A Phase 4 Open-label Randomized Controlled Study COmparing the Effectiveness of Adalimumab iNTROduction and Methotrexate Dose escaLation in Subjects With Psoriatic Arthritis (CONTROL)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 246
- 试验地点
- 60
- 主要终点
- Percentage of Participants Achieving Minimal Disease Activity (MDA) (Non-responder Imputation [NRI]) (Part 1)
研究概览
简要总结
An interventional Phase 4 open-label, randomized, controlled, parallel-group, multi-country study in participants with psoriatic arthritis (PsA) consisting of 2 parts: Part 1 (Day 1 up to Week 16) is designed to compare the achievement of minimal disease activity (MDA) between participants randomized to either adalimumab in combination with methotrexate (MTX) or MTX alone escalated to the highest recommended or tolerable dose; Part 2 (Week 16 through Week 32) is designed to evaluate the maintenance or achievement of MDA on 4 different treatment regimens using adalimumab and/or MTX, with participant allocation based on the initial randomized treatment and achievement of MDA in Part 1, and with rescue treatment option.
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
- None
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
- •PsA diagnosis established at least 4 weeks prior to the date of the Screening visit and confirmed by ClASsification of Psoriatic Arthritis (CASPAR) criteria
- •Not in MDA at the time of screening
- •Has 3 or more tender and 3 or more swollen joints
- •Treated with methotrexate 15 mg (weekly) for at least 4 weeks
排除标准
- •Contraindications to adalimumab therapy and/or known hypersensitivity to adalimumab or its excipients
- •History of methotrexate intolerance/toxicity
- •Medical conditions(s) precluding methotrexate dose increase above 15 mg
- •Had prior exposure to any tumor necrosis factor (TNF) inhibitor, other mechanism of action biologic DMARD (bDMARD) or any systemic biologic agent in general
研究组 & 干预措施
Part 1: MTX Escalated Dose
Methotrexate (MTX) escalated to 20 - 25 mg or highest tolerable dose every week (ew)
干预措施: methotrexate (MTX) (Drug)
Part 1: ADA + MTX
Adalimumab (ADA) 40 mg every other week (eow) in combination with MTX 15 mg ew
干预措施: methotrexate (MTX) (Drug)
Part 1: ADA + MTX
Adalimumab (ADA) 40 mg every other week (eow) in combination with MTX 15 mg ew
干预措施: adalimumab (ADA) (Biological)
Part 2: MTX Escalated Dose
Participants achieving minimal disease activity (MDA) at Week 16 on MTX escalated to 20 -25 mg or highest tolerable dose ew, continued with the same MTX dose
干预措施: methotrexate (MTX) (Drug)
Part 2: ADA + MTX Escalated Dose
Participants not achieving MDA at Week 16 on MTX escalated to 20 - 25 mg or highest tolerable dose ew, received ADA 40 mg eow in combination with MTX 20 - 25 mg or highest tolerable dose ew
干预措施: methotrexate (MTX) (Drug)
Part 2: ADA + MTX Escalated Dose
Participants not achieving MDA at Week 16 on MTX escalated to 20 - 25 mg or highest tolerable dose ew, received ADA 40 mg eow in combination with MTX 20 - 25 mg or highest tolerable dose ew
干预措施: adalimumab (ADA) (Biological)
Part 2: ADA
Participants achieving MDA at Week 16 on ADA 40 mg eow plus MTX 15 mg ew, had MTX completely withdrawn at Week 16 and continued receiving ADA as monotherapy
干预措施: adalimumab (ADA) (Biological)
Part 2: ADA ew + MTX
Participants not achieving MDA at Week 16 on ADA 40 mg eow plus MTX 15 mg ew, had ADA escalated to 40 mg ew in combination with MTX 15 mg ew
干预措施: methotrexate (MTX) (Drug)
Part 2: ADA ew + MTX
Participants not achieving MDA at Week 16 on ADA 40 mg eow plus MTX 15 mg ew, had ADA escalated to 40 mg ew in combination with MTX 15 mg ew
干预措施: adalimumab (ADA) (Biological)
结局指标
主要结局
Percentage of Participants Achieving Minimal Disease Activity (MDA) (Non-responder Imputation [NRI]) (Part 1)
时间窗: Week 16
Minimal disease activity (MDA) for psoriatic arthritis (PsA) was defined as fulfilling at least 5 of the following 7 criteria: tender and swollen joint counts (TJC) ≤ 1 (out of TJC68 assessed in this study), swollen joint count (SJC) ≤ 1 (out of SJC66 assessed in this study), Psoriasis Area and Severity Index (PASI) ≤ 1 or body surface area (BSA) ≤ 3; Patient's assessment of pain visual analogue scale (VAS) ≤ 15, Patient's global assessment of disease activity (PtGA) VAS ≤ 20, Health Assessment Questionnaire Disability Index (HAQ-DI) score ≤ 0.5, and tender entheseal points ≤ 1 (out of 8 assessed in this study).
次要结局
- Change in Dermatology Life Quality Index (DLQI) Score From Baseline (Part 1)(From Day 1 to Week 16)
- Change in Tender Dactylitic Digit Count From Baseline for Participants With Presence of Dactylitis at Baseline (Part 1)(From Day 1 to Week 16)
- Change in Disease Activity Score 28 (DAS28)-C-reactive Protein (CRP) Score From Baseline (Part 1)(From Day 1 to Week 16)
- Change in Leeds Enthesitis Index (LEI) From Baseline (Part 1) for Participants With Presence of LEI at Baseline(From Day 1 to Week 16)
- Change in Psoriatic Arthritis Impact of Disease Score (PsAID) Score From Baseline (Part 1)(From Day 1 to Week 16)
- Percentage of Participants Achieving American College of Rheumatology (ACR) 20/50/70 Response (Part 1)(Week 16)
- Percentage of Participants in MDA in Part 2 of the Study (Week 32)(Week 32)
- Change in Psoriatic Arthritis Disease Activity Score (PASDAS) From Baseline (Part 1)(From Day 1 to week 16)
- Change in Short Form Health Survey 36 (SF-36) Score From Baseline (Part 1)(From Day 1 to Week 16)
- Change in HAQ-DI Score From Baseline (Part 1)(From Day 1 to Week 16)
- Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) 75/90/100 Response Among Participants With BSA Greater Than or Equal to 3% at Baseline (Part 1)(Week 16)
- Change in Disease Activity in Psoriatic Arthritis Score (DAPSA) Score From Baseline (Part 1)(From Day 1 to Week 16)