Rheumatoid Arthritis
Conditions
Keywords
Rheumatoid arthritis
Brief summary
The purpose of this study is to understand the safety and tolerability of INCB018424 in patients with rheumatoid arthritis
Interventions
DRUGINCB018424
DRUGPlacebo
Sponsors
Incyte Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Established diagnosis of rheumatoid arthritis 2. Patients receiving methotrexate must be treated with for at least 6 months and receiving a stable weekly dose between 10 and 25 mg for at least 8 consecutive weeks prior to study entry.
Exclusion criteria
1. Patients who have taken the following drugs within the timeframe below: * Leflunomide, infliximab, etanercept, adalimumab, abatacept, or other biological therapies (except rituximab) - Within 12 weeks prior to the first dose of study medication; * Rituximab - Within 12 months prior to the first dose of study medication; * Disease-modifying anti-rheumatic drugs (DMARDs) or other anti-rheumatic therapies not specified above including but not limited to: gold, penicillamine, dapsone, azathioprine, 6-mercaptopurine, chlorambucil, cyclophosphamide, cyclosporin, mycophenolate mofetil - Within 12 weeks prior to the first dose of study medication; 2. Treatment with any investigational medication within 12 weeks prior to the first dose of study medication.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Percentage of Subjects Achieving American College of Rheumatology (ACR) 20 Improvement | Day 28 | 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: subject's assessment of pain, Subject's global assessment of disease activity (PGA), Physician's global assessment of disease activity (PHGA), subject's self-assessed disability Health Assessment Questionnaire (HAQ), and Erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP), whichever shows the greatest change. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Percentage of Subjects Achieving ACR 70 Improvement | Day 28 | 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: subject's assessment of pain, PGA, PHGA, subject's self-assessed disability HAQ, and ESR or CRP, whichever shows the greatest change. |
| Change From Baseline in Disease Activity Score 28 (DAS 28) ESR Score | Baseline, Day 28 | 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. |
| Change From Baseline in Disease Activity Score 28 (DAS 28) CRP Score | Baseline, Day 28 | 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). |
| The Percentage of Subjects Achieving ACR 50 Improvement | Day 28 | 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: subject's assessment of pain, PGA, PHGA, subject's self-assessed disability HAQ, and ESR or CRP, whichever shows the greatest change. |
| Percentage of Subjects Who Achieved DAS 28 CRP Low Disease | Day 28 | Subjects who achieved low disease activity based on the DAS 28 CRP (score \<3.2). Subjects who achieved low disease activity were classified as responders in this analysis. |
| Percentage of Subjects Who Achieved DAS 28 ESR Inactive Disease | Day 28 | Subjects who achieved inactive disease based on the DAS 28 ESR (score \<2.6). Subjects who achieved low disease activity were classified as responders in this analysis. |
| Percentage of Subjects Who Achieved DAS 28 CRP Inactive Disease | Day 28 | Subjects who achieved inactive disease based on DAS 28 CRP (score \<2.6). Subjects who achieved low disease activity were classified as responders in this analysis. |
| Percentage of Subjects Who Achieved DAS 28 ESR Low Disease | Day 28 | Subjects who achieved low disease activity based on the DAS 28 ESR (score \<3.2). Subjects who achieved low disease activity were classified as responders in this analysis. |
Countries
Poland, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo | 9 |
| Cohort 1: Treatment Group A INCB018424 15 mg BID | 12 |
| Cohort 2: Treatment Group B INCB018424 5 mg BID | 9 |
| Cohort 2: Treatment Group C INCB018424 25 mg BID | 10 |
| Cohort 2: Treatment Group D INCB018424 50 mg QD | 10 |
| Total | 50 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 0 | 1 | 1 |
| Overall Study | Other Reasons- Unspecified | 0 | 1 | 0 | 1 | 0 |
| Overall Study | Subject Withdrew Consent | 0 | 2 | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Placebo | Cohort 1: Treatment Group A | Cohort 2: Treatment Group B | Cohort 2: Treatment Group C | Cohort 2: Treatment Group D | Total |
|---|---|---|---|---|---|---|
| Age, Continuous | 55.2 years STANDARD_DEVIATION 12.04 | 56.9 years STANDARD_DEVIATION 8.44 | 49.6 years STANDARD_DEVIATION 10.69 | 57.5 years STANDARD_DEVIATION 11.29 | 54.5 years STANDARD_DEVIATION 14.14 | 54.9 years STANDARD_DEVIATION 11.23 |
| Sex: Female, Male Female | 8 Participants | 8 Participants | 7 Participants | 7 Participants | 8 Participants | 38 Participants |
| Sex: Female, Male Male | 1 Participants | 4 Participants | 2 Participants | 3 Participants | 2 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 5 / 9 | 6 / 12 | 2 / 9 | 6 / 10 | 7 / 10 |
| serious Total, serious adverse events | 0 / 9 | 0 / 12 | 0 / 9 | 0 / 10 | 1 / 10 |
Outcome results
Primary
The Percentage of Subjects 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: subject's assessment of pain, Subject's global assessment of disease activity (PGA), Physician's global assessment of disease activity (PHGA), subject's self-assessed disability Health Assessment Questionnaire (HAQ), and Erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP), whichever shows the greatest change.
Time frame: Day 28
Population: modified intent-to-treat (mITT) Population: subjects enrolled, took 1 dose of study drug, had predose and at least 1 post baseline Rheumatoid arthritis (RA) assessments. Subjects discontinuing before the last scheduled efficacy evaluation had data imputed for time points after discontinuation; they had their last observation carried forward (LOCF).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | The Percentage of Subjects Achieving American College of Rheumatology (ACR) 20 Improvement | No Response | 66.7 Percentage of participants |
| Placebo | The Percentage of Subjects Achieving American College of Rheumatology (ACR) 20 Improvement | Response | 33.3 Percentage of participants |
| Cohort 1: Treatment Group A | The Percentage of Subjects Achieving American College of Rheumatology (ACR) 20 Improvement | No Response | 16.7 Percentage of participants |
| Cohort 1: Treatment Group A | The Percentage of Subjects Achieving American College of Rheumatology (ACR) 20 Improvement | Response | 83.3 Percentage of participants |
| Cohort 2: Treatment Group B | The Percentage of Subjects Achieving American College of Rheumatology (ACR) 20 Improvement | No Response | 66.7 Percentage of participants |
| Cohort 2: Treatment Group B | The Percentage of Subjects Achieving American College of Rheumatology (ACR) 20 Improvement | Response | 33.3 Percentage of participants |
| Cohort 2: Treatment Group C | The Percentage of Subjects Achieving American College of Rheumatology (ACR) 20 Improvement | Response | 60.0 Percentage of participants |
| Cohort 2: Treatment Group C | The Percentage of Subjects Achieving American College of Rheumatology (ACR) 20 Improvement | No Response | 40.0 Percentage of participants |
| Cohort 2: Treatment Group D | The Percentage of Subjects Achieving American College of Rheumatology (ACR) 20 Improvement | No Response | 40.0 Percentage of participants |
| Cohort 2: Treatment Group D | The Percentage of Subjects Achieving American College of Rheumatology (ACR) 20 Improvement | Response | 60.0 Percentage of participants |
Secondary
Change From Baseline in Disease Activity Score 28 (DAS 28) CRP Score
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, Day 28
Population: mITT Population: subjects who were enrolled, took at least 1 dose of study drug, and had predose and at least 1 post baseline Rheumatoid arthritis (RA) assessments. Subjects who discontinued before the last scheduled efficacy evaluation had data imputed for time points after discontinuation; they had their last observation carried forward (LOCF).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Disease Activity Score 28 (DAS 28) CRP Score | 1.14 Units on a scale | Standard Deviation 0.907 |
| Cohort 1: Treatment Group A | Change From Baseline in Disease Activity Score 28 (DAS 28) CRP Score | 2.27 Units on a scale | Standard Deviation 1.177 |
| Cohort 2: Treatment Group B | Change From Baseline in Disease Activity Score 28 (DAS 28) CRP Score | 0.92 Units on a scale | Standard Deviation 0.985 |
| Cohort 2: Treatment Group C | Change From Baseline in Disease Activity Score 28 (DAS 28) CRP Score | 2.33 Units on a scale | Standard Deviation 1.84 |
| Cohort 2: Treatment Group D | Change From Baseline in Disease Activity Score 28 (DAS 28) CRP Score | 2.64 Units on a scale | Standard Deviation 1.275 |
Secondary
Change From Baseline in Disease Activity Score 28 (DAS 28) ESR Score
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, Day 28
Population: mITT Population: subjects who were enrolled, took at least 1 dose of study drug, and had predose and at least 1 post baseline Rheumatoid arthritis (RA) assessments. Subjects who discontinued before the last scheduled efficacy evaluation had data imputed for time points after discontinuation; they had their last observation carried forward (LOCF).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Disease Activity Score 28 (DAS 28) ESR Score | 1.32 Units on a scale | Standard Deviation 0.845 |
| Cohort 1: Treatment Group A | Change From Baseline in Disease Activity Score 28 (DAS 28) ESR Score | 2.72 Units on a scale | Standard Deviation 1.25 |
| Cohort 2: Treatment Group B | Change From Baseline in Disease Activity Score 28 (DAS 28) ESR Score | 1.09 Units on a scale | Standard Deviation 1.107 |
| Cohort 2: Treatment Group C | Change From Baseline in Disease Activity Score 28 (DAS 28) ESR Score | 2.53 Units on a scale | Standard Deviation 1.454 |
| Cohort 2: Treatment Group D | Change From Baseline in Disease Activity Score 28 (DAS 28) ESR Score | 2.88 Units on a scale | Standard Deviation 1.225 |
Secondary
Percentage of Subjects Who Achieved DAS 28 CRP Inactive Disease
Subjects who achieved inactive disease based on DAS 28 CRP (score \<2.6). Subjects who achieved low disease activity were classified as responders in this analysis.
Time frame: Day 28
Population: mITT Population: subjects who were enrolled, took at least 1 dose of study drug, and had predose and at least 1 post baseline Rheumatoid arthritis (RA) assessments. Subjects who discontinued before the last scheduled efficacy evaluation had data imputed for time points after discontinuation; they had their last observation carried forward (LOCF).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Subjects Who Achieved DAS 28 CRP Inactive Disease | Non-responders | 100.0 Percentage of participants |
| Placebo | Percentage of Subjects Who Achieved DAS 28 CRP Inactive Disease | Responders | 0.0 Percentage of participants |
| Cohort 1: Treatment Group A | Percentage of Subjects Who Achieved DAS 28 CRP Inactive Disease | Non-responders | 75.0 Percentage of participants |
| Cohort 1: Treatment Group A | Percentage of Subjects Who Achieved DAS 28 CRP Inactive Disease | Responders | 25.0 Percentage of participants |
| Cohort 2: Treatment Group B | Percentage of Subjects Who Achieved DAS 28 CRP Inactive Disease | Non-responders | 100.0 Percentage of participants |
| Cohort 2: Treatment Group B | Percentage of Subjects Who Achieved DAS 28 CRP Inactive Disease | Responders | 0.0 Percentage of participants |
| Cohort 2: Treatment Group C | Percentage of Subjects Who Achieved DAS 28 CRP Inactive Disease | Responders | 10.0 Percentage of participants |
| Cohort 2: Treatment Group C | Percentage of Subjects Who Achieved DAS 28 CRP Inactive Disease | Non-responders | 90.0 Percentage of participants |
| Cohort 2: Treatment Group D | Percentage of Subjects Who Achieved DAS 28 CRP Inactive Disease | Non-responders | 70.0 Percentage of participants |
| Cohort 2: Treatment Group D | Percentage of Subjects Who Achieved DAS 28 CRP Inactive Disease | Responders | 30.0 Percentage of participants |
Secondary
Percentage of Subjects Who Achieved DAS 28 CRP Low Disease
Subjects who achieved low disease activity based on the DAS 28 CRP (score \<3.2). Subjects who achieved low disease activity were classified as responders in this analysis.
Time frame: Day 28
Population: mITT Population: subjects who were enrolled, took at least 1 dose of study drug, and had predose and at least 1 post baseline Rheumatoid arthritis (RA) assessments. Subjects who discontinued before the last scheduled efficacy evaluation had data imputed for time points after discontinuation; they had their last observation carried forward (LOCF).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Subjects Who Achieved DAS 28 CRP Low Disease | Non-responders | 100.0 Percentage of participants |
| Placebo | Percentage of Subjects Who Achieved DAS 28 CRP Low Disease | Responders | 0.0 Percentage of participants |
| Cohort 1: Treatment Group A | Percentage of Subjects Who Achieved DAS 28 CRP Low Disease | Non-responders | 50.0 Percentage of participants |
| Cohort 1: Treatment Group A | Percentage of Subjects Who Achieved DAS 28 CRP Low Disease | Responders | 50.0 Percentage of participants |
| Cohort 2: Treatment Group B | Percentage of Subjects Who Achieved DAS 28 CRP Low Disease | Non-responders | 100.0 Percentage of participants |
| Cohort 2: Treatment Group B | Percentage of Subjects Who Achieved DAS 28 CRP Low Disease | Responders | 0.0 Percentage of participants |
| Cohort 2: Treatment Group C | Percentage of Subjects Who Achieved DAS 28 CRP Low Disease | Responders | 30.0 Percentage of participants |
| Cohort 2: Treatment Group C | Percentage of Subjects Who Achieved DAS 28 CRP Low Disease | Non-responders | 70.0 Percentage of participants |
| Cohort 2: Treatment Group D | Percentage of Subjects Who Achieved DAS 28 CRP Low Disease | Non-responders | 50.0 Percentage of participants |
| Cohort 2: Treatment Group D | Percentage of Subjects Who Achieved DAS 28 CRP Low Disease | Responders | 50.0 Percentage of participants |
Secondary
Percentage of Subjects Who Achieved DAS 28 ESR Inactive Disease
Subjects who achieved inactive disease based on the DAS 28 ESR (score \<2.6). Subjects who achieved low disease activity were classified as responders in this analysis.
Time frame: Day 28
Population: mITT Population: subjects who were enrolled, took at least 1 dose of study drug, and had predose and at least 1 post baseline Rheumatoid arthritis (RA) assessments. Subjects who discontinued before the last scheduled efficacy evaluation had data imputed for time points after discontinuation; they had their last observation carried forward (LOCF).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Subjects Who Achieved DAS 28 ESR Inactive Disease | Non-responders | 100.0 Percentage of participants |
| Placebo | Percentage of Subjects Who Achieved DAS 28 ESR Inactive Disease | Responders | 0.0 Percentage of participants |
| Cohort 1: Treatment Group A | Percentage of Subjects Who Achieved DAS 28 ESR Inactive Disease | Non-responders | 75.0 Percentage of participants |
| Cohort 1: Treatment Group A | Percentage of Subjects Who Achieved DAS 28 ESR Inactive Disease | Responders | 25.0 Percentage of participants |
| Cohort 2: Treatment Group B | Percentage of Subjects Who Achieved DAS 28 ESR Inactive Disease | Non-responders | 100.0 Percentage of participants |
| Cohort 2: Treatment Group B | Percentage of Subjects Who Achieved DAS 28 ESR Inactive Disease | Responders | 0.0 Percentage of participants |
| Cohort 2: Treatment Group C | Percentage of Subjects Who Achieved DAS 28 ESR Inactive Disease | Responders | 0.0 Percentage of participants |
| Cohort 2: Treatment Group C | Percentage of Subjects Who Achieved DAS 28 ESR Inactive Disease | Non-responders | 100.0 Percentage of participants |
| Cohort 2: Treatment Group D | Percentage of Subjects Who Achieved DAS 28 ESR Inactive Disease | Non-responders | 90.0 Percentage of participants |
| Cohort 2: Treatment Group D | Percentage of Subjects Who Achieved DAS 28 ESR Inactive Disease | Responders | 10.0 Percentage of participants |
Secondary
Percentage of Subjects Who Achieved DAS 28 ESR Low Disease
Subjects who achieved low disease activity based on the DAS 28 ESR (score \<3.2). Subjects who achieved low disease activity were classified as responders in this analysis.
Time frame: Day 28
Population: mITT Population: subjects who were enrolled, took at least 1 dose of study drug, and had predose and at least 1 post baseline Rheumatoid arthritis (RA) assessments. Subjects who discontinued before the last scheduled efficacy evaluation had data imputed for time points after discontinuation; they had their last observation carried forward (LOCF).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Subjects Who Achieved DAS 28 ESR Low Disease | Non-responders | 100.0 Percentage of participants |
| Placebo | Percentage of Subjects Who Achieved DAS 28 ESR Low Disease | Responders | 0.0 Percentage of participants |
| Cohort 1: Treatment Group A | Percentage of Subjects Who Achieved DAS 28 ESR Low Disease | Non-responders | 50.0 Percentage of participants |
| Cohort 1: Treatment Group A | Percentage of Subjects Who Achieved DAS 28 ESR Low Disease | Responders | 50.0 Percentage of participants |
| Cohort 2: Treatment Group B | Percentage of Subjects Who Achieved DAS 28 ESR Low Disease | Non-responders | 100.0 Percentage of participants |
| Cohort 2: Treatment Group B | Percentage of Subjects Who Achieved DAS 28 ESR Low Disease | Responders | 0.0 Percentage of participants |
| Cohort 2: Treatment Group C | Percentage of Subjects Who Achieved DAS 28 ESR Low Disease | Responders | 10.0 Percentage of participants |
| Cohort 2: Treatment Group C | Percentage of Subjects Who Achieved DAS 28 ESR Low Disease | Non-responders | 90.0 Percentage of participants |
| Cohort 2: Treatment Group D | Percentage of Subjects Who Achieved DAS 28 ESR Low Disease | Non-responders | 60.0 Percentage of participants |
| Cohort 2: Treatment Group D | Percentage of Subjects Who Achieved DAS 28 ESR Low Disease | Responders | 40.0 Percentage of participants |
Secondary
The Percentage of Subjects Achieving ACR 50 Improvement
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: subject's assessment of pain, PGA, PHGA, subject's self-assessed disability HAQ, and ESR or CRP, whichever shows the greatest change.
Time frame: Day 28
Population: mITT Population: subjects who were enrolled, took at least 1 dose of study drug, and had predose and at least 1 post baseline Rheumatoid arthritis (RA) assessments. Subjects who discontinued before the last scheduled efficacy evaluation had data imputed for time points after discontinuation; they had their last observation carried forward (LOCF).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | The Percentage of Subjects Achieving ACR 50 Improvement | No Response | 88.9 Percentage of participants |
| Placebo | The Percentage of Subjects Achieving ACR 50 Improvement | Response | 11.1 Percentage of participants |
| Cohort 1: Treatment Group A | The Percentage of Subjects Achieving ACR 50 Improvement | No Response | 50.0 Percentage of participants |
| Cohort 1: Treatment Group A | The Percentage of Subjects Achieving ACR 50 Improvement | Response | 50.0 Percentage of participants |
| Cohort 2: Treatment Group B | The Percentage of Subjects Achieving ACR 50 Improvement | No Response | 88.9 Percentage of participants |
| Cohort 2: Treatment Group B | The Percentage of Subjects Achieving ACR 50 Improvement | Response | 11.1 Percentage of participants |
| Cohort 2: Treatment Group C | The Percentage of Subjects Achieving ACR 50 Improvement | Response | 40.0 Percentage of participants |
| Cohort 2: Treatment Group C | The Percentage of Subjects Achieving ACR 50 Improvement | No Response | 60.0 Percentage of participants |
| Cohort 2: Treatment Group D | The Percentage of Subjects Achieving ACR 50 Improvement | No Response | 50.0 Percentage of participants |
| Cohort 2: Treatment Group D | The Percentage of Subjects Achieving ACR 50 Improvement | Response | 50.0 Percentage of participants |
Secondary
The Percentage of Subjects Achieving ACR 70 Improvement
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: subject's assessment of pain, PGA, PHGA, subject's self-assessed disability HAQ, and ESR or CRP, whichever shows the greatest change.
Time frame: Day 28
Population: mITT Population: subjects who were enrolled, took at least 1 dose of study drug, and had predose and at least 1 post baseline Rheumatoid arthritis (RA) assessments. Subjects who discontinued before the last scheduled efficacy evaluation had data imputed for time points after discontinuation; they had their last observation carried forward (LOCF).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | The Percentage of Subjects Achieving ACR 70 Improvement | No response | 100.0 Percentage of participants |
| Placebo | The Percentage of Subjects Achieving ACR 70 Improvement | Response | 0.0 Percentage of participants |
| Cohort 1: Treatment Group A | The Percentage of Subjects Achieving ACR 70 Improvement | No response | 75.0 Percentage of participants |
| Cohort 1: Treatment Group A | The Percentage of Subjects Achieving ACR 70 Improvement | Response | 25.0 Percentage of participants |
| Cohort 2: Treatment Group B | The Percentage of Subjects Achieving ACR 70 Improvement | No response | 100.0 Percentage of participants |
| Cohort 2: Treatment Group B | The Percentage of Subjects Achieving ACR 70 Improvement | Response | 0.0 Percentage of participants |
| Cohort 2: Treatment Group C | The Percentage of Subjects Achieving ACR 70 Improvement | Response | 30.0 Percentage of participants |
| Cohort 2: Treatment Group C | The Percentage of Subjects Achieving ACR 70 Improvement | No response | 70.0 Percentage of participants |
| Cohort 2: Treatment Group D | The Percentage of Subjects Achieving ACR 70 Improvement | No response | 70.0 Percentage of participants |
| Cohort 2: Treatment Group D | The Percentage of Subjects Achieving ACR 70 Improvement | Response | 30.0 Percentage of participants |