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RECRUITING Phase 2 ClinicalTrials.gov

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

Sponsor: Hoffmann-La Roche • ClinicalTrials.gov ID: NCT07620392

Registry updated: 2026-10-16
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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.

Interventions

  • Afimkibart (Drug)
    Participants will receive Afimkibart as per the schedule mentioned in the protocol.

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

Conditions

Rheumatoid Arthritis

Locations

  • Arthritis and Rheumatic Disease Specialty Inc — Tamarac, Florida, United States
  • Accurate Clinical Research Inc. — Lake Charles, Louisiana, United States
  • Accurate Clinical Management LLC — Houston, Texas, United States
  • DM Clinical Research at Tomball — Tomball, Texas, United States
  • Rheumatic Disease Center — Glendale, Wisconsin, United States
  • Centro Mineiro de Pesquisa - CMIP — Juiz de Fora, Minas Gerais, Brazil
  • Centrum Medyczne Reuma Park — Warsaw, Masovian Voivodeship, Poland
  • Nzoz Bif-Med — Bytom, Poland
  • Centrum Kliniczno-Badawcze J. Brzezicki, B. Górnikiewicz-Brzezicka Lekarze Spó?ka Partne — Elblag, Poland
  • Zespol Poradni Specjalistycznych REUMED filia nr 1 Wallenroda — Lublin, Poland
  • Twoja Przychodnia NCM — Nowa Sól, Poland
  • Reumatop Grzegorz Rozumek Karin Pistorius Spolka Jawna — Wroclaw, Poland
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record