What is the mechanism of action of this treatment?

Common treatments for Rheumatoid Arthritis (RA) include monoclonal antibodies and other biologic agents that target specific inflammatory pathways. For example, Rosnilimab, a monoclonal antibody, works by inhibiting key molecules involved in the inflammatory process, thereby reducing joint inflammation and damage. Other treatments like TNF inhibitors (e.g., infliximab, etanercept) block tumor necrosis factor-alpha (TNF-α), a cytokine that plays a significant role in systemic inflammation. These mechanisms are crucial for RA patients as they help to control symptoms, prevent joint damage, and improve overall quality of life by directly targeting the underlying causes of inflammation.

What side effects are associated with this type of intervention?

Common treatments for Rheumatoid Arthritis (RA) that target inflammatory pathways, such as monoclonal antibodies, often have side effects including increased risk of infections, injection site reactions, and potential serious adverse events like heart failure and liver toxicity. Other side effects may include gastrointestinal issues, headaches, and hypersensitivity reactions.

What prior FDA approvals exist?

Several monoclonal antibodies and biologic agents targeting inflammatory pathways have been approved by the FDA for the treatment of Rheumatoid Arthritis (RA). These include TNF inhibitors such as infliximab, adalimumab, and golimumab, which help reduce inflammation by targeting tumor necrosis factor-alpha (TNF-α). Other biologics like tocilizumab, an IL-6 receptor antagonist, and abatacept, a T-cell co-stimulation modulator, have also been approved for RA. These treatments aim to modulate the immune response and reduce the inflammatory processes associated with RA.

What other types of research exist?

Promising novel alternatives to Rosnilimab for RA patients include other monoclonal antibodies and biologics such as alternative TNF-α inhibitors (e.g., adalimumab, infliximab) and non-TNF biologics (e.g., tocilizumab, abatacept). These agents have shown considerable efficacy in patients with inadequate response to initial TNF-α inhibitors. Additionally, ongoing research and trials may introduce new biologics targeting different inflammatory pathways, providing more options for RA management in 2024.

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Monoclonal Antibodies

Rosnilimab for Rheumatoid Arthritis

Phase 2

Recruiting

Research Sponsored by AnaptysBio, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

History of an inflammatory joint disease other than Rheumatoid Arthritis

Any known or suspected condition that would compromise immune status

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to week 12

Summary

This trial is testing Rosnilimab, a new medication, to see if it can help people with moderate to severe rheumatoid arthritis by reducing joint pain and swelling. The study will check if the medication is safe and effective.

Who is the study for?

This trial is for adults with moderate to severe Rheumatoid Arthritis who have been diagnosed at least 3 months prior and are currently on stable doses of up to two conventional synthetic DMARDs. It's not open to pregnant or breastfeeding women, those with other joint diseases, previous PD-1/PD-L1 treatment, recent cancer history, or compromised immune systems.

What is being tested?

The RENOIR study is testing the safety and effectiveness of Rosnilimab compared to a placebo in treating Rheumatoid Arthritis. Participants will randomly receive either Rosnilimab or a placebo alongside their standard treatments.

What are the potential side effects?

Possible side effects of Rosnilimab may include reactions at the injection site, increased risk of infections due to immune system suppression, fatigue, headaches, and potential allergic responses.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a history of an inflammatory joint disease that is not Rheumatoid Arthritis.

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I do not have any conditions that weaken my immune system.

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I have been treated with a PD-1 or PD-L1 inhibitor before.

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I have not had any cancer, except certain skin cancers, in the last 5 years.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to week 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to week 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to week 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Mean change from Baseline in 28-Joint Disease Activity Score based on CRP (DAS28-CRP) at Week 12

Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: Rosnilimab SC Dose 3Experimental Treatment1 Intervention

This arm will receive treatment SC

Group II: Rosnilimab SC Dose 2Experimental Treatment1 Intervention

This arm will receive treatment SC

Group III: Rosnilimab SC Dose 1Experimental Treatment1 Intervention

This arm will receive treatment SC

Group IV: PlaceboPlacebo Group1 Intervention

This arm will receive Placebo

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Rheumatoid Arthritis (RA) include monoclonal antibodies and other biologic agents that target specific inflammatory pathways. For example, Rosnilimab, a monoclonal antibody, works by inhibiting key molecules involved in the inflammatory process, thereby reducing joint inflammation and damage. Other treatments like TNF inhibitors (e.g., infliximab, etanercept) block tumor necrosis factor-alpha (TNF-α), a cytokine that plays a significant role in systemic inflammation. These mechanisms are crucial for RA patients as they help to control symptoms, prevent joint damage, and improve overall quality of life by directly targeting the underlying causes of inflammation.

TNFalpha blockade in human diseases: mechanisms and future directions.