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NCT00112385 · ClinicalTrials.gov registry record · Phase 1
A Pilot Study of Etanercept in Dermatomyositis
A Phase 1 study, sponsored by Brigham and Women's Hospital.
- Completed
- Registry status
- Phase 1
- Development phase
- 16
- Enrollment target
NCT00112385 is a Phase 1 study that has completed, run by Brigham and Women's Hospital. The registered enrollment target is 16 participants.
The verdict
NCT00112385, a Phase 1 study, has completed, sponsored by Brigham and Women's Hospital.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 16 participants
- Enrollment target
Study Summary
The purpose of the study is to obtain preliminary data regarding the safety and tolerability of etanercept in DM. In addition, we will use the study to assess the variability, reliability, and responsiveness of the core set of outcome measures recommended by IMACS. The study will be performed under the aegis of the Muscle Study Group (MSG), consisting of experienced investigators with an avid interest in myopathies. The ultimate goal of this pilot study will be to obtain necessary, prerequisite information important in designing future therapeutic trials of etanercept and other agents in patients with DM. The specific aims of the study are: Aim 1: To preliminarily assess the safety and tolerability of etanercept in patients with DM. Aim 2: To assess the safety and tolerability of prednisone in the dosing schedule we propose to use. Aim 3: To evaluate outcome measures recommended by IMACS and assess their variability, reliability, and responsiveness in order to facilitate the design of future therapeutic trials in the inflammatory myopathies.
Interventions
- DRUG Placebo
- DRUG Etanercept
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2006-03 |
| Est. Completion | 2010-06 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00112385
The ClinicalTrials.gov registry entry for NCT00112385 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Brigham and Women's Hospital, which has 937 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00112385 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00112385 about?
NCT00112385 is a clinical study titled "A Pilot Study of Etanercept in Dermatomyositis". The purpose of the study is to obtain preliminary data regarding the safety and tolerability of etanercept in DM. In addition, we will use the study to assess the variability, reliability, and responsiveness of the core set of outcome measures recommended by IMACS. The study will be performed under ...
What is the current status of trial NCT00112385?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2006-03. Estimated completion is 2010-06.
What interventions are being tested in trial NCT00112385?
The interventions under investigation include: Placebo (DRUG), Etanercept (DRUG).
Who is sponsoring clinical trial NCT00112385?
This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.
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