NCT07620392PHASE2Recruiting
An Extension Study to Assess Long-Term Safety and Efficacy of Afimkibart in Participants With Rheumatoid Arthritis
Hoffmann-La Roche
Start Date
6/3/2026
Completion Date
7/8/2033
Summary
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
Age Range: 18 years to No maximum
Inclusion Criteria:
* 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 Criteria:
* 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
Interventions
DRUG
Afimkibart
Conditions
Rheumatoid Arthritis
Locations
West Broward Rheumatology Associates, Inc.
Tamarac, Florida 33321
United States
Accurate Clinical Management LLC
Houston, Texas 77089
United States
DM Clinical Research
Tomball, Texas 77375
United States
Centrum Kliniczno-Badawcze J. Brzezicki, B. Górnikiewicz-Brzezicka Lekarze Spó?ka Partne
Elblag, 82-300
Poland
Zespol Poradni Specjalistycznych REUMED filia nr 1 Wallenroda
Lublin, 20-607
Poland
Reumatop Grzegorz Rozumek Karin Pistorius Spolka Jawna
Wroclaw, 52-210
Poland