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NCT00860548 · ClinicalTrials.gov registry record
SCOT Scleroderma Treatment Alternative Registry (STAR Registry)
A clinical trial, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- 19
- Enrollment target
NCT00860548 is a clinical trial that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 19 participants.
The verdict
NCT00860548 has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- 19 participants
- Enrollment target
Study Summary
The Scleroderma Cyclophosphamide Or Transplant (SCOT) Trial is a Phase II/III interventional trial comparing two treatments for early, severe scleroderma. These two interventions are high dose immunosuppressive therapy followed by autologous stem cell transplantation and monthly high dose pulse cyclophosphamide (the later for 12 doses). While standard of care might be considered the optimal control arm for a trial such as this one, no such standard of care is available for the population of scleroderma patients defined by the eligibility criteria for this trial. The rheumatologists on the protocol team believe that the SCOT cyclophosphamide regimen represents the best control arm for this study. However, given concerns over use of a treatment arm as a control that has not been established as a standard of care, this registry was established. The registry will be a prospective, observational study of subjects with severe systemic sclerosis (SSc) who are eligible to participate in the Scleroderma Cyclophosphamide or Transplantation (SCOT) Study but are denied insurance coverage or decline to participate prior to randomization. Subjects will be accrued over the same period as the SCOT study. Subjects will follow the course of treatment prescribed by their treating physician with no interference from the registry. The primary purpose of this study is to document the disease course and outcome in a group of participants who are eligible for the SCOT study, but declined to participate, in order to determine whether their outcome is better, worse, or no different than those who participate in the treatment phase of the trial.
Interventions
- DRUG currently available therapy in the community
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2005-06 |
| Est. Completion | 2016-03 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00860548
The ClinicalTrials.gov registry entry for NCT00860548 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 19 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which currently available therapy in the community is the first listed.
NCT00860548 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00860548 about?
NCT00860548 is a clinical study titled "SCOT Scleroderma Treatment Alternative Registry (STAR Registry)". The Scleroderma Cyclophosphamide Or Transplant (SCOT) Trial is a Phase II/III interventional trial comparing two treatments for early, severe scleroderma. These two interventions are high dose immunosuppressive therapy followed by autologous stem cell transplantation and monthly high dose pulse cycl...
What is the current status of trial NCT00860548?
This trial is currently completed. The enrollment target is 19 participants. The study started on 2005-06. Estimated completion is 2016-03.
What interventions are being tested in trial NCT00860548?
The interventions under investigation include: currently available therapy in the community (DRUG).
Who is sponsoring clinical trial NCT00860548?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
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