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Trial of Early Aggressive Drug Therapy in Juvenile Idiopathic Arthritis

NCT00443430 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 85

Last updated 2013-05-31

Study results available
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Summary

The purpose of this study is to compare two aggressive drug regimens for children with poly-juvenile idiopathic arthritis (JIA) and extended oligo JIA.

Conditions

  • Juvenile Chronic Polyarthritis
  • Juvenile Idiopathic Arthritis
  • Juvenile Rheumatoid Arthritis

Interventions

DRUG

methotrexate

Methotrexate 0.5 mg/kg given by sub cutaneous injection once per week, plus placebo etanercept and and placebo prednisolone

DRUG

methotrexate - etanercept - prednisolone arm

methotrexate 0.5 mg/kg given by sub cutaneous injection once per week, plus etanercept 0.8 mg/kg given by sub cutaneous injection once per week, plus prednisolone, by mouth daily with decreasing dose tapered over 16 weeks.

Sponsors & Collaborators

  • National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

    collaborator NIH

  • Amgen

    collaborator INDUSTRY

  • Seattle Children's Hospital

    lead OTHER

Principal Investigators

  • Carol A. Wallace, MD · Childrens Hospital and Regional Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-05-31
Primary Completion
2010-10-31
Completion
2010-10-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00443430 on ClinicalTrials.gov