A Double-blind, Placebo-controlled Study Exploring the Safety, Tolerability and Efficacy of a 4 Week Course of INCB018424 in Subjects With Active Rheumatoid Arthritis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 50
- 主要终点
- The Percentage of Subjects Achieving American College of Rheumatology (ACR) 20 Improvement
研究概览
简要总结
The purpose of this study is to understand the safety and tolerability of INCB018424 in patients with rheumatoid arthritis
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Established diagnosis of rheumatoid arthritis
- •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.
排除标准
- •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;
- •Treatment with any investigational medication within 12 weeks prior to the first dose of study medication.
研究组 & 干预措施
Cohort 2: Treatment Group C
INCB018424 25 mg BID or matching placebo
干预措施: INCB018424 (Drug)
Cohort 1: Treatment Group A
INCB018424 15 mg twice daily (BID) or matching placebo
干预措施: INCB018424 (Drug)
Cohort 2: Treatment Group B
INCB018424 5 mg BID or matching placebo
干预措施: INCB018424 (Drug)
Cohort 2: Treatment Group D
INCB018424 50 mg once daily (QD) or matching placebo
干预措施: INCB018424 (Drug)
Placebo
Matching placebo, oral
干预措施: Placebo (Drug)
结局指标
主要结局
The Percentage of Subjects Achieving American College of Rheumatology (ACR) 20 Improvement
时间窗: 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.
次要结局
- Percentage of Subjects Who Achieved DAS 28 ESR Inactive Disease(Day 28)
- Percentage of Subjects Who Achieved DAS 28 CRP Low Disease(Day 28)
- Percentage of Subjects Who Achieved DAS 28 CRP Inactive Disease(Day 28)
- The Percentage of Subjects Achieving ACR 50 Improvement(Day 28)
- Change From Baseline in Disease Activity Score 28 (DAS 28) ESR Score(Baseline, Day 28)
- Percentage of Subjects Who Achieved DAS 28 ESR Low Disease(Day 28)
- The Percentage of Subjects Achieving ACR 70 Improvement(Day 28)
- Change From Baseline in Disease Activity Score 28 (DAS 28) CRP Score(Baseline, Day 28)