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Trial record 56 of 62 for:    Baricitinib

INCB028050 Compared to Background Therapy in Patients With Active Rheumatoid Arthritis (RA) With Inadequate Response to Disease Modifying Anti-Rheumatic Drugs

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ClinicalTrials.gov Identifier: NCT00902486
Recruitment Status : Completed
First Posted : May 15, 2009
Results First Posted : September 3, 2018
Last Update Posted : September 3, 2018
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Rheumatoid Arthritis
Interventions Drug: INCB028050
Drug: Placebo
Enrollment 127
Recruitment Details The study population included participants diagnosed with RA who had failed to respond adequately to any DMARD therapy, including biologics.
Pre-assignment Details 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).
Arm/Group Title Placebo Placebo Crossing Over to 7 mg INCB028050 QD Placebo Crossing Over to 10 mg INCB028050 QD INCB028050 4 mg QD INCB028050 7 mg QD INCB028050 10 mg QD
Hide Arm/Group Description 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. Participants that received placebo for the first 12 weeks were randomized to an active dosage of 7 mg INCB028050 QD. Participants that received placebo for the first 12 weeks were randomized to an active dosage of 10 mg INCB028050 QD. INCB028050 was administered qd, orally in 4 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time. INCB028050 was administered qd, orally in 7 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time. INCB028050 was administered qd, orally in 10 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
Period Title: Treatment Period (Weeks 0 Through 12)
Started 31 0 0 32 32 32
Safety Evaluable Participants 31 0 0 31 32 31
Modified Intent-to-Treat Participants 31 0 0 31 32 30
Completed [1] 29 0 0 29 30 27
Not Completed 2 0 0 3 2 5
Reason Not Completed
Adverse Event             1             0             0             1             1             2
Consent Withdrawn             1             0             0             0             0             2
Protocol Deviation             0             0             0             0             1             1
Lost to Follow-up             0             0             0             1             0             0
corrected QT (QTc) exclusion criteria             0             0             0             1             0             0
[1]
Participants completing Week 12
Period Title: Extension Period (Weeks 12 Through 24)
Started 0 14 15 29 30 27
Completed 0 14 13 27 29 24
Not Completed 0 0 2 2 1 3
Reason Not Completed
Adverse Event             0             0             0             0             1             2
Consent Withdrawn             0             0             1             1             0             0
Protocol Deviation             0             0             0             0             0             1
Disease Progression             0             0             0             1             0             0
Lost to Follow-up             0             0             1             0             0             0
Period Title: Follow-up (After Week 24)
Started [1] 0 14 13 27 29 24
Safety Evaluable Participants [2] 0 14 15 29 30 27
Completed 0 14 13 26 29 24
Not Completed 0 0 0 1 0 0
Reason Not Completed
Lost to Follow-up             0             0             0             1             0             0
[1]
Number of participants completed treatment
[2]
Population is inclusive of all safety participants continuing after Week 12.
Arm/Group Title INCB028050 4 mg QD INCB028050 7 mg QD INCB028050 10 mg QD Placebo Total
Hide Arm/Group Description INCB028050 was administered qd, orally in 4 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time. INCB028050 was administered qd, orally in 7 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time. INCB028050 was administered qd, orally in 10 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time. INCB028050 was administered qd, orally in matching placebo capsules. All participants were treated with only 1 capsule daily, without regard to meal time. Total of all reporting groups
Overall Number of Baseline Participants 32 32 32 31 127
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 32 participants 32 participants 32 participants 31 participants 127 participants
56.8  (12.28) 53.7  (10.92) 57.3  (10.38) 55.2  (10.09) 55.8  (10.92)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants 32 participants 32 participants 31 participants 127 participants
Female
29
  90.6%
26
  81.3%
25
  78.1%
22
  71.0%
102
  80.3%
Male
3
   9.4%
6
  18.8%
7
  21.9%
9
  29.0%
25
  19.7%
1.Primary Outcome
Title The Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Improvement
Hide Description 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.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo INCB028050 4 mg QD INCB028050 7 mg QD INCB028050 10 mg QD
Hide Arm/Group Description:
INCB028050 was administered qd, orally in matching placebo capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
INCB028050 was administered qd, orally in 4 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
INCB028050 was administered qd, orally in 7 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
INCB028050 was administered qd, orally in 10 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
Overall Number of Participants Analyzed 31 31 32 30
Measure Type: Count of Participants
Unit of Measure: Participants
10
  32.3%
16
  51.6%
19
  59.4%
16
  53.3%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, INCB028050 4 mg QD, INCB028050 7 mg QD, INCB028050 10 mg QD
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0619
Comments [Not Specified]
Method Cochran-Armitage trend test
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.17
Confidence Interval (2-Sided) 95%
0.77 to 6.15
Estimation Comments LOGISTIC regression model for odds ratio estimates : LOGIT(Response 0/1) = Treatment + Biologics
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, INCB028050 4 mg QD
Comments Sensitivity analysis for pairwise comparisons of 4 mg QD versus placebo.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1978
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, INCB028050 7 mg QD
Comments Sensitivity analysis for pairwise comparisons of 7 mg QD versus placebo.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0437
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, INCB028050 10 mg QD
Comments Sensitivity analysis for pairwise comparisons of 10 mg QD versus placebo.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1236
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
2.Primary Outcome
Title Participants With at Least 1 Adverse Event From Baseline Through Week 12
Hide Description [Not Specified]
Time Frame From Baseline through week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Evaluable Participants included all participants who were enrolled and took at least 1 dose of study medication.
Arm/Group Title Placebo INCB028050 4 mg QD INCB028050 7 mg QD INCB028050 10 mg QD
Hide Arm/Group Description:
INCB028050 was administered qd, orally in matching placebo capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
INCB028050 was administered qd, orally in 4 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
INCB028050 was administered qd, orally in 7 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
INCB028050 was administered qd, orally in 10 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
Overall Number of Participants Analyzed 31 31 32 31
Measure Type: Count of Participants
Unit of Measure: Participants
19
  61.3%
15
  48.4%
20
  62.5%
23
  74.2%
3.Secondary Outcome
Title Participants With at Least 1 Adverse Event From Week 12 to Week 24
Hide Description [Not Specified]
Time Frame Week 12 to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Evaluable Participants included all participants who were enrolled and took at least 1 dose of study medication.
Arm/Group Title Placebo Crossing Over to 7 mg INCB028050 QD Placebo Crossing Over to 10 mg INCB028050 QD INCB028050 4 mg QD INCB028050 7 mg QD INCB028050 10 mg QD
Hide Arm/Group Description:
Participants that received placebo for the first 12 weeks were randomized to an active dosage of 7 mg INCB028050 QD.
Participants that received placebo for the first 12 weeks were randomized to an active dosage of 10 mg INCB028050 QD.
INCB028050 was administered qd, orally in 4 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
INCB028050 was administered qd, orally in 7 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
INCB028050 was administered qd, orally in 10 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
Overall Number of Participants Analyzed 14 15 29 30 27
Measure Type: Count of Participants
Unit of Measure: Participants
6
  42.9%
5
  33.3%
12
  41.4%
16
  53.3%
16
  59.3%
4.Secondary Outcome
Title The Percentage of Participants Who Were Assigned to Active Treatment at Baseline Achieving ACR 20 Improvement at Week 24
Hide Description 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.
Time Frame From Baseline to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title INCB028050 4 mg QD INCB028050 7 mg QD INCB028050 10 mg QD
Hide Arm/Group Description:
INCB028050 was administered qd, orally in 4 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
INCB028050 was administered qd, orally in 7 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
INCB028050 was administered qd, orally in 10 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
Overall Number of Participants Analyzed 27 30 25
Measure Type: Count of Participants
Unit of Measure: Participants
18
  66.7%
20
  66.7%
18
  72.0%
5.Secondary Outcome
Title The Percentage of Participants Achieving American College of Rheumatology (ACR) 50 Improvement at Week 12 and Week 24
Hide Description 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.
Time Frame Week 12 and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo INCB028050 4 mg QD INCB028050 7 mg QD INCB028050 10 mg QD
Hide Arm/Group Description:
INCB028050 was administered qd, orally in matching placebo capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
INCB028050 was administered qd, orally in 4 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
INCB028050 was administered qd, orally in 7 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
INCB028050 was administered qd, orally in 10 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
Overall Number of Participants Analyzed 31 31 32 30
Measure Type: Number
Unit of Measure: percentage of participants
Week 12 Number Analyzed 31 participants 31 participants 32 participants 30 participants
13.0 35.0 31.0 30.0
Week 24 Number Analyzed 31 participants 27 participants 30 participants 25 participants
NA [1]  33.0 37.0 44.0
[1]
Participants assigned to placebo either discontinued or crossed-over to active treatment at Week 12.
6.Secondary Outcome
Title The Percentage of Participants Achieving American College of Rheumatology (ACR) 70 Improvement at Week 12 and Week 24
Hide Description 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.
Time Frame Week 12 and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo INCB028050 4 mg QD INCB028050 7 mg QD INCB028050 10 mg QD
Hide Arm/Group Description:
INCB028050 was administered qd, orally in matching placebo capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
INCB028050 was administered qd, orally in 4 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
INCB028050 was administered qd, orally in 7 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
INCB028050 was administered qd, orally in 10 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
Overall Number of Participants Analyzed 31 31 32 30
Measure Type: Number
Unit of Measure: percentage of participants
Week 12 Number Analyzed 31 participants 31 participants 32 participants 30 participants
3.0 16.0 9.0 10.0
Week 24 Number Analyzed 31 participants 27 participants 30 participants 25 participants
NA [1]  26.0 30.0 28.0
[1]
Participants assigned to placebo either discontinued or crossed-over to active treatment at Week 12.
7.Secondary Outcome
Title The Percentage of Participants Achieving American College of Rheumatology (ACR) 90 Improvement at Week 12 and Week 24
Hide Description 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.
Time Frame Week 12 and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo INCB028050 4 mg QD INCB028050 7 mg QD INCB028050 10 mg QD
Hide Arm/Group Description:
INCB028050 was administered qd, orally in matching placebo capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
INCB028050 was administered qd, orally in 4 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
INCB028050 was administered qd, orally in 7 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
INCB028050 was administered qd, orally in 10 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
Overall Number of Participants Analyzed 31 31 32 30
Measure Type: Number
Unit of Measure: percentage of participants
Week 12 Number Analyzed 31 participants 31 participants 32 participants 30 participants
0.0 3.0 0.0 3.0
Week 24 Number Analyzed 31 participants 27 participants 30 participants 25 participants
NA [1]  11.0 10.0 12.0
[1]
Participants assigned to placebo either discontinued or crossed-over to active treatment at Week 12.
8.Secondary Outcome
Title Change in Disease Activity Score 28 (DAS28) CRP Score From Baseline at Week 12 and Week 24
Hide Description 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).
Time Frame Baseline, Week 12 and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo INCB028050 4 mg QD INCB028050 7 mg QD INCB028050 10 mg QD
Hide Arm/Group Description:
INCB028050 was administered qd, orally in matching placebo capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
INCB028050 was administered qd, orally in 4 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
INCB028050 was administered qd, orally in 7 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
INCB028050 was administered qd, orally in 10 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
Overall Number of Participants Analyzed 31 31 32 30
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline Number Analyzed 31 participants 31 participants 32 participants 30 participants
5.71  (0.875) 5.64  (1.098) 5.76  (0.925) 5.64  (0.774)
Change from baseline at Week 12 Number Analyzed 31 participants 31 participants 32 participants 30 participants
-1.01  (1.245) -1.87  (1.231) -1.83  (1.534) -1.84  (1.143)
Change from baseline at Week 24 Number Analyzed 31 participants 27 participants 30 participants 23 participants
NA [1]   (NA) -2.13  (1.355) -2.23  (1.548) -2.75  (1.234)
[1]
Participants assigned to placebo either discontinued or crossed-over to active treatment at Week 12.
9.Secondary Outcome
Title Change in Disease Activity Score 28 (DAS28) ESR Score From Baseline at Week 12 and Week 24
Hide Description 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.
Time Frame Baseline, Week 12 and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo INCB028050 4 mg QD INCB028050 7 mg QD INCB028050 10 mg QD
Hide Arm/Group Description:
INCB028050 was administered qd, orally in matching placebo capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
INCB028050 was administered qd, orally in 4 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
INCB028050 was administered qd, orally in 7 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
INCB028050 was administered qd, orally in 10 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
Overall Number of Participants Analyzed 31 31 32 30
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline Number Analyzed 31 participants 31 participants 32 participants 30 participants
6.56  (0.840) 6.41  (1.024) 6.35  (0.968) 6.37  (0.851)
Change from baseline at Week 12 Number Analyzed 31 participants 31 participants 32 participants 30 participants
-1.25  (1.489) -1.87  (1.342) -1.97  (1.613) -1.90  (1.481)
Change from baseline at Week 24 Number Analyzed 31 participants 27 participants 30 participants 23 participants
NA [1]   (NA) -2.17  (1.524) -2.29  (1.455) -2.79  (1.394)
[1]
Participants assigned to placebo either discontinued or crossed-over to active treatment at Week 12.
10.Secondary Outcome
Title Percentage of Participants Achieving Low Disease Activity by DAS28 (ESR)≤3.2
Hide Description 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.
Time Frame Week 12 and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo INCB028050 4 mg QD INCB028050 7 mg QD INCB028050 10 mg QD
Hide Arm/Group Description:
INCB028050 was administered qd, orally in matching placebo capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
INCB028050 was administered qd, orally in 4 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
INCB028050 was administered qd, orally in 7 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
INCB028050 was administered qd, orally in 10 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
Overall Number of Participants Analyzed 31 31 32 30
Measure Type: Number
Unit of Measure: percentage of participants
Week 12 Number Analyzed 31 participants 31 participants 32 participants 30 participants
19.0 23.0 31.0 13.0
Week 24 Number Analyzed 31 participants 27 participants 30 participants 23 participants
NA [1]  48.0 53.0 65.0
[1]
Participants assigned to placebo either discontinued or crossed-over to active treatment at Week 12.
11.Secondary Outcome
Title Percentage of Participants Achieving Remission by DAS28 (ESR) ≤2.6
Hide Description 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.
Time Frame Week 12 and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo to INCB028050 7 mg QD Placebo to INCB028050 10 mg QD INCB028050 4 mg QD INCB028050 7 mg QD INCB028050 10 mg QD
Hide Arm/Group Description:
Participants who were assigned to placebo group at baseline then crossed over to active treatment groups after week 12 were analyzed.
Participants who were assigned to placebo group at baseline then crossed over to active treatment groups after week 12 were analyzed.
INCB028050 was administered qd, orally in 4 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
INCB028050 was administered qd, orally in 7 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
INCB028050 was administered qd, orally in 10 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
Overall Number of Participants Analyzed 15 16 31 32 30
Measure Type: Number
Unit of Measure: percentage of participants
Week 12 Number Analyzed 15 participants 16 participants 31 participants 32 participants 30 participants
6.7 18.8 16.0 19.0 7.0
Week 24 Number Analyzed 14 participants 13 participants 27 participants 30 participants 23 participants
21.4 23.1 22.0 27.0 26.0
12.Secondary Outcome
Title Percentage of Participants Achieving Remission by DAS28 (CRP) ≤2.6
Hide Description 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.
Time Frame Week 12 and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title INCB028050 4 mg QD INCB028050 7 mg QD INCB028050 10 mg QD
Hide Arm/Group Description:
INCB028050 was administered qd, orally in 4 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
INCB028050 was administered qd, orally in 7 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
INCB028050 was administered qd, orally in 10 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
Overall Number of Participants Analyzed 31 32 30
Measure Type: Number
Unit of Measure: percentage of participants
Week 12 Number Analyzed 31 participants 32 participants 30 participants
23.0 25.0 17.0
Week 24 Number Analyzed 27 participants 30 participants 23 participants
30.0 40.0 48.0
13.Secondary Outcome
Title Change in ACR Assessment Tender Joint Count (TJC) From Baseline to Week 12 and Week 24
Hide Description 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.
Time Frame Baseline, Week 12 and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo INCB028050 4 mg QD INCB028050 7 mg QD INCB028050 10 mg QD
Hide Arm/Group Description:
INCB028050 was administered qd, orally in matching placebo capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
INCB028050 was administered qd, orally in 4 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
INCB028050 was administered qd, orally in 7 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
INCB028050 was administered qd, orally in 10 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
Overall Number of Participants Analyzed 31 31 32 30
Mean (Standard Deviation)
Unit of Measure: Tender joints
Baseline Number Analyzed 31 participants 31 participants 32 participants 30 participants
15.9  (6.67) 14.4  (6.58) 14.7  (6.70) 15.9  (6.37)
Change from baseline at Week 12 Number Analyzed 31 participants 31 participants 32 participants 30 participants
-5.3  (6.40) -7.4  (6.21) -6.4  (7.98) -8.8  (8.86)
Change from baseline at Week 24 Number Analyzed 31 participants 27 participants 30 participants 25 participants
NA [1]   (NA) -8.3  (6.17) -8.7  (7.42) -12.0  (8.19)
[1]
Participants assigned to placebo either discontinued or crossed-over to active treatment at Week 12.
14.Secondary Outcome
Title Change in ACR Assessment Swollen Joint Count (SJC) From Baseline to Week 12 and Week 24
Hide Description 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.
Time Frame Baseline, Week 12 and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo INCB028050 4 mg QD INCB028050 7 mg QD INCB028050 10 mg QD
Hide Arm/Group Description:
INCB028050 was administered qd, orally in matching placebo capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
INCB028050 was administered qd, orally in 4 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
INCB028050 was administered qd, orally in 7 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
INCB028050 was administered qd, orally in 10 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
Overall Number of Participants Analyzed 31 31 32 30
Mean (Standard Deviation)
Unit of Measure: Swollen joints
Baseline Number Analyzed 31 participants 31 participants 32 participants 30 participants
11.0  (5.28) 12.0  (5.48) 10.6  (4.57) 12.9  (5.12)
Change from baseline at Week 12 Number Analyzed 31 participants 31 participants 32 participants 30 participants
-3.7  (4.02) -6.1  (4.43) -5.4  (5.85) -7.2  (5.57)
Change from baseline at Week 24 Number Analyzed 31 participants 27 participants 30 participants 25 participants
NA [1]   (NA) -7.3  (5.14) -6.2  (5.04) -9.1  (5.10)
[1]
Participants assigned to placebo either discontinued or crossed-over to active treatment at Week 12.
15.Secondary Outcome
Title Change in Participants' Assessment of Pain From Baseline at Week 12 and Week 24
Hide Description 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”.
Time Frame Baseline, Week 12 and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo INCB028050 4 mg QD INCB028050 7 mg QD INCB028050 10 mg QD
Hide Arm/Group Description:
INCB028050 was administered qd, orally in matching placebo capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
INCB028050 was administered qd, orally in 4 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
INCB028050 was administered qd, orally in 7 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
INCB028050 was administered qd, orally in 10 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
Overall Number of Participants Analyzed 31 31 32 30
Mean (Standard Deviation)
Unit of Measure: millimeter (mm)
Baseline Number Analyzed 31 participants 31 participants 32 participants 30 participants
62.37  (21.079) 57.08  (24.716) 63.25  (18.656) 57.00  (22.995)
Change from baseline at Week 12 Number Analyzed 31 participants 31 participants 32 participants 30 participants
-6.24  (22.065) -21.98  (26.275) -22.19  (25.631) -22.97  (37.691)
Change from baseline at Week 24 Number Analyzed 31 participants 27 participants 30 participants 25 participants
NA [1]   (NA) -22.13  (27.294) -27.62  (25.015) -30.39  (30.847)
[1]
Participants assigned to placebo either discontinued or crossed-over to active treatment at Week 12.
16.Secondary Outcome
Title Change in Participants' Global Assessment of Disease Activity From Baseline at Week 12 and Week 24
Hide Description 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.
Time Frame Baseline, Week 12 and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo INCB028050 4 mg QD INCB028050 7 mg QD INCB028050 10 mg QD
Hide Arm/Group Description:
INCB028050 was administered qd, orally in matching placebo capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
INCB028050 was administered qd, orally in 4 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
INCB028050 was administered qd, orally in 7 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
INCB028050 was administered qd, orally in 10 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
Overall Number of Participants Analyzed 31 31 32 30
Mean (Standard Deviation)
Unit of Measure: millimeter (mm)
Baseline Number Analyzed 31 participants 31 participants 32 participants 30 participants
66.19  (20.522) 59.02  (26.314) 69.69  (18.893) 62.25  (21.346)
Change from baseline at Week 12 Number Analyzed 31 participants 31 participants 32 participants 30 participants
-8.61  (22.569) -22.06  (27.366) -27.41  (21.990) -25.48  (32.879)
Change from baseline at Week 24 Number Analyzed 31 participants 27 participants 30 participants 25 participants
NA [1]   (NA) -24.02  (26.921) -31.53  (23.891) -34.08  (27.518)
[1]
Participants assigned to placebo either discontinued or crossed-over to active treatment at Week 12.
17.Secondary Outcome
Title Change in Physician’s Global Assessment of Disease Activity (PGA) From Baseline at Week 12 and Week 24
Hide Description 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.
Time Frame Baseline, Week 12 and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo INCB028050 4 mg QD INCB028050 7 mg QD INCB028050 10 mg QD
Hide Arm/Group Description:
INCB028050 was administered qd, orally in matching placebo capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
INCB028050 was administered qd, orally in 4 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
INCB028050 was administered qd, orally in 7 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
INCB028050 was administered qd, orally in 10 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
Overall Number of Participants Analyzed 31 31 32 30
Mean (Standard Deviation)
Unit of Measure: millimeter (mm)
Baseline Number Analyzed 31 participants 31 participants 32 participants 30 participants
63.45  (16.903) 61.94  (19.162) 59.80  (17.185) 59.32  (16.890)
Change from baseline at Week 12 Number Analyzed 31 participants 31 participants 32 participants 30 participants
-20.23  (19.824) -33.87  (24.283) -29.95  (25.741) -30.88  (19.334)
Change from baseline at Week 24 Number Analyzed 31 participants 27 participants 30 participants 25 participants
NA [1]   (NA) -38.78  (22.527) -36.94  (21.235) -38.94  (21.776)
[1]
Participants assigned to placebo either discontinued or crossed-over to active treatment at Week 12.
18.Secondary Outcome
Title Change in Health Assessment Questionnaire-Disability Index (HAQ-DI) From Baseline at Week 12 and Week 24
Hide Description 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.
Time Frame Baseline, Week 12 and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo INCB028050 4 mg QD INCB028050 7 mg QD INCB028050 10 mg QD
Hide Arm/Group Description:
INCB028050 was administered qd, orally in matching placebo capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
INCB028050 was administered qd, orally in 4 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
INCB028050 was administered qd, orally in 7 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
INCB028050 was administered qd, orally in 10 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
Overall Number of Participants Analyzed 31 31 32 30
Mean (Standard Deviation)
Unit of Measure: Score on a scale
Baseline Number Analyzed 31 participants 31 participants 32 participants 30 participants
1.61  (0.494) 1.50  (0.601) 1.67  (0.474) 1.50  (0.590)
Change from baseline at Week 12 (n=31, 31, 30, 30) Number Analyzed 31 participants 31 participants 32 participants 30 participants
-0.20  (0.367) -0.38  (0.568) -0.48  (0.613) -0.33  (0.539)
Change from baseline at Week 24 Number Analyzed 31 participants 27 participants 28 participants 25 participants
NA [1]   (NA) -0.56  (0.673) -0.63  (0.563) -0.39  (0.469)
[1]
Participants assigned to placebo either discontinued or crossed-over to active treatment at Week 12.
19.Secondary Outcome
Title Change in Erythrocyte Sedimentation Rate (ESR) From Baseline at Week 12 and Week 24
Hide Description 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.
Time Frame Baseline, Week 12 and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo INCB028050 4 mg QD INCB028050 7 mg QD INCB028050 10 mg QD
Hide Arm/Group Description:
INCB028050 was administered qd, orally in matching placebo capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
INCB028050 was administered qd, orally in 4 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
INCB028050 was administered qd, orally in 7 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
INCB028050 was administered qd, orally in 10 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
Overall Number of Participants Analyzed 31 31 32 30
Mean (Standard Deviation)
Unit of Measure: mm/hr
Baseline Number Analyzed 31 participants 31 participants 32 participants 30 participants
40.8  (15.40) 42.8  (17.62) 37.3  (21.56) 34.8  (29.05)
Change from baseline at Week 12 Number Analyzed 31 participants 31 participants 32 participants 30 participants
-6.1  (15.76) -7.5  (23.17) -10.7  (21.52) -5.9  (32.35)
Change from baseline at Week 24 Number Analyzed 31 participants 27 participants 30 participants 23 participants
NA [1]   (NA) -11.5  (21.96) -12.8  (20.74) -11.1  (26.00)
[1]
Participants assigned to placebo either discontinued or crossed-over to active treatment at Week 12.
20.Secondary Outcome
Title Change in C-reactive Protein (CRP) From Baseline at Week 12 and Week 24
Hide Description 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.
Time Frame Baseline, Week 12 and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo INCB028050 4 mg QD INCB028050 7 mg QD INCB028050 10 mg QD
Hide Arm/Group Description:
INCB028050 was administered qd, orally in matching placebo capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
INCB028050 was administered qd, orally in 4 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
INCB028050 was administered qd, orally in 7 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
INCB028050 was administered qd, orally in 10 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
Overall Number of Participants Analyzed 31 31 32 30
Mean (Standard Deviation)
Unit of Measure: mg/L
Baseline Number Analyzed 31 participants 31 participants 32 participants 30 participants
10.89  (11.556) 15.63  (17.327) 15.64  (16.113) 7.52  (8.581)
Change from baseline at Week 12 Number Analyzed 31 participants 31 participants 32 participants 30 participants
0.18  (10.063) -9.76  (16.053) -4.01  (26.799) -0.73  (13.488)
Change from baseline at Week 24 Number Analyzed 31 participants 27 participants 30 participants 25 participants
NA [1]   (NA) -6.74  (18.086) -7.90  (16.713) -5.52  (9.017)
[1]
Participants assigned to placebo either discontinued or crossed-over to active treatment at Week 12.
21.Secondary Outcome
Title Change in Duration of Morning Stiffness From Baseline at Week 12 and Week 24
Hide Description 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).
Time Frame Baseline, Week 12 and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo INCB028050 4 mg QD INCB028050 7 mg QD INCB028050 10 mg QD
Hide Arm/Group Description:
INCB028050 was administered qd, orally in matching placebo capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
INCB028050 was administered qd, orally in 4 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
INCB028050 was administered qd, orally in 7 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
INCB028050 was administered qd, orally in 10 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
Overall Number of Participants Analyzed 31 31 32 30
Mean (Standard Deviation)
Unit of Measure: Minutes
Baseline Number Analyzed 31 participants 31 participants 32 participants 30 participants
78.5  (61.36) 179.8  (347.48) 125.5  (246.75) 79.2  (56.83)
Change from baseline at Week 12 Number Analyzed 31 participants 31 participants 32 participants 30 participants
2.6  (69.23) -51.1  (94.80) -92.6  (250.51) -42.2  (63.97)
Change from baseline at Week 24 Number Analyzed 31 participants 27 participants 30 participants 25 participants
NA [1]   (NA) -120.6  (245.35) -99.3  (254.05) -51.5  (70.84)
[1]
Participants assigned to placebo either discontinued or crossed-over to active treatment at Week 12.
22.Secondary Outcome
Title Percentage of Participants Achieving Good European League Against Rheumatism (EULAR) Response (DAS28 ESR) at Week 12
Hide Description 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.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo INCB028050 4 mg QD INCB028050 7 mg QD INCB028050 10 mg QD
Hide Arm/Group Description:
INCB028050 was administered qd, orally in matching placebo capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
INCB028050 was administered qd, orally in 4 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
INCB028050 was administered qd, orally in 7 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
INCB028050 was administered qd, orally in 10 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
Overall Number of Participants Analyzed 31 31 32 30
Measure Type: Number
Unit of Measure: percentage of participants
19.0 23.0 31.0 13.0
23.Secondary Outcome
Title Percentage of Participants Achieving Good EULAR Response (DAS28ESR) at Week 24
Hide Description 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.
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo to INCB028050 7 mg QD Placebo to INCB028050 10 mg QD INCB028050 4 mg QD INCB028050 7 mg QD INCB028050 10 mg QD
Hide Arm/Group Description:
Participants who were assigned to placebo group at baseline then crossed over to active treatment groups after week 12 were analyzed.
Participants who were assigned to placebo group at baseline then crossed over to active treatment groups after week 12 were analyzed.
INCB028050 was administered qd, orally in 4 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
INCB028050 was administered qd, orally in 7 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
INCB028050 was administered qd, orally in 10 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
Overall Number of Participants Analyzed 15 16 27 30 23
Measure Type: Number
Unit of Measure: percentage of participants
21.0 15.0 33.0 43.0 39.0
24.Secondary Outcome
Title Percentage of Participants Achieving Good EULAR Response (DAS28CRP) at Week 12
Hide Description 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.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo INCB028050 4 mg QD INCB028050 7 mg QD INCB028050 10 mg QD
Hide Arm/Group Description:
INCB028050 was administered qd, orally in matching placebo capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
INCB028050 was administered qd, orally in 4 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
INCB028050 was administered qd, orally in 7 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
INCB028050 was administered qd, orally in 10 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
Overall Number of Participants Analyzed 31 31 32 30
Measure Type: Number
Unit of Measure: percentage of participants
26.0 39.0 34.0 33.0
25.Secondary Outcome
Title Percentage of Participants Achieving Good EULAR Response (DAS28CRP) at Week 24
Hide Description 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.
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title INCB028050 4 mg QD INCB028050 7 mg QD INCB028050 10 mg QD
Hide Arm/Group Description:
INCB028050 was administered qd, orally in 4 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
INCB028050 was administered qd, orally in 7 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
INCB028050 was administered qd, orally in 10 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
Overall Number of Participants Analyzed 27 30 23
Measure Type: Number
Unit of Measure: percentage of participants
48.0 53.0 65.0
26.Secondary Outcome
Title Change in SF-36 Mental Component Summary From Baseline at Week 12 and Week 24
Hide Description 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").
Time Frame Baseline, Week 12 and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo INCB028050 4 mg QD INCB028050 7 mg QD INCB028050 10 mg QD
Hide Arm/Group Description:
INCB028050 was administered qd, orally in matching placebo capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
INCB028050 was administered qd, orally in 4 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
INCB028050 was administered qd, orally in 7 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
INCB028050 was administered qd, orally in 10 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
Overall Number of Participants Analyzed 31 31 32 30
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Baseline Number Analyzed 31 participants 31 participants 32 participants 30 participants
71.08  (27.534) 69.03  (28.181) 78.41  (30.329) 78.62  (24.160)
Change from baseline at Week 12 Number Analyzed 31 participants 31 participants 32 participants 30 participants
2.92  (19.613) 7.87  (19.547) 2.21  (17.814) 6.36  (25.203)
Change from baseline at Week 24 Number Analyzed 31 participants 27 participants 30 participants 25 participants
NA [1]   (NA) 7.72  (17.543) 4.60  (17.146) 2.29  (28.869)
[1]
Participants assigned to placebo either discontinued or crossed-over to active treatment at Week 12.
27.Secondary Outcome
Title Change in SF-36 Physical Component Summary From Baseline at Week 12 and Week 24
Hide Description 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").
Time Frame Baseline, Week 12 and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo INCB028050 4 mg QD INCB028050 7 mg QD INCB028050 10 mg QD
Hide Arm/Group Description:
INCB028050 was administered qd, orally in matching placebo capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
INCB028050 was administered qd, orally in 4 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
INCB028050 was administered qd, orally in 7 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
INCB028050 was administered qd, orally in 10 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
Overall Number of Participants Analyzed 31 31 32 30
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Baseline Number Analyzed 31 participants 31 participants 32 participants 30 participants
29.14  (14.330) 34.67  (16.006) 26.71  (14.642) 28.82  (14.212)
Change from baseline at Week 12 Number Analyzed 31 participants 31 participants 32 participants 30 participants
3.72  (11.027) 9.57  (14.960) 12.97  (17.932) 8.35  (13.947)
Change from baseline at Week 24 Number Analyzed 31 participants 27 participants 30 participants 25 participants
NA [1]   (NA) 11.60  (14.503) 15.56  (16.144) 11.77  (13.387)
[1]
Participants assigned to placebo either discontinued or crossed-over to active treatment at Week 12.
28.Secondary Outcome
Title 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
Hide Description 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.
Time Frame Week 12 and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo INCB028050 4 mg QD INCB028050 7 mg QD INCB028050 10 mg QD
Hide Arm/Group Description:
INCB028050 was administered qd, orally in matching placebo capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
INCB028050 was administered qd, orally in 4 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
INCB028050 was administered qd, orally in 7 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
INCB028050 was administered qd, orally in 10 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
Overall Number of Participants Analyzed 31 31 32 30
Measure Type: Number
Unit of Measure: percentage of participants
Week 12 (n=31, 31, 30, 30) Number Analyzed 31 participants 31 participants 32 participants 30 participants
45.0 61.0 63.0 43.0
Week 24 Number Analyzed 31 participants 27 participants 28 participants 25 participants
NA [1]  67.0 75.0 60.0
[1]
Participants assigned to placebo either discontinued or crossed-over to active treatment at Week 12.
29.Secondary Outcome
Title Percent of Participants Achieving a MCID in the Pain Score (Participant's Assessment of Pain) at Week 12 and Week 24
Hide Description 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.
Time Frame Week 12 and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo INCB028050 4 mg QD INCB028050 7 mg QD INCB028050 10 mg QD
Hide Arm/Group Description:
INCB028050 was administered qd, orally in matching placebo capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
INCB028050 was administered qd, orally in 4 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
INCB028050 was administered qd, orally in 7 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
INCB028050 was administered qd, orally in 10 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
Overall Number of Participants Analyzed 31 31 32 30
Measure Type: Number
Unit of Measure: percentage of participants
Week 12 Number Analyzed 31 participants 31 participants 32 participants 30 participants
35.0 58.0 69.0 67.0
Week 24 Number Analyzed 31 participants 27 participants 30 participants 25 participants
NA [1]  59.0 70.0 72.0
[1]
Participants assigned to placebo either discontinued or crossed-over to active treatment at Week 12.
30.Secondary Outcome
Title Percent of Participants Achieving a MCID in the SF-36 Physical Components and Mental Components at Week 12 and Week 24
Hide Description 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").
Time Frame Week 12 and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo INCB028050 4 mg QD INCB028050 7 mg QD INCB028050 10 mg QD
Hide Arm/Group Description:
INCB028050 was administered qd, orally in matching placebo capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
INCB028050 was administered qd, orally in 4 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
INCB028050 was administered qd, orally in 7 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
INCB028050 was administered qd, orally in 10 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time.
Overall Number of Participants Analyzed 31 31 32 30
Measure Type: Number
Unit of Measure: percentage of participants
Week 12 Physical Components Number Analyzed 31 participants 31 participants 32 participants 30 participants
52.0 68.0 69.0 57.0
Week 24 Physical Components Number Analyzed 31 participants 27 participants 30 participants 25 participants
NA [1]  67.0 77.0 76.0
Week 12 Mental Components Number Analyzed 31 participants 31 participants 32 participants 30 participants
52.0 58.0 41.0 50.0
Week 24 Mental Components Number Analyzed 31 participants 27 participants 30 participants 25 participants
NA [1]  63.0 57.0 52.0
[1]
Participants assigned to placebo either discontinued or crossed-over to active treatment at Week 12.
Time Frame Screening through follow-up visit up to approximately 8 months.
Adverse Event Reporting 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.

 
Arm/Group Title Placebo (Weeks 0-12) INCB028050 4 mg QD (Weeks 0-12) INCB028050 7 mg QD (Weeks 0-12) INCB028050 10 mg QD (Weeks 0-12) Placebo to INCB028050 7 mg QD Placebo to INCB028050 10 mg QD INCB028050 4 mg QD (Weeks 12-24) INCB028050 7 mg QD (Weeks 12-24) INCB028050 10 mg QD (Weeks 12-24) Placebo to INCB028050 7 mg QD (After Week 24 to Week 28) Placebo to INCB028050 10 mg QD (After Week 24 to Week 28) INCB028050 4 mg QD (After Week 24 to Week 28) INCB028050 7 mg QD (After Week 24 to Week 28) INCB028050 10 mg QD (After Week 24 to Week 28)
Hide Arm/Group Description INCB028050 was administered qd, orally in matching placebo capsules. All participants were treated with only 1 capsule daily, without regard to meal time. INCB028050 was administered qd, orally in 4 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time. INCB028050 was administered qd, orally in 7 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time. INCB028050 was administered qd, orally in 10 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time. 12-week extension period. Participants who were assigned to placebo group at baseline then crossed over to active treatment groups after week 12. 12-week extension period. Participants who were assigned to placebo group at baseline then crossed over to active treatment groups after week 12. 12-week extension period 12-week extension period 12-week extension period Follow-up Participants who were assigned to placebo group at baseline then crossed over to active treatment groups after week 12. Follow-up Participants who were assigned to placebo group at baseline then crossed over to active treatment groups after week 12. Follow-up Follow-up Follow-up
All-Cause Mortality
Placebo (Weeks 0-12) INCB028050 4 mg QD (Weeks 0-12) INCB028050 7 mg QD (Weeks 0-12) INCB028050 10 mg QD (Weeks 0-12) Placebo to INCB028050 7 mg QD Placebo to INCB028050 10 mg QD INCB028050 4 mg QD (Weeks 12-24) INCB028050 7 mg QD (Weeks 12-24) INCB028050 10 mg QD (Weeks 12-24) Placebo to INCB028050 7 mg QD (After Week 24 to Week 28) Placebo to INCB028050 10 mg QD (After Week 24 to Week 28) INCB028050 4 mg QD (After Week 24 to Week 28) INCB028050 7 mg QD (After Week 24 to Week 28) INCB028050 10 mg QD (After Week 24 to Week 28)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo (Weeks 0-12) INCB028050 4 mg QD (Weeks 0-12) INCB028050 7 mg QD (Weeks 0-12) INCB028050 10 mg QD (Weeks 0-12) Placebo to INCB028050 7 mg QD Placebo to INCB028050 10 mg QD INCB028050 4 mg QD (Weeks 12-24) INCB028050 7 mg QD (Weeks 12-24) INCB028050 10 mg QD (Weeks 12-24) Placebo to INCB028050 7 mg QD (After Week 24 to Week 28) Placebo to INCB028050 10 mg QD (After Week 24 to Week 28) INCB028050 4 mg QD (After Week 24 to Week 28) INCB028050 7 mg QD (After Week 24 to Week 28) INCB028050 10 mg QD (After Week 24 to Week 28)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/31 (0.00%)   0/31 (0.00%)   1/32 (3.13%)   0/31 (0.00%)   0/14 (0.00%)   0/15 (0.00%)   0/29 (0.00%)   1/30 (3.33%)   0/27 (0.00%)   0/14 (0.00%)   1/15 (6.67%)   0/29 (0.00%)   0/30 (0.00%)   0/27 (0.00%) 
Gastrointestinal disorders                             
Erosive oesophagitis  1  0/31 (0.00%)  0/31 (0.00%)  1/32 (3.13%)  0/31 (0.00%)  0/14 (0.00%)  0/15 (0.00%)  0/29 (0.00%)  0/30 (0.00%)  0/27 (0.00%)  0/14 (0.00%)  0/15 (0.00%)  0/29 (0.00%)  0/30 (0.00%)  0/27 (0.00%) 
Mallory-Weiss syndrome  1  0/31 (0.00%)  0/31 (0.00%)  0/32 (0.00%)  0/31 (0.00%)  0/14 (0.00%)  0/15 (0.00%)  0/29 (0.00%)  1/30 (3.33%)  0/27 (0.00%)  0/14 (0.00%)  0/15 (0.00%)  0/29 (0.00%)  0/30 (0.00%)  0/27 (0.00%) 
Nervous system disorders                             
Cerebrovascular accident  1  0/31 (0.00%)  0/31 (0.00%)  0/32 (0.00%)  0/31 (0.00%)  0/14 (0.00%)  0/15 (0.00%)  0/29 (0.00%)  0/30 (0.00%)  0/27 (0.00%)  0/14 (0.00%)  1/15 (6.67%)  0/29 (0.00%)  0/30 (0.00%)  0/27 (0.00%) 
Vascular disorders                             
Thrombophlebitis  1  0/31 (0.00%)  0/31 (0.00%)  1/32 (3.13%)  0/31 (0.00%)  0/14 (0.00%)  0/15 (0.00%)  0/29 (0.00%)  0/30 (0.00%)  0/27 (0.00%)  0/14 (0.00%)  0/15 (0.00%)  0/29 (0.00%)  0/30 (0.00%)  0/27 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (11.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo (Weeks 0-12) INCB028050 4 mg QD (Weeks 0-12) INCB028050 7 mg QD (Weeks 0-12) INCB028050 10 mg QD (Weeks 0-12) Placebo to INCB028050 7 mg QD Placebo to INCB028050 10 mg QD INCB028050 4 mg QD (Weeks 12-24) INCB028050 7 mg QD (Weeks 12-24) INCB028050 10 mg QD (Weeks 12-24) Placebo to INCB028050 7 mg QD (After Week 24 to Week 28) Placebo to INCB028050 10 mg QD (After Week 24 to Week 28) INCB028050 4 mg QD (After Week 24 to Week 28) INCB028050 7 mg QD (After Week 24 to Week 28) INCB028050 10 mg QD (After Week 24 to Week 28)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   23/31 (74.19%)   19/31 (61.29%)   15/32 (46.88%)   20/31 (64.52%)   11/14 (78.57%)   9/15 (60.00%)   11/29 (37.93%)   17/30 (56.67%)   6/27 (22.22%)   0/14 (0.00%)   1/15 (6.67%)   3/29 (10.34%)   5/30 (16.67%)   2/27 (7.41%) 
Blood and lymphatic system disorders                             
Anemia  1  0/31 (0.00%)  0/31 (0.00%)  0/32 (0.00%)  0/31 (0.00%)  0/14 (0.00%)  0/15 (0.00%)  0/29 (0.00%)  1/30 (3.33%)  3/27 (11.11%)  0/14 (0.00%)  0/15 (0.00%)  0/29 (0.00%)  0/30 (0.00%)  0/27 (0.00%) 
Ear and labyrinth disorders                             
Cerumen impaction  1  0/31 (0.00%)  0/31 (0.00%)  2/32 (6.25%)  1/31 (3.23%)  0/14 (0.00%)  0/15 (0.00%)  0/29 (0.00%)  0/30 (0.00%)  0/27 (0.00%)  0/14 (0.00%)  0/15 (0.00%)  0/29 (0.00%)  0/30 (0.00%)  0/27 (0.00%) 
Eye disorders                             
Dry eye  1  2/31 (6.45%)  0/31 (0.00%)  0/32 (0.00%)  2/31 (6.45%)  0/14 (0.00%)  0/15 (0.00%)  0/29 (0.00%)  0/30 (0.00%)  0/27 (0.00%)  0/14 (0.00%)  0/15 (0.00%)  0/29 (0.00%)  0/30 (0.00%)  0/27 (0.00%) 
Conjunctivitis  1  0/31 (0.00%)  0/31 (0.00%)  0/32 (0.00%)  0/31 (0.00%)  1/14 (7.14%)  0/15 (0.00%)  0/29 (0.00%)  1/30 (3.33%)  0/27 (0.00%)  0/14 (0.00%)  0/15 (0.00%)  0/29 (0.00%)  0/30 (0.00%)  0/27 (0.00%) 
Gastrointestinal disorders                             
Diarrhea  1  2/31 (6.45%)  2/31 (6.45%)  2/32 (6.25%)  1/31 (3.23%)  0/14 (0.00%)  0/15 (0.00%)  0/29 (0.00%)  0/30 (0.00%)  0/27 (0.00%)  0/14 (0.00%)  0/15 (0.00%)  0/29 (0.00%)  0/30 (0.00%)  0/27 (0.00%) 
Nausea  1  1/31 (3.23%)  2/31 (6.45%)  2/32 (6.25%)  1/31 (3.23%)  0/14 (0.00%)  0/15 (0.00%)  0/29 (0.00%)  0/30 (0.00%)  0/27 (0.00%)  0/14 (0.00%)  0/15 (0.00%)  0/29 (0.00%)  0/30 (0.00%)  0/27 (0.00%) 
Constipation  1  1/31 (3.23%)  2/31 (6.45%)  0/32 (0.00%)  1/31 (3.23%)  0/14 (0.00%)  0/15 (0.00%)  0/29 (0.00%)  0/30 (0.00%)  0/27 (0.00%)  0/14 (0.00%)  0/15 (0.00%)  0/29 (0.00%)  0/30 (0.00%)  0/27 (0.00%) 
Mouth ulceration  1  0/31 (0.00%)  0/31 (0.00%)  1/32 (3.13%)  2/31 (6.45%)  0/14 (0.00%)  0/15 (0.00%)  0/29 (0.00%)  0/30 (0.00%)  0/27 (0.00%)  0/14 (0.00%)  0/15 (0.00%)  0/29 (0.00%)  0/30 (0.00%)  0/27 (0.00%) 
Vomiting  1  0/31 (0.00%)  0/31 (0.00%)  0/32 (0.00%)  0/31 (0.00%)  1/14 (7.14%)  0/15 (0.00%)  0/29 (0.00%)  2/30 (6.67%)  2/27 (7.41%)  0/14 (0.00%)  0/15 (0.00%)  0/29 (0.00%)  0/30 (0.00%)  0/27 (0.00%) 
General disorders                             
Pyrexia  1  0/31 (0.00%)  0/31 (0.00%)  0/32 (0.00%)  0/31 (0.00%)  1/14 (7.14%)  2/15 (13.33%)  0/29 (0.00%)  0/30 (0.00%)  0/27 (0.00%)  0/14 (0.00%)  0/15 (0.00%)  0/29 (0.00%)  0/30 (0.00%)  0/27 (0.00%) 
Chills  1  0/31 (0.00%)  0/31 (0.00%)  0/32 (0.00%)  0/31 (0.00%)  1/14 (7.14%)  1/15 (6.67%)  0/29 (0.00%)  0/30 (0.00%)  0/27 (0.00%)  0/14 (0.00%)  0/15 (0.00%)  0/29 (0.00%)  0/30 (0.00%)  0/27 (0.00%) 
Immune system disorders                             
Rheumatoid arthritis  1  0/31 (0.00%)  0/31 (0.00%)  0/32 (0.00%)  0/31 (0.00%)  0/14 (0.00%)  0/15 (0.00%)  2/29 (6.90%)  0/30 (0.00%)  0/27 (0.00%)  0/14 (0.00%)  0/15 (0.00%)  1/29 (3.45%)  2/30 (6.67%)  1/27 (3.70%) 
Infections and infestations                             
Upper respiratory tract infection  1  3/31 (9.68%)  2/31 (6.45%)  2/32 (6.25%)  1/31 (3.23%)  0/14 (0.00%)  0/15 (0.00%)  0/29 (0.00%)  0/30 (0.00%)  0/27 (0.00%)  0/14 (0.00%)  0/15 (0.00%)  0/29 (0.00%)  0/30 (0.00%)  0/27 (0.00%) 
Sinusitis  1  2/31 (6.45%)  1/31 (3.23%)  3/32 (9.38%)  1/31 (3.23%)  1/14 (7.14%)  0/15 (0.00%)  0/29 (0.00%)  1/30 (3.33%)  0/27 (0.00%)  0/14 (0.00%)  0/15 (0.00%)  0/29 (0.00%)  0/30 (0.00%)  0/27 (0.00%) 
Bronchitis  1  1/31 (3.23%)  1/31 (3.23%)  2/32 (6.25%)  1/31 (3.23%)  2/14 (14.29%)  0/15 (0.00%)  0/29 (0.00%)  0/30 (0.00%)  0/27 (0.00%)  0/14 (0.00%)  0/15 (0.00%)  0/29 (0.00%)  0/30 (0.00%)  0/27 (0.00%) 
Influenza  1  1/31 (3.23%)  0/31 (0.00%)  0/32 (0.00%)  2/31 (6.45%)  1/14 (7.14%)  0/15 (0.00%)  0/29 (0.00%)  1/30 (3.33%)  0/27 (0.00%)  0/14 (0.00%)  0/15 (0.00%)  0/29 (0.00%)  0/30 (0.00%)  0/27 (0.00%) 
Herpes zoster  1  0/31 (0.00%)  0/31 (0.00%)  0/32 (0.00%)  0/31 (0.00%)  0/14 (0.00%)  0/15 (0.00%)  0/29 (0.00%)  3/30 (10.00%)  0/27 (0.00%)  0/14 (0.00%)  0/15 (0.00%)  0/29 (0.00%)  0/30 (0.00%)  0/27 (0.00%) 
Urinary tract infection  1  0/31 (0.00%)  0/31 (0.00%)  0/32 (0.00%)  0/31 (0.00%)  0/14 (0.00%)  1/15 (6.67%)  1/29 (3.45%)  1/30 (3.33%)  0/27 (0.00%)  0/14 (0.00%)  0/15 (0.00%)  0/29 (0.00%)  2/30 (6.67%)  1/27 (3.70%) 
Injury, poisoning and procedural complications                             
Fall  1  0/31 (0.00%)  2/31 (6.45%)  1/32 (3.13%)  0/31 (0.00%)  0/14 (0.00%)  0/15 (0.00%)  0/29 (0.00%)  0/30 (0.00%)  0/27 (0.00%)  0/14 (0.00%)  0/15 (0.00%)  0/29 (0.00%)  0/30 (0.00%)  0/27 (0.00%) 
Investigations                             
C-reactive protein increased  1  2/31 (6.45%)  1/31 (3.23%)  0/32 (0.00%)  0/31 (0.00%)  0/14 (0.00%)  0/15 (0.00%)  0/29 (0.00%)  0/30 (0.00%)  0/27 (0.00%)  0/14 (0.00%)  0/15 (0.00%)  0/29 (0.00%)  0/30 (0.00%)  0/27 (0.00%) 
Aspartate aminotransferase increased  1  0/31 (0.00%)  0/31 (0.00%)  0/32 (0.00%)  0/31 (0.00%)  1/14 (7.14%)  0/15 (0.00%)  1/29 (3.45%)  0/30 (0.00%)  0/27 (0.00%)  0/14 (0.00%)  0/15 (0.00%)  0/29 (0.00%)  0/30 (0.00%)  0/27 (0.00%) 
Blood creatinine increased  1  0/31 (0.00%)  0/31 (0.00%)  0/32 (0.00%)  0/31 (0.00%)  1/14 (7.14%)  0/15 (0.00%)  1/29 (3.45%)  0/30 (0.00%)  0/27 (0.00%)  0/14 (0.00%)  0/15 (0.00%)  0/29 (0.00%)  0/30 (0.00%)  0/27 (0.00%) 
Metabolism and nutrition disorders                             
Hypercholesterolemia  1  0/31 (0.00%)  0/31 (0.00%)  0/32 (0.00%)  0/31 (0.00%)  1/14 (7.14%)  0/15 (0.00%)  0/29 (0.00%)  1/30 (3.33%)  1/27 (3.70%)  0/14 (0.00%)  0/15 (0.00%)  0/29 (0.00%)  0/30 (0.00%)  0/27 (0.00%) 
Musculoskeletal and connective tissue disorders                             
Back pain  1  1/31 (3.23%)  1/31 (3.23%)  0/32 (0.00%)  2/31 (6.45%)  0/14 (0.00%)  0/15 (0.00%)  0/29 (0.00%)  0/30 (0.00%)  0/27 (0.00%)  0/14 (0.00%)  1/15 (6.67%)  1/29 (3.45%)  0/30 (0.00%)  0/27 (0.00%) 
Arthralgia  1  0/31 (0.00%)  2/31 (6.45%)  0/32 (0.00%)  1/31 (3.23%)  0/14 (0.00%)  0/15 (0.00%)  0/29 (0.00%)  0/30 (0.00%)  0/27 (0.00%)  0/14 (0.00%)  0/15 (0.00%)  0/29 (0.00%)  0/30 (0.00%)  0/27 (0.00%) 
Muscle spasms  1  2/31 (6.45%)  1/31 (3.23%)  0/32 (0.00%)  0/31 (0.00%)  0/14 (0.00%)  0/15 (0.00%)  0/29 (0.00%)  0/30 (0.00%)  0/27 (0.00%)  0/14 (0.00%)  0/15 (0.00%)  0/29 (0.00%)  0/30 (0.00%)  0/27 (0.00%) 
Nervous system disorders                             
Headache  1  2/31 (6.45%)  4/31 (12.90%)  3/32 (9.38%)  3/31 (9.68%)  0/14 (0.00%)  1/15 (6.67%)  1/29 (3.45%)  1/30 (3.33%)  0/27 (0.00%)  0/14 (0.00%)  0/15 (0.00%)  0/29 (0.00%)  0/30 (0.00%)  0/27 (0.00%) 
Paraesthesia  1  0/31 (0.00%)  2/31 (6.45%)  0/32 (0.00%)  0/31 (0.00%)  0/14 (0.00%)  0/15 (0.00%)  0/29 (0.00%)  0/30 (0.00%)  0/27 (0.00%)  0/14 (0.00%)  0/15 (0.00%)  0/29 (0.00%)  0/30 (0.00%)  0/27 (0.00%) 
Psychiatric disorders                             
Insomnia  1  1/31 (3.23%)  1/31 (3.23%)  2/32 (6.25%)  1/31 (3.23%)  0/14 (0.00%)  0/15 (0.00%)  2/29 (6.90%)  1/30 (3.33%)  0/27 (0.00%)  0/14 (0.00%)  0/15 (0.00%)  0/29 (0.00%)  0/30 (0.00%)  0/27 (0.00%) 
Respiratory, thoracic and mediastinal disorders                             
Cough  1  1/31 (3.23%)  0/31 (0.00%)  3/32 (9.38%)  1/31 (3.23%)  0/14 (0.00%)  1/15 (6.67%)  1/29 (3.45%)  2/30 (6.67%)  0/27 (0.00%)  0/14 (0.00%)  0/15 (0.00%)  0/29 (0.00%)  0/30 (0.00%)  0/27 (0.00%) 
Rhinorrhoea  1  2/31 (6.45%)  0/31 (0.00%)  1/32 (3.13%)  0/31 (0.00%)  0/14 (0.00%)  0/15 (0.00%)  0/29 (0.00%)  0/30 (0.00%)  0/27 (0.00%)  0/14 (0.00%)  0/15 (0.00%)  0/29 (0.00%)  0/30 (0.00%)  0/27 (0.00%) 
Sinus congestion  1  0/31 (0.00%)  0/31 (0.00%)  2/32 (6.25%)  0/31 (0.00%)  0/14 (0.00%)  1/15 (6.67%)  1/29 (3.45%)  0/30 (0.00%)  0/27 (0.00%)  0/14 (0.00%)  0/15 (0.00%)  0/29 (0.00%)  0/30 (0.00%)  0/27 (0.00%) 
Oropharyngeal pain  1  0/31 (0.00%)  0/31 (0.00%)  0/32 (0.00%)  0/31 (0.00%)  0/14 (0.00%)  1/15 (6.67%)  1/29 (3.45%)  1/30 (3.33%)  0/27 (0.00%)  0/14 (0.00%)  0/15 (0.00%)  0/29 (0.00%)  0/30 (0.00%)  0/27 (0.00%) 
Skin and subcutaneous tissue disorders                             
Acne  1  0/31 (0.00%)  1/31 (3.23%)  2/32 (6.25%)  1/31 (3.23%)  0/14 (0.00%)  0/15 (0.00%)  0/29 (0.00%)  0/30 (0.00%)  0/27 (0.00%)  0/14 (0.00%)  0/15 (0.00%)  0/29 (0.00%)  0/30 (0.00%)  0/27 (0.00%) 
Rash  1  2/31 (6.45%)  1/31 (3.23%)  1/32 (3.13%)  0/31 (0.00%)  0/14 (0.00%)  0/15 (0.00%)  0/29 (0.00%)  0/30 (0.00%)  0/27 (0.00%)  0/14 (0.00%)  0/15 (0.00%)  1/29 (3.45%)  1/30 (3.33%)  0/27 (0.00%) 
Dermatitis  1  0/31 (0.00%)  0/31 (0.00%)  0/32 (0.00%)  2/31 (6.45%)  0/14 (0.00%)  0/15 (0.00%)  0/29 (0.00%)  0/30 (0.00%)  0/27 (0.00%)  0/14 (0.00%)  0/15 (0.00%)  0/29 (0.00%)  0/30 (0.00%)  0/27 (0.00%) 
Alopecia  1  0/31 (0.00%)  0/31 (0.00%)  0/32 (0.00%)  0/31 (0.00%)  0/14 (0.00%)  1/15 (6.67%)  0/29 (0.00%)  1/30 (3.33%)  0/27 (0.00%)  0/14 (0.00%)  0/15 (0.00%)  0/29 (0.00%)  0/30 (0.00%)  0/27 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (11.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: Incyte Corporation
Phone: 855 463-3463
Layout table for additonal information
Responsible Party: Incyte Corporation
ClinicalTrials.gov Identifier: NCT00902486     History of Changes
Other Study ID Numbers: INCB 28050-201
First Submitted: May 13, 2009
First Posted: May 15, 2009
Results First Submitted: June 10, 2018
Results First Posted: September 3, 2018
Last Update Posted: September 3, 2018