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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
Awards & highlights
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:Select...
I have a history of an inflammatory joint disease that is not Rheumatoid Arthritis.
Select...
I do not have any conditions that weaken my immune system.
Select...
I have been treated with a PD-1 or PD-L1 inhibitor before.
Select...
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
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
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.
TNFalpha blockade in human diseases: mechanisms and future directions.
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Who is running the clinical trial?
AnaptysBio, Inc.Lead Sponsor
16 Previous Clinical Trials
1,228 Total Patients Enrolled
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