Efficacy and safety of Sarilumab and Adalimumab monotherapy in patients with Rheumatoid Arthritis

Phase 1

• Conditions: Rheumatoid Arthritis; MedDRA version: 18.1Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2014-002541-22-CZ
• Lead Sponsor: sanofi-aventis recherche & développement

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-12-09
• Last Update Posted: 12 April 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 540

Inclusion Criteria

Diagnosis of rheumatoid arthritis =3 months duration.
American College of Rheumatology (ACR) Class I-III functional status.
Active RA, defined as:
- At least 6 of 66 swollen joints and 8 of 68 tender joints,
- High sensitivity C-reactive protein (hs-CRP)=8 mg/L or ESR=28 mm/H, and
- DAS28ESR >5.1.
Patients who per investigator judgment were either intolerant of, or considered
inappropriate candidates for continued treatment with methotrexate (MTX), or after at least 12 weeks of continuous treatment with MTX, or inadequate responders treated with an adequate MTX dose for at least 12 weeks.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 430
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 110

Exclusion Criteria

Age <18 years or the legal age of consent in the country of the study site, whichever is higher.
Current treatment with disease-modifying antirheumatic drug (DMARDs)/immunosuppressive agents including MTX, cyclosporine, mycophenolate, tacrolimus, gold, penicillamine, sulfasalazine or hydroxychloroquine within 2 weeks prior to the baseline (Randomization Visit) or azathioprine, cyclophosphamide within 12 weeks prior to baseline (Randomization Visit) or leflunomide within 8 weeks prior to the Randomization Visit, or 4 weeks after cholestyramine washout.
Treatment with any prior biologic agent, including anti-interleukin 6 (IL-6), IL-6 receptor (IL-6R) antagonists, and prior treatment with a Janus kinase inhibitor.
Use of parenteral corticosteroids or intra-articular corticosteroids within 4 weeks prior to screening.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified