A 16-week Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, Dose-finding Study to Evaluate the Efficacy, Safety and Tolerability of Subcutaneous Secukinumab (AIN457) Followed by an Extension Phase up to a Total of 60 Weeks in Patients With Active Rheumatoid Arthritis Despite Stable Treatment With Methotrexate
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 237
- 试验地点
- 1
- 主要终点
- Number of Participants With American College of Rheumatology Response of 20 (ACR20) at 16 Weeks
研究概览
简要总结
This study will assess at Week 16 the efficacy and safety of AIN457 at different doses in patients with active RA despite stable MTX therapy. Treatment will continue up to Week 48 with a safety follow-up at Week 60 to assess the long term efficacy and safety of AIN457 treatment in combination with MTX in RA.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Presence of RA classified by ACR 1987 revised criteria. Patients with active RA should have been on MTX for at least 3 months and must currently be treated with a stable dose of MTX (> or =7.5 mg/week - < or = 25 mg/week) for at least 4 weeks
- •At Baseline: Disease activity criteria defined by > or = 6 out of 28 tender joints and > or = 6 out of 28 swollen joints WITH either Screening value of hsCRP > or = 10 mg/L OR ESR > or = 28 mm/1st hr
排除标准
- •RA patients functional status class IV classified according to the ACR 1991 revised criteria
- •Patients taking high potency opioid analgesics (e.g., methadone, hydromorphone, or morphine)
- •Any therapy by intra-articular injections (e.g. corticosteroid) required for treatment of acute RA flare within 4 weeks before randomization
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
Secukinumab 75mg
Secukinumab 75mg s.c. q4wk
干预措施: Secukinmab (Drug)
Secukinumab 25mg
Secukinumab 25mg s.c. q4wk
干预措施: Secukinmab (Drug)
Secukinumab 150mg
Secukinumab 150mg s. c. q4wk
干预措施: Secukinmab (Drug)
Secukinumab 300mg
Secukinumab 300mg s.c. q4wk
干预措施: Secukinmab (Drug)
Secukinumab Placebo
Secukinumab Placebo s.c. q4wk
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants With American College of Rheumatology Response of 20 (ACR20) at 16 Weeks
时间窗: 16cweeks
A participant was considered to have achieved the incidence of response (ACR20 criteria) if he/she had at least a 20% improvement in both the tender and swollen 28-joint counts and had at least 20% improvement in at least 3 of the following 5 measures: patient's assessment of rheumatoid athritis (RA) pain, patient's global assessment of disease activity, physician's global assessment of disease activity, patient's self-assesseddisability (Health Assessment Questionnaire \[HAQ©\] score)and acute phase rectant (C-reactive protein \[hsCRP\]/ESR).
次要结局
- Number of Participants Who Achieved an ACR50 or ACR70 Response at Week 16(Week 16)
- Percentage of Participants With European League Against Rheumatism (EULAR) Response at Week 16(Week 16)
- Change From Baseline in Rheumatoid Factor (RF) Concentrations at Week 16(Baseline, Week 16)
- Change From Baseline in Disease Activity Score 28 Using CRP (DAS28-CRP)(Baseline, week 16)
- Number of Participants Who Achieved an ACR20, ACR50 or ACR70 Response up to Week 16(at Weeks2, 4, 8, 12, 16)
- Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) at Week 16(Baseline, Week 16)
- Change From Baseline in Medical Outcome Short Form (36) Health Survey (SF-36® v2)(Baseline, week 16)
- Anti-CCP (Cyclic Citrulinated Peptide) Antibodies Concentrations at Baseline and at Week 16(Baseline, Week 16)
- Change From Baseline in ACR Component: Adjusted Swollen 28-joint Count at Week 16(Baseline, week 16)
- Change From Baseline in Disease Activity Score 28 Using ESR (DAS28-ESR) at Week 16(Baseline, week 16)
- Change From Baseline in ACR Component: Adjusted Tender 28-joint Count at Week 16(Baseline, week 16)
- Change From Baseline in ACR Component: Patient's Assessment of RA Pain at Week 16(Baseline, week 16)
- Change From Baseline in ACR Component: Patient's Global Assessment of Disease Activity at Week 16(Baseline, week 16)
- Change From Baseline in ACR Component: Physician's Global Assessment of Disease Activity at Week 16(Baseline, week 16)
- Change From Baseline in ACR Component: Health Assessment Questionnaire (HAQ©) Score at Week 16(Baseline, week 16)
- Change From Baseline in ACR Component: High Sensitivity C-reactive Protein (hsCRP)(Baseline, week 16)
- Change From Baseline in ACR Component: Erythrocyte Sedimentation Rate (ESR) at Week 16(Baseline, week 16)