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NCT00278525 · ClinicalTrials.gov registry record · Phase 2
Cyclophosphamide and rATG With Hematopoietic Stem Cell Support in Systemic Scleroderma
A Phase 2 study of Systemic Scleroderma, sponsored by Northwestern University.
- Completed
- Registry status
- Phase 2
- Development phase
- 19
- Enrollment target
- 1
- Study location
NCT00278525 is a Phase 2 study of Systemic Scleroderma that has completed, run by Northwestern University. The registered enrollment target is 19 participants, below the 50-participant average among 4 other Systemic Scleroderma trials with a reported enrollment target (62% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00278525, a Phase 2 study of Systemic Scleroderma, has completed, sponsored by Northwestern University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 19 participants
- Enrollment target
- 1
- Study location
Study Summary
Scleroderma is a systemic disorder categorized as an immunologically mediated disease that causes collagen deposition of skin and visceral organs. The molecular pathogenesis of scleroderma has been elusive, although vasculopathy and immune mediated mechanisms are thought to be important. Once extensive cutaneous or visceral disease occurs, prognosis is significantly shorter than the general population. Although various treatments have been tried, none of them seems to have changed the natural history of scleroderma. Standard dose immunosuppressive treatment has been disappointing. Recently, cyclophosphamide at 1-2 mg/kg/day orally or 800-1400 mg intravenous (IV) monthly for 6-9 months has proven effective in treatment of scleroderma alveolitis (1). Recent phase I studies of immunoablation with autologous peripheral blood stem cell transplantation (PBSCT) showed some promising data, but the exact efficacy is undetermined (2,3). We now propose, as a phase II randomized study, autologous unmanipulated PBSCT versus pulse cyclophosphamide in patients with systemic scleroderma.
Conditions Studied
Interventions
- DRUG standard of care
- PROCEDURE stem cell transplantation
Study Locations (1)
Illinois
- Northwestern University, Feinberg School of Medicine - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2005-09 |
| Est. Completion | 2012-12 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00278525
The ClinicalTrials.gov registry entry for NCT00278525 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 19 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 50-participant average among 4 other Systemic Scleroderma trials with a reported enrollment target (62% lower). The listed sponsor is Northwestern University, which has 1,209 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Systemic Scleroderma appearing as the primary indexed condition, and to 2 interventions - of which standard of care is the first listed.
NCT00278525 reports 1 study location spanning 1 distinct geographic area - top geographies include Illinois.
Frequently Asked Questions
What is clinical trial NCT00278525 about?
NCT00278525 is a clinical study titled "Cyclophosphamide and rATG With Hematopoietic Stem Cell Support in Systemic Scleroderma". Scleroderma is a systemic disorder categorized as an immunologically mediated disease that causes collagen deposition of skin and visceral organs. The molecular pathogenesis of scleroderma has been elusive, although vasculopathy and immune mediated mechanisms are thought to be important. Once extens...
What is the current status of trial NCT00278525?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 19 participants. The study started on 2005-09. Estimated completion is 2012-12.
What conditions does trial NCT00278525 study?
This clinical trial studies the following conditions: Systemic Scleroderma.
What interventions are being tested in trial NCT00278525?
The interventions under investigation include: standard of care (DRUG), stem cell transplantation (PROCEDURE).
Who is sponsoring clinical trial NCT00278525?
This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00278525 being conducted?
This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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