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

NCT ID: NCT01673919

Last Updated: 2025-09-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-02-29
• Study Completion Date: 2014-01-31

Brief 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.

Conditions

Juvenile Idiopathic Arthritis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

RoActemra/Actemra

Group Type: EXPERIMENTAL

tocilizumab [RoActemra/Actemra]

Intervention Type: DRUG

8 mg/kg iv every 4 weeks, 104 weeks

Interventions

tocilizumab [RoActemra/Actemra]

8 mg/kg iv every 4 weeks, 104 weeks

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 4 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

Le Kremlin-Bicêtre, , France

Montpellier, , France

Paris, , France

Paris, , France

Countries

France

Other Identifiers

2011-005515-90

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

ML28166

Identifier Type: -

Identifier Source: org_study_id