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

NCT07620392 · Hoffmann-La Roche
In plain English

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Official title
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
About this study
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
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
Study design
Enrollment target: 120 participants
Allocation: randomized
Masking: quadruple
Age groups: adult, older_adult
Timeline
Starts: 2026-06-03
Estimated completion: 2033-07-08
Last updated: 2026-08-21
Interventions
Drug: Afimkibart
Primary outcomes
  • Percentage of Participants With Adverse Events (AEs) (From Baseline up to 6 years)
Sponsor
Hoffmann-La Roche · industry
Contacts & investigators
ContactReference Study ID Number: WA46440 https://forpatients.roche.com/ No attachments to email below. · contact · global-roche-genentech-trials@gene.com · 888-662-6728
ContactFastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry · contact
InvestigatorClinical Trials · study_director, Hoffmann-La Roche
All locations (9)
West Broward Rheumatology Associates, Inc.Recruiting
Tamarac, Florida, United States
Accurate Clinical Research Inc.Recruiting
Lake Charles, Louisiana, United States
Accurate Clinical Management LLCRecruiting
Houston, Texas, United States
DM Clinical ResearchRecruiting
Tomball, Texas, United States
Nzoz Bif-MedRecruiting
Bytom, Poland
Centrum Kliniczno-Badawcze J. Brzezicki, B. Górnikiewicz-Brzezicka Lekarze Spó?ka PartneRecruiting
Elblag, Poland
Zespol Poradni Specjalistycznych REUMED filia nr 1 WallenrodaRecruiting
Lublin, Poland
Twoja Przychodnia NCMRecruiting
Nowa Sól, Poland
Reumatop Grzegorz Rozumek Karin Pistorius Spolka JawnaRecruiting
Wroclaw, Poland
An Extension Study to Assess Long-Term Safety and Efficacy of Afimkibart in Participants With Rheumatoid Arthritis · TrialPath