An Open-Label Extension Study to Evaluate Long Term Safety and Efficacy of Tildrakizumab in Patients With Psoriatic Arthritis.
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 529
- 试验地点
- 172
- 主要终点
- Incidence and intensity of Adverse Events (AEs) recorded through the study period
研究概览
简要总结
An open label phase 3 study
详细描述
Subjects from both INSPIRE 1 (TILD-19-07) and INSPIRE 2 (TILD-19-19) studies to roll over into this INSPIRE LTE study (TILD-21-01).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Subjects possess the ability to understand the requirements of the study.
- •Subject has provided written informed consent as evidenced by signature on an informed consent form approved by an institutional review board/EC.
- •Agree to abide by the study restrictions, scheduled treatment, laboratory assessments, other study procedures and return to the site for the required assessments.
- •Subject with PsA who had met all eligibility criteria for the parent study, had completed the parent study treatment period and has not developed any parent protocol criteria for premature discontinuation of treatment or withdrawal from the study.
排除标准
- •Female subjects of childbearing potential who do not agree to abstain from heterosexual activity or practice a dual method of contraception.
- •Female is pregnant or breastfeeding, or planning to become pregnant or initiate breastfeeding while enrolled in the study or up to 17 weeks after the last dose of IMP.
- •Subject has previously been enrolled in this long-term extension study.
- •Any condition that in the opinion of the Investigator represents an obstacle for study conduct and/or represents a potential unacceptable risk for the subject.
研究组 & 干预措施
TILD q12 weeks
干预措施: TILD sub-cutaneous (SC) injection (Drug)
结局指标
主要结局
Incidence and intensity of Adverse Events (AEs) recorded through the study period
时间窗: Week 124
Proportion of Subject Who Reached (American College of Rheumatology Score of 20) ACR20
时间窗: Week 124
ACR20 response is an aggregate of: 1\. at least 20% reduction in tender joint count and swollen joint count and at least 3 of the following 5 assessments: 1. physician's global assessment of disease activity 2. patient's global assessment of disease activity 3. patient's assessment of pain 4. patient's self-assessed disability based on health assessment questionnaire 5. c-reactive protein
Proportion of Subjects Who Reached (American College of Rheumatology Score of 50) ACR50
时间窗: Week 124
ACR50 response is an aggregate of: 1\. at least 50% reduction in tender joint count and swollen joint count and at least 3 of the following 5 assessments: 1. physician's global assessment of disease activity 2. patient's global assessment of disease activity 3. patient's assessment of pain 4. patient's self-assessed disability based on health assessment questionnaire 5. c-reactive protein
Proportion of Subjects Who Reached (American College of Rheumatology Score of 70) ACR70
时间窗: Week 124
ACR70 response is an aggregate of: 1\. at least 70% reduction in tender joint count and swollen joint count and at least 3 of the following 5 assessments: 1. physician's global assessment of disease activity 2. patient's global assessment of disease activity 3. patient's assessment of pain 4. patient's self-assessed disability based on health assessment questionnaire 5. c-reactive protein
次要结局
未报告次要终点