Study to Evaluate the Safety and Tolerability of Two Doses of Rilonacept in Pediatric Subjects With Active Systemic Juvenile Idiopathic Arthritis (SJIA)

Regeneron Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Systemic Juvenile Idiopathic Arthritis

Treatments: Other: Placebo; Drug: rilonacept (IL-1 Trap)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01803321

IL1T-AI-0504

Details and patient eligibility

About

This study is a pilot, ascending dose, multi-center, randomized, double blind, placebo controlled, pediatric study conducted in three phases.

Enrollment: 24 patients

Sex: All

Ages: 4 to 20 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria include, but are not limited to, the following:

• Patients aged 4 to less than 21 years who meet the criteria for active SJIA
• Must have been on a stable dose of non-steroidal anti-inflammatory drugs (NSAIDs) for at least 4 weeks prior to the screening visit

Exclusion Criteria include, but are not limited to, the following:

• Use of certain medications prior to the baseline visit
• History of recurrent infections

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Quadruple Blind

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24 participants in 2 patient groups

Cohort 1

Experimental group

Description:

Dose 1

Treatment:

Drug: rilonacept (IL-1 Trap)

Other: Placebo

Cohort 2

Experimental group

Description:

Dose 2

Treatment:

Drug: rilonacept (IL-1 Trap)

Other: Placebo