Ignite Creation Date:
2024-05-05 @ 5:32 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00479934
Status:
COMPLETED
Last Update Posted:
2011-03-04
First Post:
2007-05-29
Brief Title:
Efficacy and Safety of Imatinib in Scleroderma
Sponsor:
University Hospital Bordeaux
Organization:
University Hospital Bordeaux
Study Overview
Official Title:
Phase II Randomized Double Blind Clinical Trial ofImatinib Mesylate STI571 Glivec Versus Placebo in Patients With Severe Cutaneous Scleroderma or Systemic Sclerosis With Severe Cutaneous Involvement
Status:
COMPLETED
Status Verified Date:
2011-03
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:
SCLEROGLIVEC
Brief Summary:
In vitro studies have shown that imatinib 1mM inhibits strongly the growth of cutaneous fibroblasts The hypothesis is that imatinib inhibits PDGFR which is known to be a potential target for the molecule as recently also proposed after the discovery of autoantibodies activating the PDGF receptors Recent data indicate that TGFb is also a potential target of imatinib Cutaneous scleroderma is characterized by progressive cutaneous fibrosis caused by hyperactive dermal fibroblasts Since no established treatment for skin sclerosis in scleroderma is currently available This study will test the safety and efficacy of imatinib in the treatment of patients with scleroderma and severe cutaneous involvement
Detailed Description:
This study will test the efficacy and tolerance of patients with a high score of induration modified Rodnan score 2054 Comparison 34 patients with severe forms of cutaneous involvement will be evaluated in a double blind RCT comparing imatinib 400mgj and placebo in a 6 month period Efficacy will be assessed using a cutaneous induration scale and skin biopsy and quality of life questionnaires
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
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 |
|---|---|---|---|
| 2006017 | None | None | None |