Ignite Creation Date:
2025-12-24 @ 12:35 PM
Ignite Modification Date:
2025-12-29 @ 3:00 PM
Study NCT ID:
NCT00441961
Status:
COMPLETED
Last Update Posted:
2011-08-11
First Post:
2007-02-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment With High Dose Methotrexate in Patients With Eosinophilic Fasciitis
Sponsor:
Radboud University Medical Center
Organization:
Study Overview
Official Title:
Treatment With High Dose Methotrexate in Patients With Eosinophilic Fasciitis
Status:
COMPLETED
Status Verified Date:
2010-07
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:
Evaluate the effect of high dose MTX on skin induration in patients with eosinophilic fascia.
Detailed Description:
Eosinophilic fasciitis (EF)is a fibrosing skin disorder extensively involving the deep fascia. The aim of this pilot study is to evaluate the effect of high dose MTX on skin induration in patients with EF. In addition, we study the effect of this treatment on joint mobility, peripheral blood eosinophilia, functional ability, and pulmonary function. By administering high dose MTX intravenously every four weeks with a Leukovorin rescue, we hope to induce a more pronounced and sustained effect on the involved skin with less (long-lasting) side effects.
Study Oversight
Has Oversight DMC:
False
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?: