An Extension Study to WA19977 in Patients With Active Polyarticular-Course Juvenile Idiopathic Arthritis

• Status: Terminated
• Trial end date: 2013-12-03
• Target enrollment: 0
• Participant gender: All

Summary

This long-term, interventional, open-label extension study will evaluate the safety and efficacy of RoActemra/Actemra (tocilizumab) in patients from Poland and Russia with polyarticular-course juvenile idiopathic arthritis who completed the WA19977 study. Patients will receive RoActemra/Actemra 8 mg/kg every 4 weeks. The anticipated time on study treatment is 104 weeks.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche

Criteria

Inclusion Criteria:

• Patients who completed 104 weeks of study WA19977 with at least a JIA ACR30 clinical response to RoActemra/Actemra and no serious adverse event or adverse event

• Written informed consent obtained from patient if patient is 18 years of age and older, or if under the age of 18 years from parents or legal guardian

Exclusion Criteria:

• Patient did not benefit from RoActemra/Actemra therapy in study WA19977

• Treatment with any investigational drug since the last administration of study drug in the core study WA19977

• Patients developed any other autoimmune rheumatic disease other than the permitted JIA subsets

• Any significant medical or surgical condition that would jeopardize patient's safety

• Current serious uncontrolled concomitant disease or infection