2022-501480-41-00招募中3 期
An Open-Label Extension Study to Evaluate Long Term Safety and Efficacy of Tildrakizumab in Patients with Psoriatic Arthritis.
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 247
- 试验地点
- 32
- 主要终点
- Safety - Incidence and intensity of adverse events recorded through the study period
研究概览
简要总结
-
To evaluate long term safety and tolerability of Tildrakizumab in adult subjects with active PsA.
-
To evaluate long term efficacy of Tildrakizumab in adult subjects with active PsA by assessment of American College of Rheumatology response criteria.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
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
结局指标
主要结局
Safety - Incidence and intensity of adverse events recorded through the study period
Safety - Incidence and intensity of adverse events recorded through the study period
Efficacy - Achieving ACR 20, ACR 50 and ACR 70
Efficacy - Achieving ACR 20, ACR 50 and ACR 70
次要结局
未报告次要终点
研究者
Shantanu Mehta
Scientific
Sun Pharmaceutical Industries Limited
研究点 (32)
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