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

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-19

Study Completion Date

2013-12-03

Brief Summary

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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.

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Detailed Description

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Conditions

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Juvenile Idiopathic Arthritis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

RoActemra/Actemra (tocilizumab)

Intervention Type DRUG

Tocilizumab 8 mg/kg every 4 weeks for 104 weeks

Interventions

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RoActemra/Actemra (tocilizumab)

Tocilizumab 8 mg/kg every 4 weeks for 104 weeks

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No