A Study Exploring the Safety, Tolerability and Efficacy of a 4 Week Course of INCB018424 in Subjects With Active Rheumatoid Arthritis

Phase 2

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: INCB018424; Drug: Placebo

• Registration Number: NCT00550043
• Lead Sponsor: Incyte Corporation

Brief Summary

The purpose of this study is to understand the safety and tolerability of INCB018424 in patients with rheumatoid arthritis

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10
• Study First Submitted: 2007-10-24
• Study First Submitted QC: 2007-10-24
• Study First Posted: 2007-10-26
• Primary Completion: 2008-09
• Study Completion: 2008-09
• Results First Submitted: 2015-02-09
• Status Verified: 2015-03
• Results First Submitted QC: 2015-03-09
• Last Update Submitted: 2015-03-09
• Results First Posted: 2015-03-23
• Last Update Posted: 2015-03-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort 2: Treatment Group D	INCB018424	INCB018424 50 mg once daily (QD) or matching placebo
Placebo	Placebo	Matching placebo, oral
Cohort 2: Treatment Group C	INCB018424	INCB018424 25 mg BID or matching placebo
Cohort 1: Treatment Group A	INCB018424	INCB018424 15 mg twice daily (BID) or matching placebo
Cohort 2: Treatment Group B	INCB018424	INCB018424 5 mg BID or matching placebo

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 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 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.
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.
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.
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.
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) 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).