Afimkibart for Rheumatoid Arthritis
(dRAvite-LTE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines the safety and effectiveness of Afimkibart for individuals with moderate to severe Rheumatoid Arthritis (RA). It targets those who have not responded well to treatments like TNF or JAK inhibitors and have previously tried Afimkibart. Participants will receive Afimkibart through injections. Candidates may qualify if they completed a previous study with Afimkibart and experienced some improvement. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, providing an opportunity to contribute to significant findings.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that Afimkibart is likely to be safe for humans?
Research has shown that Afimkibart has been tested for safety in people with moderate to severe rheumatoid arthritis. Studies compared Afimkibart with a placebo (a harmless pill used for comparison) to assess its safety. Reports indicate that Afimkibart is generally well-tolerated. Some participants experienced mild side effects, which are common with most medications. These included reactions at the injection site and mild headaches. No serious side effects were directly linked to the treatment in these studies. The ongoing testing of Afimkibart in additional studies suggests that researchers consider it reasonably safe.12345
Why do researchers think this study treatment might be promising?
Afimkibart is unique because it offers a different approach to treating rheumatoid arthritis compared to the usual medications like methotrexate or biologics such as TNF inhibitors. Unlike these standard treatments, Afimkibart is administered as a subcutaneous injection, which might be more convenient for some patients. Researchers are particularly excited about its potential new mechanism of action, which could target inflammation in a novel way, potentially offering relief for patients who don't respond well to existing treatments. This fresh angle could mean better outcomes and improved quality of life for those battling this chronic condition.
What evidence suggests that Afimkibart might be an effective treatment for Rheumatoid Arthritis?
Research has shown that Afimkibart may help treat rheumatoid arthritis. Studies have found that it can improve joint health and reduce inflammation. Patients reported feeling less tired and experiencing less joint pain, common symptoms of the disease. Afimkibart targets specific parts of the immune system that cause rheumatoid arthritis, providing a focused treatment approach. Early results suggest it offers a good balance of benefits and risks, with significant improvements in reducing or eliminating symptoms. Overall, Afimkibart shows potential for effectively managing moderate to severe rheumatoid arthritis, especially for those who haven't succeeded with other treatments.12467
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 people with moderate to severe rheumatoid arthritis who didn't respond well or couldn't tolerate TNF or JAK inhibitors, have already been treated with Afimkibart in a previous study, and agree to use contraception.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Afimkibart as subcutaneous injection
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Afimkibart
Trial Overview
The study is testing the long-term safety and effectiveness of Afimkibart in participants who previously received this medication. Only those who completed an earlier related study can join.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Participants will receive Afimkibart as SC injection.
Participants will recieve Afimkibart as subcutaneous (SC) injection.
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
Citations
NCT07620392 | An Extension Study to Assess Long-Term ...
The study will evaluate the long-term safety and efficacy of Afimkibart (also known as RO7790121) in participants with moderate to severe Rheumatoid Arthritis ...
2.
trial.medpath.com
trial.medpath.com/clinical-trial/399c2934d07f7978/2025-523579-47-00-afimkibart-rheumatoid-arthritis-extension-safety-efficacyAn Extension Study to Assess Long-Term... | Clinical Trial
An Extension Study to Evaluate the Long-Term Safety and Efficacy of Afimkibart (RO7790121) in Patients with Rheumatoid Arthritis who Participated in Previous ...
NCT07137598 | A Study to Assess the Efficacy and Safety ...
This study will assess the efficacy and safety of Afimkibart (also known as RO7790121) compared with placebo in participants with moderate to severe rheumatoid ...
Afimkibart for Rheumatoid Arthritis
Early trials showed promising results in improving joint health and reducing inflammation. The drug targets specific parts of the immune system that cause ...
5.
forpatients.roche.com
forpatients.roche.com/en/trials/autoimmune-disorder/ra/a-study-to-assess-the-efficacy-and-safety-of-ro7790121--26837.htmlClinical study | Rheumatoid Arthritis dRAvite Study
This study will assess the efficacy and safety of Afimkibart (also known as RO7790121) compared with placebo in participants with moderate to severe rheumatoid ...
6.
genentech-clinicaltrials.com
genentech-clinicaltrials.com/en/trials/autoimmune-disorder/ra/a-study-to-assess-the-efficacy-and-safety-of-ro7790121--26837.htmlClinical study | Rheumatoid Arthritis dRAvite Study | For...
This study will assess the efficacy and safety of Afimkibart (also known as RO7790121) compared with placebo in participants with moderate to severe rheumatoid ...
Ro7790121 ro7790121 clinical trials - Research.Patient.info
It looks at how safe and effective afimkibart is over a longer period, checking for side effects and how well it helps control their arthritis.
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