Long-term safety and effectiveness of Afimkibart in rheumatoid arthritis patients who previously used Afimkibart

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a phase 2 extension trial evaluating the long-term safety and efficacy of Afimkibart (RO7790121) in adults with rheumatoid arthritis who had an inadequate response or intolerance to TNF inhibitors and/or JAK inhibitors and previously received Afimkibart. Participants must have completed the parent study, agreed to contraception requirements, and shown improvement in joint swelling scores relative to baseline. The trial will monitor ongoing safety and track efficacy over an extended follow-up period at multiple sites in the United States. Key exclusion criteria include withdrawal from the parent study, permanent discontinuation of the drug in the parent study, use of prohibited therapies during the parent study, or new uncontrolled medical conditions that could affect participation.

Why it matters

Who can join: the full rules

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's running

• Arthritis and Rheumatic Disease Specialty Inc
  Tamarac, Florida, United States Recruiting
• Accurate Clinical Research Inc.
  Lake Charles, Louisiana, United States Recruiting
• Accurate Clinical Management LLC
  Houston, Texas, United States Recruiting
• DM Clinical Research at Tomball
  Tomball, Texas, United States Recruiting
• Rheumatic Disease Center
  Glendale, Wisconsin, United States Recruiting
• Centro Mineiro de Pesquisa - CMIP
  Juiz de Fora, Minas Gerais, Brazil Recruiting

Study contacts

• Study coordinator: Reference Study ID Number: WA46440 https://forpatients.roche.com/ No attachments to email below.
• Email: global-roche-genentech-trials@gene.com
• Phone: 888-662-6728

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.