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

Sponsor
Hoffmann-La Roche
Study ID
NCT01575769
Phase
PHASE3
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
2 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Jan 19, 2012
Status verified
Aug 2017
Primary completion
Dec 3, 2013
Completion
Dec 3, 2013

Study Design

Enrollment
41 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 1

Primary Outcome Measure

Percentage of Participants With Adverse Events (AEs) [ Time Frame: Baseline to 12 weeks after last actual study medication (up to 101 weeks) ]

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