drugset / Trial / NCT00035958

Understanding the Pathogenesis and Treatment of Childhood Onset Dermatomyositis

NCT00035958 ↗

RandomizedParallel-groupOpen-labelTreatment

Summary

Juvenile dermatomyositis (JDMS) is one of the most serious of the childhood rheumatic diseases. The theory behind this trial is that early introduction of etanercept or methotrexate will prove to be effective in the treatment of JDMS. Pretreatment muscle biopsies, we believe there will be abnormalities in the blood vessels that will be correlated with worse physical strength and daily functional ability. The long-term goal is to improve the treatment of this serious childhood onset rheumatic disease and to better understand the pathogenic mechanism for the development of the vasculopathy (disorder of blood vessels) of JDMS. Identification of the specific mechanism of the vasculopathy may allow for the rational introduction of biologic treatments focused on vascular growth.

Timeline

Start
2002-08
Primary completion
2002-08
Completion
2002-08

Outcome

Outcome not reported

Stopped (Business): “Incorporating the recommendations of the NIH-formed DSMB in the study procedures would make the project budget over the limit for this funding mechanism.”

Drugs

EvaluationDrugModalityDoseRoute
Subject Etanercept Protein / enzyme biologic — —
Subject Methotrexate Small molecule — —
Subject Prednisone Other / unclassified — —