Study To Evaluate Safety And Efficacy Of PF-06700841 In S... | NCT02969018 | Trialant
NCT02969018
Sponsor
Pfizer
Status
Completed
Last Update Posted
Mar 29, 2019Actual
Enrollment
212Actual
Phase
Phase 2
Conditions
Chronic Plaque Psoriasis
Interventions
PF-06700841
Placebo
Countries
United States
Canada
Poland
Protocol Section
Identification Module
NCT ID
NCT02969018
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
B7931004
Secondary IDs
ID
Type
Description
Link
2016-004049-96
EudraCT Number
Brief Title
Study To Evaluate Safety And Efficacy Of PF-06700841 In Subjects With Moderate To Severe Plaque Psoriasis
Official Title
A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE SAFETY AND EFFICACY OF PF-06700841 IN SUBJECTS WITH MODERATE TO SEVERE PLAQUE PSORIASIS
Acronym
Not provided
Organization
PfizerINDUSTRY
Status Module
Record Verification Date
Mar 2019
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
Dec 2016Actual
Primary Completion Date
Mar 2018Actual
Completion Date
Mar 2018Actual
First Submitted Date
Nov 17, 2016
First Submission Date that Met QC Criteria
Nov 17, 2016
First Posted Date
Nov 21, 2016Estimated
Results Waived
Not provided
Results First Submitted Date
Feb 13, 2019
Results First Submitted that Met QC Criteria
Mar 28, 2019
Results First Posted Date
Mar 29, 2019Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Mar 28, 2019
Last Update Posted Date
Mar 29, 2019Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
PfizerINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
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 determine whether PF-06700841 is safe and effective in the treatment of chronic plaque psoriasis.
Detailed Description
Not provided
Conditions Module
Conditions
Chronic Plaque Psoriasis
Keywords
plaque psoriasis
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
212Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
PF-06700841 60 mg followed by 30 mg once daily
Experimental
4 week induction with 60 mg PF-06700841 once daily, followed by 8 week chronic administration of 30 mg PF-06700841 once daily
Drug: PF-06700841
PF-06700841 60 mg followed by 10 mg once daily
Experimental
4 week induction with 60 mg PF-06700841 once daily, followed by 8 week chronic administration of 10 mg PF-06700841 once daily
Drug: PF-06700841
PF-06700841 60mg once daily followed by 100mg once weekly
Experimental
4 week induction with 60 mg PF-06700841 once daily, followed by 8 week chronic administration of 100 mg PF-06700841 once weekly
Drug: PF-06700841
PF-06700841 60mg once daily followed by placebo once daily
Experimental
4 week induction with 60 mg PF-06700841 once daily, followed by 8 week chronic administration of placebo once daily
Drug: PF-06700841
PF-06700841 30mg once daily
Experimental
4 week induction with 30 mg PF-06700841 once daily followed by 8 week chronic administration of 30 mg PF-06700841 once daily
Interventions
Name
Type
Description
Arm Group Labels
Other Names
PF-06700841
Drug
PF-06700841 30mg once daily
PF-06700841 30mg once daily followed by 100mg once weekly
PF-06700841 30mg once daily followed by 10mg once daily
PF-06700841 60 mg followed by 10 mg once daily
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 12
The PASI quantifies the severity of a participant's psoriasis based on both lesion severity and the percentage of body surface area (BSA) affected. In each area, the sum of the severity rating scores for erythema, induration and scaling is multiplied by the score representing the percentage of this area involved by psoriasis, multiplied by a weighting factor (head 0.1; upper limbs 0.2; trunk 0.3; lower limbs 0.4). The sum of the numbers obtained for each of the four body areas is the PASI. The PASI score can vary in increments of 0.1 units from 0.0 to 72.0, with higher scores representing increasing severity of psoriasis.
Baseline (Day 1 pre-dose), Week 12
Secondary Outcomes
Measure
Description
Time Frame
Percentage of Participants Achieving a Psoriasis Area and Severity Index 75 (PASI75) Response at Week 12
A PASI75 response is a 75% or greater reduction from baseline in PASI score. The PASI score can vary in increments of 0.1 units from 0.0 to 72.0, with higher scores representing increasing severity of psoriasis.
Week 12
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Have had a diagnosis of plaque psoriasis (psoriasis vulgaris) for at least 6 months prior to Baseline/Day 1 (prior to first dose of study drug)
Have a PASI score of 12 or greater AND a PGA score of 3 ("moderate") or 4 ("severe") at Baseline/Day 1 (prior to first dose of study drug)
Have plaque-type psoriasis covering at least 10% of total body surface area (BSA) at Baseline/Day 1 (prior to first dose of study drug)
Considered by dermatologist investigator to be a candidate for systemic therapy or phototherapy of psoriasis (either naïve or history of previous treatment)
Exclusion Criteria:
Currently have non-plaque forms of psoriasis, eg, erythrodermic, guttate, or pustular psoriasis, with the exception of nail psoriasis which is allowed
Have evidence of skin conditions (eg, eczema) at the time of screening or baseline visit that would interfere with the evaluation of psoriasis
Cannot discontinue systemic therapies and/or topical therapies for the treatment of psoriasis and cannot discontinue phototherapy (UVB or PUVA)
Have previously been treated with Secukinumab (Cosentyx), and Ixekizumab (Taltz).
Have taken Apremilast (Otezla) within 3 months of first dose of study drug.
Have undergone treatment with tofacitinib within 3 months of first dose.
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
75 Years
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Pfizer CT.gov Call Center
Pfizer
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Northwest Arkansas Clinical Trials Center, PLLC/Hull Dermatology, PA
Hughes JH, Qiu R, Banfield C, Dowty ME, Nicholas T. Population Pharmacokinetics of Oral Brepocitinib in Healthy Volunteers and Patients. Clin Pharmacol Drug Dev. 2022 Dec;11(12):1447-1456. doi: 10.1002/cpdd.1163. Epub 2022 Aug 31.
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.
PF-06700841 60 mg Once Daily (QD) Followed by 30 mg QD
Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 30 mg QD (blinded tablets).
PF-06700841 30mg once daily followed by 10mg once daily
Experimental
4 week induction with 30 mg PF-06700841 once daily, followed by 8 week chronic administration of 10 mg PF-06700841 once daily
Drug: PF-06700841
PF-06700841 30mg once daily followed by 100mg once weekly
Experimental
4 week induction with 30 mg PF-06700841 once daily, followed by 8 week chronic administration of 100 mg PF-06700841 once weekly
Drug: PF-06700841
Placebo
Placebo Comparator
12 weeks once daily placebo
Other: Placebo
PF-06700841 60 mg followed by 30 mg once daily
PF-06700841 60mg once daily followed by 100mg once weekly
PF-06700841 60mg once daily followed by placebo once daily
Placebo
Other
Placebo
Change From Baseline in PASI Scores at Week 4 by Induction Dose
Change from baseline in PASI scores at Week 4 was presented by induction dose (ie, PF-06700841 60 mg QD, 30 mg QD, and placebo). The PASI score can vary in increments of 0.1 units from 0.0 to 72.0, with higher scores representing increasing severity of psoriasis.
Baseline (Day 1 pre-dose), Week 4
Percentage of Participants Achieving PASI75 Responses at Weeks 1, 2, 4, 6, 8, 10, 14, 16
A PASI75 response is a 75% or greater reduction from baseline in PASI score. The PASI score can vary in increments of 0.1 units from 0.0 to 72.0, with higher scores representing increasing severity of psoriasis.
Weeks 1, 2, 4, 6, 8, 10, 14, 16
Percentage of Participants Achieving a Psoriasis Area and Severity Index 50 (PASI50) Response at Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16
A PASI50 response is a 50% or greater reduction from baseline in PASI score. The PASI score can vary in increments of 0.1 units from 0.0 to 72.0, with higher scores representing increasing severity of psoriasis.
Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16
Percentage of Participants Achieving a Psoriasis Area and Severity Index 90 (PASI90) Response at Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16
A PASI90 response is a 90% or greater reduction from baseline in PASI score. The PASI score can vary in increments of 0.1 units from 0.0 to 72.0, with higher scores representing increasing severity of psoriasis.
Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16
Change From Baseline in PASI Scores at Weeks 1, 2, 4, 6, 8, 10, 14, 16
The PASI score can vary in increments of 0.1 units from 0.0 to 72.0, with higher scores representing increasing severity of psoriasis.
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE (non-serious and serious) was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening (immediate risk of death); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect; or an important medical event. Any such events with initial onset or increasing in severity after the first dose of study treatment were counted as treatment-emergent.
From first dose of study treatment (Day 1) up to Week 20
Number of Participants Who Discontinued From the Study Due to Treatment-Emergent AEs
The number of participants who discontinued from the study due to treatment-emergent AEs is presented. Note for data reported under this Outcome Measure: Per sponsor reporting standard, pregnancy was counted as AE for AE data tables while it was counted separately in the disposition data table (Participant Flow Module).
From first dose of study treatment (Day 1) up to Week 20
Change From Baseline in Blood Lipid Level at Weeks 4 and 12
Lipid panel included low density lipoprotein (LDL) cholesterol, high density lipoprotein (HDL) cholesterol, total cholesterol, and triglycerides.
Baseline (Day 1 pre-dose), Weeks 4 and 12
Number of Participants With Any Post-Baseline Laboratory Test Abnormalities
From first dose of study treatment (Day 1) up to Week 16
Number of Participants With Post-Baseline Vital Sign Abnormalities
Vital signs categorical summarization criteria: 1) sitting systolic blood pressure (SBP) <90 millimeters of mercury (mmHg); 2) sitting diastolic blood pressure (DBP) <50 mmHg; 3) sitting pulse rate <40 or >120 beats per minute (bpm); 4) change from baseline (increase or decrease) in sitting DBP greater than or equal to (>=) 20 mmHg; 5) change from baseline (increase or decrease) in sitting SBP >=30 mmHg.
From first dose of study treatment (Day 1) up to Week 16
Number of Participants With Post-Baseline Electrocardiogram (ECG) Abnormalities
ECG categorical summarization criteria: 1) QRS duration (time from ECG Q wave to the end of the S wave corresponding to ventricle depolarization): >=140 milliseconds (msec), >=50% change from baseline; 2) PR interval (the interval between the start of the P wave and the start of the QRS complex, corresponding to the time between the onset of the atrial depolarization and onset of ventricular depolarization): >=300 msec, >=25% change when baseline is > 200 msec or >=50% change when baseline is less than or equal to (<=) 200 msec; 3) QT interval (time from ECG Q wave to the end of the T wave corresponding to electrical systole): absolute value of >=500 msec; 4) QTc interval (QT corrected for heart rate): absolute value of 450 to <480 msec, 480 to <500 msec, >=500 msec; a change from baseline of 30 to <60 msec or >=60 msec.
From first dose of study treatment (Day 1) up to Week 16
Anaheim Clinical Trials, LLC
Anaheim
California
92801
United States
California Dermatology & Clinical Research Institute
Encinitas
California
92024
United States
Emil A. Tanghetti, MD dba Center for Dermatology and Laser Surgery
Sacramento
California
95819
United States
Southern California Dermatology
Santa Ana
California
92701
United States
Tower Saint John's Imaging
Santa Monica
California
90403
United States
Clinical Science Institute
Santa Monica
California
90404
United States
Park Avenue Dermatology Administrative Annex
Orange Park
Florida
32073
United States
Park Avenue Dermatology
Orange Park
Florida
32073
United States
Olympian Clinical Research
Tampa
Florida
33609
United States
Rose Radiology
Tampa
Florida
33609
United States
Forward Clinical Trials, Inc
Tampa
Florida
33624
United States
Dundee Dermatology
West Dundee
Illinois
60118
United States
Dawes Fretzin Clinical Research Group, LLC
Indianapolis
Indiana
46256
United States
Dawes Fretzin Dermatology Group, LLC
Indianapolis
Indiana
46256
United States
Psoriasis Treatment Center of Central New Jersey
East Windsor
New Jersey
08520
United States
The Rockefeller University
New York
New York
10065
United States
Skin Search of Rochester, Inc.
Rochester
New York
14623
United States
Investigational Drug Services, UNC Hospitals
Chapel Hill
North Carolina
27514
United States
UNC Dermatology and Skin Cancer Center
Chapel Hill
North Carolina
27516
United States
UNC Clinical and Translation Research Center
Chapel Hill
North Carolina
27599
United States
Lynn Health Science Institute
Oklahoma City
Oklahoma
73112
United States
Vital Prospects Clinical Research Institute, P.C
Tulsa
Oklahoma
74136
United States
Health Concepts
Rapid City
South Dakota
57702
United States
Center for Clinical Studies
Houston
Texas
77004
United States
Lee Medical Associates, PA
San Antonio
Texas
78213
United States
Progressive Clinical Research, PA
San Antonio
Texas
78213
United States
Texas Dermatology and Laser Specialists
San Antonio
Texas
78218
United States
Virginia Clinical Research, Inc.
Norfolk
Virginia
23502
United States
Premier Clinical Research
Spokane
Washington
99202
United States
Wiseman Dermatology Research Inc.
Winnipeg
Manitoba
R3M 3Z4
Canada
Lynderm Research Inc
Markham
Ontario
L3P 1X2
Canada
Research by ICLS
Oakville
Ontario
L6J 7W5
Canada
Skin Centre for Dermatology
Peterborough
Ontario
K9J 5K2
Canada
The Centre for Dermatology
Richmond Hill
Ontario
L4B 1A5
Canada
K.Papp Clinical Research Inc.
Waterloo
Ontario
N2J 1C4
Canada
Centre de Recherche Dermatologique du Quebec metropolitain (CRDQ)
Fensome A, Ambler CM, Arnold E, Banker ME, Brown MF, Chrencik J, Clark JD, Dowty ME, Efremov IV, Flick A, Gerstenberger BS, Gopalsamy A, Hayward MM, Hegen M, Hollingshead BD, Jussif J, Knafels JD, Limburg DC, Lin D, Lin TH, Pierce BS, Saiah E, Sharma R, Symanowicz PT, Telliez JB, Trujillo JI, Vajdos FF, Vincent F, Wan ZK, Xing L, Yang X, Yang X, Zhang L. Dual Inhibition of TYK2 and JAK1 for the Treatment of Autoimmune Diseases: Discovery of (( S)-2,2-Difluorocyclopropyl)((1 R,5 S)-3-(2-((1-methyl-1 H-pyrazol-4-yl)amino)pyrimidin-4-yl)-3,8-diazabicyclo[3.2.1]octan-8-yl)methanone (PF-06700841). J Med Chem. 2018 Oct 11;61(19):8597-8612. doi: 10.1021/acs.jmedchem.8b00917. Epub 2018 Aug 16.
Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 10 mg QD (blinded tablets).
FG002
PF-06700841 60 mg QD Followed by 100 mg Once Weekly (QW)
Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 100 mg QW (blinded tablets).
FG003
PF-06700841 60 mg QD Followed by Placebo
Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of matching placebo QD (blinded tablets).
FG004
PF-06700841 30 mg QD
Participants received 12 weeks of blinded PF-06700841 30 mg QD tablets.
FG005
PF-06700841 30 mg QD Followed by 10 mg QD
Participants received 4-week induction of PF-06700841 30 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 10 mg QD (blinded tablets).
FG006
PF-06700841 30 mg QD Followed by 100 mg QW
Participants received 4-week induction of PF-06700841 30 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 100 mg QW (blinded tablets).
FG007
Placebo
Participants received 12 weeks of blinded matching placebo QD tablets.
FG00025 subjects
FG00129 subjects
FG00226 subjects
FG00325 subjects
FG00429 subjects
FG00525 subjects
FG00630 subjects
FG00723 subjects
COMPLETED
FG00021 subjects
FG00121 subjects
FG00220 subjects
FG00320 subjects
FG00427 subjects
FG00517 subjects
FG00622 subjects
FG00716 subjects
NOT COMPLETED
FG0004 subjects
FG0018 subjects
FG0026 subjects
FG0035 subjects
FG0042 subjects
FG0058 subjects
FG0068 subjects
FG0077 subjects
Type
Comment
Reasons
Adverse Event
FG0002 subjects
FG0014 subjects
FG0021 subjects
FG0032 subjects
FG0040 subjects
FG0051 subjects
FG0062 subjects
FG0070 subjects
Lack of Efficacy
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Lost to Follow-up
FG0001 subjects
FG0012 subjects
FG0022 subjects
FG0030 subjects
FG004
No Longer Meets Eligibility Criteria
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Non-Compliance With Study Drug
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Other
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Pregnancy
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Protocol Violation
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0031 subjects
FG004
Withdrawal by Subject
FG0000 subjects
FG0011 subjects
FG0022 subjects
FG0031 subjects
FG004
All participants who received at least 1 dose of PF-06700841 or placebo.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
PF-06700841 60 mg Once Daily (QD) Followed by 30 mg QD
Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 30 mg QD (blinded tablets).
BG001
PF-06700841 60 mg QD Followed by 10 mg QD
Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 10 mg QD (blinded tablets).
BG002
PF-06700841 60 mg QD Followed by 100 mg Once Weekly (QW)
Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 100 mg QW (blinded tablets).
BG003
PF-06700841 60 mg QD Followed by Placebo
Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of matching placebo QD (blinded tablets).
BG004
PF-06700841 30 mg QD
Participants received 12 weeks of blinded PF-06700841 30 mg QD tablets.
BG005
PF-06700841 30 mg QD Followed by 10 mg QD
Participants received 4-week induction of PF-06700841 30 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 10 mg QD (blinded tablets).
BG006
PF-06700841 30 mg QD Followed by 100 mg QW
Participants received 4-week induction of PF-06700841 30 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 100 mg QW (blinded tablets).
BG007
Placebo
Participants received 12 weeks of blinded matching placebo QD tablets.
BG008
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00025
BG00129
BG00226
BG00325
BG00429
BG00525
BG00630
BG00723
BG008212
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
BG00049.0± 14.69
BG00144.6± 13.71
BG00245.5± 12.93
BG003
Age, Customized
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
18-44 Years
BG0008
BG00114
BG002
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0009
BG0018
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0004
BG0014
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
White
BG00022
BG00127
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
Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 12
The PASI quantifies the severity of a participant's psoriasis based on both lesion severity and the percentage of body surface area (BSA) affected. In each area, the sum of the severity rating scores for erythema, induration and scaling is multiplied by the score representing the percentage of this area involved by psoriasis, multiplied by a weighting factor (head 0.1; upper limbs 0.2; trunk 0.3; lower limbs 0.4). The sum of the numbers obtained for each of the four body areas is the PASI. The PASI score can vary in increments of 0.1 units from 0.0 to 72.0, with higher scores representing increasing severity of psoriasis.
All randomized participants who received at least 1 dose of investigational product (PF-06700841 or placebo) and had observed PASI data for Week 12.
Posted
Least Squares Mean
90% Confidence Interval
units on a scale
Baseline (Day 1 pre-dose), Week 12
ID
Title
Description
OG000
PF-06700841 60 mg Once Daily (QD) Followed by 30 mg QD
Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 30 mg QD (blinded tablets).
OG001
PF-06700841 60 mg QD Followed by 10 mg QD
Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 10 mg QD (blinded tablets).
OG002
PF-06700841 60 mg QD Followed by 100 mg Once Weekly (QW)
Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 100 mg QW (blinded tablets).
OG003
PF-06700841 60 mg QD Followed by Placebo
Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of matching placebo QD (blinded tablets).
OG004
PF-06700841 30 mg QD
Participants received 12 weeks of blinded PF-06700841 30 mg QD tablets.
OG005
PF-06700841 30 mg QD Followed by 10 mg QD
Participants received 4-week induction of PF-06700841 30 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 10 mg QD (blinded tablets).
OG006
PF-06700841 30 mg QD Followed by 100 mg QW
Participants received 4-week induction of PF-06700841 30 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 100 mg QW (blinded tablets).
OG007
Placebo
Participants received 12 weeks of blinded matching placebo QD tablets.
Units
Counts
Participants
OG00022
OG00121
OG00221
OG003
Title
Denominators
Categories
Title
Measurements
OG000-15.85(-18.31 to -13.39)
OG001-10.56(-12.96 to -8.16)
OG002-14.28(-16.75 to -11.81)
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
OG007
Mixed Models Analysis
0.0005
Hochberg adjusted p-value
Least Squares Mean Difference
-8.64
Standard Error of the Mean
2.232
2-Sided
90
-12.33
-4.95
Other
OG001
OG007
Mixed Models Analysis
Secondary
Percentage of Participants Achieving a Psoriasis Area and Severity Index 75 (PASI75) Response at Week 12
A PASI75 response is a 75% or greater reduction from baseline in PASI score. The PASI score can vary in increments of 0.1 units from 0.0 to 72.0, with higher scores representing increasing severity of psoriasis.
All participants who received at least 1 dose of investigational product (PF-06700841 or placebo) with PASI data at Week 12 after non-responder imputation applied.
Posted
Number
90% Confidence Interval
percentage of participants
Week 12
ID
Title
Description
OG000
PF-06700841 60 mg Once Daily (QD) Followed by 30 mg QD
Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 30 mg QD (blinded tablets).
OG001
PF-06700841 60 mg QD Followed by 10 mg QD
Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 10 mg QD (blinded tablets).
OG002
PF-06700841 60 mg QD Followed by 100 mg Once Weekly (QW)
Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 100 mg QW (blinded tablets).
Secondary
Change From Baseline in PASI Scores at Week 4 by Induction Dose
Change from baseline in PASI scores at Week 4 was presented by induction dose (ie, PF-06700841 60 mg QD, 30 mg QD, and placebo). The PASI score can vary in increments of 0.1 units from 0.0 to 72.0, with higher scores representing increasing severity of psoriasis.
All participants who received at least 1 dose of investigational product (PF-06700841 or placebo) and had observed PASI data at Week 4.
Posted
Least Squares Mean
90% Confidence Interval
units on a scale
Baseline (Day 1 pre-dose), Week 4
ID
Title
Description
OG000
PF-06700841 60 mg QD as the Induction Dose
Participants received PF-06700841 60 mg QD as the induction dose.
OG001
PF-06700841 30 mg QD as the Induction Dose
Participants received PF-06700841 30 mg QD as the induction dose.
OG002
Placebo as the Induction Dose
Participants received matching placebo QD as the induction dose.
Units
Secondary
Percentage of Participants Achieving PASI75 Responses at Weeks 1, 2, 4, 6, 8, 10, 14, 16
A PASI75 response is a 75% or greater reduction from baseline in PASI score. The PASI score can vary in increments of 0.1 units from 0.0 to 72.0, with higher scores representing increasing severity of psoriasis.
All participants who received at least 1 dose of investigational product (PF-06700841 or placebo) with PASI data for each specified time point after non-responder imputation applied.
Posted
Number
90% Confidence Interval
percentage of participants
Weeks 1, 2, 4, 6, 8, 10, 14, 16
ID
Title
Description
OG000
PF-06700841 60 mg Once Daily (QD) Followed by 30 mg QD
Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 30 mg QD (blinded tablets).
OG001
PF-06700841 60 mg QD Followed by 10 mg QD
Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 10 mg QD (blinded tablets).
OG002
PF-06700841 60 mg QD Followed by 100 mg Once Weekly (QW)
Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 100 mg QW (blinded tablets).
Secondary
Percentage of Participants Achieving a Psoriasis Area and Severity Index 50 (PASI50) Response at Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16
A PASI50 response is a 50% or greater reduction from baseline in PASI score. The PASI score can vary in increments of 0.1 units from 0.0 to 72.0, with higher scores representing increasing severity of psoriasis.
All participants who received at least 1 dose of investigational product (PF-06700841 or placebo) with PASI data for each specified time point after non-responder imputation applied.
Posted
Number
90% Confidence Interval
percentage of participants
Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16
ID
Title
Description
OG000
PF-06700841 60 mg Once Daily (QD) Followed by 30 mg QD
Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 30 mg QD (blinded tablets).
OG001
PF-06700841 60 mg QD Followed by 10 mg QD
Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 10 mg QD (blinded tablets).
OG002
PF-06700841 60 mg QD Followed by 100 mg Once Weekly (QW)
Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 100 mg QW (blinded tablets).
Secondary
Percentage of Participants Achieving a Psoriasis Area and Severity Index 90 (PASI90) Response at Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16
A PASI90 response is a 90% or greater reduction from baseline in PASI score. The PASI score can vary in increments of 0.1 units from 0.0 to 72.0, with higher scores representing increasing severity of psoriasis.
All participants who received at least 1 dose of investigational product (PF-06700841 or placebo) with PASI data for each specified time point after non-responder imputation applied.
Posted
Number
90% Confidence Interval
percentage of participants
Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16
ID
Title
Description
OG000
PF-06700841 60 mg Once Daily (QD) Followed by 30 mg QD
Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 30 mg QD (blinded tablets).
OG001
PF-06700841 60 mg QD Followed by 10 mg QD
Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 10 mg QD (blinded tablets).
OG002
PF-06700841 60 mg QD Followed by 100 mg Once Weekly (QW)
Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 100 mg QW (blinded tablets).
Secondary
Change From Baseline in PASI Scores at Weeks 1, 2, 4, 6, 8, 10, 14, 16
The PASI score can vary in increments of 0.1 units from 0.0 to 72.0, with higher scores representing increasing severity of psoriasis.
"Number of participants analyzed" represents all participants who received at least 1 dose of investigational product (PF-06700841 or placebo). "Number analyzed" represents all participants who received at least 1 dose of investigational product (PF-06700841 or placebo) and had observed PASI data for each specified time point.
PF-06700841 60 mg Once Daily (QD) Followed by 30 mg QD
Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 30 mg QD (blinded tablets).
OG001
PF-06700841 60 mg QD Followed by 10 mg QD
Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 10 mg QD (blinded tablets).
OG002
PF-06700841 60 mg QD Followed by 100 mg Once Weekly (QW)
Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 100 mg QW (blinded tablets).
Secondary
Percent Change From Baseline in PASI Scores at Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16
The PASI score can vary in increments of 0.1 units from 0.0 to 72.0, with higher scores representing increasing severity of psoriasis.
"Number of participants analyzed" represents all participants who received at least 1 dose of investigational product (PF-06700841 or placebo). "Number analyzed" represents all participants who received at least 1 dose of investigational product (PF-06700841 or placebo) and had observed PASI data for each specified time point.
PF-06700841 60 mg Once Daily (QD) Followed by 30 mg QD
Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 30 mg QD (blinded tablets).
OG001
PF-06700841 60 mg QD Followed by 10 mg QD
Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 10 mg QD (blinded tablets).
OG002
PF-06700841 60 mg QD Followed by 100 mg Once Weekly (QW)
Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 100 mg QW (blinded tablets).
Secondary
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE (non-serious and serious) was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening (immediate risk of death); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect; or an important medical event. Any such events with initial onset or increasing in severity after the first dose of study treatment were counted as treatment-emergent.
All participants who received at least 1 dose of investigational product (PF-06700841 or placebo).
Posted
Count of Participants
Participants
From first dose of study treatment (Day 1) up to Week 20
ID
Title
Description
OG000
PF-06700841 60 mg Once Daily (QD) Followed by 30 mg QD
Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 30 mg QD (blinded tablets).
OG001
PF-06700841 60 mg QD Followed by 10 mg QD
Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 10 mg QD (blinded tablets).
Secondary
Number of Participants Who Discontinued From the Study Due to Treatment-Emergent AEs
The number of participants who discontinued from the study due to treatment-emergent AEs is presented. Note for data reported under this Outcome Measure: Per sponsor reporting standard, pregnancy was counted as AE for AE data tables while it was counted separately in the disposition data table (Participant Flow Module).
All participants who received at least 1 dose of investigational product (PF-06700841 or placebo).
Posted
Count of Participants
Participants
From first dose of study treatment (Day 1) up to Week 20
ID
Title
Description
OG000
PF-06700841 60 mg Once Daily (QD) Followed by 30 mg QD
Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 30 mg QD (blinded tablets).
OG001
PF-06700841 60 mg QD Followed by 10 mg QD
Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 10 mg QD (blinded tablets).
OG002
PF-06700841 60 mg QD Followed by 100 mg Once Weekly (QW)
Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 100 mg QW (blinded tablets).
Secondary
Change From Baseline in Blood Lipid Level at Weeks 4 and 12
Lipid panel included low density lipoprotein (LDL) cholesterol, high density lipoprotein (HDL) cholesterol, total cholesterol, and triglycerides.
"Number of participants analyzed" represents all participants who received at least 1 dose of investigational product (PF-06700841 or placebo). "Number analyzed" represents all participants who received at least 1 dose of investigational product (PF-06700841 or placebo) and had data for each specified category.
Posted
Mean
90% Confidence Interval
milligram per deciliter (mg/dL)
Baseline (Day 1 pre-dose), Weeks 4 and 12
ID
Title
Description
OG000
PF-06700841 60 mg Once Daily (QD) Followed by 30 mg QD
Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 30 mg QD (blinded tablets).
OG001
PF-06700841 60 mg QD Followed by 10 mg QD
Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 10 mg QD (blinded tablets).
OG002
PF-06700841 60 mg QD Followed by 100 mg Once Weekly (QW)
Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 100 mg QW (blinded tablets).
Secondary
Number of Participants With Any Post-Baseline Laboratory Test Abnormalities
All participants who received at least 1 dose of investigational product (PF-06700841 or placebo) and had post-baseline laboratory data.
Posted
Count of Participants
Participants
From first dose of study treatment (Day 1) up to Week 16
ID
Title
Description
OG000
PF-06700841 60 mg Once Daily (QD) Followed by 30 mg QD
Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 30 mg QD (blinded tablets).
OG001
PF-06700841 60 mg QD Followed by 10 mg QD
Secondary
Number of Participants With Post-Baseline Vital Sign Abnormalities
Vital signs categorical summarization criteria: 1) sitting systolic blood pressure (SBP) <90 millimeters of mercury (mmHg); 2) sitting diastolic blood pressure (DBP) <50 mmHg; 3) sitting pulse rate <40 or >120 beats per minute (bpm); 4) change from baseline (increase or decrease) in sitting DBP greater than or equal to (>=) 20 mmHg; 5) change from baseline (increase or decrease) in sitting SBP >=30 mmHg.
All participants who received at least 1 dose of investigational product (PF-06700841 or placebo) and had post-baseline vital signs data.
Posted
Count of Participants
Participants
From first dose of study treatment (Day 1) up to Week 16
ID
Title
Description
OG000
PF-06700841 60 mg Once Daily (QD) Followed by 30 mg QD
Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 30 mg QD (blinded tablets).
OG001
PF-06700841 60 mg QD Followed by 10 mg QD
Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 10 mg QD (blinded tablets).
OG002
PF-06700841 60 mg QD Followed by 100 mg Once Weekly (QW)
Secondary
Number of Participants With Post-Baseline Electrocardiogram (ECG) Abnormalities
ECG categorical summarization criteria: 1) QRS duration (time from ECG Q wave to the end of the S wave corresponding to ventricle depolarization): >=140 milliseconds (msec), >=50% change from baseline; 2) PR interval (the interval between the start of the P wave and the start of the QRS complex, corresponding to the time between the onset of the atrial depolarization and onset of ventricular depolarization): >=300 msec, >=25% change when baseline is > 200 msec or >=50% change when baseline is less than or equal to (<=) 200 msec; 3) QT interval (time from ECG Q wave to the end of the T wave corresponding to electrical systole): absolute value of >=500 msec; 4) QTc interval (QT corrected for heart rate): absolute value of 450 to <480 msec, 480 to <500 msec, >=500 msec; a change from baseline of 30 to <60 msec or >=60 msec.
All participants who received at least 1 dose of investigational product (PF-06700841 or placebo) and had post-baseline ECG data.
Posted
Count of Participants
Participants
From first dose of study treatment (Day 1) up to Week 16
ID
Title
Description
OG000
PF-06700841 60 mg Once Daily (QD) Followed by 30 mg QD
Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 30 mg QD (blinded tablets).
OG001
PF-06700841 60 mg QD Followed by 10 mg QD
Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 10 mg QD (blinded tablets).
Time Frame
From first dose of study treatment up to 20 weeks
Description
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious 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-06700841 60 mg Once Daily (QD) Followed by 30 mg QD
Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 30 mg QD (blinded tablets).
1
25
2
25
11
25
EG001
PF-06700841 60 mg QD Followed by 10 mg QD
Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 10 mg QD (blinded tablets).
0
29
1
29
14
29
EG002
PF-06700841 60 mg QD Followed by 100 mg Once Weekly (QW)
Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 100 mg QW (blinded tablets).
0
26
1
26
13
26
EG003
PF-06700841 60 mg QD Followed by Placebo
Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of matching placebo QD (blinded tablets).
0
25
1
25
13
25
EG004
PF-06700841 30 mg QD
Participants received 12 weeks of blinded PF-06700841 30 mg QD tablets.
0
29
0
29
13
29
EG005
PF-06700841 30 mg QD Followed by 10 mg QD
Participants received 4-week induction of PF-06700841 30 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 10 mg QD (blinded tablets).
0
25
0
25
12
25
EG006
PF-06700841 30 mg QD Followed by 100 mg QW
Participants received 4-week induction of PF-06700841 30 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 100 mg QW (blinded tablets).
0
30
0
30
16
30
EG007
Placebo
Participants received 12 weeks of blinded matching placebo QD tablets.
0
23
0
23
9
23
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA v20.1
Non-systematic Assessment
EG0000 events0 affected25 at risk
EG0011 events1 affected29 at risk
EG0020 events0 affected26 at risk
EG0030 events0 affected25 at risk
EG0040 events0 affected29 at risk
EG0050 events0 affected25 at risk
EG0060 events0 affected30 at risk
EG0070 events0 affected23 at risk
Angina pectoris
Cardiac disorders
MedDRA v20.1
Non-systematic Assessment
EG0001 events1 affected25 at risk
EG0010 events0 affected29 at risk
EG0020 events0 affected26 at risk
EG003
Chest pain
General disorders
MedDRA v20.1
Non-systematic Assessment
EG0000 events0 affected25 at risk
EG0010 events0 affected29 at risk
EG0020 events0 affected26 at risk
EG003
Pneumonia
Infections and infestations
MedDRA v20.1
Non-systematic Assessment
EG0000 events0 affected25 at risk
EG0010 events0 affected29 at risk
EG0021 events1 affected26 at risk
EG003
Sepsis
Infections and infestations
MedDRA v20.1
Non-systematic Assessment
EG0000 events0 affected25 at risk
EG0010 events0 affected29 at risk
EG0021 events1 affected26 at risk
EG003
Gun shot wound
Injury, poisoning and procedural complications
MedDRA v20.1
Non-systematic Assessment
EG0001 events1 affected25 at risk
EG0010 events0 affected29 at risk
EG0020 events0 affected26 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Diarrhoea
Gastrointestinal disorders
MedDRA v20.1
Non-systematic Assessment
EG0000 events0 affected25 at risk
EG0011 events1 affected29 at risk
EG0020 events0 affected26 at risk
EG0031 events1 affected25 at risk
EG0040 events0 affected29 at risk
EG0051 events1 affected25 at risk
EG0064 events3 affected30 at risk
EG0071 events1 affected23 at risk
Nausea
Gastrointestinal disorders
MedDRA v20.1
Non-systematic Assessment
EG0001 events1 affected25 at risk
EG0011 events1 affected29 at risk
EG0021 events1 affected26 at risk
EG003
Fatigue
General disorders
MedDRA v20.1
Non-systematic Assessment
EG0001 events1 affected25 at risk
EG0011 events1 affected29 at risk
EG0021 events1 affected26 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA v20.1
Non-systematic Assessment
EG0002 events2 affected25 at risk
EG0011 events1 affected29 at risk
EG0025 events5 affected26 at risk
EG003
Headache
Nervous system disorders
MedDRA v20.1
Non-systematic Assessment
EG0001 events1 affected25 at risk
EG0012 events2 affected29 at risk
EG0023 events3 affected26 at risk
EG003
Psoriasis
Skin and subcutaneous tissue disorders
MedDRA v20.1
Non-systematic Assessment
EG0000 events0 affected25 at risk
EG0011 events1 affected29 at risk
EG0023 events3 affected26 at risk
EG003
Cheilitis
Gastrointestinal disorders
MedDRA v20.1
Non-systematic Assessment
EG0000 events0 affected25 at risk
EG0010 events0 affected29 at risk
EG0020 events0 affected26 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA v20.1
Non-systematic Assessment
EG0000 events0 affected25 at risk
EG0011 events1 affected29 at risk
EG0021 events1 affected26 at risk
EG003
Bronchitis
Infections and infestations
MedDRA v20.1
Non-systematic Assessment
EG0000 events0 affected25 at risk
EG0012 events2 affected29 at risk
EG0020 events0 affected26 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA v20.1
Non-systematic Assessment
EG0004 events4 affected25 at risk
EG0014 events3 affected29 at risk
EG0023 events3 affected26 at risk
EG003
Sinusitis
Infections and infestations
MedDRA v20.1
Non-systematic Assessment
EG0001 events1 affected25 at risk
EG0010 events0 affected29 at risk
EG0022 events1 affected26 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA v20.1
Non-systematic Assessment
EG0000 events0 affected25 at risk
EG0011 events1 affected29 at risk
EG0021 events1 affected26 at risk
EG003
Hot flush
Vascular disorders
MedDRA v20.1
Non-systematic Assessment
EG0000 events0 affected25 at risk
EG0010 events0 affected29 at risk
EG0020 events0 affected26 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA v20.1
Non-systematic Assessment
EG0000 events0 affected25 at risk
EG0010 events0 affected29 at risk
EG0021 events1 affected26 at risk
EG003
Acne
Skin and subcutaneous tissue disorders
MedDRA v20.1
Non-systematic Assessment
EG0000 events0 affected25 at risk
EG0012 events2 affected29 at risk
EG0020 events0 affected26 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA v20.1
Non-systematic Assessment
EG0000 events0 affected25 at risk
EG0010 events0 affected29 at risk
EG0021 events1 affected26 at risk
EG003
Irritability
Psychiatric disorders
MedDRA v20.1
Non-systematic Assessment
EG0000 events0 affected25 at risk
EG0010 events0 affected29 at risk
EG0020 events0 affected26 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA v20.1
Non-systematic Assessment
EG0001 events1 affected25 at risk
EG0012 events2 affected29 at risk
EG0020 events0 affected26 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA v20.1
Non-systematic Assessment
EG0003 events1 affected25 at risk
EG0012 events2 affected29 at risk
EG0020 events0 affected26 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA v20.1
Non-systematic Assessment
EG0000 events0 affected25 at risk
EG0010 events0 affected29 at risk
EG0021 events1 affected26 at risk
EG003
Ligament sprain
Injury, poisoning and procedural complications
MedDRA v20.1
Non-systematic Assessment
EG0000 events0 affected25 at risk
EG0011 events1 affected29 at risk
EG0020 events0 affected26 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.
Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of matching placebo QD (blinded tablets).
OG004
PF-06700841 30 mg QD
Participants received 12 weeks of blinded PF-06700841 30 mg QD tablets.
OG005
PF-06700841 30 mg QD Followed by 10 mg QD
Participants received 4-week induction of PF-06700841 30 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 10 mg QD (blinded tablets).
OG006
PF-06700841 30 mg QD Followed by 100 mg QW
Participants received 4-week induction of PF-06700841 30 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 100 mg QW (blinded tablets).
OG007
Placebo
Participants received 12 weeks of blinded matching placebo QD tablets.
Units
Counts
Participants
OG00025
OG00129
OG00226
OG00325
OG00429
OG00525
OG00630
OG00723
Title
Denominators
Categories
Title
Measurements
OG00060.0(41.68 to 76.44)
OG00124.1(11.92 to 40.60)
OG00257.7(39.84 to 74.16)
OG00324.0(11.01 to 41.95)
OG00486.2(71.16 to 95.15)
OG00524.0(11.01 to 41.95)
OG00636.7(22.11 to 53.31)
OG00713.0(3.65 to 30.36)
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
OG007
Odds Ratio (OR)
10.00
2-Sided
90
2.95
33.87
Other
Logistic regression
OG001
OG007
Odds Ratio (OR)
2.12
2-Sided
90
0.61
7.36
Other
Logistic regression
OG002
OG007
Odds Ratio (OR)
9.09
2-Sided
90
2.71
30.48
Other
Logistic regression
OG003
OG007
Odds Ratio (OR)
2.11
2-Sided
90
0.59
7.55
Other
Logistic regression
OG004
OG007
Odds Ratio (OR)
41.67
2-Sided
90
10.80
160.68
Other
Logistic regression
OG005
OG007
Odds Ratio (OR)
2.11
2-Sided
90
0.59
7.55
Other
Logistic regression
OG006
OG007
Odds Ratio (OR)
3.86
2-Sided
90
1.17
12.74
Other
Logistic regression
Counts
Participants
OG000100
OG00181
OG00221
Title
Denominators
Categories
Title
Measurements
OG000-13.17(-14.20 to -12.15)
OG001-12.16(-13.31 to -11.02)
OG002-4.17(-6.38 to -1.97)
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
OG002
Mixed Models Analysis
<0.0001
Least Squares Mean Difference
-9.00
Standard Error of the Mean
1.470
2-Sided
90
-11.43
-6.57
Other
OG001
OG002
Mixed Models Analysis
<0.0001
Least Squares Mean Difference
-7.99
Standard Error of the Mean
1.502
2-Sided
90
-10.48
-5.51
Other
OG003
PF-06700841 60 mg QD Followed by Placebo
Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of matching placebo QD (blinded tablets).
OG004
PF-06700841 30 mg QD
Participants received 12 weeks of blinded PF-06700841 30 mg QD tablets.
OG005
PF-06700841 30 mg QD Followed by 10 mg QD
Participants received 4-week induction of PF-06700841 30 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 10 mg QD (blinded tablets).
OG006
PF-06700841 30 mg QD Followed by 100 mg QW
Participants received 4-week induction of PF-06700841 30 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 100 mg QW (blinded tablets).
OG007
Placebo
Participants received 12 weeks of blinded matching placebo QD tablets.
Units
Counts
Participants
OG00025
OG00129
OG00226
OG00325
OG00429
OG00525
OG00630
OG00723
Title
Denominators
Categories
Week 1
Title
Measurements
OG0000(0.00 to 11.29)
OG0016.9(1.24 to 20.16)
OG0027.7(1.38 to 22.29)
OG0034.0(0.20 to 17.61)
OG0040(0.00 to 9.81)
OG0054.0(0.20 to 17.61)
OG0060(0.00 to 9.50)
OG0070(0.00 to 12.21)
Week 2
Title
Measurements
OG0008.0(1.44 to 23.10)
OG00113.8(4.85 to 28.84)
OG00226.9(13.38 to 44.68)
OG003
Week 4
Title
Measurements
OG00024.0(11.01 to 41.95)
OG00141.4(25.89 to 58.25)
OG00261.5(43.57 to 77.43)
OG003
Week 6
Title
Measurements
OG00044.0(26.99 to 62.14)
OG00141.4(25.89 to 58.25)
OG00265.4(47.38 to 80.60)
OG003
Week 8
Title
Measurements
OG00060.0(41.68 to 76.44)
OG00137.9(22.93 to 54.88)
OG00265.4(47.38 to 80.60)
OG003
Week 10
Title
Measurements
OG00048.0(30.51 to 65.86)
OG00124.1(11.92 to 40.60)
OG00261.5(43.57 to 77.43)
OG003
Week 14
Title
Measurements
OG00048.0(30.51 to 65.86)
OG00117.2(7.05 to 32.89)
OG00234.6(19.40 to 52.62)
OG003
Week 16
Title
Measurements
OG00036.0(20.24 to 54.39)
OG00110.3(2.88 to 24.61)
OG00230.8(16.33 to 48.70)
OG003
OG003
PF-06700841 60 mg QD Followed by Placebo
Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of matching placebo QD (blinded tablets).
OG004
PF-06700841 30 mg QD
Participants received 12 weeks of blinded PF-06700841 30 mg QD tablets.
OG005
PF-06700841 30 mg QD Followed by 10 mg QD
Participants received 4-week induction of PF-06700841 30 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 10 mg QD (blinded tablets).
OG006
PF-06700841 30 mg QD Followed by 100 mg QW
Participants received 4-week induction of PF-06700841 30 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 100 mg QW (blinded tablets).
OG007
Placebo
Participants received 12 weeks of blinded matching placebo QD tablets.
Units
Counts
Participants
OG00025
OG00129
OG00226
OG00325
OG00429
OG00525
OG00630
OG00723
Title
Denominators
Categories
Week 1
Title
Measurements
OG00012.0(3.35 to 28.17)
OG00113.8(4.85 to 28.84)
OG00219.2(7.90 to 36.26)
OG00320.0(8.23 to 37.54)
OG00410.3(2.88 to 24.61)
OG0058.0(1.44 to 23.10)
OG0063.3(0.17 to 14.86)
OG0070(0.00 to 12.21)
Week 2
Title
Measurements
OG00044.0(26.99 to 62.14)
OG00137.9(22.93 to 54.88)
OG00246.2(29.21 to 63.79)
OG003
Week 4
Title
Measurements
OG00060.0(41.68 to 76.44)
OG00169.0(52.10 to 82.75)
OG00269.2(51.30 to 83.67)
OG003
Week 6
Title
Measurements
OG00072.0(53.78 to 86.05)
OG00162.1(45.12 to 77.07)
OG00273.1(55.32 to 86.62)
OG003
Week 8
Title
Measurements
OG00072.0(53.78 to 86.05)
OG00155.2(38.44 to 71.07)
OG00273.1(55.32 to 86.62)
OG003
Week 10
Title
Measurements
OG00068.0(49.64 to 82.97)
OG00144.8(28.93 to 61.56)
OG00273.1(55.32 to 86.62)
OG003
Week 12
Title
Measurements
OG00068.0(49.64 to 82.97)
OG00144.8(28.93 to 61.56)
OG00269.2(51.30 to 83.67)
OG003
Week 14
Title
Measurements
OG00064.0(45.61 to 79.76)
OG00144.8(28.93 to 61.56)
OG00261.5(43.57 to 77.43)
OG003
Week 16
Title
Measurements
OG00060.0(41.68 to 76.44)
OG00134.5(20.05 to 51.43)
OG00253.8(36.21 to 70.79)
OG003
OG003
PF-06700841 60 mg QD Followed by Placebo
Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of matching placebo QD (blinded tablets).
OG004
PF-06700841 30 mg QD
Participants received 12 weeks of blinded PF-06700841 30 mg QD tablets.
OG005
PF-06700841 30 mg QD Followed by 10 mg QD
Participants received 4-week induction of PF-06700841 30 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 10 mg QD (blinded tablets).
OG006
PF-06700841 30 mg QD Followed by 100 mg QW
Participants received 4-week induction of PF-06700841 30 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 100 mg QW (blinded tablets).
OG007
Placebo
Participants received 12 weeks of blinded matching placebo QD tablets.
Units
Counts
Participants
OG00025
OG00129
OG00226
OG00325
OG00429
OG00525
OG00630
OG00723
Title
Denominators
Categories
Week 1
Title
Measurements
OG0000(0.00 to 11.29)
OG0013.4(0.18 to 15.34)
OG0020(0.00 to 10.88)
OG0030(0.00 to 11.29)
OG0040(0.00 to 9.81)
OG0050(0.00 to 11.29)
OG0060(0.00 to 9.50)
OG0070(0.00 to 12.21)
Week 2
Title
Measurements
OG0000(0.00 to 11.29)
OG0013.4(0.18 to 15.34)
OG0027.7(1.38 to 22.29)
OG003
Week 4
Title
Measurements
OG00012.0(3.35 to 28.17)
OG00120.7(9.42 to 36.80)
OG00242.3(25.84 to 60.16)
OG003
Week 6
Title
Measurements
OG00016.0(5.66 to 32.96)
OG00120.7(9.42 to 36.80)
OG00226.9(13.38 to 44.68)
OG003
Week 8
Title
Measurements
OG00024.0(11.01 to 41.95)
OG00117.2(7.05 to 32.89)
OG00230.8(16.33 to 48.70)
OG003
Week 10
Title
Measurements
OG00028.0(13.95 to 46.22)
OG00117.2(7.05 to 32.89)
OG00226.9(13.38 to 44.68)
OG003
Week 12
Title
Measurements
OG00036.0(20.24 to 54.39)
OG00113.8(4.85 to 28.84)
OG00226.9(13.38 to 44.68)
OG003
Week 14
Title
Measurements
OG00028.0(13.95 to 46.22)
OG00113.8(4.85 to 28.84)
OG00211.5(3.22 to 27.19)
OG003
Week 16
Title
Measurements
OG00020.0(8.23 to 37.54)
OG0013.4(0.18 to 15.34)
OG00215.4(5.43 to 31.82)
OG003
OG003
PF-06700841 60 mg QD Followed by Placebo
Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of matching placebo QD (blinded tablets).
OG004
PF-06700841 30 mg QD
Participants received 12 weeks of blinded PF-06700841 30 mg QD tablets.
OG005
PF-06700841 30 mg QD Followed by 10 mg QD
Participants received 4-week induction of PF-06700841 30 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 10 mg QD (blinded tablets).
OG006
PF-06700841 30 mg QD Followed by 100 mg QW
Participants received 4-week induction of PF-06700841 30 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 100 mg QW (blinded tablets).
OG007
Placebo
Participants received 12 weeks of blinded matching placebo QD tablets.
Units
Counts
Participants
OG00025
OG00129
OG00226
OG00325
OG00429
OG00525
OG00630
OG00723
Title
Denominators
Categories
Week 1
ParticipantsOG00025
ParticipantsOG00129
ParticipantsOG00224
ParticipantsOG00325
ParticipantsOG00428
ParticipantsOG00525
ParticipantsOG00630
ParticipantsOG00723
Title
Measurements
OG000-5.74(-7.61 to -3.86)
OG001-4.60(-6.06 to -3.14)
OG002-5.85(-7.62 to -4.08)
OG003
Week 2
ParticipantsOG00024
ParticipantsOG00128
ParticipantsOG00224
ParticipantsOG00324
Week 4
ParticipantsOG00023
ParticipantsOG00128
ParticipantsOG00225
ParticipantsOG00324
Week 6
ParticipantsOG00023
ParticipantsOG00125
ParticipantsOG00224
ParticipantsOG00323
Week 8
ParticipantsOG00023
ParticipantsOG00124
ParticipantsOG00222
ParticipantsOG00322
Week 10
ParticipantsOG00021
ParticipantsOG00122
ParticipantsOG00222
ParticipantsOG00323
Week 14
ParticipantsOG00021
ParticipantsOG00121
ParticipantsOG00221
ParticipantsOG00322
Week 16
ParticipantsOG00021
ParticipantsOG00121
ParticipantsOG00220
ParticipantsOG00321
OG003
PF-06700841 60 mg QD Followed by Placebo
Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of matching placebo QD (blinded tablets).
OG004
PF-06700841 30 mg QD
Participants received 12 weeks of blinded PF-06700841 30 mg QD tablets.
OG005
PF-06700841 30 mg QD Followed by 10 mg QD
Participants received 4-week induction of PF-06700841 30 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 10 mg QD (blinded tablets).
OG006
PF-06700841 30 mg QD Followed by 100 mg QW
Participants received 4-week induction of PF-06700841 30 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 100 mg QW (blinded tablets).
OG007
Placebo
Participants received 12 weeks of blinded matching placebo QD tablets.
Units
Counts
Participants
OG00025
OG00129
OG00226
OG00325
OG00429
OG00525
OG00630
OG00723
Title
Denominators
Categories
Week 1
ParticipantsOG00025
ParticipantsOG00129
ParticipantsOG00224
ParticipantsOG00325
ParticipantsOG00428
ParticipantsOG00525
ParticipantsOG00630
ParticipantsOG00723
Title
Measurements
OG000-26.70(-33.80 to -19.60)
OG001-24.66(-33.24 to -16.08)
OG002-30.25(-39.07 to -21.44)
OG003
Week 2
ParticipantsOG00024
ParticipantsOG00128
ParticipantsOG00224
ParticipantsOG00324
Week 4
ParticipantsOG00023
ParticipantsOG00128
ParticipantsOG00225
ParticipantsOG00324
Week 6
ParticipantsOG00023
ParticipantsOG00125
ParticipantsOG00224
ParticipantsOG00323
Week 8
ParticipantsOG00023
ParticipantsOG00124
ParticipantsOG00222
ParticipantsOG00322
Week 10
ParticipantsOG00021
ParticipantsOG00122
ParticipantsOG00222
ParticipantsOG00323
Week 12
ParticipantsOG00022
ParticipantsOG00121
ParticipantsOG00221
ParticipantsOG00321
Week 14
ParticipantsOG00021
ParticipantsOG00121
ParticipantsOG00221
ParticipantsOG00322
Week 16
ParticipantsOG00021
ParticipantsOG00121
ParticipantsOG00220
ParticipantsOG00321
OG002
PF-06700841 60 mg QD Followed by 100 mg Once Weekly (QW)
Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 100 mg QW (blinded tablets).
OG003
PF-06700841 60 mg QD Followed by Placebo
Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of matching placebo QD (blinded tablets).
OG004
PF-06700841 30 mg QD
Participants received 12 weeks of blinded PF-06700841 30 mg QD tablets.
OG005
PF-06700841 30 mg QD Followed by 10 mg QD
Participants received 4-week induction of PF-06700841 30 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 10 mg QD (blinded tablets).
OG006
PF-06700841 30 mg QD Followed by 100 mg QW
Participants received 4-week induction of PF-06700841 30 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 100 mg QW (blinded tablets).
OG007
Placebo
Participants received 12 weeks of blinded matching placebo QD tablets.
Units
Counts
Participants
OG00025
OG00129
OG00226
OG00325
OG00429
OG00525
OG00630
OG00723
Title
Denominators
Categories
Treatment-emergent AEs
Title
Measurements
OG00019
OG00121
OG00218
OG00318
OG00421
OG00516
OG00623
OG00713
Treatment-emergent SAEs
Title
Measurements
OG0002
OG0011
OG0021
OG003
OG003
PF-06700841 60 mg QD Followed by Placebo
Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of matching placebo QD (blinded tablets).
OG004
PF-06700841 30 mg QD
Participants received 12 weeks of blinded PF-06700841 30 mg QD tablets.
OG005
PF-06700841 30 mg QD Followed by 10 mg QD
Participants received 4-week induction of PF-06700841 30 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 10 mg QD (blinded tablets).
OG006
PF-06700841 30 mg QD Followed by 100 mg QW
Participants received 4-week induction of PF-06700841 30 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 100 mg QW (blinded tablets).
OG007
Placebo
Participants received 12 weeks of blinded matching placebo QD tablets.
Units
Counts
Participants
OG00025
OG00129
OG00226
OG00325
OG00429
OG00525
OG00630
OG00723
Title
Denominators
Categories
Title
Measurements
OG0002
OG0014
OG0021
OG0032
OG0040
OG0052
OG0062
OG0070
OG003
PF-06700841 60 mg QD Followed by Placebo
Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of matching placebo QD (blinded tablets).
OG004
PF-06700841 30 mg QD
Participants received 12 weeks of blinded PF-06700841 30 mg QD tablets.
OG005
PF-06700841 30 mg QD Followed by 10 mg QD
Participants received 4-week induction of PF-06700841 30 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 10 mg QD (blinded tablets).
OG006
PF-06700841 30 mg QD Followed by 100 mg QW
Participants received 4-week induction of PF-06700841 30 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 100 mg QW (blinded tablets).
OG007
Placebo
Participants received 12 weeks of blinded matching placebo QD tablets.
Units
Counts
Participants
OG00025
OG00129
OG00226
OG00325
OG00429
OG00525
OG00630
OG00723
Title
Denominators
Categories
LDL Cholesterol, Week 4
ParticipantsOG00022
ParticipantsOG00126
ParticipantsOG00221
ParticipantsOG00324
ParticipantsOG00423
ParticipantsOG00524
ParticipantsOG00625
ParticipantsOG00718
Title
Measurements
OG00015.91(7.95 to 23.86)
OG00111.27(4.31 to 18.23)
OG00215.00(-0.63 to 30.63)
OG003
LDL Cholesterol, Week 12
ParticipantsOG00021
ParticipantsOG00120
ParticipantsOG00219
ParticipantsOG00320
HDL Cholesterol, Week 4
ParticipantsOG00023
ParticipantsOG00128
ParticipantsOG00225
ParticipantsOG00324
HDL Cholesterol, Week 12
ParticipantsOG00022
ParticipantsOG00121
ParticipantsOG00221
ParticipantsOG00321
Total Cholesterol, Week 4
ParticipantsOG00023
ParticipantsOG00128
ParticipantsOG00225
ParticipantsOG00324
Total Cholesterol, Week 12
ParticipantsOG00022
ParticipantsOG00121
ParticipantsOG00221
ParticipantsOG00321
Triglycerides, Week 4
ParticipantsOG00023
ParticipantsOG00128
ParticipantsOG00225
ParticipantsOG00324
Triglycerides, Week 12
ParticipantsOG00022
ParticipantsOG00121
ParticipantsOG00221
ParticipantsOG00321
Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 10 mg QD (blinded tablets).
OG002
PF-06700841 60 mg QD Followed by 100 mg Once Weekly (QW)
Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 100 mg QW (blinded tablets).
OG003
PF-06700841 60 mg QD Followed by Placebo
Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of matching placebo QD (blinded tablets).
OG004
PF-06700841 30 mg QD
Participants received 12 weeks of blinded PF-06700841 30 mg QD tablets.
OG005
PF-06700841 30 mg QD Followed by 10 mg QD
Participants received 4-week induction of PF-06700841 30 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 10 mg QD (blinded tablets).
OG006
PF-06700841 30 mg QD Followed by 100 mg QW
Participants received 4-week induction of PF-06700841 30 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 100 mg QW (blinded tablets).
OG007
Placebo
Participants received 12 weeks of blinded matching placebo QD tablets.
Units
Counts
Participants
OG00025
OG00129
OG00225
OG00325
OG00428
OG00525
OG00630
OG00723
Title
Denominators
Categories
Title
Measurements
OG00017
OG00120
OG00220
OG00316
OG00421
OG00520
OG00618
OG00711
Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 100 mg QW (blinded tablets).
OG003
PF-06700841 60 mg QD Followed by Placebo
Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of matching placebo QD (blinded tablets).
OG004
PF-06700841 30 mg QD
Participants received 12 weeks of blinded PF-06700841 30 mg QD tablets.
OG005
PF-06700841 30 mg QD Followed by 10 mg QD
Participants received 4-week induction of PF-06700841 30 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 10 mg QD (blinded tablets).
OG006
PF-06700841 30 mg QD Followed by 100 mg QW
Participants received 4-week induction of PF-06700841 30 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 100 mg QW (blinded tablets).
OG007
Placebo
Participants received 12 weeks of blinded matching placebo QD tablets.
Units
Counts
Participants
OG00025
OG00129
OG00225
OG00325
OG00428
OG00525
OG00630
OG00723
Title
Denominators
Categories
Sitting DBP <50 mm Hg
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
Sitting DBP increase >=20 mm Hg
Title
Measurements
OG0001
OG0011
OG0023
OG003
Sitting DBP decrease >=20 mm Hg
Title
Measurements
OG0003
OG0010
OG0022
OG003
Sitting SBP <90 mm Hg
Title
Measurements
OG0001
OG0011
OG0020
OG003
Sitting SBP increase >=30 mm Hg
Title
Measurements
OG0001
OG0013
OG0022
OG003
Sitting SBP decrease >=30 mm Hg
Title
Measurements
OG0002
OG0012
OG0021
OG003
Sitting pulse rate <40 bpm
Title
Measurements
OG0000
OG0010
OG0020
OG003
Sitting pulse rate >120 bpm
Title
Measurements
OG0000
OG0010
OG0020
OG003
OG002
PF-06700841 60 mg QD Followed by 100 mg Once Weekly (QW)
Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 100 mg QW (blinded tablets).
OG003
PF-06700841 60 mg QD Followed by Placebo
Participants received 4-week induction of PF-06700841 60 mg QD (blinded tablets) followed by 8-week maintenance of matching placebo QD (blinded tablets).
OG004
PF-06700841 30 mg QD
Participants received 12 weeks of blinded PF-06700841 30 mg QD tablets.
OG005
PF-06700841 30 mg QD Followed by 10 mg QD
Participants received 4-week induction of PF-06700841 30 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 10 mg QD (blinded tablets).
OG006
PF-06700841 30 mg QD Followed by 100 mg QW
Participants received 4-week induction of PF-06700841 30 mg QD (blinded tablets) followed by 8-week maintenance of PF-06700841 100 mg QW (blinded tablets).
OG007
Placebo
Participants received 12 weeks of blinded matching placebo QD tablets.