A Three-year Extension Study to Evaluate the Long Term Efficacy, Safety and Tolerability of Secukinumab in Patients With Active Psoriatic Arthritis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 460
- 试验地点
- 1
- 主要终点
- Proportion of Subject Who Reached (American College of Rheumatology Score of 20) ACR20
研究概览
简要总结
This study was designed as a 3-year extension to the phase III core study CAIN457F2306. It aimed to provide continuous treatment with secukinumab in pre-filled syringes (PFS) for subjects who completed the core study CAIN457F2306, to obtain further long term efficacy, safety and tolerability information in subjects with active psoriatic arthritis receiving secukinumab every 4 weeks. At Week 104 of the study CAIN457F2306, eligible subjects completed the assessments associated with the core study visit and subsequently continued in this extension study on the same dose that they were receiving during the core study. The regular assessments of disease activity ensure that subjects who are experienced worsening of disease in any of the treatment groups could exit the study upon their own wish or based on the advice of the investigator at any time.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Secukinumab 75mg
Subjects continued to receive secukinumab 75mg in PFS (same dose as that was received in core study CAIN457F2306) every 4 weeks up to Week 256. From Week 156, patients may have been escalated to 150 mg or 300 mg as judged appropriate by investigator
干预措施: Secukinumab (Drug)
Secukinumab 150mg
Subjects continued to receive secukinumab 150mg in PFS (same dose as that was received in core study CAIN457F2306) every 4 weeks up to Week 256. From Week 156, patients may have been escalated to 300 mg as judged appropriate by the investigator
干预措施: Secukinumab (Drug)
Placebo - AIN457A 75mg
Placebo (for maintaining the blind till Week 152): Placebo to secukinumab 0.5 mL solution solution for injection was provided in PFS for s.c. administration (a single use pre-filled 1mL long glass syringe). It contained a mixture of inactive excipients, matching the composition of secukinumab 75mg
干预措施: Secukinumab (Drug)
Placebo - AIN457A 75mg
Placebo (for maintaining the blind till Week 152): Placebo to secukinumab 0.5 mL solution solution for injection was provided in PFS for s.c. administration (a single use pre-filled 1mL long glass syringe). It contained a mixture of inactive excipients, matching the composition of secukinumab 75mg
干预措施: Placebo (Drug)
Placebo - AIN457 150mg
Placebo (for maintaining the blind till Week 152): Placebo to secukinumab 1 mL solution for injection was provided in PFS for s.c. administration (a single use pre-filled 1mL long glass syringe). It contained a mixture of inactive excipients, matching the composition of secukinumab 150 mg
干预措施: Secukinumab (Drug)
Placebo - AIN457 150mg
Placebo (for maintaining the blind till Week 152): Placebo to secukinumab 1 mL solution for injection was provided in PFS for s.c. administration (a single use pre-filled 1mL long glass syringe). It contained a mixture of inactive excipients, matching the composition of secukinumab 150 mg
干预措施: Placebo (Drug)
结局指标
主要结局
Proportion of Subject Who Reached (American College of Rheumatology Score of 20) ACR20
时间窗: weeks 116, 128, 140, 156, 180, 208, 232 and 260
Proportion of subjects with a positive clinical response to treatment (individual improvement) in disease activity according to ACR20 criteria if he/she has at least 20% improvement in 1. Tender 68-joint count 2. Swollen 66-joint count and 3. At least 3 of the following 5 measures: * Patient's assessment of Psoriatic Arthritis (PsA) pain * Patient's global assessment of disease activity * Physician's global assessment of disease activity * Subject self-assessed disability (Health-Assessment Questionnaire \[HAQ-DI\] score) * Acute phase reactant (hsCRP or ESR)
Proportion of Subjects Who Reached ACR50
时间窗: weeks 116, 128, 140, 156, 180, 208, 232 and 260
Proportion of subjects that have a positive clinical response to treatment (individual improvement) in disease activity according to ACR50 criteria if he/she has at least 50% improvement in 1. Tender 68-joint count 2. Swollen 66-joint count and 3. At least 3 of the following 5 measures: * Patient's assessment of PsA pain * Patient's global assessment of disease activity * Physician's global assessment of disease activity * Subject self-assessed disability (Health-Assessment Questionnaire \[HAQ-DI\] score) * Acute phase reactant (hsCRP or ESR)
Proportion of Subjects Who Reached ACR70
时间窗: weeks 116, 128, 140, 156, 180, 208, 232 and 260
Proportion of subjects that have a positive clinical response to treatment (individual improvement) in disease activity according to ACR70 criteria if he/she has at least 70% improvement in 1. Tender 68-joint count 2. Swollen 66-joint count and 3. At least 3 of the following 5 measures:- Patient's assessment of PsA pain * Patient's global assessment of disease activity * Physician's global assessment of disease activity * Subject self-assessed disability (Health-Assessment Questionnaire \[HAQ-DI\] score) * Acute phase reactant (hsCRP or ESR)
次要结局
- Minimal Clinically Important Difference (MCID) in Health Assessment Questionnaire Disability Index (HAQ-DI)(weeks 116, 128, 140, 156, 180, 208, 232 and 260)
- Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI)(weeks 116, 128, 140, 156, 180, 208, 232 and 260)
- Change From Baseline in Disease Activity Score-CRP (DAS28)(weeks 116, 128, 140, 156, 180, 208, 232 and 260)
- Percentage of Subjects Achieving Low Disease Activity(weeks 116, 128, 140, 156, 180, 208, 232 and 260)
- Percentage of Subjects Achieving Disease Remission (DAS28<2.6)(weeks 116, 128, 140, 156, 180, 208, 232 and 260)