Status:
COMPLETED
A Study of Tocilizumab in Patients With Active Polyarticular Juvenile Idiopathic Arthritis
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Juvenile Idiopathic Arthritis
Eligibility:
All Genders
2-17 years
Phase:
PHASE3
Brief Summary
This 3-part study evaluated the efficacy and safety of tocilizumab in patients with active polyarticular-course juvenile idiopathic arthritis who have an inadequate response to, or were intolerant of ...
Eligibility Criteria
Inclusion
- Children/juveniles, 2-17 years of age.
- Polyarticular-course juvenile idiopathic arthritis (pcJIA) ≥ 6 months duration.
- Active disease (≥ 5 active joints, ≥ 3 with limitation of motion).
- Inadequate response to or inability to tolerate methotrexate.
- Methotrexate, oral corticosteroids, and non-steroidal anti-inflammatory drugs (NSAID) at stable dose(at least 8, 4, and 2 weeks,respectively) prior to baseline.
- Biologics discontinued, between at least 1 and 20 weeks prior to baseline, depending on biologic.
Exclusion
- Auto-immune, rheumatic disease or overlap syndrome other than pcJIA.
- Wheelchair bound or bedridden.
- Intra-articular, intramuscular, intravenous, or long-acting corticosteroids within 4 weeks prior to baseline.
- Disease-modifying anti-rheumatic drugs (DMARD) (other than methotrexate) within 4 weeks prior to baseline.
- Previous treatment with tocilizumab.
Key Trial Info
Start Date :
November 30 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 28 2013
Estimated Enrollment :
188 Patients enrolled
Trial Details
Trial ID
NCT00988221
Start Date
November 30 2009
End Date
January 28 2013
Last Update
July 26 2017
Active Locations (69)
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1
Connecticut Children's Medical Center; 5E Clinical Trials Unit
Hartford, Connecticut, United States, 06106
2
Children's National Medical Center; Pediatric Rheumatology
Washington D.C., District of Columbia, United States, 20010-2970
3
Delray Research Associates
Delray Beach, Florida, United States, 33484
4
Miami Children's Hospital
Miami, Florida, United States, 33155-3009