A Multicenter, 2 Part Study to Assess the Efficacy and Safety of Acthar Gel in Subjects With Rheumatoid Arthritis With Persistently Active Disease Despite Dual-DMARD Treatment
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Mallinckrodt
- 入组人数
- 259
- 试验地点
- 58
- 主要终点
- Part 1: Number of Participants With Low Disease Activity (LDA) by Visit
研究概览
简要总结
This is a 2-part study to examine the effect of Acthar Gel in adult participants with rheumatoid arthritis (RA) with persistently active disease even after receiving two other treatments intended to modify the disease.
Part 1 is an Open Label Period in which all eligible participants receive Acthar Gel for 12 weeks. After these 12 weeks of treatment with Acthar Gel, participants will be evaluated for treatment response using the DAS28-ESR.
Participants who have achieved low disease activity (LDA) will enter a double-blind randomized maintenance period (Part 2) and be randomized in a 1:1 ratio to receive either Acthar Gel or matching placebo for an additional 12 weeks.
A single participant might be involved in the trial for as many as 32 weeks.
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
- Double (Participant, Investigator)
盲法说明
Part 1: Open Label ; Part 2: Double-blind
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or nonpregnant, nonlactating female subjects
- •Meets criteria for definite rheumatoid arthritis as defined by 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification at screening
- •Has active disease defined as a score of >3.2 on DAS28-ESR prior to study drug administration despite dual-DMARD treatment
- •Is on a stable dose of ≤ 20 mg per week of methotrexate for at least 8 weeks AND a stable dose of an allowed DMARD for at least 24 weeks prior to the screening visit
- •May also be on a stable dose of 10 mg or less of prednisone or other the dose equivalent of another corticosteroid for 4 weeks prior to study drug administration
排除标准
- •Has current rheumatoid disease or inflammatory joint disease other than RA
- •Has any history of use of adrenocorticotropic hormone (ACTH) for the treatment of RA
- •Has taken B-cell mediated therapies in the 6 months prior to screening
- •Has hepatitis B, hepatitis C, history of tuberculosis (TB) or other contraindication as per the United States (US) Prescribing Information for Acthar
- •Has history of Type 1 or Type 2 diabetes
- •Has any clinically significant infection
研究组 & 干预措施
Part 1: All Enrolled Participants
All participants receive Acthar Gel 1 mL twice weekly for 12 weeks
干预措施: Acthar Gel (Drug)
Part 2: Acthar Gel
Participants receive Acthar Gel 1 mL twice weekly for an additional 12 weeks
干预措施: Acthar Gel (Drug)
Part 2: Placebo
Participants receive Placebo 1 mL twice weekly for an additional 12 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Part 1: Number of Participants With Low Disease Activity (LDA) by Visit
时间窗: Baseline to Week 12
LDA is defined as DAS28 \<3.2.
Part 2: Number of Participants Who Maintained Low Disease Activity by Visit
时间窗: Week 12 to Week 24
Low disease activity is defined as DAS28 \<3.2.
次要结局
- Part 1: Patient-Reported General Health by Visit(Baseline to Week 12)
- Part 1: Erythrocyte Sedimentation Rate (ESR) by Visit(Baseline to Week 12)
- Part 2: Erythrocyte Sedimentation Rate (ESR) by Visit(Baseline, Week 12 to Week 24)
- Part 1: Swollen Joint Count by Visit(Baseline to Week 12)
- Part 2: Swollen Joint Count by Visit During Part 2(Baseline, Week 12 to Week 24)
- Part 1: Tender Joint Count by Visit(Baseline to Week 12)
- Part 2: Tender Joint Count by Visit(Baseline, Week 12 to Week 24)
- Part 2: Patient-Reported General Health by Visit(Baseline, Week 12 to Week 24)
- Part 1: Physician's Global Assessment of Disease Activities by Visit(Baseline to Week 12)
- Part 1: Patient's Global Assessment of Pain by Visit(Baseline to Week 12)
- Part 2: Patient's Global Assessment of Pain by Visit(Baseline, Week 12 to Week 24)
- Part 2: Physician's Global Assessment of Disease Activities by Visit(Week 12 to Week 24)