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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: Clinical Trial Phase 2 study, sponsored by Children's Hospital Medical Center, Cincinnati.

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, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (44% lower). According to ClinicalTrials.gov, the official US trial registry.

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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

Why NCT00035958 stopped before completion

NCT00035958 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 75 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (44% lower).

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

NCT00035958 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT00035958's enrollment target sits among peer trials

75 900th of 2000 higher than 1,081 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00035958, the US trial registry maintained by the National Library of Medicine. NCT00035958 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.