Juvenile Rheumatoid Arthritis

A Randomized, Multi-center, Blinded, Placebo-controlled Study With an Open-label Run-in Period to Evaluate the Efficacy, Safety, and Pharmacokinetics of Daily, Single, Subcutaneous Injections of r-metHuIL-1ra (Anakinra) in Polyarticular-Course Juvenile Rheumatoid Arthritis

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00037648

Enrollment

Registered

2002-05-20

Start date

2000-07-31

Completion date

2003-11-30

Last updated

2009-11-26

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

Conditions

Juvenile Chronic Arthritis

Brief summary

The purpose of this study is to determine the safety of anakinra in patients with Polyarticular-Course Juvenile Rheumatoid Arthritis, a form of rheumatoid arthritis affecting children.

Interventions

DRUGAnakinra

anakinra

DRUGPlacebo

placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

2 Years to 17 Years

Healthy volunteers

Inclusion criteria

* Male or female age 2-17 yrs inclusive \* Minimum weight 10 KG \* Diagnosis of Chronic Arthritis

Design outcomes

Primary

Measure	Time frame
The primary outcome of the study was to evaluate the safety of anakinra	28 weeks

Outcome results

None listed

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