Status:
COMPLETED
A Study of RoActemra/Actemra (Tocilizumab) in Patients With Active Systemic Juvenile Idiopathic Arthritis (JIA)
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Juvenile Idiopathic Arthritis
Eligibility:
All Genders
2-17 years
Phase:
PHASE3
Brief Summary
This study will evaluate the efficacy and safety of RoActemra/Actemra (tocilizumab) in patients with active systemic juvenile idiopathic arthritis (sJIA) who have an inadequate clinical response to NS...
Eligibility Criteria
Inclusion
- Patients aged 2-17 years of age
- Systemic juvenile idiopathic arthritis with \>= 6 months persistent activity
- Presence of active disease (\>=5 active joints, or \>=2 active joints + fever + steroids)
- Inadequate clinical response to nonsteroidal anti-inflammatory drugs (NSAIDs) and corticosteroids due to toxicity or lack of efficacy
Exclusion
- Wheelchair-bound or bed-ridden
- Any other autoimmune, rheumatic disease or overlap syndrome other than systemic juvenile idiopathic arthritis
- Intravenous long-acting corticosteroids or intra-articular corticosteroids within 4 weeks of baseline, or throughout study
- Disease-modifying antirheumatic drugs (DMARDs), other than methotrexate
- Previous treatment with tocilizumab
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2014
Estimated Enrollment :
112 Patients enrolled
Trial Details
Trial ID
NCT00642460
Start Date
May 1 2008
End Date
August 1 2014
Last Update
July 25 2016
Active Locations (54)
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1
Little Rock, Arkansas, United States, 45229-3039
2
Los Angeles, California, United States, 90027
3
Hartford, Connecticut, United States, 06106
4
Augusta, Georgia, United States, 30912