None listed
Conditions
Interventions
Group 1 Type of group
Sarilumab 150 mg qw and placebo (matched to golimumab) q4w on top of MTX (15-25 mg) qw for 12 weeks.
Group name:Group 3 Type of group
Placebo 2 mL to match sarilumab once a week (qw) and 0.5 mL to match golimumab every 4 weeks (q4w) on top of MTX (15-25 mg) qw for 12 weeks.
Sponsors
sanofi-aventis Recherche & Development,
Eligibility
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: • Diagnosis of rheumatoid arthritis> 6 months duration and functional status Class I-III of the American College of Rheumatology (ACR) in the selection and baseline. • Active disease • Continuous treatment with MTX for at least 12 weeks prior to selection and maintaining a stable dose (minimum 10 mg / week) for at least 6 weeks prior to the selection visit. • Not responding to the primary TNF-a blocker (up to 2 agents) • Patients who have signed an informed written consent prior to performing any of the procedures related to the study.
Exclusion criteria
Exclusion criteria: • Age 75 years. • Treatment with DMARD (other than MTX) in a period of 4 weeks or 12 weeks prior to the baseline visit (depending on DMARDs) (see Section 7.3.1) • Use of parenteral glucocorticoids or intraarticular glucocorticoids in a period of 4 weeks prior to the baseline visit. • Use of an oral prednisone glucocorticoid greater than 10 mg per day or equivalent per day, or a change in dosage over a period of 4 weeks prior to the baseline visit. • Previous treatment with golimumab. • Previous treatment with anti-IL-6 therapies or IL-6R antagonists, including tocilizumab or SAR15319I or other experimental therapies. • Treatment with a TNF-a blocker in a period of 4 weeks (etanercept), in a period of 6 weeks (infliximab, adalimumab, certolizumab pegol), prior to the baseline visit. • Treatment with biological agents targeting RA with non-TNF-a antagonistic mechanisms, in a period of 4 weeks (anakinra), 6 weeks (abatacept), 6 months (rituximab) with a normal lymphocyte count, prior to baseline.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Percentage of patients who achieve an improvement of 20% from baseline to 12 weeks, evaluated according to the disease activity index of the central group of the American College of Rheumatology [ACR] Measure:Improvement in the ACR20% response rate (composite index) at 12 weeks. Timepoints:Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:The disease activity status will be measured and presented using DAS28. DAS28 is a composite score that includes 4 variables: - Counting painful joints on palpation (based on 28 joints) - Counting inflamed joints (based on 28 joints) - General Health Assessment (GH), here evaluated from of the ACR questionnaire (Global Patient Evaluation) - Inflammation marker, here evaluated by hs-CRP. Measure:Change in Disease Activity Score - 28 Protein-C Reactive (DAS28-CRP) in Weeks 1, 2, 4, 8 and 12. Timepoints:Weeks 1, 2, 4, 8 and 12. ; Outcome name:Percentage of patients who achieve an improvement of CR 50% / ACR 70% from baseline to 12 weeks, evaluated according to the disease activity index of the Central Group of the American College of Rheumatology [ACR] Measure:Improvement in response rates ACR 50% / ACR 70% (composite index of disease activity) for Week 12. Timepoints:Week 12. ; Outcome name:Percentage of patients who achieve an improvement in ACR 20% / ACR 50% / ACR 70% from baseline, evaluated according to the disease activity index of the Central Group of the American College of Rheumatology [ACR] Measure:Improvement in response rates ACR 20% / ACR 50% / ACR 70% (composite index of disease activity) in Weeks 1,2,4 and 8. Timepoints:Weeks 1,2,4 and 8. ; Outcome name:The disease activity response will also be presented using the EULAR (European League Against Rheumatism) response criteria. - Good response = percentage of patients with an improvement> 1.2 and a current DAS score 0.6 to 1.2 and a current score> 3.2. - No response = percentage of patients with an improvement 0.6 to 5.1. Measure:BULAR response rates in Weeks 1, 2,4, 8 and 12. Timepoints:Weeks 1, 2,4, 8 and 12. | — |
Countries
Czech Republic, Germany, Hungaria, Italy, Peru, Spain
Contacts
Public ContactShellah Albites
SANOFI AVENTIS DEL PERU S.A.
Outcome results
None listed