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

Roche

Status and phase

Completed

Phase 3

Conditions

Juvenile Idiopathic Arthritis

Treatments

Drug: tocilizumab [RoActemra/Actemra]

Study type

Interventional

Funder types

Industry

Identifiers

NCT01673919

ML28166

2011-005515-90 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

7 patients

Sex

All

Ages

4+ years old

Volunteers

No Healthy Volunteers

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