An Extension Study to Assess Long-Term Safety and Efficacy of Afimkibart in Participants With Rheumatoid Arthritis
Recruiting · NCT07620392 · Interventional (participants receive a specific treatment) · Lead sponsor: Hoffmann-La Roche
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
9 locations listed across 3 US states.
- West Broward Rheumatology Associates, 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 - Tomball, Texas, United States
- 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