Afimkibart for Rheumatoid Arthritis
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called Afimkibart to determine its effectiveness for people with moderate to severe rheumatoid arthritis (RA) who haven't responded to medications like TNF or JAK inhibitors. The study compares Afimkibart with a placebo (a harmless, inactive substance) to assess both effectiveness and safety. It suits those who have had RA for at least three months and experience significant joint swelling and tenderness. Participants will receive injections as part of the treatment. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.
Do I have to stop taking my current medications for the trial?
The trial information does not specify if you need to stop taking your current medications. However, it does exclude those who have used certain treatments recently, like corticosteroids in the last 8 weeks, or investigational therapies within a certain timeframe. It's best to discuss your specific medications with the trial coordinators.
Is there any evidence suggesting that Afimkibart is likely to be safe for humans?
Research has shown that Afimkibart is generally well-tolerated. In earlier studies, participants taking the treatment reported six serious side effects, compared to four in those taking a placebo. Although this might sound concerning, such events can occur in any clinical study. Importantly, the treatment was found to be safe overall, meaning most participants did not experience severe side effects, and it was safe enough to proceed to more advanced studies. As this is a Phase 2 trial, there is good early evidence of safety, but further research is needed for confirmation.12345
Why do researchers think this study treatment might be promising?
Afimkibart is unique because it offers a new approach for treating rheumatoid arthritis by targeting specific pathways involved in the inflammation process. Unlike traditional treatments like methotrexate or TNF inhibitors, which work broadly to suppress the immune system, afimkibart focuses more precisely on certain immune cells, potentially reducing side effects. Researchers are excited about afimkibart because it is administered via subcutaneous injections, which can be more convenient and less invasive than intravenous infusions, offering patients a more manageable treatment option.
What evidence suggests that Afimkibart might be an effective treatment for rheumatoid arthritis?
Studies have shown that Afimkibart may help people with moderate to severe rheumatoid arthritis, particularly those who haven't succeeded with other treatments. Early trials showed promising results in improving joint health and reducing inflammation. The drug targets specific parts of the immune system that cause arthritis symptoms. While more research is needed, these early findings suggest Afimkibart could be a helpful option for those dealing with rheumatoid arthritis. Although experts are still forming a consensus, the data so far is encouraging.13678
Who Is on the Research Team?
Clinical Trials
Principal Investigator
Hoffmann-La Roche
Are You a Good Fit for This Trial?
This trial is for adults with moderate to severe rheumatoid arthritis who haven't had success with or can't tolerate TNF and/or JAK inhibitors. They should have at least 6 swollen and tender joints, been diagnosed with RA for over 3 months, and meet specific RA classification criteria.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Afimkibart or placebo via subcutaneous injection
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Afimkibart
Find a Clinic Near You
Who Is Running the Clinical Trial?
Hoffmann-La Roche
Lead Sponsor
Dr. Levi Garraway
Hoffmann-La Roche
Chief Medical Officer since 2019
MD from the University of Basel
Dr. Thomas Schinecker
Hoffmann-La Roche
Chief Executive Officer since 2023
PhD in Molecular Biology from New York University