NCT07620392招募中2 期
An Extension Study to Evaluate the Long-term Safety and Efficacy of Afimkibart (RO7790121) in Patients With Rheumatoid Arthritis Who Participated in Previous Afimkibart Clinical Trials
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 10
研究概览
简要总结
The study will evaluate the long-term safety and efficacy of Afimkibart (also known as RO7790121) in participants with moderate to severe Rheumatoid Arthritis (RA) who have an inadequate response or intolerance to tumor necrosis factor (TNF) and/or Janus kinase (JAK) inhibitors, and who were previously treated with Afimkibart.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Completed the treatment period of the parent study
- •Agreement to adhere to the contraception requirements
- •Continued to be evaluated at the follow-up visit of the parent study and achieved improvement in the SJC66/TJC68 relative to baseline
排除标准
- •Withdrawal of consent and/or premature discontinuation from parent study
- •Any permanent discontinuation of study drug in parent study
- •Use of a prohibited therapy during the parent study
- •Evidence of any new or uncontrolled concomitant disease that, in the investigator's judgment, would preclude participant participation in the trial
研究组 & 干预措施
Afimkibart Group I
Experimental
Participants will recieve Afimkibart as subcutaneous (SC) injection.
干预措施: Afimkibart (Drug)
Afimkibart Group II
Experimental
Participants will receive Afimkibart as SC injection.
干预措施: Afimkibart (Drug)
研究者
研究点 (10)
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