An Extension Study to Assess Long-Term Safety and Efficacy of Afimkibart in Participants With Rheumatoid Arthritis

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorHoffmann-La Roche

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

Qualifiers

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

Treatments tested in this trial

  • Afimkibart

Treatment groups

120 Participants
are divided into 2 treatment groups

Sponsors and collaborators