A 28-week, Randomized, Double-blind, Active Controlled, Multicenter Study to Evaluate the Efficacy of Subcutaneously Administered Secukinumab Compared to Ustekinumab in Adult Patients With Psoriatic Arthritis and Failure of TNFα- Inhibitor Treatment (AgAIN)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 119
- 试验地点
- 1
- 主要终点
- Proportion of Patients With Health Assessment Questionnaire - Disability Index (HAQ-DI) Response at Week 28
研究概览
简要总结
The purpose of this study is to compare the safety and efficacy of secukinumab and ustekinumab in patients with active psoriatic arthritis who showed failure to previous TNFα-inhibitor treatment
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, 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
- •Diagnosis of PsA as classified by CASPAR criteria for at least 6 months before randomization.
- •Active PsA at baseline defined as ≥ 3 tender joints out of 68 and ≥ 3 swollen joints out of 66 (dactylitis of a digit counts as one joint each).
- •Inadequate response or intolerance to previous or current treatment with at least one TNFα inhibitor
- •Inadequate response or intolerance to conventional disease modifying anti-rheumatic drugs (cDMARDs)
- •Diagnosis of active plaque psoriasis, with at least one psoriatic plaque of ≥ 2 cm diameter and/or nail changes consistent with psoriasis and/or documented history of plaque psoriasis.
- •Rheumatoid factor (RF) and anti-cyclic citrullinated peptide (CCP) antibodies negative at screening.
排除标准
- •Pregnant or nursing women,
- •Previous exposure to secukinumab, ustekinumab or any other biologic drug directly targeting IL-17, IL-17 receptor, IL-12 or IL-
- •Patients for whom the use of secukinumab or ustekinumab is contraindicated.
- •Use of any other investigational drug. Previous treatment with any cell-depleting therapies including but not limited to anti-CD20 or investigational agents
- •Evidence of ongoing infectious or malignant process
- •Subjects receiving high potency opioid analgesics
- •Ongoing use of prohibited psoriasis treatments/medications
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
Secukinumab
AIN457
干预措施: Secukinumab (Biological)
Secukinumab
AIN457
干预措施: Ustekinumab (Biological)
Ustekinumab
干预措施: Secukinumab (Biological)
Ustekinumab
干预措施: Ustekinumab (Biological)
结局指标
主要结局
Proportion of Patients With Health Assessment Questionnaire - Disability Index (HAQ-DI) Response at Week 28
时间窗: Baseline, Week 28
The disability assessment component of the HAQ evaluated a subject's level of functional ability through 20 questions grouped into 8 categories: dressing, rising, eating, walking, hygiene, reach, grip, and usual activities. Each item began with the prompt "Over the past week, are you able to…" and is scored on a 4-point scale: 0 (no difficulty), 1 (some difficulty), 2 (much difficulty), and 3 (unable to do). The overall score was calculated by averaging the scores across all answered domains, resulting in a total score ranging from 0 (no disability) to 3 (severe disability). A HAQ-DI response was defined as an improvement of ≥0.35 points from baseline at Week 28. Missing values were imputed as non-responders
次要结局
- Number of Participants Achieving Psoriasis Area and Severity Index (PASI) 90 Response at Week 28(Baseline, Week 28)
- Change From Baseline in Patient's Assessment of Pain on VAS at Week 28(Baseline, Week 28)
- Change From Baseline in Tender Joint Count (TJC) 68 at Week 28(Baseline, Week 28)
- Change From Baseline in Swollen Joint Count (SJC) 66 at Week 28(Baseline, Week 28)
- Number of Patients Achieving PASI 100 at Week 28(Bseline, Week 28)
- Number of Patients Achieving PASI 75 at Week 28(Baseline, Week 28)
- Change From Baseline in Patient's Global Assessment of Disease Activity on VAS(Baseline, Week 28)
- Change From Baseline in Patient's Global Assessment of Psoriasis and Arthritis Disease Activity on VAS(Baseline, Week 28)
- Number of Patients Achieving Minimal Disease Activity (MDA) at Week 28(Week 28)
- Change From Baseline in the Leeds Enthesitis Index (LEI)(Baseline, Week 28)
- Change From Baseline in the Leeds Dactylitis Index (LDI)(Baseline, Week 28)
- Change From Baseline in Psoriatic Arthritis Quality of Life (PsAQoL)(Baseline, Week 28)
- Percentage of Participants Achieving a Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Response at Week 28(Baseline, Week 28)
- Percentage of Participants Achieving a Dermatology Life Quality Index (DLQI) Response at Week 28(Week 28)