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

A Pilot, Multi-center, Randomized, Double-Blind, Placebo-Controlled, Ascending Dose, Safety, Tolerability and Preliminary Efficacy Study of Two Dose Levels of IL-1 Trap Administered Subcutaneously in Pediatric Subjects With Active Systemic Juvenile Idiopathic Arthritis (SJIA)

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01803321

Enrollment

Registered

2013-03-04

Start date

2005-11-30

Completion date

2008-06-30

Last updated

2013-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Systemic Juvenile Idiopathic Arthritis

Keywords

SJIA

Brief summary

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

Interventions

DRUGrilonacept (IL-1 Trap)

OTHERPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

4 Years to 20 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Frequency of treatment emergent adverse events (TEAEs)	Baseline to Week 123

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026