A Phase III Randomized, Double-blind, Placebo Controlled, Multicenter, Bridging Study of Subcutaneous Secukinumab, to Demonstrate Efficacy After Sixteen Weeks of Treatment and to Assess Safety, Tolerability and Long-term Efficacy Follow-up to One Year in Chinese Subjects With Active Psoriatic Arthritis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- ACR20 Response at Week 16
研究概览
简要总结
The purpose of this study was to assess the efficacy and safety of secukinumab in Chinese participants with active Psoriatic arthritis (PsA ) compared to placebo.
详细描述
This study used a randomized, double-blind, placebo-controlled, parallel-group design.
A screening period running up to 10 weeks before randomization was used to assess participant eligibility followed by 52 weeks of treatment.
A follow-up visit was done 12 weeks after last study treatment administration for all participants, regardless of whether they completed the entire study as planned or discontinued prematurely.
At Baseline, the patients fulfilling the inclusion criteria were randomized to one of the following two groups.
Group 1 : Secukinumab Dose level 1 s.c. at BSL, Week 1, 2, 3, 4, 8, and 12 Group 2 : Secukinumab Placebo s.c. at BSL, Week 1, 2, 3, 4, 8, and 12.
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant must be able to understand and communicate with the investigator and comply with the requirements of the study and must give a written, signed and dated informed consent before any study assessment is performed.
- •Chinese male or non-pregnant, non-lactating Chinese female participants at least 18 years of age.
- •Diagnosis of PsA classified by Classification of Psoriatic Arthritis (CASPAR) criteria and with symptoms for at least 6 months with moderate to severe Psoriatic arthritis (PsA).
- •Rheumatoid factor (RF) and anti-cyclic citrullinated peptide (anti-CCP) antibodies negative at screening.
- •Diagnosis of active plaque psoriasis or nail changes consistent with psoriasis or a documented history of plaque psoriasis.
- •Participants on Methotrexate (MTX) must be on folic acid supplementation at randomization.
- •Participants who are on a DMARD other than MTX must discontinue the DMARD 4 weeks prior to randomization visit except for leflunomide, which has to be discontinued for 8 weeks prior to randomization unless a cholestyramine washout has been performed.
排除标准
- •Chest X-ray or chest MRI with evidence of ongoing infectious or malignant process, obtained within 3 months prior to screening and evaluated by a qualified physician
- •Participants taking high potency opioid analgesics (e.g., methadone, hydromorphone, morphine).
- •Previous exposure to secukinumab or other biologic drug directly targeting interleukin- 17 (IL-17) or IL-17 receptor
- •Participants who have ever received biologic immunomodulating agents except for those targeting Tumor necrosis factor alpha (TNFα).
- •Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective contraception during the entire study (during the entire study).
研究组 & 干预措施
Arm 1
Participants received 150 mg dose (dose level 1) of Secukinumab
干预措施: AIN457 (Drug)
Arm 2
Participants received Placebo of the study drug.
干预措施: Secukinumab Placebo (Other)
Arm 3
Participants who received Placebo and switched to dose level 1 (150 mg) of secukinumab.
干预措施: AIN457 (Drug)
Arm 3
Participants who received Placebo and switched to dose level 1 (150 mg) of secukinumab.
干预措施: Secukinumab Placebo (Other)
Arm 4
Participants who received Placebo and switched to dose level 2 (300 mg) of secukinumab.
干预措施: AIN457 (Drug)
Arm 4
Participants who received Placebo and switched to dose level 2 (300 mg) of secukinumab.
干预措施: Secukinumab Placebo (Other)
结局指标
主要结局
ACR20 Response at Week 16
时间窗: 16 weeks
Assessed the efficacy of secukinumab relative to placebo at week 16 using Non-responder imputation (NRI) and based on the percentage of participants achieving an ACR20 response (ACR = American College of Rheumatology). ACR20 response criteria is response ≥ 20% improvement based on: Swollen Joint Count (SJC)/Tender Joint Count (TJC), Patient's global assessment of disease activity (PaGA) (Visual Analog Scale (VAS)), Physician's global assessment of disease activity (PhGA) (VAS), Patient's assessment of PsA pain intensity (VAS), Health Assessment Questionnaire - Disability Index (HAQ-DI), and High-sensitivity C-reactive protein (hsCRP) or Erythrocyte sedimentation rate (ESR).
次要结局
- Change From Baseline in PASDAS Scores Using MMRM at Week 16(16 weeks)
- ACR50 Response at Week 16(16 weeks)
- Change From Baseline in DAS28-CRP Scores Using Mixed Model Repeated Scores (MMRM) at Week 16(16 weeks)
- Change From Baseline in SF36-PCS Scores Using MMRM at Week 16(16 weeks)
- Change From Baseline in HAQ-DI Scores Using MMRM at Week 16(16 weeks)