What this study is
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.
What's being tested
- Afimkibart
Intervention · DRUG
Participants will receive Afimkibart as per the schedule mentioned in the protocol.
Study details
- 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
- Sponsor
- Hoffmann-La Roche
- Conditions
- Rheumatoid Arthritis
- Enrolling
- 120 people
- Starts
- 2026-06-03
- Est. completion
- 2033-07-08
- Design
- Quadruple-blind, randomized, parallel groups, Phase 2
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (12)
12 openArthritis and Rheumatic Disease Specialty Inc
Tamarac, Florida, United States
RecruitingAccurate Clinical Research Inc.
Lake Charles, Louisiana, United States
RecruitingAccurate Clinical Management LLC
Houston, Texas, United States
RecruitingDM Clinical Research at Tomball
Tomball, Texas, United States
RecruitingRheumatic Disease Center
Glendale, Wisconsin, United States
Recruiting
7 sites outside the US
Centro Mineiro de Pesquisa - CMIP
Juiz de Fora, Minas Gerais, Brazil
RecruitingCentrum Medyczne Reuma Park
Warsaw, Masovian Voivodeship, Poland
RecruitingNzoz Bif-Med
Bytom, Poland
RecruitingCentrum Kliniczno-Badawcze J. Brzezicki, B. Górnikiewicz-Brzezicka Lekarze Spó?ka Partne
Elblag, Poland
RecruitingZespol Poradni Specjalistycznych REUMED filia nr 1 Wallenroda
Lublin, Poland
RecruitingTwoja Przychodnia NCM
Nowa Sól, Poland
RecruitingReumatop Grzegorz Rozumek Karin Pistorius Spolka Jawna
Wroclaw, Poland
Recruiting
Study team
Sponsor
Hoffmann-La Roche
Study ID WA46440
Study director
Clinical Trials
Hoffmann-La Roche
CONTACT
Reference Study ID Number: WA46440 https://forpatients.roche.com/ No attachments to email below.
CONTACT
Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.