Superiority or Other (legacy)
OG002
OG005
Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-0.87
2-Sided
95
-8.26
6.52
Superiority or Other (legacy)
OG003
OG005
Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
1.13
2-Sided
95
-6.23
8.49
Superiority or Other (legacy)
OG000
OG005
Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
9.26
2-Sided
95
1.46
17.06
Superiority or Other (legacy)
OG001
OG005
Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
1.58
2-Sided
95
-6.23
9.38
Superiority or Other (legacy)
OG002
OG005
Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-2.50
2-Sided
95
-10.27
5.27
Superiority or Other (legacy)
OG003
OG005
Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
1.79
2-Sided
95
-5.95
9.53
Superiority or Other (legacy)
OG002
PF-04171327 10 mg
Participants received PF-04171327 10 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.
OG003
PF-04171327 15 mg
Participants received PF-04171327 15 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.
OG004
Prednisone 5 mg
Participants received prednisone 5 mg QD for 8 weeks. From week 9 through 10, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every 3 days.
OG005
Prednisone 10 mg
Participants received prednisone 10 mg QD for 8 weeks. After 8 weeks of treatment, participants were tapered off prednisone dosage. From week 9 through 10, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every 3 days.
OG006
Placebo
Participants received placebo QD until week 12.
Units
Counts
Participants
OG00043
OG00141
OG00244
OG00343
OG00444
OG00542
OG00640
Title
Denominators
Categories
Title
Measurements
OG000-25.00± 21.57
OG001-28.56± 26.41
OG002-23.04± 22.00
OG003-24.30± 28.15
OG004-27.25± 23.71
OG005-27.25± 20.42
OG006-19.34± 27.21
PF-04171327 10 mg
Participants received PF-04171327 10 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.
OG003
PF-04171327 15 mg
Participants received PF-04171327 15 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.
OG004
Prednisone 5 mg
Participants received prednisone 5 mg QD for 8 weeks. From week 9 through 10, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every 3 days.
OG005
Prednisone 10 mg
Participants received prednisone 10 mg QD for 8 weeks. After 8 weeks of treatment, participants were tapered off prednisone dosage. From week 9 through 10, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every 3 days.
OG006
Placebo
Participants received placebo QD until week 12.
Units
Counts
Participants
OG00045
OG00147
OG00245
OG00348
OG00445
OG00546
OG00647
Title
Denominators
Categories
Week 2
ParticipantsOG00044
ParticipantsOG00146
ParticipantsOG00245
ParticipantsOG00347
ParticipantsOG00445
ParticipantsOG00545
ParticipantsOG00644
Title
Measurements
OG000-13.41± 2.88
OG001-17.40± 2.83
OG002-24.90± 2.86
OG003
Week 4
ParticipantsOG00045
ParticipantsOG00144
ParticipantsOG00244
ParticipantsOG00345
Week 6
ParticipantsOG00043
ParticipantsOG00142
ParticipantsOG00244
ParticipantsOG00344
Week 8
ParticipantsOG00044
ParticipantsOG00142
ParticipantsOG00244
ParticipantsOG00344
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG006
Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-2.87
2-Sided
95
-10.89
5.14
Superiority or Other (legacy)
OG001
OG006
Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-6.86
2-Sided
95
-14.80
1.08
Superiority or Other (legacy)
OG002
OG006
Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-14.36
2-Sided
95
-22.34
-6.38
Superiority or Other (legacy)
OG003
OG006
Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-12.32
2-Sided
95
-20.22
-4.41
Superiority or Other (legacy)
OG004
OG006
Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-2.14
2-Sided
95
-10.12
5.85
Superiority or Other (legacy)
OG005
OG006
Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-14.05
2-Sided
95
-22.05
-6.04
Superiority or Other (legacy)
OG000
OG006
Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-1.26
2-Sided
95
-9.83
7.30
Superiority or Other (legacy)
OG001
OG006
Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-10.10
2-Sided
95
-18.67
-1.53
Superiority or Other (legacy)
OG002
OG006
Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-15.41
2-Sided
95
-24.01
-6.82
Superiority or Other (legacy)
OG003
OG006
Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-11.79
2-Sided
95
-20.33
-3.26
Superiority or Other (legacy)
OG004
OG006
Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-5.98
2-Sided
95
-14.57
2.62
Superiority or Other (legacy)
OG005
OG006
Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-15.37
2-Sided
95
-23.98
-6.76
Superiority or Other (legacy)
OG000
OG006
Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-0.23
2-Sided
95
-9.49
9.03
Superiority or Other (legacy)
OG001
OG006
Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-10.36
2-Sided
95
-19.64
-1.08
Superiority or Other (legacy)
OG002
OG006
Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-15.57
2-Sided
95
-24.83
-6.32
Superiority or Other (legacy)
OG003
OG006
Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-11.34
2-Sided
95
-20.56
-2.13
Superiority or Other (legacy)
OG004
OG006
Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-5.36
2-Sided
95
-14.61
3.89
Superiority or Other (legacy)
OG005
OG006
Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-15.88
2-Sided
95
-25.15
-6.61
Superiority or Other (legacy)
OG000
OG006
Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-0.69
2-Sided
95
-10.32
8.94
Superiority or Other (legacy)
OG001
OG006
Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-10.27
2-Sided
95
-19.95
-0.59
Superiority or Other (legacy)
OG002
OG006
Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-19.70
2-Sided
95
-29.34
-10.06
Superiority or Other (legacy)
OG003
OG006
Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-12.65
2-Sided
95
-22.25
-3.04
Superiority or Other (legacy)
OG004
OG006
Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-7.60
2-Sided
95
-17.24
2.04
Superiority or Other (legacy)
OG005
OG006
Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-19.34
2-Sided
95
-28.99
-9.68
Superiority or Other (legacy)
OG000
OG005
Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
11.17
2-Sided
95
3.18
19.16
Superiority or Other (legacy)
OG001
OG005
Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
7.19
2-Sided
95
-0.78
15.15
Superiority or Other (legacy)
OG002
OG005
Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-0.31
2-Sided
95
-8.28
7.65
Superiority or Other (legacy)
OG003
OG005
Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
1.73
2-Sided
95
-6.14
9.61
Superiority or Other (legacy)
OG000
OG005
Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
14.11
2-Sided
95
5.51
22.71
Superiority or Other (legacy)
OG001
OG005
Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
5.27
2-Sided
95
-3.38
13.92
Superiority or Other (legacy)
OG002
OG005
Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-0.04
2-Sided
95
-8.68
8.59
Superiority or Other (legacy)
OG003
OG005
Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
3.58
2-Sided
95
-4.99
12.15
Superiority or Other (legacy)
OG000
OG005
Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
15.65
2-Sided
95
6.38
24.93
Superiority or Other (legacy)
OG001
OG005
Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
5.53
2-Sided
95
-3.81
14.86
Superiority or Other (legacy)
OG002
OG005
Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
0.31
2-Sided
95
-8.97
9.59
Superiority or Other (legacy)
OG003
OG005
Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
4.54
2-Sided
95
-4.69
13.77
Superiority or Other (legacy)
OG000
OG005
Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
18.65
2-Sided
95
9.03
28.27
Superiority or Other (legacy)
OG001
OG005
Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
9.07
2-Sided
95
-0.64
18.78
Superiority or Other (legacy)
OG002
OG005
Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-0.36
2-Sided
95
-10.00
9.28
Superiority or Other (legacy)
OG003
OG005
Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
6.69
2-Sided
95
-2.91
16.29
Superiority or Other (legacy)
Participants received PF-04171327 10 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.
OG003
PF-04171327 15 mg
Participants received PF-04171327 15 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.
OG004
Prednisone 5 mg
Participants received prednisone 5 mg QD for 8 weeks. From week 9 through 10, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every 3 days.
OG005
Prednisone 10 mg
Participants received prednisone 10 mg QD for 8 weeks. After 8 weeks of treatment, participants were tapered off prednisone dosage. From week 9 through 10, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every 3 days.
OG006
Placebo
Participants received placebo QD until week 12.
Units
Counts
Participants
OG00044
OG00140
OG00244
OG00343
OG00444
OG00542
OG00641
Title
Denominators
Categories
Title
Measurements
OG000-17.86± 26.70
OG001-19.40± 29.04
OG002-18.23± 27.75
OG003-16.60± 30.50
OG004-21.52± 24.69
OG005-25.17± 29.60
OG006-16.30± 22.41
OG002
PF-04171327 10 mg
Participants received PF-04171327 10 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.
OG003
PF-04171327 15 mg
Participants received PF-04171327 15 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.
OG004
Prednisone 5 mg
Participants received prednisone 5 mg QD for 8 weeks. From week 9 through 10, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every 3 days.
OG005
Prednisone 10 mg
Participants received prednisone 10 mg QD for 8 weeks. After 8 weeks of treatment, participants were tapered off prednisone dosage. From week 9 through 10, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every 3 days.
OG006
Placebo
Participants received placebo QD until week 12.
Units
Counts
Participants
OG00045
OG00147
OG00245
OG00348
OG00445
OG00546
OG00647
Title
Denominators
Categories
Week 2
ParticipantsOG00044
ParticipantsOG00146
ParticipantsOG00245
ParticipantsOG00347
ParticipantsOG00445
ParticipantsOG00545
ParticipantsOG00644
Title
Measurements
OG000-0.25± 0.06
OG001-0.34± 0.06
OG002-0.33± 0.06
OG003
Week 4
ParticipantsOG00045
ParticipantsOG00144
ParticipantsOG00244
ParticipantsOG00345
Week 6
ParticipantsOG00044
ParticipantsOG00142
ParticipantsOG00244
ParticipantsOG00344
Week 8
ParticipantsOG00044
ParticipantsOG00142
ParticipantsOG00244
ParticipantsOG00344
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG006
Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-0.19
2-Sided
95
-0.37
-0.02
Superiority or Other (legacy)
OG001
OG006
Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-0.29
2-Sided
95
-0.46
-0.11
Superiority or Other (legacy)
OG002
OG006
Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-0.28
2-Sided
95
-0.45
-0.10
Superiority or Other (legacy)
OG003
OG006
Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-0.35
2-Sided
95
-0.52
-0.18
Superiority or Other (legacy)
OG004
OG006
Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-0.17
2-Sided
95
-0.35
0.00
Superiority or Other (legacy)
OG005
OG006
Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-0.36
2-Sided
95
-0.53
-0.18
Superiority or Other (legacy)
OG000
OG006
Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-0.12
2-Sided
95
-0.31
0.07
Superiority or Other (legacy)
OG001
OG006
Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-0.36
2-Sided
95
-0.54
-0.17
Superiority or Other (legacy)
OG002
OG006
Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-0.28
2-Sided
95
-0.47
-0.09
Superiority or Other (legacy)
OG003
OG006
Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-0.37
2-Sided
95
-0.56
-0.18
Superiority or Other (legacy)
OG004
OG006
Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-0.20
2-Sided
95
-0.39
-0.01
Superiority or Other (legacy)
OG005
OG006
Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-0.44
2-Sided
95
-0.63
-0.25
Superiority or Other (legacy)
OG000
OG006
Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-0.14
2-Sided
95
-0.34
0.05
Superiority or Other (legacy)
OG001
OG006
Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-0.40
2-Sided
95
-0.59
-0.20
Superiority or Other (legacy)
OG002
OG006
Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-0.32
2-Sided
95
-0.51
-0.12
Superiority or Other (legacy)
OG003
OG006
Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-0.35
2-Sided
95
-0.55
-0.16
Superiority or Other (legacy)
OG004
OG006
Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-0.18
2-Sided
95
-0.38
0.01
Superiority or Other (legacy)
OG005
OG006
Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-0.47
2-Sided
95
-0.67
-0.27
Superiority or Other (legacy)
OG000
OG006
Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-0.07
2-Sided
95
-0.30
0.15
Superiority or Other (legacy)
OG001
OG006
Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-0.40
2-Sided
95
-0.63
-0.18
Superiority or Other (legacy)
OG002
OG006
Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-0.41
2-Sided
95
-0.64
-0.18
Superiority or Other (legacy)
OG003
OG006
Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-0.36
2-Sided
95
-0.59
-0.14
Superiority or Other (legacy)
OG004
OG006
Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-0.32
2-Sided
95
-0.54
-0.09
Superiority or Other (legacy)
OG005
OG006
Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-0.58
2-Sided
95
-0.81
-0.35
Superiority or Other (legacy)
OG000
OG005
Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
0.16
2-Sided
95
-0.01
0.34
Superiority or Other (legacy)
OG001
OG005
Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
0.07
2-Sided
95
-0.10
0.24
Superiority or Other (legacy)
OG002
OG005
Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
0.08
2-Sided
95
-0.10
0.25
Superiority or Other (legacy)
OG003
OG005
Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
0.00
2-Sided
95
-0.17
0.18
Superiority or Other (legacy)
OG000
OG005
Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
0.32
2-Sided
95
0.13
0.51
Superiority or Other (legacy)
OG001
OG005
Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
0.08
2-Sided
95
-0.11
0.27
Superiority or Other (legacy)
OG002
OG005
Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
0.15
2-Sided
95
-0.04
0.34
Superiority or Other (legacy)
OG003
OG005
Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
0.06
2-Sided
95
-0.13
0.25
Superiority or Other (legacy)
OG000
OG005
Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
0.32
2-Sided
95
0.13
0.52
Superiority or Other (legacy)
OG001
OG005
Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
0.07
2-Sided
95
-0.12
0.27
Superiority or Other (legacy)
OG002
OG005
Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
0.15
2-Sided
95
-0.05
0.35
Superiority or Other (legacy)
OG003
OG005
Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
0.12
2-Sided
95
-0.08
0.31
Superiority or Other (legacy)
OG000
OG005
Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
0.51
2-Sided
95
0.28
0.73
Superiority or Other (legacy)
OG001
OG005
Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
0.18
2-Sided
95
-0.05
0.40
Superiority or Other (legacy)
OG002
OG005
Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
0.17
2-Sided
95
-0.06
0.40
Superiority or Other (legacy)
OG003
OG005
Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
0.22
2-Sided
95
-0.01
0.44
Superiority or Other (legacy)
OG002
PF-04171327 10 mg
Participants received PF-04171327 10 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.
OG003
PF-04171327 15 mg
Participants received PF-04171327 15 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.
OG004
Prednisone 5 mg
Participants received prednisone 5 mg QD for 8 weeks. From week 9 through 10, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every 3 days.
OG005
Prednisone 10 mg
Participants received prednisone 10 mg QD for 8 weeks. After 8 weeks of treatment, participants were tapered off prednisone dosage. From week 9 through 10, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every 3 days.
OG006
Placebo
Participants received placebo QD until week 12.
Units
Counts
Participants
OG00044
OG00141
OG00244
OG00343
OG00444
OG00542
OG00641
Title
Denominators
Categories
Title
Measurements
OG000-0.28± 0.63
OG001-0.57± 0.65
OG002-0.37± 0.50
OG003-0.38± 0.50
OG004-0.52± 0.63
OG005-0.56± 0.59
OG006-0.26± 0.56
OG002
PF-04171327 10 mg
Participants received PF-04171327 10 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.
OG003
PF-04171327 15 mg
Participants received PF-04171327 15 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.
OG004
Prednisone 5 mg
Participants received prednisone 5 mg QD for 8 weeks. From week 9 through 10, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every 3 days.
OG005
Prednisone 10 mg
Participants received prednisone 10 mg QD for 8 weeks. After 8 weeks of treatment, participants were tapered off prednisone dosage. From week 9 through 10, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every 3 days.
OG006
Placebo
Participants received placebo QD until week 12.
Units
Counts
Participants
OG00045
OG00147
OG00245
OG00348
OG00445
OG00546
OG00647
Title
Denominators
Categories
Week 2
ParticipantsOG00044
ParticipantsOG00146
ParticipantsOG00245
ParticipantsOG00346
ParticipantsOG00445
ParticipantsOG00545
ParticipantsOG00644
Title
Measurements
OG000-0.81± 0.13
OG001-1.15± 0.13
OG002-1.21± 0.13
OG003
Week 4
ParticipantsOG00044
ParticipantsOG00143
ParticipantsOG00243
ParticipantsOG00343
Week 6
ParticipantsOG00044
ParticipantsOG00142
ParticipantsOG00244
ParticipantsOG00343
Week 8
ParticipantsOG00043
ParticipantsOG00142
ParticipantsOG00244
ParticipantsOG00342
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG006
Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-0.41
2-Sided
95
-0.78
-0.04
Superiority or Other (legacy)
OG001
OG006
Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-0.75
2-Sided
95
-1.12
-0.39
Superiority or Other (legacy)
OG002
OG006
Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-0.81
2-Sided
95
-1.18
-0.44
Superiority or Other (legacy)
OG003
OG006
Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-1.11
2-Sided
95
-1.48
-0.74
Superiority or Other (legacy)
OG004
OG006
Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-0.35
2-Sided
95
-0.72
0.02
Superiority or Other (legacy)
OG005
OG006
Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-0.83
2-Sided
95
-1.19
-0.46
Superiority or Other (legacy)
OG000
OG006
Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-0.43
2-Sided
95
-0.85
-0.00
Superiority or Other (legacy)
OG001
OG006
Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-0.73
2-Sided
95
-1.15
-0.31
Superiority or Other (legacy)
OG002
OG006
Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-0.95
2-Sided
95
-1.37
-0.52
Superiority or Other (legacy)
OG003
OG006
Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-0.96
2-Sided
95
-1.39
-0.54
Superiority or Other (legacy)
OG004
OG006
Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-0.24
2-Sided
95
-0.67
0.18
Superiority or Other (legacy)
OG005
OG006
Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-0.91
2-Sided
95
-1.33
-0.49
Superiority or Other (legacy)
OG000
OG006
Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-0.44
2-Sided
95
-0.90
0.02
Superiority or Other (legacy)
OG001
OG006
Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-0.87
2-Sided
95
-1.32
-0.41
Superiority or Other (legacy)
OG002
OG006
Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-1.07
2-Sided
95
-1.53
-0.62
Superiority or Other (legacy)
OG003
OG006
Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-1.05
2-Sided
95
-1.51
-0.60
Superiority or Other (legacy)
OG004
OG006
Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-0.43
2-Sided
95
-0.89
0.03
Superiority or Other (legacy)
OG005
OG006
Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-1.04
2-Sided
95
-1.50
-0.59
Superiority or Other (legacy)
OG000
OG006
Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-0.51
2-Sided
95
-1.00
-0.03
Superiority or Other (legacy)
OG001
OG006
Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-0.91
2-Sided
95
-1.40
-0.43
Superiority or Other (legacy)
OG002
OG006
Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-1.29
2-Sided
95
-1.77
-0.80
Superiority or Other (legacy)
OG003
OG006
Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-1.20
2-Sided
95
-1.69
-0.72
Superiority or Other (legacy)
OG004
OG006
Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-0.49
2-Sided
95
-0.98
-0.01
Superiority or Other (legacy)
OG005
OG006
Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-1.21
2-Sided
95
-1.69
-0.73
Superiority or Other (legacy)
OG000
OG005
Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
0.41
2-Sided
95
0.04
0.78
Superiority or Other (legacy)
OG001
OG005
Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
0.07
2-Sided
95
-0.29
0.44
Superiority or Other (legacy)
OG002
OG005
Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
0.02
2-Sided
95
-0.35
0.38
Superiority or Other (legacy)
OG003
OG005
Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-0.29
2-Sided
95
-0.65
0.08
Superiority or Other (legacy)
OG000
OG005
Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
0.48
2-Sided
95
0.06
0.91
Superiority or Other (legacy)
OG001
OG005
Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
0.18
2-Sided
95
-0.24
0.60
Superiority or Other (legacy)
OG002
OG005
Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-0.04
2-Sided
95
-0.46
0.38
Superiority or Other (legacy)
OG003
OG005
Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-0.05
2-Sided
95
-0.48
0.37
Superiority or Other (legacy)
OG000
OG005
Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
0.61
2-Sided
95
0.15
1.06
Superiority or Other (legacy)
OG001
OG005
Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
0.18
2-Sided
95
-0.28
0.63
Superiority or Other (legacy)
OG002
OG005
Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-0.03
2-Sided
95
-0.49
0.42
Superiority or Other (legacy)
OG003
OG005
Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-0.01
2-Sided
95
-0.47
0.44
Superiority or Other (legacy)
OG000
OG005
Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
0.70
2-Sided
95
0.22
1.18
Superiority or Other (legacy)
OG001
OG005
Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
0.30
2-Sided
95
-0.18
0.78
Superiority or Other (legacy)
OG002
OG005
Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-0.08
2-Sided
95
-0.55
0.40
Superiority or Other (legacy)
OG003
OG005
Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
0.01
2-Sided
95
-0.47
0.49
Superiority or Other (legacy)
OG002
PF-04171327 10 mg
Participants received PF-04171327 10 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.
OG003
PF-04171327 15 mg
Participants received PF-04171327 15 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.
OG004
Prednisone 5 mg
Participants received prednisone 5 mg QD for 8 weeks. From week 9 through 10, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every 3 days.
OG005
Prednisone 10 mg
Participants received prednisone 10 mg QD for 8 weeks. After 8 weeks of treatment, participants were tapered off prednisone dosage. From week 9 through 10, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every 3 days.
OG006
Placebo
Participants received placebo QD until week 12.
Units
Counts
Participants
OG00043
OG00141
OG00244
OG00341
OG00444
OG00543
OG00640
Title
Denominators
Categories
Title
Measurements
OG000-1.30± 1.21
OG001-1.37± 1.05
OG002-1.29± 1.14
OG003-1.25± 1.36
OG004-1.45± 1.05
OG005-1.62± 1.00
OG006-1.13± 1.08
OG002
PF-04171327 10 mg
Participants received PF-04171327 10 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.
OG003
PF-04171327 15 mg
Participants received PF-04171327 15 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.
OG004
Prednisone 5 mg
Participants received prednisone 5 mg QD for 8 weeks. From week 9 through 10, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every 3 days.
OG005
Prednisone 10 mg
Participants received prednisone 10 mg QD for 8 weeks. After 8 weeks of treatment, participants were tapered off prednisone dosage. From week 9 through 10, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every 3 days.
OG006
Placebo
Participants received placebo QD until week 12.
Units
Counts
Participants
OG00045
OG00147
OG00245
OG00348
OG00445
OG00546
OG00647
Title
Denominators
Categories
Week 2
ParticipantsOG00044
ParticipantsOG00146
ParticipantsOG00245
ParticipantsOG00346
ParticipantsOG00445
ParticipantsOG00544
ParticipantsOG00644
Title
Measurements
OG000-0.88± 0.14
OG001-1.29± 0.14
OG002-1.45± 0.14
OG003
Week 4
ParticipantsOG00044
ParticipantsOG00143
ParticipantsOG00243
ParticipantsOG00343
Week 6
ParticipantsOG00044
ParticipantsOG00142
ParticipantsOG00244
ParticipantsOG00343
Week 8
ParticipantsOG00043
ParticipantsOG00142
ParticipantsOG00244
ParticipantsOG00342
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG006
Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-0.36
2-Sided
95
-0.76
0.03
Superiority or Other (legacy)
OG001
OG006
Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-0.78
2-Sided
95
-1.17
-0.39
Superiority or Other (legacy)
OG002
OG006
Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-0.93
2-Sided
95
-1.32
-0.54
Superiority or Other (legacy)
OG003
OG006
Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-1.17
2-Sided
95
-1.56
-0.78
Superiority or Other (legacy)
OG004
OG006
Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-0.30
2-Sided
95
-0.70
0.09
Superiority or Other (legacy)
OG005
OG006
Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-0.95
2-Sided
95
-1.34
-0.55
Superiority or Other (legacy)
OG000
OG006
Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-0.39
2-Sided
95
-0.84
0.07
Superiority or Other (legacy)
OG001
OG006
Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-0.78
2-Sided
95
-1.23
-0.32
Superiority or Other (legacy)
OG002
OG006
Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-1.06
2-Sided
95
-1.52
-0.61
Superiority or Other (legacy)
OG003
OG006
Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-1.00
2-Sided
95
-1.45
-0.54
Superiority or Other (legacy)
OG004
OG006
Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-0.25
2-Sided
95
-0.71
0.21
Superiority or Other (legacy)
OG005
OG006
Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-1.02
2-Sided
95
-1.48
-0.57
Superiority or Other (legacy)
OG000
OG006
Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-0.39
2-Sided
95
-0.89
0.11
Superiority or Other (legacy)
OG001
OG006
Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-0.94
2-Sided
95
-1.44
-0.45
Superiority or Other (legacy)
OG002
OG006
Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-1.21
2-Sided
95
-1.71
-0.71
Superiority or Other (legacy)
OG003
OG006
Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-1.09
2-Sided
95
-1.59
-0.59
Superiority or Other (legacy)
OG004
OG006
Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-0.45
2-Sided
95
-0.95
0.05
Superiority or Other (legacy)
OG005
OG006
Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-1.15
2-Sided
95
-1.65
-0.66
Superiority or Other (legacy)
OG000
OG006
Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-0.44
2-Sided
95
-0.96
0.08
Superiority or Other (legacy)
OG001
OG006
Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-0.96
2-Sided
95
-1.48
-0.44
Superiority or Other (legacy)
OG002
OG006
Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-1.43
2-Sided
95
-1.94
-0.91
Superiority or Other (legacy)
OG003
OG006
Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-1.28
2-Sided
95
-1.80
-0.76
Superiority or Other (legacy)
OG004
OG006
Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-0.55
2-Sided
95
-1.06
-0.03
Superiority or Other (legacy)
OG005
OG006
Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-1.33
2-Sided
95
-1.85
-0.81
Superiority or Other (legacy)
OG000
OG005
Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
0.59
2-Sided
95
0.19
0.98
Superiority or Other (legacy)
OG001
OG005
Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
0.17
2-Sided
95
-0.22
0.56
Superiority or Other (legacy)
OG002
OG005
Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
0.02
2-Sided
95
-0.38
0.41
Superiority or Other (legacy)
OG003
OG005
Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-0.23
2-Sided
95
-0.62
0.16
Superiority or Other (legacy)
OG000
OG005
Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
0.64
2-Sided
95
0.18
1.09
Superiority or Other (legacy)
OG001
OG005
Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
0.24
2-Sided
95
-0.21
0.70
Superiority or Other (legacy)
OG002
OG005
Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-0.04
2-Sided
95
-0.50
0.42
Superiority or Other (legacy)
OG003
OG005
Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
0.02
2-Sided
95
-0.43
0.48
Superiority or Other (legacy)
OG000
OG005
Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
0.76
2-Sided
95
0.26
1.26
Superiority or Other (legacy)
OG001
OG005
Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
0.21
2-Sided
95
-0.29
0.70
Superiority or Other (legacy)
OG002
OG005
Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-0.06
2-Sided
95
-0.55
0.44
Superiority or Other (legacy)
OG003
OG005
Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
0.06
2-Sided
95
-0.43
0.56
Superiority or Other (legacy)
OG000
OG005
Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
0.89
2-Sided
95
0.37
1.41
Superiority or Other (legacy)
OG001
OG005
Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
0.37
2-Sided
95
-0.15
0.89
Superiority or Other (legacy)
OG002
OG005
Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-0.09
2-Sided
95
-0.61
0.42
Superiority or Other (legacy)
OG003
OG005
Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
0.05
2-Sided
95
-0.46
0.57
Superiority or Other (legacy)
OG002
PF-04171327 10 mg
Participants received PF-04171327 10 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.
OG003
PF-04171327 15 mg
Participants received PF-04171327 15 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.
OG004
Prednisone 5 mg
Participants received prednisone 5 mg QD for 8 weeks. From week 9 through 10, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every 3 days.
OG005
Prednisone 10 mg
Participants received prednisone 10 mg QD for 8 weeks. After 8 weeks of treatment, participants were tapered off prednisone dosage. From week 9 through 10, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every 3 days.
OG006
Placebo
Participants received placebo QD until week 12.
Units
Counts
Participants
OG00043
OG00141
OG00244
OG00341
OG00444
OG00542
OG00640
Title
Denominators
Categories
Title
Measurements
OG000-1.39± 1.31
OG001-1.56± 1.17
OG002-1.42± 1.19
OG003-1.38± 1.47
OG004-1.59± 1.22
OG005-1.80± 1.14
OG006-1.29± 1.21
Participants received PF-04171327 5 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.
OG002
PF-04171327 10 mg
Participants received PF-04171327 10 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.
OG003
PF-04171327 15 mg
Participants received PF-04171327 15 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.
OG004
Prednisone 5 mg
Participants received prednisone 5 mg QD for 8 weeks. From week 9 through 10, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every 3 days.
OG005
Prednisone 10 mg
Participants received prednisone 10 mg QD for 8 weeks. After 8 weeks of treatment, participants were tapered off prednisone dosage. From week 9 through 10, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every 3 days.
OG006
Placebo
Participants received placebo QD until week 12.
Units
Counts
Participants
OG00045
OG00147
OG00245
OG00348
OG00445
OG00546
OG00647
Title
Denominators
Categories
Week 4
ParticipantsOG00045
ParticipantsOG00146
ParticipantsOG00244
ParticipantsOG00347
ParticipantsOG00444
ParticipantsOG00544
ParticipantsOG00645
Title
Measurements
OG0003.59± 1.28
OG0014.53± 1.26
OG0025.22± 1.30
OG003
Week 8
ParticipantsOG00044
ParticipantsOG00142
ParticipantsOG00244
ParticipantsOG00344
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG006
Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-1.38
2-Sided
95
-4.94
2.17
Superiority or Other (legacy)
OG001
OG006
Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-0.45
2-Sided
95
-3.98
3.08
Superiority or Other (legacy)
OG002
OG006
Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
0.24
2-Sided
95
-3.34
3.82
Superiority or Other (legacy)
OG003
OG006
Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
0.76
2-Sided
95
-2.75
4.28
Superiority or Other (legacy)
OG004
OG006
Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-1.31
2-Sided
95
-4.88
2.27
Superiority or Other (legacy)
OG005
OG006
Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
2.25
2-Sided
95
-1.32
5.82
Superiority or Other (legacy)
OG000
OG006
Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-2.01
2-Sided
95
-5.89
1.87
Superiority or Other (legacy)
OG001
OG006
Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
1.49
2-Sided
95
-2.41
5.40
Superiority or Other (legacy)
OG002
OG006
Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
1.45
2-Sided
95
-2.44
5.34
Superiority or Other (legacy)
OG003
OG006
Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
1.89
2-Sided
95
-1.98
5.76
Superiority or Other (legacy)
OG004
OG006
Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
0.73
2-Sided
95
-3.16
4.61
Superiority or Other (legacy)
OG005
OG006
Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
4.18
2-Sided
95
0.29
8.06
Superiority or Other (legacy)
OG000
OG005
Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-3.64
2-Sided
95
-7.21
-0.06
Superiority or Other (legacy)
OG001
OG005
Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-2.70
2-Sided
95
-6.25
0.85
Superiority or Other (legacy)
OG002
OG005
Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-2.01
2-Sided
95
-5.63
1.60
Superiority or Other (legacy)
OG003
OG005
Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-1.49
2-Sided
95
-5.02
2.05
Superiority or Other (legacy)
OG000
OG005
Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-6.19
2-Sided
95
-10.07
-2.31
Superiority or Other (legacy)
OG001
OG005
Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-2.69
2-Sided
95
-6.60
1.23
Superiority or Other (legacy)
OG002
OG005
Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-2.73
2-Sided
95
-6.64
1.18
Superiority or Other (legacy)
OG003
OG005
Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-2.29
2-Sided
95
-6.16
1.58
Superiority or Other (legacy)
OG002
PF-04171327 10 mg
Participants received PF-04171327 10 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.
OG003
PF-04171327 15 mg
Participants received PF-04171327 15 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.
OG004
Prednisone 5 mg
Participants received prednisone 5 mg QD for 8 weeks. From week 9 through 10, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every 3 days.
OG005
Prednisone 10 mg
Participants received prednisone 10 mg QD for 8 weeks. After 8 weeks of treatment, participants were tapered off prednisone dosage. From week 9 through 10, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every 3 days.
OG006
Placebo
Participants received placebo QD until week 12.
Units
Counts
Participants
OG00044
OG00141
OG00244
OG00343
OG00443
OG00542
OG00641
Title
Denominators
Categories
Title
Measurements
OG0003.35± 11.99
OG0014.19± 9.19
OG0020.48± 8.97
OG0032.72± 10.67
OG0043.08± 12.91
OG0056.11± 12.90
OG0064.69± 10.72
Participants received PF-04171327 5 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.
OG002
PF-04171327 10 mg
Participants received PF-04171327 10 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.
OG003
PF-04171327 15 mg
Participants received PF-04171327 15 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.
OG004
Prednisone 5 mg
Participants received prednisone 5 mg QD for 8 weeks. From week 9 through 10, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every 3 days.
OG005
Prednisone 10 mg
Participants received prednisone 10 mg QD for 8 weeks. After 8 weeks of treatment, participants were tapered off prednisone dosage. From week 9 through 10, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every 3 days.
OG006
Placebo
Participants received placebo QD until week 12.
Units
Counts
Participants
OG00045
OG00147
OG00245
OG00348
OG00445
OG00546
OG00647
Title
Denominators
Categories
Week 4
ParticipantsOG00045
ParticipantsOG00146
ParticipantsOG00244
ParticipantsOG00347
ParticipantsOG00444
ParticipantsOG00544
ParticipantsOG00645
Title
Measurements
OG0003.84± 0.92
OG0015.00± 0.91
OG0028.22± 0.93
OG003
Week 8
ParticipantsOG00044
ParticipantsOG00142
ParticipantsOG00244
ParticipantsOG00344
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG006
Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
1.73
2-Sided
95
-0.83
4.30
Superiority or Other (legacy)
OG001
OG006
Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
2.90
2-Sided
95
0.35
5.45
Superiority or Other (legacy)
OG002
OG006
Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
6.12
2-Sided
95
3.54
8.70
Superiority or Other (legacy)
OG003
OG006
Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
4.73
2-Sided
95
2.19
7.26
Superiority or Other (legacy)
OG004
OG006
Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
2.18
2-Sided
95
-0.39
4.76
Superiority or Other (legacy)
OG005
OG006
Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
5.41
2-Sided
95
2.83
7.99
Superiority or Other (legacy)
OG000
OG006
Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
1.79
2-Sided
95
-1.08
4.65
Superiority or Other (legacy)
OG001
OG006
Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
4.40
2-Sided
95
1.52
7.28
Superiority or Other (legacy)
OG002
OG006
Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
6.20
2-Sided
95
3.33
9.07
Superiority or Other (legacy)
OG003
OG006
Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
3.70
2-Sided
95
0.85
6.55
Superiority or Other (legacy)
OG004
OG006
Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
3.61
2-Sided
95
0.74
6.47
Superiority or Other (legacy)
OG005
OG006
Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
6.17
2-Sided
95
3.29
9.04
Superiority or Other (legacy)
OG000
OG005
Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-3.68
2-Sided
95
-6.27
-1.09
Superiority or Other (legacy)
OG001
OG005
Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-2.51
2-Sided
95
-5.07
0.05
Superiority or Other (legacy)
OG002
OG005
Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
0.71
2-Sided
95
-1.88
3.30
Superiority or Other (legacy)
OG003
OG005
Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-0.68
2-Sided
95
-3.23
1.87
Superiority or Other (legacy)
OG000
OG005
Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-4.38
2-Sided
95
-7.26
-1.50
Superiority or Other (legacy)
OG001
OG005
Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-1.76
2-Sided
95
-4.65
1.12
Superiority or Other (legacy)
OG002
OG005
Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
0.03
2-Sided
95
-2.84
2.91
Superiority or Other (legacy)
OG003
OG005
Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Mean Difference (Final Values)
-2.47
2-Sided
95
-5.33
0.39
Superiority or Other (legacy)
OG002
PF-04171327 10 mg
Participants received PF-04171327 10 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.
OG003
PF-04171327 15 mg
Participants received PF-04171327 15 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.
OG004
Prednisone 5 mg
Participants received prednisone 5 mg QD for 8 weeks. From week 9 through 10, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every 3 days.
OG005
Prednisone 10 mg
Participants received prednisone 10 mg QD for 8 weeks. After 8 weeks of treatment, participants were tapered off prednisone dosage. From week 9 through 10, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every 3 days.