None listed
Conditions
Interventions
Investigational medicinal product(s) - Open label phase:
Adalimumab formulation: Single-use, prefilled glass syringe providing 40 mg of adalimumab solution for injection. Route(s) of administration
Sponsors
Sanofi Aventis Recherche & Development,
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: Main inclusion criteria for the open label treatment phase: •Diagnosis of rheumatoid arthritis, according to the American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) 2010 Rheumatoid Arthritis Classification Criteria with ≥3 months disease duration (Aletaha 2010a) •ACR Class I-III functional status, based on the 1991 revised criteria (Hotchberg 1992b) •Continuous treatment with MTX 10 to 25 mg/wk (or per local labeling requirements if the dose range differs) for at least 12 weeks prior to the Screening Visit and on a stable dose(s) for at least 8 weeks prior to the Screening Visit •Active disease defined as: -at least 6 of 66 swollen joints and 8 of 68 tender joints and; -high sensitivity C-reactive protein (hs-CRP) >10 mg/L (>1.0 mg/dL) at the Screening Visit •Signed a written informed consent prior to performance of any study-related procedures Main inclusion criteria for the randomized phase: •Participated in the run-in phase and willing to continue in the randomized controlled study phase. •DAS28-CRP >3.5 Main exclusion criteria for the sub-study: •Adverse event or laboratory abnormality(ies) at the open label end of treatment visit which, based on Investigator judgment, would adversely influence the patient by participation in the sarilumab sub-study
Exclusion criteria
Exclusion criteria: Main exclusion criteria for the open label treatment phase: •Age <18 years •Use of parenteral corticosteroids or intra-articular corticosteroids within 4 weeks of the Screening Visit •Use of oral corticosteroids in a dose higher than prednisone 10 mg or equivalent per day, or a change in dosage within 4 weeks of the Screening Visit •Prior treatment with a TNF-α inhibitor, or other biological disease modifying anti-rheumatic drug (DMARD) or Janus Kinase inhibitor (eg, tofacitinib)
Countries
Argentina, Australia, Brazil, Chile, Colombia, Czech Republic, Ecuador, Finland, France, Germany, Greece, Guatemala, Hungary, India, Israel, Italy, Korea South, Lithuania, Malasya, Mexico, New Zealand, Poland, Romania, Russian Federation, South Africa, Spain, Taiwan, Ukraine, United States
Contacts
Public ContactKatia Lourdes Meza
SANOFI AVENTIS DEL PERU S.A.
Outcome results
None listed