INCB028050 Compared to Background Therapy in Patients Wit... | NCT00902486 | Trialant
NCT00902486
Sponsor
Incyte Corporation
Status
Completed
Last Update Posted
Sep 4, 2018Actual
Enrollment
127Actual
Phase
Phase 2
Conditions
Rheumatoid Arthritis
Interventions
INCB028050
INCB028050
INCB028050
Placebo
Countries
United States
Czechia
Protocol Section
Identification Module
NCT ID
NCT00902486
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
INCB 28050-201
Secondary IDs
Not provided
Brief Title
INCB028050 Compared to Background Therapy in Patients With Active Rheumatoid Arthritis (RA) With Inadequate Response to Disease Modifying Anti-Rheumatic Drugs
Official Title
A Randomized, Double-blind, Placebo Controlled, Dose Ranging, Parallel Group, Phase 2 Study of INCB028050 Compared to Background Therapy in Patients With Active RA With Inadequate Response to Any Disease Modifying Anti-Rheumatic Drugs (DMARD) Therapy Including Biologics
Acronym
Not provided
Organization
Incyte CorporationINDUSTRY
Status Module
Record Verification Date
Aug 2018
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
May 2009
Primary Completion Date
Jun 2010Actual
Completion Date
Jul 2010Actual
First Submitted Date
May 13, 2009
First Submission Date that Met QC Criteria
May 14, 2009
First Posted Date
May 15, 2009Estimated
Results Waived
Not provided
Results First Submitted Date
Jun 10, 2018
Results First Submitted that Met QC Criteria
Aug 28, 2018
Results First Posted Date
Sep 4, 2018Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Jun 18, 2010
Certification/Extension First Submitted that Passed QC Review
Jun 18, 2010
Certification/Extension First Posted Date
Jun 22, 2010Estimated
Last Update Submitted Date
Aug 28, 2018
Last Update Posted Date
Sep 4, 2018Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Incyte CorporationINDUSTRY
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
This was a randomized, double blind, placebo controlled, dose ranging, parallel group study. Participants who had active rheumatoid arthritis (RA) who had inadequate response to any disease modifying anti-rheumatic drug (DMARD) therapy including biologics were enrolled. Screening evaluations were performed within approximately 28 days of randomization. The duration of the study was 6 months with the primary endpoint assessed at 3 months. Eligible participants were randomly assigned to one of three doses (4, 7 or 10 mg QD) of INCB028050 (Baricitinib) or placebo.
Detailed Description
Not provided
Conditions Module
Conditions
Rheumatoid Arthritis
Keywords
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
127Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
INCB028050 4 mg QD
Experimental
INCB028050 4mg Once daily (QD)
Drug: INCB028050
INCB028050 7 mg QD
Experimental
INCB028050 7mg QD
Drug: INCB028050
INCB028050 10 mg QD
Experimental
INCB028050 10mg QD
Drug: INCB028050
Placebo
Placebo Comparator
Placebo group may 'cross-over' following 3 months of treatment to receive either active arm #2 (7mg QD) or active arm #3 (10mg QD) of INCB028050 capsules.
Drug: Placebo
Interventions
Name
Type
Description
Arm Group Labels
Other Names
INCB028050
Drug
4 mg capsules QD
INCB028050 4 mg QD
Baricitinib
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
The Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Improvement
The ACR 20 is defined as ≥ 20% improvement in tender joint count plus ≥ 20% improvement in swollen joint count plus ≥ 20% improvement in 3 of the following 5 criteria: participants' assessment of pain, participants' global assessment of disease activity (PGA), Physician's global assessment of disease activity (PHGA), participants' self-assessed disability Health Assessment Questionnaire (HAQ), and Erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP), whichever shows the greatest change.
Week 12
Participants With at Least 1 Adverse Event From Baseline Through Week 12
From Baseline through week 12
Secondary Outcomes
Measure
Description
Time Frame
Participants With at Least 1 Adverse Event From Week 12 to Week 24
Week 12 to Week 24
The Percentage of Participants Who Were Assigned to Active Treatment at Baseline Achieving ACR 20 Improvement at Week 24
The ACR 20 is defined as ≥ 20% improvement in tender joint count plus ≥ 20% improvement in swollen joint count plus ≥ 20% improvement in 3 of the following 5 criteria: participants' assessment of pain, participants' global assessment of disease activity (PGA), Physician's global assessment of disease activity (PHGA), participants' self-assessed disability Health Assessment Questionnaire (HAQ), and Erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP), whichever shows the greatest change.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Must have rheumatoid arthritis which has been inadequately controlled with at least one DMARD
For subjects receiving antimalarials, they must be treated with antimalarials for at least 6 months and receiving a stable daily dose
For subjects receiving sulfasalazine, they must be treated with Sulfasalazine (SSZ) for at least 6 months and receiving a stable daily dose of no more than 3 grams per day
For subjects on methotrexate, they must be treated with methotrexate for at least 6 months, and receiving a stable weekly dose of methotrexate between 7.5 and 25 mg
For subjects on leflunomide, they must be treated with leflunomide for at least 6 months, and receiving a stable dose of leflunomide between 10 to 20 mg
For subjects receiving corticosteroids, they must be on a dose not to exceed 10 mg of prednisone daily
Active rheumatoid arthritis at the time of screening defined by the following: 6 or more joints tender or painful on motion and 4 or more swollen joints and at least one of the following two: Erythrocyte sedimentation rate (ESR) greater than or equal to 28 mm/hr or C-reactive protein (CRP) greater than or equal to 7 mg/liter
Have evidence of lack of risk for tuberculosis
Exclusion Criteria:
Current or recent viral, bacterial, fungal, parasitic or mycobacterial infection requiring systemic therapy
History of infected joint prosthesis
Subjects who have a current or recent history of severe, progressive, uncontrolled renal, hepatic, hematological, gastrointestinal, pulmonary, cardiac, neurological or cerebral disease
Subjects who have received treatment with the following drugs or drug classes within the specified timeframe: prior treatment with rituximab within 12 months, prior treatment with an oral Janus kinase (JAK) inhibitor, DMARDs or other anti-rheumatic therapies not specified and allowed according to protocol, treatment with any investigational medication within 12 weeks or 5 half-lives (whichever is longer), and treatment with a biologic agent within 12 weeks prior to the first dose of study medication
Subjects with a past history of neutropenia, thrombocytopenia or anemia requiring transfusion other than at the time of trauma or surgery, and subjects that meet protocol specified laboratory measures
Taylor PC, Takeuchi T, Burmester GR, Durez P, Smolen JS, Deberdt W, Issa M, Terres JR, Bello N, Winthrop KL. Safety of baricitinib for the treatment of rheumatoid arthritis over a median of 4.6 and up to 9.3 years of treatment: final results from long-term extension study and integrated database. Ann Rheum Dis. 2022 Mar;81(3):335-343. doi: 10.1136/annrheumdis-2021-221276. Epub 2021 Oct 27.
The study was divided into 3 distinct phases: Screening Phase (up to 28 days before randomization), Treatment Phase (12 weeks + 12-week extension period), and the Follow-up (4 ± 1 weeks following final dose of study medication).
Recruitment Details
The study population included participants diagnosed with RA who had failed to respond adequately to any DMARD therapy, including biologics.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Placebo
INCB028050 was administered once daily (QD), orally in matching placebo capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
FG001
Placebo Crossing Over to 7 mg INCB028050 QD
Periods
Title
Milestones
Reasons Not Completed
Treatment Period (Weeks 0 Through 12)
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
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
Not provided
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
INCB028050
Drug
7 mg capsules QD
INCB028050 7 mg QD
Baricitinib
INCB028050
Drug
10 mg capsule QD
INCB028050 10 mg QD
Baricitinib
Placebo
Drug
Placebo matching INCB028050 QD
Placebo
From Baseline to Week 24
The Percentage of Participants Achieving American College of Rheumatology (ACR) 50 Improvement at Week 12 and Week 24
The ACR 50 is defined as ≥ 50% improvement in tender joint count plus ≥ 50% improvement in swollen joint count plus ≥50% improvement in 3 of the following 5 criteria: participants' assessment of pain, PGA, PHGA, participants' self-assessed disability HAQ, and ESR or CRP, whichever shows the greatest change.
Week 12 and Week 24
The Percentage of Participants Achieving American College of Rheumatology (ACR) 70 Improvement at Week 12 and Week 24
The ACR 70 is defined as ≥ 70% improvement in tender joint count plus ≥ 70% improvement in swollen joint count plus ≥ 70% improvement in 3 of the following 5 criteria: participants' assessment of pain, PGA, PHGA, participants' self-assessed disability HAQ, and ESR or CRP, whichever shows the greatest change.
Week 12 and Week 24
The Percentage of Participants Achieving American College of Rheumatology (ACR) 90 Improvement at Week 12 and Week 24
The ACR 90 is defined greater than or equal to (>=) 90 percent (%) improvement in painful and tender joint count; >= 90% improvement in swollen joint count; and >= 90% 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) at each visit.
Week 12 and Week 24
Change in Disease Activity Score 28 (DAS28) CRP Score From Baseline at Week 12 and Week 24
Calculation of the disease activity score 28 (DAS 28) score was based on the tender joint count, plus swollen joint count, plus PGA, plus C-reactive protein (CRP). A higher score indicated more disease activity. The mean change from baseline (which represent decreases in the DAS 28 CRP scores) are shown as positive numbers in these analyses. The DAS28 provides a score on a scale from 0 to 10 indicating the current activity of the rheumatoid arthritis (>5.1=high disease activity; <3.2=low disease activity; <2.6=remission).
Baseline, Week 12 and Week 24
Change in Disease Activity Score 28 (DAS28) ESR Score From Baseline at Week 12 and Week 24
Calculation of the disease activity score 28 (DAS 28) score was based on the tender joint count, plus swollen joint count, plus PGA, plus Erythrocyte sedimentation rate (ESR). The DAS28-ESR is expressed as units on a scale with the minimum score=0 (best) to maximum score=10 (worst). Remission was defined as DAS28-ESR <2.6. The mean change from baseline (which represent decreases in the DAS 28 ESR scores) are shown as positive numbers in these analyses.
Baseline, Week 12 and Week 24
Percentage of Participants Achieving Low Disease Activity by DAS28 (ESR)≤3.2
Participants who achieved low disease activity based on the DAS 28 ESR (score ≤3.2). Participants who achieved low disease activity were classified as responders in this analysis.
Week 12 and Week 24
Percentage of Participants Achieving Remission by DAS28 (ESR) ≤2.6
Participants who achieved inactive disease based on the DAS 28 ESR (score ≤2.6). Participants who achieved low disease activity were classified as responders in this analysis.
Week 12 and Week 24
Percentage of Participants Achieving Remission by DAS28 (CRP) ≤2.6
Participants who achieved inactive disease based on DAS 28 CRP (score ≤2.6). Participants who achieved low disease activity were classified as responders in this analysis.
Week 12 and Week 24
Change in ACR Assessment Tender Joint Count (TJC) From Baseline to Week 12 and Week 24
The 28 joints to be assessed for tenderness and swelling were shoulder, elbow, wrist, metacarpophalangeal (MCP) joints 1-5, proximal interphalangeal (PIP) joints 1-5, and knee on both sides of the body. The sum of tender joints ranged from 0 to 28 with 0 as best possible health status and 28 as worst health status.
Baseline, Week 12 and Week 24
Change in ACR Assessment Swollen Joint Count (SJC) From Baseline to Week 12 and Week 24
The 28 joints to be assessed for tenderness and swelling were shoulder, elbow, wrist, metacarpophalangeal (MCP) joints 1-5, proximal interphalangeal (PIP) joints 1-5, and knee on both sides of the body. The sum of tender joints ranged from 0 to 28 with 0 as best possible health status and 28 as worst health status.
Baseline, Week 12 and Week 24
Change in Participants' Assessment of Pain From Baseline at Week 12 and Week 24
Participants were to assess their current level of pain on a 100 mm horizontal Visual Analog Scale (VAS). The left-hand extreme of the line (0 mm) was described as "no pain" and the right-hand (100 mm) as "most imaginable pain".
Baseline, Week 12 and Week 24
Change in Participants' Global Assessment of Disease Activity From Baseline at Week 12 and Week 24
Participants were to assess the disease (RA) activity on a 100 mm horizontal VAS. The left-hand extreme of the line (0 mm) was described as "no arthritis activity" (symptom-free and no arthritis symptoms) and the right hand extreme (100 mm) as "extremely active arthritis" (maximum arthritis disease activity). A decreasing mean score, therefore, indicates improvement.
Baseline, Week 12 and Week 24
Change in Physician's Global Assessment of Disease Activity (PGA) From Baseline at Week 12 and Week 24
Physicians were to assess the disease (RA) activity on a 100 mm horizontal VAS. The left-hand extreme of the line (0 mm) was described as "no arthritis activity" (symptom-free and no arthritis symptoms) and the right hand extreme (100 mm) as "extremely active arthritis" (maximum arthritis disease activity). A decreasing mean score, therefore, indicates improvement.
Baseline, Week 12 and Week 24
Change in Health Assessment Questionnaire-Disability Index (HAQ-DI) From Baseline at Week 12 and Week 24
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.
Baseline, Week 12 and Week 24
Change in Erythrocyte Sedimentation Rate (ESR) From Baseline at Week 12 and Week 24
ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 millimeter/hour (mm/hr). A higher rate is consistent with inflammation.
Baseline, Week 12 and Week 24
Change in C-reactive Protein (CRP) From Baseline at Week 12 and Week 24
The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.
Baseline, Week 12 and Week 24
Change in Duration of Morning Stiffness From Baseline at Week 12 and Week 24
Duration of morning stiffness was defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in minutes (If none was present = 0; If morning stiffness was continuing at the time of assessment or was unusual compared to the recent past, average of duration of stiffness over the past 3 days was reported; If stiffness persisted the entire day, 1440 minutes was recorded).
Baseline, Week 12 and Week 24
Percentage of Participants Achieving Good European League Against Rheumatism (EULAR) Response (DAS28 ESR) at Week 12
EULAR response reflects an improvement in disease activity and an attainment of a lower degree of disease activity based on the DAS-28 score. A Good Response is defined as an improvement (decrease) in the DAS28 of more than 1.2 compared with Baseline and attainment of a DAS28 score less than or equal to 3.2.
Week 12
Percentage of Participants Achieving Good EULAR Response (DAS28ESR) at Week 24
EULAR response reflects an improvement in disease activity and an attainment of a lower degree of disease activity based on the DAS-28 score. A Good Response is defined as an improvement (decrease) in the DAS28 of more than 1.2 compared with Baseline and attainment of a DAS28 score less than or equal to 3.2.
Week 24
Percentage of Participants Achieving Good EULAR Response (DAS28CRP) at Week 12
EULAR response reflects an improvement in disease activity and an attainment of a lower degree of disease activity based on the DAS-28 score. A Good Response is defined as an improvement (decrease) in the DAS28 of more than 1.2 compared with Baseline and attainment of a DAS28 score less than or equal to 2.6.
Week 12
Percentage of Participants Achieving Good EULAR Response (DAS28CRP) at Week 24
EULAR response reflects an improvement in disease activity and an attainment of a lower degree of disease activity based on the DAS-28 score. A Good Response is defined as an improvement (decrease) in the DAS28 of more than 1.2 compared with Baseline and attainment of a DAS28 score less than or equal to 2.6.
Week 24
Change in SF-36 Mental Component Summary From Baseline at Week 12 and Week 24
The Health Assessment Questionnaire Short Form 36 (SF-36) determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Scales 5-8 primarily contribute to the mental component summary score (PCS) of the SF-36. Scores on each scale are summed and averaged (range = 0 "worst"-100 "best").
Baseline, Week 12 and Week 24
Change in SF-36 Physical Component Summary From Baseline at Week 12 and Week 24
The Health Assessment Questionnaire Short Form 36 (SF-36) determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Scales 1-4 primarily contribute to the physical component summary score (PCS) of the SF-36. Scores on each scale are summed and averaged (range = 0 "worst"-100 "best").
Baseline, Week 12 and Week 24
Percent of Participants Achieving a Minimum Clinically Important Difference (MCID) in the Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12 and Week 24
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. The MCID score for HAQ-DI is -0.22.
Week 12 and Week 24
Percent of Participants Achieving a MCID in the Pain Score (Participant's Assessment of Pain) at Week 12 and Week 24
Participants were to assess their current level of pain on a 100 mm horizontal VAS. The left-hand extreme of the line (0 mm) was described as "no pain" and the right-hand (100 mm) as "most imaginable pain". MCID for the pain score is a decrease of at least 10 mm on a 100 mm scale.
Week 12 and Week 24
Percent of Participants Achieving a MCID in the SF-36 Physical Components and Mental Components at Week 12 and Week 24
The Health Assessment Questionnaire Short Form 36 (SF-36) determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Scales 5-8 primarily contribute to the mental component summary score (PCS) of the SF-36. Scores on each scale are summed and averaged (range = 0 "worst"-100 "best").
Week 12 and Week 24
Paradise Valley
Arizona
United States
Peoria
Arizona
United States
Phoenix
Arizona
United States
Palm Desert
California
United States
Santa Maria
California
United States
Santa Monica
California
United States
Westlake Village
California
United States
Whittier
California
United States
Denver
Colorado
United States
Aventura
Florida
United States
Daytona Beach
Florida
United States
Gainesville
Florida
United States
Lake Mary
Florida
United States
Naples
Florida
United States
Palm Harbor
Florida
United States
Sarasota
Florida
United States
Springfield
Illinois
United States
South Bend
Indiana
United States
Wichita
Kansas
United States
Lexington
Kentucky
United States
Frederick
Maryland
United States
Wheaton
Maryland
United States
St Louis
Missouri
United States
Lincoln
Nebraska
United States
Reno
Nevada
United States
Freehold
New Jersey
United States
Lake Success
New York
United States
Syracuse
New York
United States
Charlotte
North Carolina
United States
Hickory
North Carolina
United States
Middleburg Heights
Ohio
United States
Toledo
Ohio
United States
Tulsa
Oklahoma
United States
Duncansville
Pennsylvania
United States
Pittsburgh
Pennsylvania
United States
Sellersville
Pennsylvania
United States
Houston
Texas
United States
San Antonio
Texas
United States
Arlington
Virginia
United States
Spokane
Washington
United States
Brno
Czechia
Chomutov
Czechia
Česká Lípa
Czechia
Hlučín
Czechia
Hustopeče
Czechia
Kroměříž
Czechia
Prague
Czechia
Zlín
Czechia
Derived
Combe B, Balsa A, Sarzi-Puttini P, Tony HP, de la Torre I, Rogai V, Durand F, Witt S, Zhong J, Dougados M. Efficacy and safety data based on historical or pre-existing conditions at baseline for patients with active rheumatoid arthritis who were treated with baricitinib. Ann Rheum Dis. 2019 Aug;78(8):1135-1138. doi: 10.1136/annrheumdis-2018-214261. Epub 2019 Mar 6. No abstract available.
Taylor PC, Kremer JM, Emery P, Zuckerman SH, Ruotolo G, Zhong J, Chen L, Witt S, Saifan C, Kurzawa M, Otvos JD, Connelly MA, Macias WL, Schlichting DE, Rooney TP, de Bono S, McInnes IB. Lipid profile and effect of statin treatment in pooled phase II and phase III baricitinib studies. Ann Rheum Dis. 2018 Jul;77(7):988-995. doi: 10.1136/annrheumdis-2017-212461. Epub 2018 Feb 20.
Participants that received placebo for the first 12 weeks were randomized to an active dosage of 7 mg INCB028050 QD.
FG002
Placebo Crossing Over to 10 mg INCB028050 QD
Participants that received placebo for the first 12 weeks were randomized to an active dosage of 10 mg INCB028050 QD.
FG003
INCB028050 4 mg QD
INCB028050 was administered qd, orally in 4 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
FG004
INCB028050 7 mg QD
INCB028050 was administered qd, orally in 7 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
FG005
INCB028050 10 mg QD
INCB028050 was administered qd, orally in 10 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
FG00031 subjects
FG0010 subjects
FG0020 subjects
FG00332 subjects
FG00432 subjects
FG00532 subjects
Safety Evaluable Participants
FG00031 subjects
FG0010 subjects
FG0020 subjects
FG00331 subjects
FG00432 subjects
FG00531 subjects
Modified Intent-to-Treat Participants
FG00031 subjects
FG0010 subjects
FG0020 subjects
FG00331 subjects
FG00432 subjects
FG00530 subjects
COMPLETED
Participants completing Week 12
FG00029 subjects
FG0010 subjects
FG0020 subjects
FG00329 subjects
FG00430 subjects
FG00527 subjects
NOT COMPLETED
FG0002 subjects
FG0010 subjects
FG0020 subjects
FG0033 subjects
FG0042 subjects
FG0055 subjects
Type
Comment
Reasons
Adverse Event
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG0041 subjects
FG0052 subjects
Consent Withdrawn
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Protocol Deviation
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
corrected QT (QTc) exclusion criteria
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Extension Period (Weeks 12 Through 24)
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG00114 subjects
FG00215 subjects
FG00329 subjects
FG00430 subjects
FG00527 subjects
COMPLETED
FG0000 subjects
FG00114 subjects
FG00213 subjects
FG00327 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0022 subjects
FG0032 subjects
FG004
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Follow-up (After Week 24)
Type
Comment
Milestone Data
STARTED
Number of participants completed treatment
FG0000 subjects
FG00114 subjects
FG00213 subjects
FG00327 subjects
FG00429 subjects
FG00524 subjects
Safety Evaluable Participants
Population is inclusive of all safety participants continuing after Week 12.
FG0000 subjects
FG00114 subjects
FG00215 subjects
FG003
COMPLETED
FG0000 subjects
FG00114 subjects
FG00213 subjects
FG00326 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Type
Comment
Reasons
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
INCB028050 4 mg QD
INCB028050 was administered qd, orally in 4 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
BG001
INCB028050 7 mg QD
INCB028050 was administered qd, orally in 7 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
BG002
INCB028050 10 mg QD
INCB028050 was administered qd, orally in 10 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
BG003
Placebo
INCB028050 was administered qd, orally in matching placebo capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
BG004
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00032
BG00132
BG00232
BG00331
BG004127
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
BG00056.8± 12.28
BG00153.7± 10.92
BG00257.3± 10.38
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00029
BG00126
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
The Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Improvement
The ACR 20 is defined as ≥ 20% improvement in tender joint count plus ≥ 20% improvement in swollen joint count plus ≥ 20% improvement in 3 of the following 5 criteria: participants' assessment of pain, participants' global assessment of disease activity (PGA), Physician's global assessment of disease activity (PHGA), participants' self-assessed disability Health Assessment Questionnaire (HAQ), and Erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP), whichever shows the greatest change.
Modified Intent-to-Treat (mITT) population included all participants that enrolled, took at least 1 dose of study medication, and had both pre-dose and at least 1 post-baseline Rheumatoid arthritis (RA) assessment before Week 12.
Posted
Count of Participants
Participants
Week 12
ID
Title
Description
OG000
Placebo
INCB028050 was administered qd, orally in matching placebo capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
OG001
INCB028050 4 mg QD
INCB028050 was administered qd, orally in 4 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
OG002
INCB028050 7 mg QD
INCB028050 was administered qd, orally in 7 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
OG003
INCB028050 10 mg QD
INCB028050 was administered qd, orally in 10 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
Units
Counts
Participants
OG00031
OG00131
OG00232
OG003
Title
Denominators
Categories
Title
Measurements
OG00010
OG00116
OG00219
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
OG001
OG002
OG003
The prespecified primary analysis for ACR 20 was the Cochran-Armitage trend test looking for a dose-response relationship. The treatment effect was also assessed using a logistic regression model including background therapy (more than 8 weeks of biologics or not) and treatment.
Cochran-Armitage trend test
0.0619
Odds Ratio (OR)
2.17
2-Sided
95
0.77
6.15
LOGISTIC regression model for odds ratio estimates : LOGIT(Response 0/1) = Treatment + Biologics
Superiority or Other
Primary
Participants With at Least 1 Adverse Event From Baseline Through Week 12
Safety Evaluable Participants included all participants who were enrolled and took at least 1 dose of study medication.
Posted
Count of Participants
Participants
From Baseline through week 12
ID
Title
Description
OG000
Placebo
INCB028050 was administered qd, orally in matching placebo capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
OG001
INCB028050 4 mg QD
INCB028050 was administered qd, orally in 4 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
OG002
INCB028050 7 mg QD
INCB028050 was administered qd, orally in 7 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
OG003
INCB028050 10 mg QD
INCB028050 was administered qd, orally in 10 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
Secondary
Participants With at Least 1 Adverse Event From Week 12 to Week 24
Safety Evaluable Participants included all participants who were enrolled and took at least 1 dose of study medication.
Posted
Count of Participants
Participants
Week 12 to Week 24
ID
Title
Description
OG000
Placebo Crossing Over to 7 mg INCB028050 QD
Participants that received placebo for the first 12 weeks were randomized to an active dosage of 7 mg INCB028050 QD.
OG001
Placebo Crossing Over to 10 mg INCB028050 QD
Participants that received placebo for the first 12 weeks were randomized to an active dosage of 10 mg INCB028050 QD.
OG002
INCB028050 4 mg QD
INCB028050 was administered qd, orally in 4 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
OG003
INCB028050 7 mg QD
INCB028050 was administered qd, orally in 7 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
Secondary
The Percentage of Participants Who Were Assigned to Active Treatment at Baseline Achieving ACR 20 Improvement at Week 24
The ACR 20 is defined as ≥ 20% improvement in tender joint count plus ≥ 20% improvement in swollen joint count plus ≥ 20% improvement in 3 of the following 5 criteria: participants' assessment of pain, participants' global assessment of disease activity (PGA), Physician's global assessment of disease activity (PHGA), participants' self-assessed disability Health Assessment Questionnaire (HAQ), and Erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP), whichever shows the greatest change.
Modified Intent-to-Treat (mITT) population included all participants who were assigned to active treatment at baseline and had both pre-dose and at least 1 post-baseline Rheumatoid arthritis (RA) assessment before Week 12.
Posted
Count of Participants
Participants
From Baseline to Week 24
ID
Title
Description
OG000
INCB028050 4 mg QD
INCB028050 was administered qd, orally in 4 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
OG001
INCB028050 7 mg QD
INCB028050 was administered qd, orally in 7 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
OG002
INCB028050 10 mg QD
Secondary
The Percentage of Participants Achieving American College of Rheumatology (ACR) 50 Improvement at Week 12 and Week 24
The ACR 50 is defined as ≥ 50% improvement in tender joint count plus ≥ 50% improvement in swollen joint count plus ≥50% improvement in 3 of the following 5 criteria: participants' assessment of pain, PGA, PHGA, participants' self-assessed disability HAQ, and ESR or CRP, whichever shows the greatest change.
Modified Intent-to-Treat (mITT) population included all participants that enrolled, took at least 1 dose of study medication, and had both pre-dose and at least 1 post-baseline Rheumatoid arthritis (RA) assessment before Week 12.
Posted
Number
percentage of participants
Week 12 and Week 24
ID
Title
Description
OG000
Placebo
INCB028050 was administered qd, orally in matching placebo capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
OG001
INCB028050 4 mg QD
INCB028050 was administered qd, orally in 4 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
OG002
INCB028050 7 mg QD
INCB028050 was administered qd, orally in 7 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
Secondary
The Percentage of Participants Achieving American College of Rheumatology (ACR) 70 Improvement at Week 12 and Week 24
The ACR 70 is defined as ≥ 70% improvement in tender joint count plus ≥ 70% improvement in swollen joint count plus ≥ 70% improvement in 3 of the following 5 criteria: participants' assessment of pain, PGA, PHGA, participants' self-assessed disability HAQ, and ESR or CRP, whichever shows the greatest change.
Modified Intent-to-Treat (mITT) population included all participants that enrolled, took at least 1 dose of study medication, and had both pre-dose and at least 1 post-baseline Rheumatoid arthritis (RA) assessment before Week 12.
Posted
Number
percentage of participants
Week 12 and Week 24
ID
Title
Description
OG000
Placebo
INCB028050 was administered qd, orally in matching placebo capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
OG001
INCB028050 4 mg QD
INCB028050 was administered qd, orally in 4 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
OG002
INCB028050 7 mg QD
INCB028050 was administered qd, orally in 7 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
Secondary
The Percentage of Participants Achieving American College of Rheumatology (ACR) 90 Improvement at Week 12 and Week 24
The ACR 90 is defined greater than or equal to (>=) 90 percent (%) improvement in painful and tender joint count; >= 90% improvement in swollen joint count; and >= 90% 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) at each visit.
Modified Intent-to-Treat (mITT) population included all participants that enrolled, took at least 1 dose of study medication, and had both pre-dose and at least 1 post-baseline Rheumatoid arthritis (RA) assessment before Week 12.
Posted
Number
percentage of participants
Week 12 and Week 24
ID
Title
Description
OG000
Placebo
INCB028050 was administered qd, orally in matching placebo capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
OG001
INCB028050 4 mg QD
INCB028050 was administered qd, orally in 4 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
OG002
INCB028050 7 mg QD
Secondary
Change in Disease Activity Score 28 (DAS28) CRP Score From Baseline at Week 12 and Week 24
Calculation of the disease activity score 28 (DAS 28) score was based on the tender joint count, plus swollen joint count, plus PGA, plus C-reactive protein (CRP). A higher score indicated more disease activity. The mean change from baseline (which represent decreases in the DAS 28 CRP scores) are shown as positive numbers in these analyses. The DAS28 provides a score on a scale from 0 to 10 indicating the current activity of the rheumatoid arthritis (>5.1=high disease activity; <3.2=low disease activity; <2.6=remission).
Modified Intent-to-Treat (mITT) population included all participants that enrolled, took at least 1 dose of study medication, and had both pre-dose and at least 1 post-baseline Rheumatoid arthritis (RA) assessment before Week 12.
Posted
Mean
Standard Deviation
Units on a scale
Baseline, Week 12 and Week 24
ID
Title
Description
OG000
Placebo
INCB028050 was administered qd, orally in matching placebo capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
OG001
INCB028050 4 mg QD
INCB028050 was administered qd, orally in 4 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
OG002
INCB028050 7 mg QD
Secondary
Change in Disease Activity Score 28 (DAS28) ESR Score From Baseline at Week 12 and Week 24
Calculation of the disease activity score 28 (DAS 28) score was based on the tender joint count, plus swollen joint count, plus PGA, plus Erythrocyte sedimentation rate (ESR). The DAS28-ESR is expressed as units on a scale with the minimum score=0 (best) to maximum score=10 (worst). Remission was defined as DAS28-ESR <2.6. The mean change from baseline (which represent decreases in the DAS 28 ESR scores) are shown as positive numbers in these analyses.
Modified Intent-to-Treat (mITT) population included all participants that enrolled, took at least 1 dose of study medication, and had both pre-dose and at least 1 post-baseline Rheumatoid arthritis (RA) assessment before Week 12.
Posted
Mean
Standard Deviation
Units on a scale
Baseline, Week 12 and Week 24
ID
Title
Description
OG000
Placebo
INCB028050 was administered qd, orally in matching placebo capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
OG001
INCB028050 4 mg QD
INCB028050 was administered qd, orally in 4 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
OG002
INCB028050 7 mg QD
Secondary
Percentage of Participants Achieving Low Disease Activity by DAS28 (ESR)≤3.2
Participants who achieved low disease activity based on the DAS 28 ESR (score ≤3.2). Participants who achieved low disease activity were classified as responders in this analysis.
Modified Intent-to-Treat (mITT) population included all participants that enrolled, took at least 1 dose of study medication, and had both pre-dose and at least 1 post-baseline Rheumatoid arthritis (RA) assessment before Week 12.
Posted
Number
percentage of participants
Week 12 and Week 24
ID
Title
Description
OG000
Placebo
INCB028050 was administered qd, orally in matching placebo capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
OG001
INCB028050 4 mg QD
INCB028050 was administered qd, orally in 4 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
OG002
INCB028050 7 mg QD
INCB028050 was administered qd, orally in 7 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
OG003
Secondary
Percentage of Participants Achieving Remission by DAS28 (ESR) ≤2.6
Participants who achieved inactive disease based on the DAS 28 ESR (score ≤2.6). Participants who achieved low disease activity were classified as responders in this analysis.
Modified Intent-to-Treat (mITT) population included all participants that enrolled, took at least 1 dose of study medication, and had both pre-dose and at least 1 post-baseline Rheumatoid arthritis (RA) assessment before Week 12.
Posted
Number
percentage of participants
Week 12 and Week 24
ID
Title
Description
OG000
Placebo to INCB028050 7 mg QD
Participants who were assigned to placebo group at baseline then crossed over to active treatment groups after week 12 were analyzed.
OG001
Placebo to INCB028050 10 mg QD
Participants who were assigned to placebo group at baseline then crossed over to active treatment groups after week 12 were analyzed.
OG002
INCB028050 4 mg QD
INCB028050 was administered qd, orally in 4 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
OG003
Secondary
Percentage of Participants Achieving Remission by DAS28 (CRP) ≤2.6
Participants who achieved inactive disease based on DAS 28 CRP (score ≤2.6). Participants who achieved low disease activity were classified as responders in this analysis.
Modified Intent-to-Treat (mITT) population included all participants that enrolled, took at least 1 dose of study medication, and had both pre-dose and at least 1 post-baseline Rheumatoid arthritis (RA) assessment before Week 12.
Posted
Number
percentage of participants
Week 12 and Week 24
ID
Title
Description
OG000
INCB028050 4 mg QD
INCB028050 was administered qd, orally in 4 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
OG001
INCB028050 7 mg QD
INCB028050 was administered qd, orally in 7 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
OG002
INCB028050 10 mg QD
INCB028050 was administered qd, orally in 10 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
Secondary
Change in ACR Assessment Tender Joint Count (TJC) From Baseline to Week 12 and Week 24
The 28 joints to be assessed for tenderness and swelling were shoulder, elbow, wrist, metacarpophalangeal (MCP) joints 1-5, proximal interphalangeal (PIP) joints 1-5, and knee on both sides of the body. The sum of tender joints ranged from 0 to 28 with 0 as best possible health status and 28 as worst health status.
Modified Intent-to-Treat (mITT) population included all participants that enrolled, took at least 1 dose of study medication, and had both pre-dose and at least 1 post-baseline Rheumatoid arthritis (RA) assessment before Week 12.
Posted
Mean
Standard Deviation
Tender joints
Baseline, Week 12 and Week 24
ID
Title
Description
OG000
Placebo
INCB028050 was administered qd, orally in matching placebo capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
OG001
INCB028050 4 mg QD
INCB028050 was administered qd, orally in 4 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
OG002
INCB028050 7 mg QD
INCB028050 was administered qd, orally in 7 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
Secondary
Change in ACR Assessment Swollen Joint Count (SJC) From Baseline to Week 12 and Week 24
The 28 joints to be assessed for tenderness and swelling were shoulder, elbow, wrist, metacarpophalangeal (MCP) joints 1-5, proximal interphalangeal (PIP) joints 1-5, and knee on both sides of the body. The sum of tender joints ranged from 0 to 28 with 0 as best possible health status and 28 as worst health status.
Modified Intent-to-Treat (mITT) population included all participants that enrolled, took at least 1 dose of study medication, and had both pre-dose and at least 1 post-baseline Rheumatoid arthritis (RA) assessment before Week 12.
Posted
Mean
Standard Deviation
Swollen joints
Baseline, Week 12 and Week 24
ID
Title
Description
OG000
Placebo
INCB028050 was administered qd, orally in matching placebo capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
OG001
INCB028050 4 mg QD
INCB028050 was administered qd, orally in 4 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
OG002
INCB028050 7 mg QD
INCB028050 was administered qd, orally in 7 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
Secondary
Change in Participants' Assessment of Pain From Baseline at Week 12 and Week 24
Participants were to assess their current level of pain on a 100 mm horizontal Visual Analog Scale (VAS). The left-hand extreme of the line (0 mm) was described as "no pain" and the right-hand (100 mm) as "most imaginable pain".
Modified Intent-to-Treat (mITT) population included all participants that enrolled, took at least 1 dose of study medication, and had both pre-dose and at least 1 post-baseline Rheumatoid arthritis (RA) assessment before Week 12.
Posted
Mean
Standard Deviation
millimeter (mm)
Baseline, Week 12 and Week 24
ID
Title
Description
OG000
Placebo
INCB028050 was administered qd, orally in matching placebo capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
OG001
INCB028050 4 mg QD
INCB028050 was administered qd, orally in 4 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
OG002
INCB028050 7 mg QD
INCB028050 was administered qd, orally in 7 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
Secondary
Change in Participants' Global Assessment of Disease Activity From Baseline at Week 12 and Week 24
Participants were to assess the disease (RA) activity on a 100 mm horizontal VAS. The left-hand extreme of the line (0 mm) was described as "no arthritis activity" (symptom-free and no arthritis symptoms) and the right hand extreme (100 mm) as "extremely active arthritis" (maximum arthritis disease activity). A decreasing mean score, therefore, indicates improvement.
Modified Intent-to-Treat (mITT) population included all participants that enrolled, took at least 1 dose of study medication, and had both pre-dose and at least 1 post-baseline Rheumatoid arthritis (RA) assessment before Week 12.
Posted
Mean
Standard Deviation
millimeter (mm)
Baseline, Week 12 and Week 24
ID
Title
Description
OG000
Placebo
INCB028050 was administered qd, orally in matching placebo capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
OG001
INCB028050 4 mg QD
INCB028050 was administered qd, orally in 4 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
OG002
INCB028050 7 mg QD
INCB028050 was administered qd, orally in 7 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
Secondary
Change in Physician's Global Assessment of Disease Activity (PGA) From Baseline at Week 12 and Week 24
Physicians were to assess the disease (RA) activity on a 100 mm horizontal VAS. The left-hand extreme of the line (0 mm) was described as "no arthritis activity" (symptom-free and no arthritis symptoms) and the right hand extreme (100 mm) as "extremely active arthritis" (maximum arthritis disease activity). A decreasing mean score, therefore, indicates improvement.
Modified Intent-to-Treat (mITT) population included all participants that enrolled, took at least 1 dose of study medication, and had both pre-dose and at least 1 post-baseline Rheumatoid arthritis (RA) assessment before Week 12.
Posted
Mean
Standard Deviation
millimeter (mm)
Baseline, Week 12 and Week 24
ID
Title
Description
OG000
Placebo
INCB028050 was administered qd, orally in matching placebo capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
OG001
INCB028050 4 mg QD
INCB028050 was administered qd, orally in 4 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
OG002
INCB028050 7 mg QD
INCB028050 was administered qd, orally in 7 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
Secondary
Change in Health Assessment Questionnaire-Disability Index (HAQ-DI) From Baseline at Week 12 and Week 24
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.
Modified Intent-to-Treat (mITT) population included all participants that enrolled, took at least 1 dose of study medication, and had both pre-dose and at least 1 post-baseline Rheumatoid arthritis (RA) assessment before Week 12.
Posted
Mean
Standard Deviation
Score on a scale
Baseline, Week 12 and Week 24
ID
Title
Description
OG000
Placebo
INCB028050 was administered qd, orally in matching placebo capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
OG001
INCB028050 4 mg QD
INCB028050 was administered qd, orally in 4 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
OG002
INCB028050 7 mg QD
Secondary
Change in Erythrocyte Sedimentation Rate (ESR) From Baseline at Week 12 and Week 24
ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 millimeter/hour (mm/hr). A higher rate is consistent with inflammation.
Modified Intent-to-Treat (mITT) population included all participants that enrolled, took at least 1 dose of study medication, and had both pre-dose and at least 1 post-baseline Rheumatoid arthritis (RA) assessment before Week 12.
Posted
Mean
Standard Deviation
mm/hr
Baseline, Week 12 and Week 24
ID
Title
Description
OG000
Placebo
INCB028050 was administered qd, orally in matching placebo capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
OG001
INCB028050 4 mg QD
INCB028050 was administered qd, orally in 4 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
OG002
INCB028050 7 mg QD
INCB028050 was administered qd, orally in 7 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
Secondary
Change in C-reactive Protein (CRP) From Baseline at Week 12 and Week 24
The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.
Modified Intent-to-Treat (mITT) population included all participants that enrolled, took at least 1 dose of study medication, and had both pre-dose and at least 1 post-baseline Rheumatoid arthritis (RA) assessment before Week 12.
Posted
Mean
Standard Deviation
mg/L
Baseline, Week 12 and Week 24
ID
Title
Description
OG000
Placebo
INCB028050 was administered qd, orally in matching placebo capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
OG001
INCB028050 4 mg QD
INCB028050 was administered qd, orally in 4 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
OG002
INCB028050 7 mg QD
INCB028050 was administered qd, orally in 7 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
Secondary
Change in Duration of Morning Stiffness From Baseline at Week 12 and Week 24
Duration of morning stiffness was defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in minutes (If none was present = 0; If morning stiffness was continuing at the time of assessment or was unusual compared to the recent past, average of duration of stiffness over the past 3 days was reported; If stiffness persisted the entire day, 1440 minutes was recorded).
Modified Intent-to-Treat (mITT) population included all participants that enrolled, took at least 1 dose of study medication, and had both pre-dose and at least 1 post-baseline Rheumatoid arthritis (RA) assessment before Week 12.
Posted
Mean
Standard Deviation
Minutes
Baseline, Week 12 and Week 24
ID
Title
Description
OG000
Placebo
INCB028050 was administered qd, orally in matching placebo capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
OG001
INCB028050 4 mg QD
INCB028050 was administered qd, orally in 4 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
OG002
INCB028050 7 mg QD
Secondary
Percentage of Participants Achieving Good European League Against Rheumatism (EULAR) Response (DAS28 ESR) at Week 12
EULAR response reflects an improvement in disease activity and an attainment of a lower degree of disease activity based on the DAS-28 score. A Good Response is defined as an improvement (decrease) in the DAS28 of more than 1.2 compared with Baseline and attainment of a DAS28 score less than or equal to 3.2.
Modified Intent-to-Treat (mITT) population included all participants that enrolled, took at least 1 dose of study medication, and had both pre-dose and at least 1 post-baseline Rheumatoid arthritis (RA) assessment before Week 12.
Posted
Number
percentage of participants
Week 12
ID
Title
Description
OG000
Placebo
INCB028050 was administered qd, orally in matching placebo capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
OG001
INCB028050 4 mg QD
INCB028050 was administered qd, orally in 4 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
OG002
INCB028050 7 mg QD
INCB028050 was administered qd, orally in 7 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
Secondary
Percentage of Participants Achieving Good EULAR Response (DAS28ESR) at Week 24
EULAR response reflects an improvement in disease activity and an attainment of a lower degree of disease activity based on the DAS-28 score. A Good Response is defined as an improvement (decrease) in the DAS28 of more than 1.2 compared with Baseline and attainment of a DAS28 score less than or equal to 3.2.
Modified Intent-to-Treat (mITT) population included all participants that enrolled, took at least 1 dose of study medication, and had both pre-dose and at least 1 post-baseline Rheumatoid arthritis (RA) assessment before Week 12.
Posted
Number
percentage of participants
Week 24
ID
Title
Description
OG000
Placebo to INCB028050 7 mg QD
Participants who were assigned to placebo group at baseline then crossed over to active treatment groups after week 12 were analyzed.
OG001
Placebo to INCB028050 10 mg QD
Participants who were assigned to placebo group at baseline then crossed over to active treatment groups after week 12 were analyzed.
OG002
INCB028050 4 mg QD
INCB028050 was administered qd, orally in 4 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
Secondary
Percentage of Participants Achieving Good EULAR Response (DAS28CRP) at Week 12
EULAR response reflects an improvement in disease activity and an attainment of a lower degree of disease activity based on the DAS-28 score. A Good Response is defined as an improvement (decrease) in the DAS28 of more than 1.2 compared with Baseline and attainment of a DAS28 score less than or equal to 2.6.
Modified Intent-to-Treat (mITT) population included all participants that enrolled, took at least 1 dose of study medication, and had both pre-dose and at least 1 post-baseline Rheumatoid arthritis (RA) assessment before Week 12.
Posted
Number
percentage of participants
Week 12
ID
Title
Description
OG000
Placebo
INCB028050 was administered qd, orally in matching placebo capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
OG001
INCB028050 4 mg QD
INCB028050 was administered qd, orally in 4 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
OG002
INCB028050 7 mg QD
INCB028050 was administered qd, orally in 7 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
Secondary
Percentage of Participants Achieving Good EULAR Response (DAS28CRP) at Week 24
EULAR response reflects an improvement in disease activity and an attainment of a lower degree of disease activity based on the DAS-28 score. A Good Response is defined as an improvement (decrease) in the DAS28 of more than 1.2 compared with Baseline and attainment of a DAS28 score less than or equal to 2.6.
Modified Intent-to-Treat (mITT) population included all participants that enrolled, took at least 1 dose of study medication, and had both pre-dose and at least 1 post-baseline Rheumatoid arthritis (RA) assessment before Week 12.
Posted
Number
percentage of participants
Week 24
ID
Title
Description
OG000
INCB028050 4 mg QD
INCB028050 was administered qd, orally in 4 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
OG001
INCB028050 7 mg QD
INCB028050 was administered qd, orally in 7 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
OG002
INCB028050 10 mg QD
INCB028050 was administered qd, orally in 10 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
Secondary
Change in SF-36 Mental Component Summary From Baseline at Week 12 and Week 24
The Health Assessment Questionnaire Short Form 36 (SF-36) determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Scales 5-8 primarily contribute to the mental component summary score (PCS) of the SF-36. Scores on each scale are summed and averaged (range = 0 "worst"-100 "best").
Modified Intent-to-Treat (mITT) population included all participants that enrolled, took at least 1 dose of study medication, and had both pre-dose and at least 1 post-baseline Rheumatoid arthritis (RA) assessment before Week 12.
Posted
Mean
Standard Deviation
scores on a scale
Baseline, Week 12 and Week 24
ID
Title
Description
OG000
Placebo
INCB028050 was administered qd, orally in matching placebo capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
OG001
INCB028050 4 mg QD
INCB028050 was administered qd, orally in 4 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
Secondary
Change in SF-36 Physical Component Summary From Baseline at Week 12 and Week 24
The Health Assessment Questionnaire Short Form 36 (SF-36) determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Scales 1-4 primarily contribute to the physical component summary score (PCS) of the SF-36. Scores on each scale are summed and averaged (range = 0 "worst"-100 "best").
Modified Intent-to-Treat (mITT) population included all participants that enrolled, took at least 1 dose of study medication, and had both pre-dose and at least 1 post-baseline Rheumatoid arthritis (RA) assessment before Week 12.
Posted
Mean
Standard Deviation
scores on a scale
Baseline, Week 12 and Week 24
ID
Title
Description
OG000
Placebo
INCB028050 was administered qd, orally in matching placebo capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
OG001
INCB028050 4 mg QD
INCB028050 was administered qd, orally in 4 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
Secondary
Percent of Participants Achieving a Minimum Clinically Important Difference (MCID) in the Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12 and Week 24
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. The MCID score for HAQ-DI is -0.22.
Modified Intent-to-Treat (mITT) population included all participants that enrolled, took at least 1 dose of study medication, and had both pre-dose and at least 1 post-baseline Rheumatoid arthritis (RA) assessment before Week 12.
Posted
Number
percentage of participants
Week 12 and Week 24
ID
Title
Description
OG000
Placebo
INCB028050 was administered qd, orally in matching placebo capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
OG001
INCB028050 4 mg QD
INCB028050 was administered qd, orally in 4 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
Secondary
Percent of Participants Achieving a MCID in the Pain Score (Participant's Assessment of Pain) at Week 12 and Week 24
Participants were to assess their current level of pain on a 100 mm horizontal VAS. The left-hand extreme of the line (0 mm) was described as "no pain" and the right-hand (100 mm) as "most imaginable pain". MCID for the pain score is a decrease of at least 10 mm on a 100 mm scale.
Modified Intent-to-Treat (mITT) population included all participants that enrolled, took at least 1 dose of study medication, and had both pre-dose and at least 1 post-baseline Rheumatoid arthritis (RA) assessment before Week 12.
Posted
Number
percentage of participants
Week 12 and Week 24
ID
Title
Description
OG000
Placebo
INCB028050 was administered qd, orally in matching placebo capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
OG001
INCB028050 4 mg QD
INCB028050 was administered qd, orally in 4 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
OG002
INCB028050 7 mg QD
INCB028050 was administered qd, orally in 7 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
Secondary
Percent of Participants Achieving a MCID in the SF-36 Physical Components and Mental Components at Week 12 and Week 24
The Health Assessment Questionnaire Short Form 36 (SF-36) determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Scales 5-8 primarily contribute to the mental component summary score (PCS) of the SF-36. Scores on each scale are summed and averaged (range = 0 "worst"-100 "best").
Modified Intent-to-Treat (mITT) population included all participants that enrolled, took at least 1 dose of study medication, and had both pre-dose and at least 1 post-baseline Rheumatoid arthritis (RA) assessment before Week 12.
Posted
Number
percentage of participants
Week 12 and Week 24
ID
Title
Description
OG000
Placebo
INCB028050 was administered qd, orally in matching placebo capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
OG001
INCB028050 4 mg QD
INCB028050 was administered qd, orally in 4 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
Time Frame
Screening through follow-up visit up to approximately 8 months.
Description
Safety evaluable population included all randomized participants who received at least 1 dose of study drug. Those participants that continued after week 24 were safety subjects who continued after week 12.
The data presented has been expanded to best represent the number at risk based on the dose and the period in which it was given to the participant.
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
Placebo (Weeks 0-12)
INCB028050 was administered qd, orally in matching placebo capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
0
31
23
31
EG001
INCB028050 4 mg QD (Weeks 0-12)
INCB028050 was administered qd, orally in 4 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
0
31
19
31
EG002
INCB028050 7 mg QD (Weeks 0-12)
INCB028050 was administered qd, orally in 7 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
1
32
15
32
EG003
INCB028050 10 mg QD (Weeks 0-12)
INCB028050 was administered qd, orally in 10 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
0
31
20
31
EG004
Placebo to INCB028050 7 mg QD
12-week extension period. Participants who were assigned to placebo group at baseline then crossed over to active treatment groups after week 12.
0
14
11
14
EG005
Placebo to INCB028050 10 mg QD
12-week extension period. Participants who were assigned to placebo group at baseline then crossed over to active treatment groups after week 12.
0
15
9
15
EG006
INCB028050 4 mg QD (Weeks 12-24)
12-week extension period
0
29
11
29
EG007
INCB028050 7 mg QD (Weeks 12-24)
12-week extension period
1
30
17
30
EG008
INCB028050 10 mg QD (Weeks 12-24)
12-week extension period
0
27
6
27
EG009
Placebo to INCB028050 7 mg QD (After Week 24 to Week 28)
Follow-up Participants who were assigned to placebo group at baseline then crossed over to active treatment groups after week 12.
0
14
0
14
EG010
Placebo to INCB028050 10 mg QD (After Week 24 to Week 28)
Follow-up Participants who were assigned to placebo group at baseline then crossed over to active treatment groups after week 12.
1
15
1
15
EG011
INCB028050 4 mg QD (After Week 24 to Week 28)
Follow-up
0
29
3
29
EG012
INCB028050 7 mg QD (After Week 24 to Week 28)
Follow-up
0
30
5
30
EG013
INCB028050 10 mg QD (After Week 24 to Week 28)
Follow-up
0
27
2
27
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Erosive oesophagitis
Gastrointestinal disorders
MedDRA (11.0)
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected31 at risk
EG0021 affected32 at risk
EG0030 affected31 at risk
EG0040 affected14 at risk
EG0050 affected15 at risk
EG0060 affected29 at risk
EG0070 affected30 at risk
EG0080 affected27 at risk
EG0090 affected14 at risk
EG0100 affected15 at risk
EG0110 affected29 at risk
EG0120 affected30 at risk
EG0130 affected27 at risk
Thrombophlebitis
Vascular disorders
MedDRA (11.0)
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected31 at risk
EG0021 affected32 at risk
EG003
Mallory-Weiss syndrome
Gastrointestinal disorders
MedDRA (11.0)
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected31 at risk
EG0020 affected32 at risk
EG003
Cerebrovascular accident
Nervous system disorders
MedDRA (11.0)
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected31 at risk
EG0020 affected32 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Headache
Nervous system disorders
MedDRA (11.0)
Systematic Assessment
EG0002 affected31 at risk
EG0014 affected31 at risk
EG0023 affected32 at risk
EG0033 affected31 at risk
EG0040 affected14 at risk
EG0051 affected15 at risk
EG0061 affected29 at risk
EG0071 affected30 at risk
EG0080 affected27 at risk
EG0090 affected14 at risk
EG0100 affected15 at risk
EG0110 affected29 at risk
EG0120 affected30 at risk
EG0130 affected27 at risk
Upper respiratory tract infection
Infections and infestations
MedDRA (11.0)
Systematic Assessment
EG0003 affected31 at risk
EG0012 affected31 at risk
EG0022 affected32 at risk
EG003
Diarrhea
Gastrointestinal disorders
MedDRA (11.0)
Systematic Assessment
EG0002 affected31 at risk
EG0012 affected31 at risk
EG0022 affected32 at risk
EG003
Sinusitis
Infections and infestations
MedDRA (11.0)
Systematic Assessment
EG0002 affected31 at risk
EG0011 affected31 at risk
EG0023 affected32 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA (11.0)
Systematic Assessment
EG0001 affected31 at risk
EG0012 affected31 at risk
EG0022 affected32 at risk
EG003
Bronchitis
Infections and infestations
MedDRA (11.0)
Systematic Assessment
EG0001 affected31 at risk
EG0011 affected31 at risk
EG0022 affected32 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA (11.0)
Systematic Assessment
EG0001 affected31 at risk
EG0010 affected31 at risk
EG0023 affected32 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA (11.0)
Systematic Assessment
EG0001 affected31 at risk
EG0011 affected31 at risk
EG0022 affected32 at risk
EG003
Acne
Skin and subcutaneous tissue disorders
MedDRA (11.0)
Systematic Assessment
EG0000 affected31 at risk
EG0011 affected31 at risk
EG0022 affected32 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA (11.0)
Systematic Assessment
EG0001 affected31 at risk
EG0011 affected31 at risk
EG0020 affected32 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA (11.0)
Systematic Assessment
EG0001 affected31 at risk
EG0012 affected31 at risk
EG0020 affected32 at risk
EG003
Dry eye
Eye disorders
MedDRA (11.0)
Systematic Assessment
EG0002 affected31 at risk
EG0010 affected31 at risk
EG0020 affected32 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA (11.0)
Systematic Assessment
EG0002 affected31 at risk
EG0011 affected31 at risk
EG0021 affected32 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA (11.0)
Systematic Assessment
EG0000 affected31 at risk
EG0012 affected31 at risk
EG0020 affected32 at risk
EG003
C-reactive protein increased
Investigations
MedDRA (11.0)
Systematic Assessment
EG0002 affected31 at risk
EG0011 affected31 at risk
EG0020 affected32 at risk
EG003
Cerumen impaction
Ear and labyrinth disorders
MedDRA (11.0)
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected31 at risk
EG0022 affected32 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA (11.0)
Systematic Assessment
EG0000 affected31 at risk
EG0012 affected31 at risk
EG0021 affected32 at risk
EG003
Mouth ulceration
Gastrointestinal disorders
MedDRA (11.0)
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected31 at risk
EG0021 affected32 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA (11.0)
Systematic Assessment
EG0002 affected31 at risk
EG0011 affected31 at risk
EG0020 affected32 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA (11.0)
Systematic Assessment
EG0002 affected31 at risk
EG0010 affected31 at risk
EG0021 affected32 at risk
EG003
Influenza
Infections and infestations
MedDRA (11.0)
Systematic Assessment
EG0001 affected31 at risk
EG0010 affected31 at risk
EG0020 affected32 at risk
EG003
Dermatitis
Skin and subcutaneous tissue disorders
MedDRA (11.0)
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected31 at risk
EG0020 affected32 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA (11.0)
Systematic Assessment
EG0000 affected31 at risk
EG0012 affected31 at risk
EG0020 affected32 at risk
EG003
Sinus congestion
Respiratory, thoracic and mediastinal disorders
MedDRA (11.0)
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected31 at risk
EG0022 affected32 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA (11.0)
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected31 at risk
EG0020 affected32 at risk
EG003
Anemia
Blood and lymphatic system disorders
MedDRA (11.0)
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected31 at risk
EG0020 affected32 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA (11.0)
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected31 at risk
EG0020 affected32 at risk
EG003
Hypercholesterolemia
Metabolism and nutrition disorders
MedDRA (11.0)
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected31 at risk
EG0020 affected32 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA (11.0)
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected31 at risk
EG0020 affected32 at risk
EG003
Pyrexia
General disorders
MedDRA (11.0)
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected31 at risk
EG0020 affected32 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA (11.0)
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected31 at risk
EG0020 affected32 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA (11.0)
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected31 at risk
EG0020 affected32 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA (11.0)
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected31 at risk
EG0020 affected32 at risk
EG003
Blood creatinine increased
Investigations
MedDRA (11.0)
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected31 at risk
EG0020 affected32 at risk
EG003
Chills
General disorders
MedDRA (11.0)
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected31 at risk
EG0020 affected32 at risk
EG003
Conjunctivitis
Eye disorders
MedDRA (11.0)
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected31 at risk
EG0020 affected32 at risk
EG003
Rheumatoid arthritis
Immune system disorders
MedDRA (11.0)
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected31 at risk
EG0020 affected32 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
Following the first publication, the Institution and/or Principal Investigator may publish data or results from the Study; provided, however, that the Institution and/or Principal Investigator submits the proposed publication to the Sponsor for review at least sixty (60) days prior to the date of the proposed publication. Sponsor may remove from the proposed publication any information that is considered confidential and/or proprietary other than Study data and results.
Point of Contact
Title
Organization
Phone
Extension
Email
Study Director
Incyte Corporation
855 463-3463
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
C000596027
baricitinib
Ancestor Terms
Not provided
Browse Leaves
Not provided
Browse Branches
Not provided
0 subjects
FG0052 subjects
1 subjects
FG0051 subjects
0 subjects
FG0050 subjects
0 subjects
FG0050 subjects
29 subjects
FG00524 subjects
1 subjects
FG0053 subjects
0 subjects
FG0041 subjects
FG0052 subjects
Consent Withdrawn
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0031 subjects
FG0040 subjects
FG0050 subjects
Protocol Deviation
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0051 subjects
Disease Progression
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG0040 subjects
FG0050 subjects
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
29 subjects
FG00430 subjects
FG00527 subjects
29 subjects
FG00524 subjects
0 subjects
FG0050 subjects
1 subjects
FG0040 subjects
FG0050 subjects
55.2
± 10.09
BG00455.8± 10.92
25
BG00322
BG004102
Male
BG0003
BG0016
BG0027
BG0039
BG00425
30
16
OG000
OG001
Sensitivity analysis for pairwise comparisons of 4 mg QD versus placebo.
Fisher Exact
0.1978
Other
OG000
OG002
Sensitivity analysis for pairwise comparisons of 7 mg QD versus placebo.
Fisher Exact
0.0437
Other
OG000
OG003
Sensitivity analysis for pairwise comparisons of 10 mg QD versus placebo.
Fisher Exact
0.1236
Other
Units
Counts
Participants
OG00031
OG00131
OG00232
OG00331
Title
Denominators
Categories
Title
Measurements
OG00019
OG00115
OG00220
OG00323
OG004
INCB028050 10 mg QD
INCB028050 was administered qd, orally in 10 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
Units
Counts
Participants
OG00014
OG00115
OG00229
OG00330
OG00427
Title
Denominators
Categories
Title
Measurements
OG0006
OG0015
OG00212
OG00316
OG00416
INCB028050 was administered qd, orally in 10 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
Units
Counts
Participants
OG00027
OG00130
OG00225
Title
Denominators
Categories
Title
Measurements
OG00018
OG00120
OG00218
OG003
INCB028050 10 mg QD
INCB028050 was administered qd, orally in 10 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
Units
Counts
Participants
OG00031
OG00131
OG00232
OG00330
Title
Denominators
Categories
Week 12
ParticipantsOG00031
ParticipantsOG00131
ParticipantsOG00232
ParticipantsOG00330
Title
Measurements
OG00013.0
OG00135.0
OG00231.0
OG003
Week 24
ParticipantsOG00031
ParticipantsOG00127
ParticipantsOG00230
ParticipantsOG00325
OG003
INCB028050 10 mg QD
INCB028050 was administered qd, orally in 10 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
Units
Counts
Participants
OG00031
OG00131
OG00232
OG00330
Title
Denominators
Categories
Week 12
ParticipantsOG00031
ParticipantsOG00131
ParticipantsOG00232
ParticipantsOG00330
Title
Measurements
OG0003.0
OG00116.0
OG0029.0
OG003
Week 24
ParticipantsOG00031
ParticipantsOG00127
ParticipantsOG00230
ParticipantsOG00325
INCB028050 was administered qd, orally in 7 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
OG003
INCB028050 10 mg QD
INCB028050 was administered qd, orally in 10 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
Units
Counts
Participants
OG00031
OG00131
OG00232
OG00330
Title
Denominators
Categories
Week 12
ParticipantsOG00031
ParticipantsOG00131
ParticipantsOG00232
ParticipantsOG00330
Title
Measurements
OG0000.0
OG0013.0
OG0020.0
OG003
Week 24
ParticipantsOG00031
ParticipantsOG00127
ParticipantsOG00230
ParticipantsOG00325
INCB028050 was administered qd, orally in 7 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
OG003
INCB028050 10 mg QD
INCB028050 was administered qd, orally in 10 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
Units
Counts
Participants
OG00031
OG00131
OG00232
OG00330
Title
Denominators
Categories
Baseline
ParticipantsOG00031
ParticipantsOG00131
ParticipantsOG00232
ParticipantsOG00330
Title
Measurements
OG0005.71± 0.875
OG0015.64± 1.098
OG0025.76± 0.925
OG003
Change from baseline at Week 12
ParticipantsOG00031
ParticipantsOG00131
ParticipantsOG00232
ParticipantsOG00330
Change from baseline at Week 24
ParticipantsOG00031
ParticipantsOG00127
ParticipantsOG00230
ParticipantsOG00323
INCB028050 was administered qd, orally in 7 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
OG003
INCB028050 10 mg QD
INCB028050 was administered qd, orally in 10 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
Units
Counts
Participants
OG00031
OG00131
OG00232
OG00330
Title
Denominators
Categories
Baseline
ParticipantsOG00031
ParticipantsOG00131
ParticipantsOG00232
ParticipantsOG00330
Title
Measurements
OG0006.56± 0.840
OG0016.41± 1.024
OG0026.35± 0.968
OG003
Change from baseline at Week 12
ParticipantsOG00031
ParticipantsOG00131
ParticipantsOG00232
ParticipantsOG00330
Change from baseline at Week 24
ParticipantsOG00031
ParticipantsOG00127
ParticipantsOG00230
ParticipantsOG00323
INCB028050 10 mg QD
INCB028050 was administered qd, orally in 10 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
Units
Counts
Participants
OG00031
OG00131
OG00232
OG00330
Title
Denominators
Categories
Week 12
ParticipantsOG00031
ParticipantsOG00131
ParticipantsOG00232
ParticipantsOG00330
Title
Measurements
OG00019.0
OG00123.0
OG00231.0
OG003
Week 24
ParticipantsOG00031
ParticipantsOG00127
ParticipantsOG00230
ParticipantsOG00323
INCB028050 7 mg QD
INCB028050 was administered qd, orally in 7 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
OG004
INCB028050 10 mg QD
INCB028050 was administered qd, orally in 10 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
Units
Counts
Participants
OG00015
OG00116
OG00231
OG00332
OG00430
Title
Denominators
Categories
Week 12
ParticipantsOG00015
ParticipantsOG00116
ParticipantsOG00231
ParticipantsOG00332
ParticipantsOG00430
Title
Measurements
OG0006.7
OG00118.8
OG00216.0
OG003
Week 24
ParticipantsOG00014
ParticipantsOG00113
ParticipantsOG00227
ParticipantsOG00330
Units
Counts
Participants
OG00031
OG00132
OG00230
Title
Denominators
Categories
Week 12
ParticipantsOG00031
ParticipantsOG00132
ParticipantsOG00230
Title
Measurements
OG00023.0
OG00125.0
OG00217.0
Week 24
ParticipantsOG00027
ParticipantsOG00130
ParticipantsOG00223
Title
Measurements
OG000
OG003
INCB028050 10 mg QD
INCB028050 was administered qd, orally in 10 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
Units
Counts
Participants
OG00031
OG00131
OG00232
OG00330
Title
Denominators
Categories
Baseline
ParticipantsOG00031
ParticipantsOG00131
ParticipantsOG00232
ParticipantsOG00330
Title
Measurements
OG00015.9± 6.67
OG00114.4± 6.58
OG00214.7± 6.70
OG003
Change from baseline at Week 12
ParticipantsOG00031
ParticipantsOG00131
ParticipantsOG00232
ParticipantsOG00330
Change from baseline at Week 24
ParticipantsOG00031
ParticipantsOG00127
ParticipantsOG00230
ParticipantsOG00325
OG003
INCB028050 10 mg QD
INCB028050 was administered qd, orally in 10 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
Units
Counts
Participants
OG00031
OG00131
OG00232
OG00330
Title
Denominators
Categories
Baseline
ParticipantsOG00031
ParticipantsOG00131
ParticipantsOG00232
ParticipantsOG00330
Title
Measurements
OG00011.0± 5.28
OG00112.0± 5.48
OG00210.6± 4.57
OG003
Change from baseline at Week 12
ParticipantsOG00031
ParticipantsOG00131
ParticipantsOG00232
ParticipantsOG00330
Change from baseline at Week 24
ParticipantsOG00031
ParticipantsOG00127
ParticipantsOG00230
ParticipantsOG00325
OG003
INCB028050 10 mg QD
INCB028050 was administered qd, orally in 10 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
Units
Counts
Participants
OG00031
OG00131
OG00232
OG00330
Title
Denominators
Categories
Baseline
ParticipantsOG00031
ParticipantsOG00131
ParticipantsOG00232
ParticipantsOG00330
Title
Measurements
OG00062.37± 21.079
OG00157.08± 24.716
OG00263.25± 18.656
OG003
Change from baseline at Week 12
ParticipantsOG00031
ParticipantsOG00131
ParticipantsOG00232
ParticipantsOG00330
Change from baseline at Week 24
ParticipantsOG00031
ParticipantsOG00127
ParticipantsOG00230
ParticipantsOG00325
OG003
INCB028050 10 mg QD
INCB028050 was administered qd, orally in 10 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
Units
Counts
Participants
OG00031
OG00131
OG00232
OG00330
Title
Denominators
Categories
Baseline
ParticipantsOG00031
ParticipantsOG00131
ParticipantsOG00232
ParticipantsOG00330
Title
Measurements
OG00066.19± 20.522
OG00159.02± 26.314
OG00269.69± 18.893
OG003
Change from baseline at Week 12
ParticipantsOG00031
ParticipantsOG00131
ParticipantsOG00232
ParticipantsOG00330
Change from baseline at Week 24
ParticipantsOG00031
ParticipantsOG00127
ParticipantsOG00230
ParticipantsOG00325
OG003
INCB028050 10 mg QD
INCB028050 was administered qd, orally in 10 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
Units
Counts
Participants
OG00031
OG00131
OG00232
OG00330
Title
Denominators
Categories
Baseline
ParticipantsOG00031
ParticipantsOG00131
ParticipantsOG00232
ParticipantsOG00330
Title
Measurements
OG00063.45± 16.903
OG00161.94± 19.162
OG00259.80± 17.185
OG003
Change from baseline at Week 12
ParticipantsOG00031
ParticipantsOG00131
ParticipantsOG00232
ParticipantsOG00330
Change from baseline at Week 24
ParticipantsOG00031
ParticipantsOG00127
ParticipantsOG00230
ParticipantsOG00325
INCB028050 was administered qd, orally in 7 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
OG003
INCB028050 10 mg QD
INCB028050 was administered qd, orally in 10 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
Units
Counts
Participants
OG00031
OG00131
OG00232
OG00330
Title
Denominators
Categories
Baseline
ParticipantsOG00031
ParticipantsOG00131
ParticipantsOG00232
ParticipantsOG00330
Title
Measurements
OG0001.61± 0.494
OG0011.50± 0.601
OG0021.67± 0.474
OG003
Change from baseline at Week 12 (n=31, 31, 30, 30)
ParticipantsOG00031
ParticipantsOG00131
ParticipantsOG00232
ParticipantsOG003
Change from baseline at Week 24
ParticipantsOG00031
ParticipantsOG00127
ParticipantsOG00228
ParticipantsOG00325
OG003
INCB028050 10 mg QD
INCB028050 was administered qd, orally in 10 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
Units
Counts
Participants
OG00031
OG00131
OG00232
OG00330
Title
Denominators
Categories
Baseline
ParticipantsOG00031
ParticipantsOG00131
ParticipantsOG00232
ParticipantsOG00330
Title
Measurements
OG00040.8± 15.40
OG00142.8± 17.62
OG00237.3± 21.56
OG003
Change from baseline at Week 12
ParticipantsOG00031
ParticipantsOG00131
ParticipantsOG00232
ParticipantsOG00330
Change from baseline at Week 24
ParticipantsOG00031
ParticipantsOG00127
ParticipantsOG00230
ParticipantsOG00323
OG003
INCB028050 10 mg QD
INCB028050 was administered qd, orally in 10 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
Units
Counts
Participants
OG00031
OG00131
OG00232
OG00330
Title
Denominators
Categories
Baseline
ParticipantsOG00031
ParticipantsOG00131
ParticipantsOG00232
ParticipantsOG00330
Title
Measurements
OG00010.89± 11.556
OG00115.63± 17.327
OG00215.64± 16.113
OG003
Change from baseline at Week 12
ParticipantsOG00031
ParticipantsOG00131
ParticipantsOG00232
ParticipantsOG00330
Change from baseline at Week 24
ParticipantsOG00031
ParticipantsOG00127
ParticipantsOG00230
ParticipantsOG00325
INCB028050 was administered qd, orally in 7 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
OG003
INCB028050 10 mg QD
INCB028050 was administered qd, orally in 10 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
Units
Counts
Participants
OG00031
OG00131
OG00232
OG00330
Title
Denominators
Categories
Baseline
ParticipantsOG00031
ParticipantsOG00131
ParticipantsOG00232
ParticipantsOG00330
Title
Measurements
OG00078.5± 61.36
OG001179.8± 347.48
OG002125.5± 246.75
OG003
Change from baseline at Week 12
ParticipantsOG00031
ParticipantsOG00131
ParticipantsOG00232
ParticipantsOG00330
Change from baseline at Week 24
ParticipantsOG00031
ParticipantsOG00127
ParticipantsOG00230
ParticipantsOG00325
OG003
INCB028050 10 mg QD
INCB028050 was administered qd, orally in 10 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
Units
Counts
Participants
OG00031
OG00131
OG00232
OG00330
Title
Denominators
Categories
Title
Measurements
OG00019.0
OG00123.0
OG00231.0
OG00313.0
OG003
INCB028050 7 mg QD
INCB028050 was administered qd, orally in 7 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
OG004
INCB028050 10 mg QD
INCB028050 was administered qd, orally in 10 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
Units
Counts
Participants
OG00015
OG00116
OG00227
OG00330
OG00423
Title
Denominators
Categories
Title
Measurements
OG00021.0
OG00115.0
OG00233.0
OG00343.0
OG00439.0
OG003
INCB028050 10 mg QD
INCB028050 was administered qd, orally in 10 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
Units
Counts
Participants
OG00031
OG00131
OG00232
OG00330
Title
Denominators
Categories
Title
Measurements
OG00026.0
OG00139.0
OG00234.0
OG00333.0
Units
Counts
Participants
OG00027
OG00130
OG00223
Title
Denominators
Categories
Title
Measurements
OG00048.0
OG00153.0
OG00265.0
OG002
INCB028050 7 mg QD
INCB028050 was administered qd, orally in 7 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
OG003
INCB028050 10 mg QD
INCB028050 was administered qd, orally in 10 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
Units
Counts
Participants
OG00031
OG00131
OG00232
OG00330
Title
Denominators
Categories
Baseline
ParticipantsOG00031
ParticipantsOG00131
ParticipantsOG00232
ParticipantsOG00330
Title
Measurements
OG00071.08± 27.534
OG00169.03± 28.181
OG00278.41± 30.329
OG003
Change from baseline at Week 12
ParticipantsOG00031
ParticipantsOG00131
ParticipantsOG00232
ParticipantsOG00330
Change from baseline at Week 24
ParticipantsOG00031
ParticipantsOG00127
ParticipantsOG00230
ParticipantsOG00325
OG002
INCB028050 7 mg QD
INCB028050 was administered qd, orally in 7 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
OG003
INCB028050 10 mg QD
INCB028050 was administered qd, orally in 10 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
Units
Counts
Participants
OG00031
OG00131
OG00232
OG00330
Title
Denominators
Categories
Baseline
ParticipantsOG00031
ParticipantsOG00131
ParticipantsOG00232
ParticipantsOG00330
Title
Measurements
OG00029.14± 14.330
OG00134.67± 16.006
OG00226.71± 14.642
OG003
Change from baseline at Week 12
ParticipantsOG00031
ParticipantsOG00131
ParticipantsOG00232
ParticipantsOG00330
Change from baseline at Week 24
ParticipantsOG00031
ParticipantsOG00127
ParticipantsOG00230
ParticipantsOG00325
OG002
INCB028050 7 mg QD
INCB028050 was administered qd, orally in 7 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
OG003
INCB028050 10 mg QD
INCB028050 was administered qd, orally in 10 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
Units
Counts
Participants
OG00031
OG00131
OG00232
OG00330
Title
Denominators
Categories
Week 12 (n=31, 31, 30, 30)
ParticipantsOG00031
ParticipantsOG00131
ParticipantsOG00232
ParticipantsOG00330
Title
Measurements
OG00045.0
OG00161.0
OG00263.0
OG003
Week 24
ParticipantsOG00031
ParticipantsOG00127
ParticipantsOG00228
ParticipantsOG00325
OG003
INCB028050 10 mg QD
INCB028050 was administered qd, orally in 10 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
Units
Counts
Participants
OG00031
OG00131
OG00232
OG00330
Title
Denominators
Categories
Week 12
ParticipantsOG00031
ParticipantsOG00131
ParticipantsOG00232
ParticipantsOG00330
Title
Measurements
OG00035.0
OG00158.0
OG00269.0
OG003
Week 24
ParticipantsOG00031
ParticipantsOG00127
ParticipantsOG00230
ParticipantsOG00325
OG002
INCB028050 7 mg QD
INCB028050 was administered qd, orally in 7 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
OG003
INCB028050 10 mg QD
INCB028050 was administered qd, orally in 10 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
Units
Counts
Participants
OG00031
OG00131
OG00232
OG00330
Title
Denominators
Categories
Week 12 Physical Components
ParticipantsOG00031
ParticipantsOG00131
ParticipantsOG00232
ParticipantsOG00330
Title
Measurements
OG00052.0
OG00168.0
OG00269.0
OG003
Week 24 Physical Components
ParticipantsOG00031
ParticipantsOG00127
ParticipantsOG00230
ParticipantsOG00325
Week 12 Mental Components
ParticipantsOG00031
ParticipantsOG00131
ParticipantsOG00232
ParticipantsOG00330
Week 24 Mental Components
ParticipantsOG00031
ParticipantsOG00127
ParticipantsOG00230
ParticipantsOG00325
0 affected
31 at risk
EG0040 affected14 at risk
EG0050 affected15 at risk
EG0060 affected29 at risk
EG0070 affected30 at risk
EG0080 affected27 at risk
EG0090 affected14 at risk
EG0100 affected15 at risk
EG0110 affected29 at risk
EG0120 affected30 at risk
EG0130 affected27 at risk
0 affected
31 at risk
EG0040 affected14 at risk
EG0050 affected15 at risk
EG0060 affected29 at risk
EG0071 affected30 at risk
EG0080 affected27 at risk
EG0090 affected14 at risk
EG0100 affected15 at risk
EG0110 affected29 at risk
EG0120 affected30 at risk
EG0130 affected27 at risk
0 affected
31 at risk
EG0040 affected14 at risk
EG0050 affected15 at risk
EG0060 affected29 at risk
EG0070 affected30 at risk
EG0080 affected27 at risk
EG0090 affected14 at risk
EG0101 affected15 at risk
EG0110 affected29 at risk
EG0120 affected30 at risk
EG0130 affected27 at risk
1 affected
31 at risk
EG0040 affected14 at risk
EG0050 affected15 at risk
EG0060 affected29 at risk
EG0070 affected30 at risk
EG0080 affected27 at risk
EG0090 affected14 at risk
EG0100 affected15 at risk
EG0110 affected29 at risk
EG0120 affected30 at risk
EG0130 affected27 at risk
1 affected
31 at risk
EG0040 affected14 at risk
EG0050 affected15 at risk
EG0060 affected29 at risk
EG0070 affected30 at risk
EG0080 affected27 at risk
EG0090 affected14 at risk
EG0100 affected15 at risk
EG0110 affected29 at risk
EG0120 affected30 at risk
EG0130 affected27 at risk
1 affected
31 at risk
EG0041 affected14 at risk
EG0050 affected15 at risk
EG0060 affected29 at risk
EG0071 affected30 at risk
EG0080 affected27 at risk
EG0090 affected14 at risk
EG0100 affected15 at risk
EG0110 affected29 at risk
EG0120 affected30 at risk
EG0130 affected27 at risk
1 affected
31 at risk
EG0040 affected14 at risk
EG0050 affected15 at risk
EG0060 affected29 at risk
EG0070 affected30 at risk
EG0080 affected27 at risk
EG0090 affected14 at risk
EG0100 affected15 at risk
EG0110 affected29 at risk
EG0120 affected30 at risk
EG0130 affected27 at risk
1 affected
31 at risk
EG0042 affected14 at risk
EG0050 affected15 at risk
EG0060 affected29 at risk
EG0070 affected30 at risk
EG0080 affected27 at risk
EG0090 affected14 at risk
EG0100 affected15 at risk
EG0110 affected29 at risk
EG0120 affected30 at risk
EG0130 affected27 at risk
1 affected
31 at risk
EG0040 affected14 at risk
EG0051 affected15 at risk
EG0061 affected29 at risk
EG0072 affected30 at risk
EG0080 affected27 at risk
EG0090 affected14 at risk
EG0100 affected15 at risk
EG0110 affected29 at risk
EG0120 affected30 at risk
EG0130 affected27 at risk
1 affected
31 at risk
EG0040 affected14 at risk
EG0050 affected15 at risk
EG0062 affected29 at risk
EG0071 affected30 at risk
EG0080 affected27 at risk
EG0090 affected14 at risk
EG0100 affected15 at risk
EG0110 affected29 at risk
EG0120 affected30 at risk
EG0130 affected27 at risk
1 affected
31 at risk
EG0040 affected14 at risk
EG0050 affected15 at risk
EG0060 affected29 at risk
EG0070 affected30 at risk
EG0080 affected27 at risk
EG0090 affected14 at risk
EG0100 affected15 at risk
EG0110 affected29 at risk
EG0120 affected30 at risk
EG0130 affected27 at risk
2 affected
31 at risk
EG0040 affected14 at risk
EG0050 affected15 at risk
EG0060 affected29 at risk
EG0070 affected30 at risk
EG0080 affected27 at risk
EG0090 affected14 at risk
EG0101 affected15 at risk
EG0111 affected29 at risk
EG0120 affected30 at risk
EG0130 affected27 at risk
1 affected
31 at risk
EG0040 affected14 at risk
EG0050 affected15 at risk
EG0060 affected29 at risk
EG0070 affected30 at risk
EG0080 affected27 at risk
EG0090 affected14 at risk
EG0100 affected15 at risk
EG0110 affected29 at risk
EG0120 affected30 at risk
EG0130 affected27 at risk
2 affected
31 at risk
EG0040 affected14 at risk
EG0050 affected15 at risk
EG0060 affected29 at risk
EG0070 affected30 at risk
EG0080 affected27 at risk
EG0090 affected14 at risk
EG0100 affected15 at risk
EG0110 affected29 at risk
EG0120 affected30 at risk
EG0130 affected27 at risk
0 affected
31 at risk
EG0040 affected14 at risk
EG0050 affected15 at risk
EG0060 affected29 at risk
EG0070 affected30 at risk
EG0080 affected27 at risk
EG0090 affected14 at risk
EG0100 affected15 at risk
EG0111 affected29 at risk
EG0121 affected30 at risk
EG0130 affected27 at risk
1 affected
31 at risk
EG0040 affected14 at risk
EG0050 affected15 at risk
EG0060 affected29 at risk
EG0070 affected30 at risk
EG0080 affected27 at risk
EG0090 affected14 at risk
EG0100 affected15 at risk
EG0110 affected29 at risk
EG0120 affected30 at risk
EG0130 affected27 at risk
0 affected
31 at risk
EG0040 affected14 at risk
EG0050 affected15 at risk
EG0060 affected29 at risk
EG0070 affected30 at risk
EG0080 affected27 at risk
EG0090 affected14 at risk
EG0100 affected15 at risk
EG0110 affected29 at risk
EG0120 affected30 at risk
EG0130 affected27 at risk
1 affected
31 at risk
EG0040 affected14 at risk
EG0050 affected15 at risk
EG0060 affected29 at risk
EG0070 affected30 at risk
EG0080 affected27 at risk
EG0090 affected14 at risk
EG0100 affected15 at risk
EG0110 affected29 at risk
EG0120 affected30 at risk
EG0130 affected27 at risk
0 affected
31 at risk
EG0040 affected14 at risk
EG0050 affected15 at risk
EG0060 affected29 at risk
EG0070 affected30 at risk
EG0080 affected27 at risk
EG0090 affected14 at risk
EG0100 affected15 at risk
EG0110 affected29 at risk
EG0120 affected30 at risk
EG0130 affected27 at risk
2 affected
31 at risk
EG0040 affected14 at risk
EG0050 affected15 at risk
EG0060 affected29 at risk
EG0070 affected30 at risk
EG0080 affected27 at risk
EG0090 affected14 at risk
EG0100 affected15 at risk
EG0110 affected29 at risk
EG0120 affected30 at risk
EG0130 affected27 at risk
0 affected
31 at risk
EG0040 affected14 at risk
EG0050 affected15 at risk
EG0060 affected29 at risk
EG0070 affected30 at risk
EG0080 affected27 at risk
EG0090 affected14 at risk
EG0100 affected15 at risk
EG0110 affected29 at risk
EG0120 affected30 at risk
EG0130 affected27 at risk
0 affected
31 at risk
EG0040 affected14 at risk
EG0050 affected15 at risk
EG0060 affected29 at risk
EG0070 affected30 at risk
EG0080 affected27 at risk
EG0090 affected14 at risk
EG0100 affected15 at risk
EG0110 affected29 at risk
EG0120 affected30 at risk
EG0130 affected27 at risk
2 affected
31 at risk
EG0041 affected14 at risk
EG0050 affected15 at risk
EG0060 affected29 at risk
EG0071 affected30 at risk
EG0080 affected27 at risk
EG0090 affected14 at risk
EG0100 affected15 at risk
EG0110 affected29 at risk
EG0120 affected30 at risk
EG0130 affected27 at risk
2 affected
31 at risk
EG0040 affected14 at risk
EG0050 affected15 at risk
EG0060 affected29 at risk
EG0070 affected30 at risk
EG0080 affected27 at risk
EG0090 affected14 at risk
EG0100 affected15 at risk
EG0110 affected29 at risk
EG0120 affected30 at risk
EG0130 affected27 at risk
0 affected
31 at risk
EG0040 affected14 at risk
EG0050 affected15 at risk
EG0060 affected29 at risk
EG0070 affected30 at risk
EG0080 affected27 at risk
EG0090 affected14 at risk
EG0100 affected15 at risk
EG0110 affected29 at risk
EG0120 affected30 at risk
EG0130 affected27 at risk
0 affected
31 at risk
EG0040 affected14 at risk
EG0051 affected15 at risk
EG0061 affected29 at risk
EG0070 affected30 at risk
EG0080 affected27 at risk
EG0090 affected14 at risk
EG0100 affected15 at risk
EG0110 affected29 at risk
EG0120 affected30 at risk
EG0130 affected27 at risk
0 affected
31 at risk
EG0041 affected14 at risk
EG0050 affected15 at risk
EG0060 affected29 at risk
EG0072 affected30 at risk
EG0082 affected27 at risk
EG0090 affected14 at risk
EG0100 affected15 at risk
EG0110 affected29 at risk
EG0120 affected30 at risk
EG0130 affected27 at risk
0 affected
31 at risk
EG0040 affected14 at risk
EG0050 affected15 at risk
EG0060 affected29 at risk
EG0071 affected30 at risk
EG0083 affected27 at risk
EG0090 affected14 at risk
EG0100 affected15 at risk
EG0110 affected29 at risk
EG0120 affected30 at risk
EG0130 affected27 at risk
0 affected
31 at risk
EG0040 affected14 at risk
EG0050 affected15 at risk
EG0060 affected29 at risk
EG0073 affected30 at risk
EG0080 affected27 at risk
EG0090 affected14 at risk
EG0100 affected15 at risk
EG0110 affected29 at risk
EG0120 affected30 at risk
EG0130 affected27 at risk
0 affected
31 at risk
EG0041 affected14 at risk
EG0050 affected15 at risk
EG0060 affected29 at risk
EG0071 affected30 at risk
EG0081 affected27 at risk
EG0090 affected14 at risk
EG0100 affected15 at risk
EG0110 affected29 at risk
EG0120 affected30 at risk
EG0130 affected27 at risk
0 affected
31 at risk
EG0040 affected14 at risk
EG0051 affected15 at risk
EG0061 affected29 at risk
EG0071 affected30 at risk
EG0080 affected27 at risk
EG0090 affected14 at risk
EG0100 affected15 at risk
EG0110 affected29 at risk
EG0120 affected30 at risk
EG0130 affected27 at risk
0 affected
31 at risk
EG0041 affected14 at risk
EG0052 affected15 at risk
EG0060 affected29 at risk
EG0070 affected30 at risk
EG0080 affected27 at risk
EG0090 affected14 at risk
EG0100 affected15 at risk
EG0110 affected29 at risk
EG0120 affected30 at risk
EG0130 affected27 at risk
0 affected
31 at risk
EG0040 affected14 at risk
EG0051 affected15 at risk
EG0061 affected29 at risk
EG0071 affected30 at risk
EG0080 affected27 at risk
EG0090 affected14 at risk
EG0100 affected15 at risk
EG0110 affected29 at risk
EG0122 affected30 at risk
EG0131 affected27 at risk
0 affected
31 at risk
EG0040 affected14 at risk
EG0051 affected15 at risk
EG0060 affected29 at risk
EG0071 affected30 at risk
EG0080 affected27 at risk
EG0090 affected14 at risk
EG0100 affected15 at risk
EG0110 affected29 at risk
EG0120 affected30 at risk
EG0130 affected27 at risk
0 affected
31 at risk
EG0041 affected14 at risk
EG0050 affected15 at risk
EG0061 affected29 at risk
EG0070 affected30 at risk
EG0080 affected27 at risk
EG0090 affected14 at risk
EG0100 affected15 at risk
EG0110 affected29 at risk
EG0120 affected30 at risk
EG0130 affected27 at risk
0 affected
31 at risk
EG0041 affected14 at risk
EG0050 affected15 at risk
EG0061 affected29 at risk
EG0070 affected30 at risk
EG0080 affected27 at risk
EG0090 affected14 at risk
EG0100 affected15 at risk
EG0110 affected29 at risk
EG0120 affected30 at risk
EG0130 affected27 at risk
0 affected
31 at risk
EG0041 affected14 at risk
EG0051 affected15 at risk
EG0060 affected29 at risk
EG0070 affected30 at risk
EG0080 affected27 at risk
EG0090 affected14 at risk
EG0100 affected15 at risk
EG0110 affected29 at risk
EG0120 affected30 at risk
EG0130 affected27 at risk
0 affected
31 at risk
EG0041 affected14 at risk
EG0050 affected15 at risk
EG0060 affected29 at risk
EG0071 affected30 at risk
EG0080 affected27 at risk
EG0090 affected14 at risk
EG0100 affected15 at risk
EG0110 affected29 at risk
EG0120 affected30 at risk
EG0130 affected27 at risk
0 affected
31 at risk
EG0040 affected14 at risk
EG0050 affected15 at risk
EG0062 affected29 at risk
EG0070 affected30 at risk
EG0080 affected27 at risk
EG0090 affected14 at risk
EG0100 affected15 at risk
EG0111 affected29 at risk
EG0122 affected30 at risk
EG0131 affected27 at risk
30.0
Title
Measurements
OG000NAParticipants assigned to placebo either discontinued or crossed-over to active treatment at Week 12.
OG00133.0
OG00237.0
OG00344.0
10.0
Title
Measurements
OG000NAParticipants assigned to placebo either discontinued or crossed-over to active treatment at Week 12.
OG00126.0
OG00230.0
OG00328.0
3.0
Title
Measurements
OG000NAParticipants assigned to placebo either discontinued or crossed-over to active treatment at Week 12.
OG00111.0
OG00210.0
OG00312.0
5.64
± 0.774
Title
Measurements
OG000-1.01± 1.245
OG001-1.87± 1.231
OG002-1.83± 1.534
OG003-1.84± 1.143
Title
Measurements
OG000NA± NAParticipants assigned to placebo either discontinued or crossed-over to active treatment at Week 12.
OG001-2.13± 1.355
OG002-2.23± 1.548
OG003-2.75± 1.234
6.37
± 0.851
Title
Measurements
OG000-1.25± 1.489
OG001-1.87± 1.342
OG002-1.97± 1.613
OG003-1.90± 1.481
Title
Measurements
OG000NA± NAParticipants assigned to placebo either discontinued or crossed-over to active treatment at Week 12.
OG001-2.17± 1.524
OG002-2.29± 1.455
OG003-2.79± 1.394
13.0
Title
Measurements
OG000NAParticipants assigned to placebo either discontinued or crossed-over to active treatment at Week 12.
OG00148.0
OG00253.0
OG00365.0
19.0
OG0047.0
Participants
OG004
23
Title
Measurements
OG00021.4
OG00123.1
OG00222.0
OG00327.0
OG00426.0
30.0
OG00140.0
OG00248.0
15.9
± 6.37
Title
Measurements
OG000-5.3± 6.40
OG001-7.4± 6.21
OG002-6.4± 7.98
OG003-8.8± 8.86
Title
Measurements
OG000NA± NAParticipants assigned to placebo either discontinued or crossed-over to active treatment at Week 12.
OG001-8.3± 6.17
OG002-8.7± 7.42
OG003-12.0± 8.19
12.9
± 5.12
Title
Measurements
OG000-3.7± 4.02
OG001-6.1± 4.43
OG002-5.4± 5.85
OG003-7.2± 5.57
Title
Measurements
OG000NA± NAParticipants assigned to placebo either discontinued or crossed-over to active treatment at Week 12.
OG001-7.3± 5.14
OG002-6.2± 5.04
OG003-9.1± 5.10
57.00
± 22.995
Title
Measurements
OG000-6.24± 22.065
OG001-21.98± 26.275
OG002-22.19± 25.631
OG003-22.97± 37.691
Title
Measurements
OG000NA± NAParticipants assigned to placebo either discontinued or crossed-over to active treatment at Week 12.
OG001-22.13± 27.294
OG002-27.62± 25.015
OG003-30.39± 30.847
62.25
± 21.346
Title
Measurements
OG000-8.61± 22.569
OG001-22.06± 27.366
OG002-27.41± 21.990
OG003-25.48± 32.879
Title
Measurements
OG000NA± NAParticipants assigned to placebo either discontinued or crossed-over to active treatment at Week 12.
OG001-24.02± 26.921
OG002-31.53± 23.891
OG003-34.08± 27.518
59.32
± 16.890
Title
Measurements
OG000-20.23± 19.824
OG001-33.87± 24.283
OG002-29.95± 25.741
OG003-30.88± 19.334
Title
Measurements
OG000NA± NAParticipants assigned to placebo either discontinued or crossed-over to active treatment at Week 12.
OG001-38.78± 22.527
OG002-36.94± 21.235
OG003-38.94± 21.776
1.50
± 0.590
30
Title
Measurements
OG000-0.20± 0.367
OG001-0.38± 0.568
OG002-0.48± 0.613
OG003-0.33± 0.539
Title
Measurements
OG000NA± NAParticipants assigned to placebo either discontinued or crossed-over to active treatment at Week 12.
OG001-0.56± 0.673
OG002-0.63± 0.563
OG003-0.39± 0.469
34.8
± 29.05
Title
Measurements
OG000-6.1± 15.76
OG001-7.5± 23.17
OG002-10.7± 21.52
OG003-5.9± 32.35
Title
Measurements
OG000NA± NAParticipants assigned to placebo either discontinued or crossed-over to active treatment at Week 12.
OG001-11.5± 21.96
OG002-12.8± 20.74
OG003-11.1± 26.00
7.52
± 8.581
Title
Measurements
OG0000.18± 10.063
OG001-9.76± 16.053
OG002-4.01± 26.799
OG003-0.73± 13.488
Title
Measurements
OG000NA± NAParticipants assigned to placebo either discontinued or crossed-over to active treatment at Week 12.
OG001-6.74± 18.086
OG002-7.90± 16.713
OG003-5.52± 9.017
79.2
± 56.83
Title
Measurements
OG0002.6± 69.23
OG001-51.1± 94.80
OG002-92.6± 250.51
OG003-42.2± 63.97
Title
Measurements
OG000NA± NAParticipants assigned to placebo either discontinued or crossed-over to active treatment at Week 12.
OG001-120.6± 245.35
OG002-99.3± 254.05
OG003-51.5± 70.84
78.62
± 24.160
Title
Measurements
OG0002.92± 19.613
OG0017.87± 19.547
OG0022.21± 17.814
OG0036.36± 25.203
Title
Measurements
OG000NA± NAParticipants assigned to placebo either discontinued or crossed-over to active treatment at Week 12.
OG0017.72± 17.543
OG0024.60± 17.146
OG0032.29± 28.869
28.82
± 14.212
Title
Measurements
OG0003.72± 11.027
OG0019.57± 14.960
OG00212.97± 17.932
OG0038.35± 13.947
Title
Measurements
OG000NA± NAParticipants assigned to placebo either discontinued or crossed-over to active treatment at Week 12.
OG00111.60± 14.503
OG00215.56± 16.144
OG00311.77± 13.387
43.0
Title
Measurements
OG000NAParticipants assigned to placebo either discontinued or crossed-over to active treatment at Week 12.
OG00167.0
OG00275.0
OG00360.0
67.0
Title
Measurements
OG000NAParticipants assigned to placebo either discontinued or crossed-over to active treatment at Week 12.
OG00159.0
OG00270.0
OG00372.0
57.0
Title
Measurements
OG000NAParticipants assigned to placebo either discontinued or crossed-over to active treatment at Week 12.
OG00167.0
OG00277.0
OG00376.0
Title
Measurements
OG00052.0
OG00158.0
OG00241.0
OG00350.0
Title
Measurements
OG000NAParticipants assigned to placebo either discontinued or crossed-over to active treatment at Week 12.