An Extension Study to Assess Long-Term Safety and Efficacy of Afimkibart in Participants With Rheumatoid Arthritis
Key facts
- Where
- Frederiksberg and Koege, DenmarkSee the 2 sites
- Phase
- Phase 2
Where in Denmark
- Region HovedstadenFrederiksberg, DenmarkTaking people
- Region SjaellandKoege, DenmarkTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Hoffmann-La Roche
- Trial code
- NCT07620392EU 2025-523579-47-00
- Record updated
- 16 October 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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.
Exclusion: 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; Withdrawal of consent and/or premature discontinuation from parent study.