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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to week 12
Awards & highlights

Study Summary

This trial looks at how safe & effective a new drug is for people with moderate to severe Rheumatoid Arthritis.

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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Mean change from Baseline in 28-Joint Disease Activity Score based on CRP (DAS28-CRP) at Week 12
Secondary outcome measures
American College of Rheumatology 20% Improvement Criteria (ACR20) response rate at Week 12
American College of Rheumatology 50% and 70% Improvement Criteria (ACR50 and ACR70) response rates 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

Find a Location

Who is running the clinical trial?

AnaptysBio, Inc.Lead Sponsor
16 Previous Clinical Trials
1,228 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What qualifications must an individual meet to be enrolled in this clinical trial?

"To participate in this rheumatoid arthritis trial, prospective candidates must be aged 18 to 65. The research team is currently recruiting approximately 420 patients for the study."

Answered by AI

Has the FDA ratified ANB030 SC Dose 1?

"Considering the Phase 2 status of this treatment, ANB030 SC Dose 1 was assigned a score of 2 for safety; as there is clinical data attesting to its security but none that attest to its efficacy."

Answered by AI

How many individuals are currently participating in this clinical trial?

"This medical study seeks 420 participants who meet the criteria for inclusion. Enrollment can take place at AnaptysBio Investigative Site 10-103 in Aventura, Florida or at AnaptysBio Investigative Site 10-122 in Homestead, Tennessee."

Answered by AI

Does the patient population for this study incorporate those under 45 years of age?

"The age range for patients accepted into this clinical trial is 18 to 65. For those below the legal age of consent or beyond retirement, there are an additional 52 and 351 studies respectively that may be more suitable."

Answered by AI

Are there still opportunities for individuals to take part in this investigation?

"Yes, as noted on clinicaltrials.gov this experiment is still actively recruiting participants. The trial was initially published on August 31st 2023 and has since been amended for the last time on September 11th of the same year."

Answered by AI

How many locations is this trial supervised in?

"At present, 32 geographically dispersed medical centres are operating this trial. These locations range from Aventura and Homestead to Miami, offering an accessible site for interested participants to minimize travel when possible."

Answered by AI

Who else is applying?

What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
What site did they apply to?
AnaptysBio Investigative Site 10-108
Anaptys Bio Investigative Site 10-130

Why did patients apply to this trial?

I took Homeo medicine and I am fine.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
A Study of Efficacy and Safety of Rosnilimab in Subjects With Moderate to Severe Rheumatoid Arthritis (RENOIR)
2023. "A Study of Efficacy and Safety of Rosnilimab in Subjects With Moderate to Severe Rheumatoid Arthritis (RENOIR)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06041269.
All > Albuquerque > Tucson
~233 spots leftby Mar 2025
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