A STUDY ASSESSING THE EFFICACY AND SAFETY OF SARILUMAB ADDED TO NON-BIOLOGIC DMARD THERAPY IN PATIENTS WITH RHEUMATOID ARTHRITIS.

Not Applicable

• Conditions: -M069; M069

• Registration Number: PER-033-13
• Lead Sponsor: Sanofi Aventis Recherche & Development,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-02-18
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Sex: All
• Target Recruitment: 67

Inclusion Criteria

• Diagnosis of rheumatoid arthritis ≥6 months duration, according to the American College of Rheumatology (ACR)/European League against Rheumatism (EULAR) 2010 Rheumatoid Arthritis Classification Criteria
• ACR Class I-III functional status, based on 1991 revised criteria
• Patients who, per Investigator assessment, have had an inadequate response to at least one TNF antagonist, after being treated for at least 3 consecutive months, any time before screening or patients intolerant to at least 1 TNF antagonist, resulting in discontinuation
- TNF-antagonists may include etanercept, infliximab,
adalimumab, golimumab and/or certolizumab pegol
• Active disease defined as:
- at least 6 of 66 swollen joints and 8 of 68 tender at screening and baseline visits, and
- hs-CRP ≥8 mg/L at screening
• Continuous treatment with one or a combination of non-biologic DMARDs (except for simultaneous combination use of leflunomide and methotrexate) for at least 12 consecutive weeks prior to randomization and on a stable dose(s) for at least 6 consecutive weeks prior to screening.
Patients who have signed a written informed consent prior to performance of any study-related procedures.

Exclusion Criteria

• Age <18 years
• Treatment with TNF antagonists as follows:
- Etanercept: Within 28 days prior to randomization
- Infliximab, adalimumab, golimumab and certolizumab pegol: Within 42 days prior to randomization
• Treatment with RA-directed biologic agents with non-TNF-α antagonist mechanisms as follows:
- Anakinra: Within 28 days prior to randomization
- Abatacept: Within 42 days prior to randomization
- Rituximab or other cell depleting agent: Within 6 months prior to randomization or until total lymphocyte count and CD 19+ lymphocyte count are normalized, whichever is longer
• Prior treatment with anti-interleukin-6 (anti-IL-6) or anti-interleukin-6 receptor (IL-6R) antagonist therapies, including but not limited to tocilizumab or sarilumab
• Use of oral glucocorticoid greater than prednisone 10 mg per day or equivalent per day, or a change in dosage within 4 weeks prior to randomization
• Use of parenteral glucocorticoids or intra-articular glucocorticoids within 4 weeks prior to randomization

Study & Design

• Study Type: Interventional
• Study Design: Not specified