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

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

Long-term, Interventional, Open Label Extension Study Evaluating the Safety of Tocilizumab Treatment in Patients With Polyarticular-course Juvenile Idiopathic Arthritis From France Who Completed the Global, Multinational Trial (WA19977)

NCT01673919•Hoffmann-La Roche

View on ClinicalTrials.gov

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.

Eligibility

Age

4 - No limit years

Sex

ALL

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

Locations (4)

Le Kremlin-Bicêtre, France

Montpellier, France

Paris, France

Key Dates

Start Date

February 1, 2012

Primary Completion Date

January 1, 2014

Completion Date

January 1, 2014

Last Updated

September 12, 2025

Enrollment

ACTUAL participants

Conditions

Juvenile Idiopathic Arthritis

Interventions

tocilizumab [RoActemra/Actemra]

DRUG

Dynamic Gait Index as a Functional Gait Assessment Measure in Children With JIA

NCT06870045

Juvenile Idiopathic ArthritisChildhood Rheumatic Disease

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RECRUITING

Conception of a Diagnosis, Prognosis and Therapeutic Decision Tool for Patients With Autoimmunity and Inflammation

NCT04902807

Autoimmune Lymphoproliferative SyndromeAutoimmune Cytopenia+18 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 12, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Dynamic Gait Index as a Functional Gait Assessment Measure in Children With JIA

Conception of a Diagnosis, Prognosis and Therapeutic Decision Tool for Patients With Autoimmunity and Inflammation

Development of a Therapeutic Endpoint in Pediatric Rheumatologic Conditions

Medical Follow-up of New Cases of Polyarthritis in Children and Young Adults

Clinical, Laboratory and Ultrasound Stratification of Patients With Juvenile Idiopathic Arthritis

Interest of an Adapted Physical Activity (APA) Program Among Patients With Juvenile Idiopathic Arthritis: a Feasibility and Efficacy Preliminary Study