A Study of RoActemra/Actemra (Tocilizumab) in Patients With Active Systemic Juvenile Idiopathic Arthritis (JIA)
| Status: | Completed |
|---|---|
| Conditions: | Arthritis |
| Therapuetic Areas: | Rheumatology |
| Healthy: | No |
| Age Range: | 2 - 17 |
| Updated: | 4/21/2016 |
| Start Date: | May 2008 |
| End Date: | August 2014 |
A Randomized, Placebo-controlled Study to Evaluate the Effect of Tocilizumab on Disease Response in Patients With Active Systemic Juvenile Idiopathic Arthritis (JIA), With an Open-label Extension to Examine the Long Term Use of Tocilizumab
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 NSAIDs and corticosteroids. In Part I of the study patients will be
randomized 2:1 to receive iv infusions of RoActemra/Actemra (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 II of the study to receive open-label treatment with
RoActemra/Actemra for a further 92 weeks, followed by a 3-year continuation of the study in
Part III in which, for patients who meet specific criteria, an optional alternative dosing
schedule decreasing the study drug administration frequency will be introduced. Anticipated
time on study treatment is up to 5 years.
patients with active systemic juvenile idiopathic arthritis (sJIA) who have an inadequate
clinical response to NSAIDs and corticosteroids. In Part I of the study patients will be
randomized 2:1 to receive iv infusions of RoActemra/Actemra (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 II of the study to receive open-label treatment with
RoActemra/Actemra for a further 92 weeks, followed by a 3-year continuation of the study in
Part III in which, for patients who meet specific criteria, an optional alternative dosing
schedule decreasing the study drug administration frequency will be introduced. Anticipated
time on study treatment is up to 5 years.
Inclusion Criteria:
- 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 Criteria:
- 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
We found this trial at
14
sites
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