None listed
Conditions
Interventions
Before Phase 3 pivotal dose selection decision: vials (75 mg/ml)
After Phase 3 pivotal dose selection decision, and prior to
availability of prefilled syringes: vials (75 mg/mL, 100 mg/mL)
Af
Sponsors
Sanofi Aventis Recherche & Development,
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: Patients with RA who were randomized: • in the study EFC11072 (a randomized, double-blind, placebocontrolled study in patients with active rheumatoid arthritis who are inadequate responders to MTX therapy) - and who have completed Part A (12 weeks) or Part B (52 weeks) of the study EFC11072. - or patients randomized in Part B of EFC11072 to a treatment arm subsequently not retained following pivotal dose selection. • in the study ACT11575 and completed the treatment period. • in the study EFC10832 - and completed the study treatment period. - or patients from 12 weeks onward with per protocoldefined lack of efficacy • in the study SFY13370 and completed the treatment period
Exclusion criteria
Exclusion criteria: − Patients with any adverse event leading to permanent study drug (active or placebo) discontinuation from a prior study − Treatment with any concurrent biologic agents including investigational drugs for the treatment of RA − Patients with an abnormality(ies) or adverse event(s) that per investigator judgment would adversely affect participation of the patient in the study
Countries
Australia, Austria, Brazil, Canada, China, Colombia, Czech Republic, Ecuador, Egypt, Estonia, Finland, France, French Polynesia, Georgia, Greece, Guayana, Hungary, India, Iran, Israel, Italy, Japan, Lithuania, Maldives, Mexico, Netherlands, New Zealand, Portugal, Russian Federation, Slovakia, Sweden, Taiwan, Turkey, Ukraine, Vietnam
Contacts
Public ContactKatia Lourdes Meza
SANOFI AVENTIS DEL PERU S.A.
Outcome results
None listed