An Extension Study to Assess Long-Term Safety and Efficacy of Afimkibart in Participants With Rheumatoid Arthritis
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
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests the long-term safety of afimkibart (RO7790121) and how well it works for moderate to severe rheumatoid arthritis, a disease that causes swollen, painful joints. It is for people who already received afimkibart and whose arthritis did not improve enough with TNF or JAK inhibitors, or who could not tolerate these medicines.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Finished the treatment period in the earlier study.
- Agree to follow the birth control rules.
- Had a follow-up visit in the earlier study, with improved swollen and tender joint counts compared with the start of that study.
Who can't join
- Withdrew permission to take part or left the earlier study before it ended.
- Permanently stopped the study drug during the earlier study.
- Used a treatment that was not allowed during the earlier study.
- Have a new or uncontrolled health condition that the study doctor believes would prevent you from taking part.
Simplified for readability. The official criteria below are what the study team uses.
Official 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 sites (5)
FL
- Arthritis and Rheumatic Disease Specialty Inc · Tamarac, FL 33321More trials in Tamarac
LA
- Accurate Clinical Research Inc. · Lake Charles, LA 70605More trials in Lake Charles
TX
- Accurate Clinical Management LLC · Houston, TX 77089More trials in Houston
- DM Clinical Research at Tomball · Tomball, TX 77375More trials in Tomball
WI
- Rheumatic Disease Center · Glendale, WI 53217More trials in Glendale