Ignite Creation Date:
2024-05-05 @ 6:33 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00506831
Status:
COMPLETED
Last Update Posted:
2018-08-13
First Post:
2007-07-24
Brief Title:
Imatinib in Systemic Sclerosis
Sponsor:
Stanford University
Organization:
Stanford University
Study Overview
Official Title:
A Pilot Study of Imatinib in the Treatment of Refractory Systemic Sclerosis
Status:
COMPLETED
Status Verified Date:
2018-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 Raynauds 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 treatments Validated measures of skin thickness and disease activity will be determined over 6-months of therapy and compared with baseline measures
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 treatments Validated measures of skin thickness and disease activity will be determined over 6-months of therapy and compared with baseline measures
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 9598 | None | None | None |