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NCT00506831 · ClinicalTrials.gov registry record · Phase 1
Imatinib in Systemic Sclerosis
A Phase 1 study of Scleroderma, Systemic, sponsored by Stanford University.
- Completed
- Registry status
- Phase 1
- Development phase
- 9
- Enrollment target
- 1
- Study location
NCT00506831: Completed Phase 1 study of Scleroderma, Systemic, sponsored by Stanford University.
NCT00506831 is a Phase 1 study of Scleroderma, Systemic that has completed, run by Stanford University. The registered enrollment target is 9 participants, below the 83-participant average among 6 other Scleroderma, Systemic trials with a reported enrollment target (89% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00506831, a Phase 1 study of Scleroderma, Systemic, has completed, sponsored by Stanford University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 9 participants
- Enrollment target
- 1
- Study location
Study Summary
Systemic sclerosis (SSc) is an autoimmune disease characterized by fibrosis of the skin and internal organs and widespread vasculopathy. Patients with SSc are classified according to the extent of cutaneous sclerosis: patients with limited SSc have skin thickening of the face, neck, and distal extremities, while those with diffuse SSc have involvement of the trunk, abdomen, and proximal extremities as well. The disease course varies depending on the subtype of SSc. However, common features that result in significant morbidity and mortality, in addition to cutaneous fibrosis, include Raynaud's phenomenon and digital ulcerations, interstitial lung disease (ILD), and pulmonary arterial hypertension (PAH). Current therapeutic options for patients with SSc and these clinical manifestations have shown limited efficacy. Imatinib antagonizes specific tyrosine kinases that mediate fibrotic pathways involved in the pathogenesis of SSc, including c-Abl, a downstream mediator of transforming growth factor (TGF)-beta, and platelet derived growth factor (PDGF) receptors. The efficacy of imatinib has also been reported in the treatment of patients with refractory idiopathic PAH through its effects on vascular remodeling. Based on the mechanism of action and preliminary patient data, we hypothesize that imatinib may be effective in the treatment of the fibrotic and vasculopathic features of patients with SSc. This is an open label pilot study to evaluate the safety and efficacy of imatinib in patients with progressive SSc refractory to other treatment(s). Validated measures of skin thickness and disease activity will be determined over 6-months of therapy and compared with baseline measures.
Primary Outcome
Modified Rodnan skin score (mRSS) on scale of 0 (no skin disease) to 51 severe skin disease. %change in mRSS=(score at 6 months - baseline score)/baseline score. Negative values indicate improvement in skin disease. Clinical important improvement defined as \> 25% improvement.
Conditions Studied
Interventions
- DRUG Imatinib mesylate
Study Locations (1)
California
- Stanford University School of Medicine - Stanford
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2007-07 |
| Est. Completion | 2010-09 |
| Phase | Phase 1 |
What the finished NCT00506831 record still lists
NCT00506831 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 9 participants, a relatively small participant target, below the 83-participant average among 6 other Scleroderma, Systemic trials with a reported enrollment target (89% lower).
The record links to 1 condition, with Scleroderma, Systemic appearing as the primary indexed condition, and to 1 intervention - of which Imatinib mesylate is the first listed.
NCT00506831 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT00506831 about?
NCT00506831 is a clinical study titled "Imatinib in Systemic Sclerosis". Systemic sclerosis (SSc) is an autoimmune disease characterized by fibrosis of the skin and internal organs and widespread vasculopathy. Patients with SSc are classified according to the extent of cutaneous sclerosis: patients with limited SSc have skin thickening of the face, neck, and distal extre...
What is the current status of trial NCT00506831?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 9 participants. The study started on 2007-07. Estimated completion is 2010-09.
What conditions does trial NCT00506831 study?
This clinical trial studies the following conditions: Scleroderma, Systemic.
What interventions are being tested in trial NCT00506831?
The interventions under investigation include: Imatinib mesylate (DRUG).
Who is sponsoring clinical trial NCT00506831?
This trial is sponsored by Stanford University, which has 1,744 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00506831 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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