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RAPPORT: Rilonacept in Systemic Juvenile Idiopathic Arthritis
NCT00534495Phase 2
Key facts
- Status
- Completed
- Start
- Nov 2008
- Primary completion
- Jun 2013
- Countries
- 1
- Sponsor
- Montefiore Medical Center
- Modality
- Fc-Fusion Proteins
- Drugs
- rilonacept
- Conditions
- systemic juvenile idiopathic arthritis (SJIA)
01
Overview
Phase 2, randomised, double-blind trial in systemic juvenile idiopathic arthritis (SJIA) comparing Rilonacept Early Start with Placebo / Rilonacept Delayed Start (2 arms). Primary endpoints: Time to Response to Treatment at 12 weeks and Number of Serious Adverse Events, Adverse Events, Infections, Development of MAS at 24 weeks. Started Nov 2008; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Rilonacept Early Start
Rilonacept loading dose at Week 0, then weekly.
Placebo / Rilonacept Delayed Start
Placebo for 4 weeks, then Rilonacept loading dose at Week 4, then weekly.
03
Endpoints
Primary
Time to Response to Treatment
Number of Serious Adverse Events, Adverse Events, Infections, Development of MAS
Secondary
JIA ACR50 and JIA ACR70 Response
Pediatric Quality of Life Inventory
Childhood Health Assessment Questionnaire
Presence of Systemic Features (Fever, Rash)
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