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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 week 2 to week 12

Awards & highlights

SPECIFI-RA Trial 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.Check my eligibility

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.See study design

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.

SPECIFI-RA Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with adult-onset rheumatoid arthritis for at least 6 months.

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My condition did not improve after taking MTX as prescribed.

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I have 6 or more tender and swollen joints.

SPECIFI-RA Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 2 to week 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 2 to week 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 2 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

Proportion of participants achieving at least 20% improvement from baseline in the American College of Rheumatology (ACR) score at week 12

Secondary outcome measures

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)

Plasma post-dose concentrations of SAR441566

+2 more

SPECIFI-RA 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

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

SanofiLead Sponsor

2,164 Previous Clinical Trials

3,514,740 Total Patients Enrolled

25 Trials studying Rheumatoid Arthritis

7,004 Patients Enrolled for Rheumatoid Arthritis

Clinical Sciences & OperationsStudy DirectorSanofi

862 Previous Clinical Trials

2,019,598 Total Patients Enrolled

16 Trials studying Rheumatoid Arthritis

2,888 Patients Enrolled for Rheumatoid Arthritis

Frequently Asked Questions

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

Is enrollment for this research endeavor currently open?

"Affirmative. The data published on clinicaltrials.gov affirms that recruitment for this experiment is still ongoing, having first gone up on November 7th 2023 and most recently updated on the 27th of the same month. 240 participants are needed between two medical centres."

Answered by AI

What is the capacity of this research initiative?

"Affirmative, according to the clinicaltrials.gov listing this trial has begun recruiting patients since November 7th 2023 and is still ongoing. A total of 240 participants are sought from two separate medical centres."

Answered by AI

Have the FDA sanctioned SAR441566 dose regimen A?

"Our team at Power deemed the safety of SAR441566 dose regimen A as a 2 on a 3-point scale, given that there is evidence confirming its security but no proof indicating potency."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Evaluate SAR441566 Efficacy and Safety in Adults With Rheumatoid Arthritis

2023. "A Study to Evaluate SAR441566 Efficacy and Safety in Adults With Rheumatoid Arthritis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06073093.

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