A Phase 2b, Double-Blind, Placebo-Controlled Study to Evaluate Peresolimab in Adult Participants With Moderately-to-Severely Active Rheumatoid Arthritis
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 491
- 试验地点
- 127
- 主要终点
- Percentage of Participants Achieving 20% Improvement in American College of Rheumatology Criteria (ACR20) Response at Week 12
研究概览
简要总结
The main purpose of this study is to assess the safety and efficacy of peresolimab in adult participants with moderately-to-severely active 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
- Double (Participant, Investigator)
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
- •Have a diagnosis of adult onset rheumatoid arthritis (RA) for at least 3 months prior to screening, as defined by the 2010 ACR/European League Against Rheumatism (EULAR) classification criteria
- •Have moderately-to-severely active RA, at screening and baseline, defined by the presence of
- •≥6 swollen joints based on 66 joint count, and
- •≥6 tender joints based on 68 joint count.
- •Have had an inadequate response to, or loss of response or intolerance to at least 1 conventional synthetic DMARD (csDMARD), biologic DMARD ( bDMARD), or targeted synthetic DMARD (tsDMARD) treatment.
排除标准
- •Have Class IV RA according to ACR revised criteria.
- •Have presence of 1 or more significant concurrent medical conditions per investigator judgment, including but not limited to
- •poorly controlled diabetes or hypertension
- •chronic kidney disease stage IIIb, IV, or V
- •symptomatic heart failure according to New York Heart Association Class II, III, or IV
- •myocardial infarction, unstable angina pectoris, stroke or transient ischemic attack, within the past 12 months before randomization
- •severe chronic pulmonary disease, for example, requiring oxygen therapy
- •major chronic inflammatory disease or connective tissue disease other than RA, including but not limited to,
- •systemic lupus erythematosus
- •psoriatic arthritis
- •axial spondyloarthritis including ankylosing spondylitis and non-radiographic axial spondyloarthritis
- •reactive arthritis
- •scleroderma
- •polymyositis
- •dermatomyositis
- •active fibromyalgia, or
- •multiple sclerosis
研究组 & 干预措施
Peresolimab 1000 mg SC Q4W
Participants received peresolimab 1000 milligram (mg) subcutaneously (SC) once every 4 weeks (Q4W) from Week 0 to Week 24. At Week 24, based on their Clinical Disease Activity Index (CDAI) score, participants continued peresolimab 1000 mg SC Q4W from Week 24 to Week 60.
干预措施: Peresolimab (Drug)
Peresolimab 1000 mg SC Q4W to Peresolimab 1000 mg SC Q12W
Participants received peresolimab 1000 mg SC Q4W from Week 0 to Week 24. At Week 24, based on their CDAI score, participants switched to peresolimab 1000 mg SC once every 12 weeks (Q12W) from Week 24 to Week 60.
干预措施: Peresolimab (Drug)
Peresolimab 400 mg SC Q4W
Participants received peresolimab 400 mg SC Q4W from Week 0 to Week 24. At Week 24, based on their CDAI score, participants continued peresolimab 400 mg SC Q4W from Week 24 to Week 60.
干预措施: Peresolimab (Drug)
Peresolimab 400 mg SC Q4W to Peresolimab 400 mg SC Q12W
Participants received peresolimab 400 mg SC Q4W from Week 0 to Week 24. At Week 24, based on their CDAI score, participants switched to peresolimab 400 mg SC Q12W from Week 24 to Week 60.
干预措施: Peresolimab (Drug)
Peresolimab 100 mg SC Q4W
Participants received peresolimab 100 mg SC Q4W from Week 0 to Week 60.
干预措施: Peresolimab (Drug)
Placebo SC Q4W to Peresolimab 1000 mg SC Q4W
Participants received peresolimab-matched placebo SC Q4W from Week 0 to Week 12 and then switched to peresolimab 1000 mg SC Q4W from Week 12 to Week 60.
干预措施: Peresolimab (Drug)
Placebo SC Q4W to Peresolimab 1000 mg SC Q4W
Participants received peresolimab-matched placebo SC Q4W from Week 0 to Week 12 and then switched to peresolimab 1000 mg SC Q4W from Week 12 to Week 60.
干预措施: Placebo (Drug)
Placebo SC Q4W to Peresolimab 400 mg SC Q4W
Participants received peresolimab-matched placebo SC Q4W from Week 0 to Week 12 and then switched to peresolimab 400 mg SC Q4W from Week 12 to Week 60.
干预措施: Peresolimab (Drug)
Placebo SC Q4W to Peresolimab 400 mg SC Q4W
Participants received peresolimab-matched placebo SC Q4W from Week 0 to Week 12 and then switched to peresolimab 400 mg SC Q4W from Week 12 to Week 60.
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of Participants Achieving 20% Improvement in American College of Rheumatology Criteria (ACR20) Response at Week 12
时间窗: Week 12
The ACR20 response was a composite measure of clinical, laboratory, and functional assessments used to evaluate improvement in rheumatoid arthritis signs and symptoms. ACR20 responders were participants with at least 20% improvement from baseline in tender joint count (TJC) and swollen joint count (SJC), and at least 20% improvement in 3 of the 5 remaining core measures: Patient's Assessment of Arthritis Pain, Patient's Global Assessment of Disease Activity, Physician's Global Assessment of Disease Activity, Health Assessment Questionnaire-Disability Index (HAQ-DI) which measures participants' perceived degree of difficulty performing daily activities, and acute phase reactant as measured by high-sensitivity C-reactive protein (hsCRP). Percentage of participants achieving ACR20 response= (number of ACR20 responders)/ (number of participants analyzed) \*100.
次要结局
- Percentage of Participants Achieving 50% Improvement in American College of Rheumatology Criteria (ACR50) Response at Week 12(Week 12)
- Percentage of Participants Achieving 70% Improvement in American College of Rheumatology Criteria (ACR70) Response at Week 12(Week 12)
- Percentage of Participants With Low Disease Activity (LDA) According to Disease Activity Score Modified to Include the 28 Diarthrodial Joint Count-High-Sensitivity C-Reactive Protein (DAS28-hsCRP) ≤3.2 at Week 12(Week 12)
- Percentage of Participants With Remission According to DAS28-hsCRP Score <2.6 at Week 12(Week 12)
- Percentage of Participants Achieving LDA According to Clinical Disease Activity Index (CDAI) Score ≤10 at Week 12(Week 12)
- Percentage of Participants Achieving Remission According to CDAI Score ≤2.8 at Week 12(Week 12)
- Change From Baseline in DAS28-hsCRP Score at Week 12(Baseline, Week 12)
- Change From Baseline in CDAI Score at Week 12(Baseline, Week 12)
- Change From Baseline in HAQ-DI Score at Week 12(Baseline, Week 12)
- Minimum Observed Concentration of Peresolimab by Treatment-Emergent Anti-Drug Antibody (TE ADA) Status(Baseline through Week 12)