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Therapeutic Areas: Rheumatology | Pediatrics/Neonatology
Disease Category: Arthritis and Arthritic Pain (Pediatric)
Trial Information
A Study of Tocilizumab in Patients With Active Systemic Juvenile Idiopathic Arthritis
Status: Recruiting
Protocol Number: WA18221
Sponsor: Hoffmann-La Roche
Company Division: Pharmaceutical
Official Scientific Title: A randomized, placebo-controlled study to evaluate the effect of tocilizumab on disease response in patients with active systemic juvenile idiopathic arthritis, with an open-label extension to examine the long term use of tocilizumab
Brief Summary: This study will evaluate the efficacy and safety of tocilizumab in patients with active systemic juvenile idiopathic arthritis (sJIA) who have an inadequate clinical response to NSAIDs and corticosteroids. In Part 1 of the study patients will be randomized 2:1 to receive iv infusions of tocilizumab (8mg/kg iv for patients >=30kg, or 12mg/kg for patients <30kg) or placebo, every 2 weeks. Stable NSAIDs and methotrexate will be continued throughout. After 12 weeks of double-blind treatment, all patients will have the option to enter Part 2 of the study to receive open-label treatment with tocilizumab for a further 92 weeks. The anticipated time on study treatment is 2 years, and the target sample size is 100-500 individuals. Target sample size is 108.
Study Phase: III
Study Design / Study Details:
- Purpose: Treatment
- Allocation: Randomized
- Masking: Double Blind
- Control: Placebo
- Assignment: Parallel
- Endpoints: Safety/Efficacy
Study Type:
Interventional
Condition: Juvenile Idiopathic Arthritis
Intervention Type: Drug
Intervention Name: tocilizumab
Primary Outcome: 1. Proportion of patients with >=30% improvement in JIA core set and absence of fever Time frame: Week 12
Key Secondary Outcomes: 1. % patients with 30/50/70/90% improvement in JIA core set; reduction in steroid use; change in individual components of JIA core set; change in hsCRP, anemia, platelet count, total WBC, incidence of rash;improvement in CHAQ, and VAS Time frame: Week 12
2. Time from baseline to achievement of JIA ACR 30/50/70/90 Time frame: Throughout study
3. AEs, lab parameters Time frame: Throughout study
Inclusion Criteria:
- patients aged 2-17 years of age;
- systemic JIA with >= 6 months persistent activity;
- presence of active disease (>=5 active joints, or >=2 active joints + fever + steroids);
- inadequate clinical response to NSAIDs and corticosteroids due to toxicity or lack of efficacy.
Exclusion Criteria:
- wheelchair or bed-ridden;
- any other autoimmune, rheumatic disease or overlap syndrome other than sJIA;
- intravenous long-acting corticosteroids or intra-articular corticosteroids within 4 weeks of baseline, or throughout study;
- DMARDs (other than methotrexate);
- previous treatment with tocilizumab.
Gender: Males or Females
Age Limits: Min: 2 Years Max: 17 Years
Accepts Healthy Volunteers: No
Anticipated Start Date: May, 2008
Trial Registration Date: 03/18/2008
Date Last Updated: 12/08/2008
Link To Trial Results
Research Site:
Located In:
Halifax, NS B3H 1V7
Canada
Phone: 973-235-5000 or 800-526-6367
View Google Map
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