A Randomized, Double-blind, Active Control, Multicenter Study to Evaluate the Efficacy at Week 52 of Secukinumab Monotherapy Compared With Adalimumab Monotherapy in Patients With Active Psoriatic Arthritis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 853
- 试验地点
- 156
- 主要终点
- Percentage of Participants Who Achieved an American College of Rheumatology 20% (ACR20) Response at Week 52
研究概览
简要总结
This was a randomized, double-blind, active controlled, multicenter, parallel-group study evaluating secukinumab monotherapy and adalimumab monotherapy in approximately 850 patients with active psoriatic arthritis (PsA) who are naïve to biologic therapy and are intolerant or having inadequate response to conventional disease modifying anti-rheumatic drugs (also known as non-biologic DMARDs).
详细描述
The total maximum study duration, including the screening period was up to 76 weeks.
At Baseline, patients whose eligibility was confirmed were randomized to 1 of 2 groups (1:1): Group 1 (secukinumab 300 mg) or Group 2 (adalimumab 40 mg).
In order to maintain the blind, both groups received 1 or 2 placebo s.c. injections to keep consistency in the number of injections at each dosing visit. Secukinumab (300 mg) was available in 2 x 1.0 mL pre-filled syringes (PFS) and adalimumab was available in 1 x 0.4 mL PFS. Placebo (1.0 and 0.5 mL PFS) was also available.
Secukinumab 300 mg s.c injection (2 x 1 mL PFS) was administered at Baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks to Week 48.
Adalimumab 40 mg (1 x 0.4 mL PFS) was administered at Baseline followed by dosing every 2 weeks until Week 50.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Diagnosis of PsA classified by CASPAR
- •Rheumatoid factor and anti-CCP antibodies negative
- •Diagnosis of active plaque psoriasis, with at least one psoriatic plaque of >= 2cm diameter or nail changes consistent with psoriasis or documented history of plaque psoriasis
- •Inadequate control of symptoms with NSAIDs
- •Inadequate control of symptoms with a conventional DMARD.
排除标准
- •Pregnant or nursing women
- •Evidence of ongoing infectious or malignant process
- •Previous exposure to any biologic drug for Psoriatic Arthritis or Psoriasis
- •Subjects taking high potency opioid analgesics
- •Ongoing use of prohibited psoriasis treatments/medications
- •Previous treatment with any cell-depleting therapies including but not limited to anti-CD20 investigational agents.
研究组 & 干预措施
Adalimumab 40 mg s.c.
Adalimumab 40 mg administered at Baseline followed by dosing every 2 weeks until Week 50.
干预措施: Adalimumab (Biological)
Secukinumab 300 mg s.c.
Secukinumab 300 mg administered at Baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks until Week 48.
干预措施: Secukinumab (Biological)
结局指标
主要结局
Percentage of Participants Who Achieved an American College of Rheumatology 20% (ACR20) Response at Week 52
时间窗: Week 52
Clinical response, failure to permanently discontinue study medication prematurely, and lack of need for rescue medication was required for a patient to achieve treatment success. The primary endpoint is the proportion of patients with monotherapy ACR20 response at Week 52 where monotherapy ACR20 response is defined as meeting the following 3 conditions: 1. achieving American College of Rheumatology 20 (ACR20) response 2. no permanent study treatment (secukinumab or adalimumab) discontinuation before or at Week 50 (the last dosing visit) 3. no use of conventional disease modifying anti-rheumatic drugs (also known as non-biologic DMARDs) cDMARDs (including Methotrexate (MTX)) after Week 36 (regardless of the starting time of taking cDMARDs)
次要结局
- Percentage of Participants Who Achieved a Psoriasis Area and Severity Index (PASI)-90 Response at Week 52(Week 52)
- Percentage of Participants Who Achieved an American College of Rheumatology 50% (ACR50) Response at Week 52(Week 52)
- Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI Score) at Week 52(Baseline, Week 52)
- Percentage of Participants Who Achieved Resolution of Enthesitis at Week 52(Week 52)