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

Sponsor
Hoffmann-La Roche
Study ID
NCT01667471
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
9 Years - 18 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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 aged 9-18 years with at least JIA ACR30 clinical response to RoActemra/Actemra in the core study will be eligible to receive RoActemra/Actemra 8 mg/kg intravenously every 4 weeks. Anticipated time on study treatment is 104 weeks.

Key Dates

Start date
Jan 31, 2012
Status verified
Nov 2016
Primary completion
Aug 31, 2013
Completion
Aug 31, 2013

Study Design

Enrollment
6 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: RoActemra/Actemra

Primary Outcome Measure

Number of Participants With Adverse Events of Special Interest and Study-Drug Related Adverse Events [ Time Frame: Baseline and every 4 weeks up to Week 76 and Final Follow-Up Visit (up to 82 weeks) ]

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