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A Phase 2 Randomized, Double-blind, Placebo-controlled, Dose-ranging, Efficacy and Safety study of SAR441566 plus Methotrexate in Adults with Moderate to Severe Rheumatoid Arthritis

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-503910-60-00
Acronym
DRI17821
Enrollment
194
Registered
2024-02-01
Start date
2024-03-05
Completion date
2025-07-02
Last updated
2025-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid arthritis

Brief summary

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

Detailed description

Change from baseline in Disease activity score – C-reactive protein (DAS-28 CRP) at week 12, Proportion of participants achieving at least 50% improvement from baseline in the ACR score at week 12, Number of participants with Treatment-Emergent Adverse Events (TEAEs), serious AEs (SAEs), and AEs of special interest (AESIs), Plasma pre-dose concentrations of SAR441566, Plasma post-dose concentrations of SAR441566

Interventions

Sponsors

Sanofi-Aventis Recherche & Developpement
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

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

Secondary

MeasureTime frame
Change from baseline in Disease activity score – C-reactive protein (DAS-28 CRP) at week 12, Proportion of participants achieving at least 50% improvement from baseline in the ACR score at week 12, Number of participants with Treatment-Emergent Adverse Events (TEAEs), serious AEs (SAEs), and AEs of special interest (AESIs), Plasma pre-dose concentrations of SAR441566, Plasma post-dose concentrations of SAR441566

Countries

Czechia, Germany, Greece, Poland, Slovakia, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026