2025-523579-47-00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
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 46
- 试验地点
- 31
- 主要终点
- Incidence and severity of adverse events, serious adverse events, adverse events leading to study treatment discontinuation, adverse events of special interest
研究概览
简要总结
To evaluate the long-term safety and tolerability of afimkibart
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
- 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 ≥ 20%improvement in the Swollen Joint Count (SJC)66/ Tender Joint Count (TJC)68 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
RO7790121
Test
干预措施: RO7790121 (Drug)
结局指标
主要结局
Incidence and severity of adverse events, serious adverse events, adverse events leading to study treatment discontinuation, adverse events of special interest
Incidence and severity of adverse events, serious adverse events, adverse events leading to study treatment discontinuation, adverse events of special interest
次要结局
- Proportion of participants with American College of Rheumatology ACR20, ACR50, and ACR70 response (improvements will be assessed using the baseline of the parent study)
- Change from baseline DAS28-CRP)
- Proportion of participants achieving LDA, CR based on DAS28-CRP, DAS28-ESR, CDAI, or SDAI
- Change from baseline in selected clinical laboratory test results
- Change from baseline in selected vital signs
- Serum concentration of afimkibart at specified timepoints
研究者
Trial Information System - TISL
Scientific
F. Hoffmann-La Roche AG
研究点 (31)
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