Randomized, Double-blind Placebo-controlled Multi-center Proof-of-concept Study to Assess the Efficacy of AIN457 in Patients With Psoriatic Arthritis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 10
- 主要终点
- Percentage of ACR Responders Per Treatment at Week 6
研究概览
简要总结
This study is designed as a proof of concept of AIN457 in patients with psoriatic arthritis. The study will address the evaluation of the efficacy at 6 and up to 24 weeks after two doses of AIN457 10 mg/kg administered three weeks apart.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A diagnosis of psoriatic arthritis
排除标准
- •Patients with arthritis or ankylosing spondyitis
- •Drug-induced psoriasis
- •Male or female patients who plan to conceive during the time course of the study, or for 6 months after the administration of the second dose.
- •Participation in any clinical trial within 4 weeks prior to initial dosing or longer.
- •Previous use of immunosuppressive agents eg cyclosporine, without the necessary wash-out period
- •History of severe allergy to food or drugs
- •Positive TB test. Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
Placebo
Each patient received 10 mg/kg of matching placebo intravenously, on Day 1 and Day 22.
干预措施: Placebo (Biological)
AIN457 (2x 10mg/kg)
Each patient received 10 mg/kg AIN457 intravenously, on Day 1 and Day 22.
干预措施: AIN457 (Biological)
结局指标
主要结局
Percentage of ACR Responders Per Treatment at Week 6
时间窗: week 6
A participant was considered to be a responder according to the ACR20, 50 or 70 criteria if the participant had at least 20% 50% or 70% improvement in both the tender joint count and swollen joint count measures, and in at least 3 of the following 5 measures: patient's assessment of pain, patient's global assessment of disease activity, physician's global assessment of disease activity, Health Assessment Questionnaire (HAQ©) score, and/or C-reactive protein (CRP)
Percentage of PsARC Responders Per Treatment at Week 6
时间窗: week 6
Psoriatic Arthritis Response Criteria (PsARC) includes measures of tender and swollen joint counts, patient's assessment of pain, physician's and patient's global assessment of disease activity A subject is defined as a PsARC responder if, and only if, they have an improvement in two of the following four factors (with at least one factor being a joint count) and no worsening in the remaining factors: 1) Patient global assessment (0-100 VAS scale, improvement defined as decrease of at least 20 units) 2) Physician global assessment (0-100 VAS scale, improvement defined as decrease of at least 20 units) 3) Tender 78-joint count (improvement defined as decrease of at least 30%) 4) Swollen 76-joint count (improvement defined as decrease of at least 30%)
次要结局
- Leeds Dactylitis Instrument (LDI) Score in Patients Over Time Per Treatment(Baseline, Day 8, 15 and weeks 6, 8, 12, 16 and 24)
- Pharmacokinetic (PK) of AIN457: Time to Reach the Maximum Concentration After Drug Administration (Tmax)(Day 1 till end of the study (169))
- Pharmacokinetic (PK) of AIN457: Clearance of AIN457 After Single Dose Administration(Day 1 till end of the study (169))
- Pharmacokinetic (PK) of AIN457: Observed Maximum Serum Concentration Following Drug Administration (Cmax)(Day 1 till end of the study (169))
- PK of AIN457: Area Under the Serum Concentration-time Curve From Time Zero to the Time of Last Quantifiable Concentration (AUClast), Area Under the Serum Concentration-time Curve From Time Zero to (AUCinf)(Day 1 till end of the study (169))
- Pharmacokinetic (PK) of AIN457: Volume of Distribution During the Terminal Phase Following Intravenous Elimination (Vz)(Day 1 till end of the study (169))
- SpA Research Consortium of Canada (SPARCC) Score Score in Patients Over Time Per Treatment(Baseline, Day 8, 15 and weeks 6, 8, 12, 16 and 24)
- Disease Activity Score 28 (DA28) in Patients Over Time Per Treatment(Baseline, day 8, 15 and weeks 6, 8, 12, 16 and 24)
- Pharmacokinetic (PK) of AIN457: Terminal Elimination Half-life (T1/2)(Day 1 till end of the study (169))
- Percentage of Participants Who Achieved 20%, 50% or 70% Improvement as Measured by ACR Response Criteria(Day 8 and 15, Weeks 6, 8, 12, 16 and 24)
- Percentage of Participants Who Achieved PsARC Response(Day 8 and 15, Weeks 6, 8, 12, 16 and 24)
- Mastricht Ankylosing Spondylitis Enthesis Score (MASES) Over Time Per Treatment(Baseline and Day 8, 15 and weeks 6, 8, 12, 16 and 24)
- Psoriatic Area and Severity Index (PASI) Score in Patients Over Time Per Treatment(Baseline, Day 8, 15 and weeks 6, 8, 12, 16, 20 and 24)