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NCT00106184 · ClinicalTrials.gov registry record · Phase 2
Rituximab for the Treatment of Refractory Adult and Juvenile Dermatomyositis (DM) and Adult Polymyositis (PM)
A Phase 2 study, sponsored by University of Pittsburgh.
- Completed
- Registry status
- Phase 2
- Development phase
- 200
- Enrollment target
NCT00106184: Completed Phase 2 study, sponsored by University of Pittsburgh.
NCT00106184 is a Phase 2 study that has completed, run by University of Pittsburgh. The registered enrollment target is 200 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (50% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00106184, a Phase 2 study, has completed, sponsored by University of Pittsburgh.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 200 participants
- Enrollment target
Study Summary
Rituximab is a man-made antibody used to treat certain types of cancer. This study will determine whether rituximab is an effective treatment for adult and pediatric patients with dermatomyositis or polymyositis. Study hypotheses: 1) The time to improvement in Group A patients (receiving rituximab first) will occur significantly earlier than in Group B patients (receiving rituximab later). 2) The proportion of patients improved at Week 8 of the treatment phase will be significantly greater in Group A than in Group B.
Primary Outcome
The Definition of Improvement for both adult and pediatric patients will be: 3 of any of the 6 core set measures improved by ≥ 20%, with no more than 2 of the core set measures worsening by ≥25% (worsening measure cannot include the MMT) at two consecutive visits. Of note, the MMT could not be one of the worsening measures. Core Set Measures Included: 1. Manual Muscle Testing (MMT)- Muscle Strength 2. Physician Global Disease Activity VAS Score 3. Health Assessment Questionnaire Index Score -
Interventions
- DRUG Placebo
- DRUG Rituximab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2006-03 |
| Est. Completion | 2010-08 |
| Phase | Phase 2 |
What the finished NCT00106184 record still lists
NCT00106184 is an interventional study that assigns participants to a tested intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (50% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00106184 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00106184 about?
NCT00106184 is a clinical study titled "Rituximab for the Treatment of Refractory Adult and Juvenile Dermatomyositis (DM) and Adult Polymyositis (PM)". Rituximab is a man-made antibody used to treat certain types of cancer. This study will determine whether rituximab is an effective treatment for adult and pediatric patients with dermatomyositis or polymyositis. Study hypotheses: 1) The time to improvement in Group A patients (receiving rituximab ...
What is the current status of trial NCT00106184?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 200 participants. The study started on 2006-03. Estimated completion is 2010-08.
What interventions are being tested in trial NCT00106184?
The interventions under investigation include: Placebo (DRUG), Rituximab (DRUG).
Who is sponsoring clinical trial NCT00106184?
This trial is sponsored by University of Pittsburgh, which has 1,238 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00106184's enrollment target sits among peer trials
200 304th of 2000 higher than 1,652 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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