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

Roche

Status and phase: Terminated; Phase 3

Conditions: Juvenile Idiopathic Arthritis

Treatments: Drug: RoActemra/Actemra (tocilizumab)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01575769

ML27783

Details and patient eligibility

About

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.

Enrollment: 41 patients

Sex: All

Ages: 2+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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41 participants in 1 patient group

1

Experimental group

Treatment:

Drug: RoActemra/Actemra (tocilizumab)