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Monoclonal Antibodies
SAR441566 for Rheumatoid Arthritis (SPECIFI-RA Trial)
Phase 2
Recruiting
Research Sponsored by Sanofi
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosis of adult-onset RA classified by ACR/EULAR 2010 revised classification criteria for RA of at least 3 months duration, with the onset of signs and symptoms of RA of at least 6 months duration
Inadequate clinical response to MTX at a dose of 10-25 mg/week after proper dose escalation according to local standards (eg, for Japan, a stable dose of MTX is 6 to 16 mg/week)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to week 14
Summary
This trial is testing a new drug treatment for rheumatoid arthritis in adults not adequately controlled on methotrexate. It will include 8 visits over 12 wks to assess safety & efficacy.
Who is the study for?
Adults with moderate-to-severe rheumatoid arthritis not well-controlled on methotrexate, who haven't used biologic or targeted synthetic DMARDs. Participants must have had RA symptoms for at least 6 months, be taking a stable dose of methotrexate for 12 weeks prior to the trial, and have a BMI between 18-35 kg/m^2.
What is being tested?
The study is testing SAR441566's effectiveness and safety in treating rheumatoid arthritis over a period of 12 weeks. It compares different doses of SAR441566 against a placebo while all participants continue their regular methotrexate therapy.
What are the potential side effects?
Specific side effects are not listed here but typically include reactions at the injection site, increased risk of infection, headaches, nausea, and potential abnormal blood tests reflecting liver or kidney issues.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with adult-onset rheumatoid arthritis for at least 6 months.
Select...
My condition did not improve after taking MTX as prescribed.
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I have 6 or more tender and swollen joints.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to week 14
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to week 14
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Proportion of participants achieving at least 20% improvement from baseline in the American College of Rheumatology (ACR) score at week 12
Secondary study objectives
Change from baseline in Disease activity score - C-reactive protein (DAS-28 CRP) at week 12
Number of participants with Treatment-Emergent Adverse Events (TEAEs), serious AEs (SAEs), and AEs of special interest (AESIs)
Proportion of participants achieving at least 50% improvement from baseline in the ACR score at week 12
Trial Design
5Treatment groups
Experimental Treatment
Placebo Group
Group I: SAR441566 dose regimen DExperimental Treatment1 Intervention
Participant will receive dose regimen D of SAR441566 for 12 weeks
Group II: SAR441566 dose regimen CExperimental Treatment1 Intervention
Participant will receive dose regimen C of SAR441566 for 12 weeks
Group III: SAR441566 dose regimen BExperimental Treatment1 Intervention
Participant will receive dose regimen B of SAR441566 for 12 weeks
Group IV: SAR441566 dose regimen AExperimental Treatment1 Intervention
Participant will receive dose regimen A of SAR441566 for 12 weeks
Group V: PlaceboPlacebo Group1 Intervention
Participant will receive SAR441566-matching placebo for 12 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
SAR441566
2023
Completed Phase 1
~110
Find a Location
Who is running the clinical trial?
SanofiLead Sponsor
2,215 Previous Clinical Trials
4,046,892 Total Patients Enrolled
26 Trials studying Rheumatoid Arthritis
10,504 Patients Enrolled for Rheumatoid Arthritis
Clinical Sciences & OperationsStudy DirectorSanofi
876 Previous Clinical Trials
2,021,418 Total Patients Enrolled
16 Trials studying Rheumatoid Arthritis
2,888 Patients Enrolled for Rheumatoid Arthritis