120 Participants NeededMy employer runs this trial

Afimkibart for Rheumatoid Arthritis

(dRAvite-LTE Trial)

Recruiting at 9 trial locations
RS
RS
Fr
Overseen ByFastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Hoffmann-La Roche
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human 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?

CT

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

I showed joint improvement at my follow-up visit in the parent study.
Completed the treatment period of the parent study
Agreement to adhere to the contraception requirements

Exclusion Criteria

Withdrawal of consent and/or premature discontinuation from parent study
Any permanent discontinuation of study drug in parent study
I used a treatment that was not allowed during the main study.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Afimkibart as subcutaneous injection

Long-term

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

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

Group I: Afimkibart Group IIExperimental Treatment1 Intervention
Group II: Afimkibart Group IExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Hoffmann-La Roche

Lead Sponsor

Trials
2,482
Recruited
1,107,000+
Headquarters
Basel, Switzerland
Known For
Precision medicine
Top Products
Avastin, Herceptin, Rituxan, Accu-Chek
Dr. Levi Garraway profile image

Dr. Levi Garraway

Hoffmann-La Roche

Chief Medical Officer since 2019

MD from the University of Basel

Dr. Thomas Schinecker profile image

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 ...

An 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 ...

Clinical 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 ...

Clinical 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.