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NCT00035958 · ClinicalTrials.gov registry record · Phase 2

Understanding the Pathogenesis and Treatment of Childhood Onset Dermatomyositis

A Phase 2 study, sponsored by Children's Hospital Medical Center, Cincinnati.

Terminated
Registry status
Phase 2
Development phase
75
Enrollment target

NCT00035958 is a Phase 2 study that was terminated before completion, run by Children's Hospital Medical Center, Cincinnati. The registered enrollment target is 75 participants.

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The verdict

NCT00035958, a Phase 2 study, was terminated before completion, sponsored by Children's Hospital Medical Center, Cincinnati.

TERMINATED
Registry status
Phase 2
Development phase
75 participants
Enrollment target

Study 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.

Interventions

  • DRUG Prednisone
  • DRUG Methotrexate
  • DRUG Etanercept

Trial Details

FieldValue
Enrollment Target 75 participants
Start Date 2002-08
Est. Completion 2002-08
Phase Phase 2

What the Registry Record Tells You About NCT00035958

The ClinicalTrials.gov registry entry for NCT00035958 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 75 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Children's Hospital Medical Center, Cincinnati, which has 571 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 3 interventions - of which Prednisone is the first listed.

NCT00035958 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00035958 about?

NCT00035958 is a clinical study titled "Understanding the Pathogenesis and Treatment of Childhood Onset Dermatomyositis". 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 abnormalit...

What is the current status of trial NCT00035958?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 75 participants. The study started on 2002-08. Estimated completion is 2002-08.

What interventions are being tested in trial NCT00035958?

The interventions under investigation include: Prednisone (DRUG), Methotrexate (DRUG), Etanercept (DRUG).

Who is sponsoring clinical trial NCT00035958?

This trial is sponsored by Children's Hospital Medical Center, Cincinnati, which has 571 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.