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RecruitingPHASE2INTERVENTIONAL

A Study to Assess the Efficacy and Safety of RO7790121 in Participants With Moderate to Severe Rheumatoid Arthritis Who Have Not Responded to or Who Cannot Tolerate Tumor Necrosis Factor (TNF) and/or Janus Kinase (JAK Inhibitors)

This research study is investigating a new medication, Afimkibart (also known as RO7790121), for adults suffering from moderate to severe rheumatoid arthritis (RA). It specifically focuses on individuals whose RA hasn't responded well to, or who can't tolerate, other commonly used treatments like TNF or JAK inhibitors. The study wants to understand if Afimkibart can help improve symptoms and quality of life for these patients. Another important goal is to assess the safety of Afimkibart, looking for any side effects it might cause. Half of the participants will receive Afimkibart, while the other half will receive a placebo (a dummy treatment, like a sugar pill) to fairly compare its effects.

At a glance

Status
Recruiting
Phase
PHASE2
Sponsor
Hoffmann-La Roche
Enrolment target
160
Start
05 Dec 2025
Estimated completion
08 Oct 2027

What is this study about?

This research is focused on helping people with rheumatoid arthritis (RA), a long-term condition that causes pain, swelling, and stiffness in the joints. For many, existing treatments work well, but some individuals don't get enough relief or experience side effects that prevent them from continuing treatment. This study is for those who are still struggling with moderate to severe RA, even after trying commonly prescribed medications called TNF and/or JAK inhibitors.

The main aim of this study is to test a new medication called Afimkibart. We want to see how effective it is at reducing RA symptoms and improving the lives of patients. We'll also be carefully monitoring its safety, looking for any potential side effects. By comparing Afimkibart to a placebo (a treatment with no active drug), researchers can get a clear picture of whether the new medication is truly making a difference.

Finding new and effective treatments for rheumatoid arthritis is really important, especially for those who haven't found success with current options. The information gathered from this study will help us understand if Afimkibart could be a valuable new treatment choice in the future, offering hope to many who live with this challenging condition.

Key takeaways

  • This study is for adults with moderate to severe rheumatoid arthritis.
  • It's for those who haven't responded well to or can't take other common RA treatments.
  • It's testing a new medication called Afimkibart against a placebo.
  • Participation involves regular clinic visits and health check-ups.
  • The aim is to assess both how well Afimkibart works and its safety.

Who may be eligible?

To join this study, you would typically need to be an adult aged 18 or over. You must have been diagnosed with rheumatoid arthritis for at least three months and your condition should be moderate to severe, meaning you have a certain number of swollen and tender joints at the time of screening. Crucially, you should have tried and not fully responded to, or not been able to tolerate, at least one of the standard rheumatoid arthritis medications known as a 'conventional synthetic disease-modifying antirheumatic drug' (csDMARD).

There are also some reasons why you wouldn't be able to take part. For example, if you've previously tried more than two TNF inhibitors or JAK inhibitors without success, you might not be eligible. If you have very severe rheumatoid arthritis (Class IV) or have used other types of biologic medications (apart from TNF inhibitors) or rituximab, you wouldn't qualify. You also couldn't have participated in another research study involving an experimental drug in the last few weeks.

Other reasons to not be eligible include having different types of arthritis, having had recent steroid injections, allergies to the study drug, recent major surgery, or serious ongoing health problems. A history of certain cancers (except for easily treated skin cancers or cervical cancer) or severe recurring infections would also prevent participation.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you 18 years old or older?
  2. Do you have a diagnosis of moderate to severe rheumatoid arthritis?
  3. Have you tried and not fully responded to, or couldn't tolerate, at least one standard RA drug (a csDMARD)?
  4. Have you NOT tried more than two TNF or JAK inhibitor medications?
  5. Do you have a general good health apart from your rheumatoid arthritis?
Answer every question to see your result.

What does participation involve?

If you join this study, you'll be randomly assigned to either receive the new medication, Afimkibart, or a placebo (a dummy treatment). You won't know which one you're receiving, and neither will your study doctor, to keep the results fair. You'll have regular visits to the clinic where you'll have check-ups, blood tests, and assessments of your joints to see how your rheumatoid arthritis is progressing. You'll also be asked about any side effects you might experience. The total duration of your participation in the study involves a screening period, a treatment period, and a follow-up period after your last dose of medication. All study medication and doctor's visits related to the study will be provided at no cost.

Potential risks and benefits

Taking part in a clinical trial may offer potential benefits, such as access to a new medication before it's widely available, and close monitoring of your health by a medical team. However, there are potential risks, including side effects from the study medication, which might be unknown or range from mild to more serious. Since some participants will receive a placebo, they may not experience any direct benefits from the study drug. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (51)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • SunValley Arthritis Center Ltd.
    Verified postcode
    Peoria, United States· Recruiting
  • Cedars Sinai Medical Center
    Verified postcode
    Los Angeles, United States· Recruiting
  • Inland Rheumatology Clinical Trials Incorporated
    Verified postcode
    Upland, United States· Recruiting
  • West Broward Rheumatology Associates, Inc.
    Verified postcode
    Tamarac, United States· Recruiting
  • Willow Rheumatology and Wellness PLLC
    Verified postcode
    Willowbrook, United States· Recruiting
  • Accurate Clinical Research Inc.
    Verified postcode
    Lake Charles, United States· Recruiting
  • Ohio State University Wexner Medical Center
    Verified postcode
    Columbus, United States· Recruiting
  • Altoona Center For Clinical Research
    Verified postcode
    Duncansville, United States· Recruiting
  • Accurate Clinical Management
    Verified postcode
    Houston, United States· Recruiting
  • DM Clinical Research
    Verified postcode
    Tomball, United States· Recruiting
  • Tidewater Clinical Research
    Verified postcode
    Chesapeake, United States· Recruiting
  • Rheumatic Disease Center
    Verified postcode
    Glendale, United States· Recruiting

Common questions

What is rheumatoid arthritis?

Rheumatoid arthritis is a long-term condition that causes pain, swelling, and stiffness in the joints, typically affecting more than one joint. It's an autoimmune disease, meaning the body's immune system mistakenly attacks its own tissues.

What is Afimkibart?

Afimkibart is a new medication being investigated in this study to see if it can help reduce the symptoms of moderate to severe rheumatoid arthritis.

What is a placebo?

A placebo is a 'dummy' treatment that looks exactly like the study medication but contains no active drug. It's used to fairly compare the effects of the new medication.

How long will the study last if I join?

The study involves a screening period, a treatment period, and a follow-up after your last dose. The overall duration will be explained in detail by the study team if you are suitable.

Will I know if I'm getting the active drug or the placebo?

No, neither you nor the study doctor will know whether you are receiving Afimkibart or the placebo. This helps ensure the study results are unbiased and reliable.

How to find out more

Reference Study ID Number: WA45846 https://forpatients.roche.com/

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "A Study to Assess the Efficacy and Safety of RO7790121 in Pa…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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