A Long-Term Extension Study of RoActemra/Actemra (Tocilizumab) in Patients With Juvenile Idiopathic Arthritis From France Who Completed WA19977 Core Study

• Status: Completed
• Trial end date: 2014-01-01
• Target enrollment: 0
• Participant gender: All

Summary

This long-term, open-label extension study will evaluate the safety of RoActemra/Actemra (tocilizumab) in patients with polyarticular-course juvenile idiopathic arthritis who completed the WA19977 core study. Patients will continue to receive RoActemra/Actemra 8 mg/kg intravenously every 4 weeks. 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 visit 33 (week 104) of WA19977 study and who may benefit from study drug treatment according to the investigator's assessment

• Patients have to receive the first RoActemra/Actemra infusion in this study at the Week 8 visit at the latest

• Females of child-bearing potential and males with female partners of child-bearing potential must agree to use effective contraception as defined by protocol

Exclusion Criteria:

• Patients with, according to investigator judgment, not satisfactory benefit from RoActemra/Actemra therapy within WA19977

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

• Patient developed any other autoimmune rheumatic disease or overlap syndrome other than the permitted polyarticular-course Juvenile Idiopathic Arthritis (JIA) subsets: rheumatoid factor positive or negative JIA or extended oligoarticular JIA

• Patient is pregnant , lactating, or intending to become pregnant during the study and up to 12 weeks after the last administration of study drug

• Any significant concomitant disease or medical or surgical condition

• History of significant allergic or infusion reactions to prior biologic therapy

• Currently active primary or secondary immunodeficiency

• Any infections with contraindications to RoActemra/Actemra therapy according to investigator judgment

• Inadequate hepatic, renal or bone marrow function