NCT00037648

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
86

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jul 2000

Typical duration for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2000

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

May 17, 2002

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 20, 2002

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2003

Completed
Last Updated

November 26, 2009

Status Verified

February 1, 2008

Enrollment Period

3.3 years

First QC Date

May 17, 2002

Last Update Submit

November 25, 2009

Conditions

Juvenile Chronic Arthritis

Outcome Measures

Primary Outcomes (1)

  • The primary outcome of the study was to evaluate the safety of anakinra

    28 weeks

Study Arms (2)

placebo

PLACEBO COMPARATOR
Drug: Placebo

anakinra

EXPERIMENTAL
Drug: Anakinra

Interventions

AnakinraDRUG

anakinra

anakinra
PlaceboDRUG

placebo

placebo

Eligibility Criteria

Age2 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
* Male or female age 2-17 yrs inclusive \* Minimum weight 10 KG \* Diagnosis of Chronic Arthritis

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Arthritis, Juvenile

Interventions

Interleukin 1 Receptor Antagonist Protein

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

CytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Officials

  • MD

    Amgen

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 17, 2002

First Posted

May 20, 2002

Study Start

July 1, 2000

Primary Completion

November 1, 2003

Study Completion

November 1, 2003

Last Updated

November 26, 2009

Record last verified: 2008-02