Rheumatoid Arthritis MedDRA version: 18.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Conditions
Sponsors
sanofi-aventis recherche & développement
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate that sarilumab monotherapy is superior to adalimumab monotherapy with respect to signs and symptoms as assessed by disease activity score 28 (DAS28)-erythrocyte sedimentation rate (ESR) in patients with active rheumatoid arthritis (RA) who are either intolerant of, or considered inappropriate candidates for continued treatment with methotrexate (MTX), or after at least 12 weeks of continuous treatment with MTX, are determined to be inadequate responders.;Secondary Objective: To demonstrate that sarilumab monotherapy is superior to adalimumab monotherapy in patients with active RA who are either intolerant of, or considered inappropriate candidates for continued treatment with methotrexate (MTX), or after at least 12 weeks of continuous treatment with MTX, are determined to be inadequate responders, with respect to: • Reduction of signs and symptoms of RA • Improvement in quality of life assessed by patient reported outcome questionnaires. Assessment of the safety and tolerability of sarilumab monotherapy (including immunogenicity) throughout the study.;Primary end point(s): Change from baseline in disease activity score 28 (DAS28) - erythrocyte sedimentation rate (ESR);Timepoint(s) of evaluation of this end point: Week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1- American College of Rheumatology 20 (ACR2020, ACR50 and ACR70 response 2- Change from baseline in each individual ACR component 3- Change from baseline in DAS28-CRP 4- DAS28-ESR remission (<2.6) 5- DAS28-CRP remission (<2.6) 6- Low disease activity (DAS28-ESR <3.2) 7- Remission based on clinical disease activity index (CDAI) (=2.8) 8- Change from baseline in CDAI 9- Sarilumab exposure assessed by trough serum sarilumab concentrations. 10- Change from baseline in: short form 36 (SF-36) scores Change from baseline in: EQ-5D-3L scores Change from baseline in: rheumatoid arthritis impact of disease (RAID) scores Change from baseline in: work productivity survey-rheumatoid arthritis (WPS-RA) scores Change from baseline in: functional assessment of chronic illness therapy-fatigue (FACIT-F) scores Change from baseline in: morning stiffness visual analog scale (VAS) scores 11- Number of patients with adverse events Clinically significant changes in laboratory values: hematology, clinical chemistry, and urinalysis Clinically significant changes in ECG Clinically significant changes in vital signs Measurement of anti-drug antibody (ADA) levels ;Timepoint(s) of evaluation of this end point: 1 to 8: week 24 9: over time, maximum to week 306 10: week 24 11: over time, maximum to week 306 | — |
Countries
Chile, Czech Republic, Germany, Hungary, Israel, Korea, Republic of, Peru, Poland, Puerto Rico, Romania, Russian Federation, South Africa, Spain, Ukraine, United Kingdom, United States
Contacts
Public Contactwww.sanofi.cz
sanofi-aventis, s.r.o.
Outcome results
None listed