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
- RoActemra/Actemra (tocilizumab) — DRUGTocilizumab 8 mg/kg every 4 weeks for 104 weeks
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) ]
Related Studies
- Development of a Therapeutic Endpoint in Pediatric Rheumatologic ConditionsRecruiting · Children's National Research Institute · Washington D.C., District of Columbia
- Study of Oral Upadacitinib and Subcutaneous/Intravenous Tocilizumab to Evaluate Change in Disease Activity, Adverse Events and How Drug Moves Through the Body of Pediatric and Adolescent Participants With Active Systemic Juvenile Idiopathic Arthritis.PHASE3 · Recruiting · AbbVie · Phoenix, Arizona
- Pain in Juvenile ArthritisRecruiting · Washington University School of Medicine · St Louis, Missouri