About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Afimkibart
DrugParticipants will receive Afimkibart as per the schedule mentioned in the protocol.
Treatment groups
Trial outcomes
Primary outcomes
Percentage of Participants With Adverse Events (AEs)
Secondary outcomes
Percentage of Participants Achieving an American College of Rheumatology 20 Percent (%), 50% or 70% Improvement (ACR20/ACR50/ACR70)
Change from baseline in Individual Components of ACR
Change From Baseline in Disease Activity Score-28 for Rheumatoid Arthritis With C-Reactive Protein (DAS28-CRP)
Percentage of Participants Achieving Low Disease Activity (LDA) Based on DAS28-CRP Score
Sponsors and contacts
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