A Study of RoActemra/Actemra (Tocilizumab) in Patients With Active Systemic Juvenile Idiopathic Arthritis (JIA)

Conditions

• Juvenile Idiopathic Arthritis

Eligibility Criteria

Sex

ALL

Age

2 Years - 17 Years

Healthy Volunteers

Not accepted

Interventions

• tocilizumab [RoActemra/Actemra] — DRUG
  8mg/kg (patients\>=30kg) or 12mg/kg (patients \<30kg) iv every 2 weeks. In Part III, administration frequency may be reduced to every 3 and every 4 weeks, respectively, according to an optional alternative dosing schedule.
• Placebo — DRUG
  iv every 2 weeks for 12 weeks
• Non-steroidal anti-inflammatory drugs (NSAIDs) — DRUG
  as prescribed
• methotrexate — DRUG
  as prescribed
• corticosteroids — DRUG
  orally, as prescribed

Study Details

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.

Key Dates

Start date

May 31, 2008

Status verified

Jun 2016

Primary completion

Sep 30, 2009

Completion

Aug 31, 2014

Study Design

Enrollment

112 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: 1
• Placebo Comparator: 2

Primary Outcome Measure

Part I: Percentage of Participants With ≥30% Improvement in Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) Core Set and Absence of Fever [ Time Frame: Baseline, Week 12 ]

Locations (13)

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• Development of a Therapeutic Endpoint in Pediatric Rheumatologic Conditions
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• Pain in Juvenile Arthritis
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