Back to resultsTreatment With High Dose Methotrexate in Patients With Eosinophilic Fasciitis
Primary Purpose
Fasciitis
Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
methotrexate
Sponsored by
About this trial
This is an interventional treatment trial for Fasciitis focused on measuring Eosinophilic fasciitis, Shulman's syndrome, methotrexate
Eligibility Criteria
Inclusion Criteria:
- Eosinophilic fasciitis as defined by clinical judgement of an expert,
Histologically confirmed with a skin-fascia-muscle biopsy, and in additon:
- Either the presence of a modified skin score according to Zachariae of 8 or higher (0-18), regarded as a generalised eosinophilic fasciitis or the presence of severe contractures due to eosinophilic fasciitis lesions.
Exclusion Criteria:
- Age < 18 yrs
- Contraindications to MTX: AST/ALT level > 2 times upper limit of normal, WBC count < 3.5 x 109/l or platelet count < 150 x 109/l, serum creatinine > 130 micromol/l or clearance < 50 ml/min, confirmed by two repeated tests within one month.
- Chronic liver disease, insulin dependant diabetes mellitus, alcohol abuse
- Restrictive pulmonary disease (total lung capacity or vital capacity < 40% of predicted) or interstitial lung disease (KCO < 60% of predicted)
- Pregnancy or child bearing potential without adequate contraception
- The presence of any serious co-morbidity or malignancy
- Use of other anti-folate drugs than MTX
Sites / Locations
- Radboud University Nijmegen Medical Centre
Outcomes
Primary Outcome Measures
Efficacy is evaluated after 6 months.
Secondary Outcome Measures
Full Information
NCT ID
NCT00441961
First Posted
February 28, 2007
Last Updated
August 10, 2011
Sponsor
Radboud University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT00441961
Brief Title
Treatment With High Dose Methotrexate in Patients With Eosinophilic Fasciitis
Official Title
Treatment With High Dose Methotrexate in Patients With Eosinophilic Fasciitis
Study Type
Interventional
2. Study Status
Record Verification Date
July 2010
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
June 2011 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Radboud University Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fasciitis
Keywords
Eosinophilic fasciitis, Shulman's syndrome, methotrexate
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
methotrexate
Intervention Description
methotrexate
Primary Outcome Measure Information:
Title
Efficacy is evaluated after 6 months.
Time Frame
December 2008
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Eosinophilic fasciitis as defined by clinical judgement of an expert,
Histologically confirmed with a skin-fascia-muscle biopsy, and in additon:
Either the presence of a modified skin score according to Zachariae of 8 or higher (0-18), regarded as a generalised eosinophilic fasciitis or the presence of severe contractures due to eosinophilic fasciitis lesions.
Exclusion Criteria:
Age < 18 yrs
Contraindications to MTX: AST/ALT level > 2 times upper limit of normal, WBC count < 3.5 x 109/l or platelet count < 150 x 109/l, serum creatinine > 130 micromol/l or clearance < 50 ml/min, confirmed by two repeated tests within one month.
Chronic liver disease, insulin dependant diabetes mellitus, alcohol abuse
Restrictive pulmonary disease (total lung capacity or vital capacity < 40% of predicted) or interstitial lung disease (KCO < 60% of predicted)
Pregnancy or child bearing potential without adequate contraception
The presence of any serious co-morbidity or malignancy
Use of other anti-folate drugs than MTX
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
H. Knaapen, MD
Organizational Affiliation
Radboud University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Radboud University Nijmegen Medical Centre
City
Nijmegen
ZIP/Postal Code
6500 HB
Country
Netherlands
12. IPD Sharing Statement
Citations:
PubMed Identifier
27541801
Citation
Mertens JS, Zweers MC, Kievit W, Knaapen HK, Gerritsen M, Radstake TR, van den Hoogen FH, Creemers MC, de Jong EM. High-Dose Intravenous Pulse Methotrexate in Patients With Eosinophilic Fasciitis. JAMA Dermatol. 2016 Nov 1;152(11):1262-1265. doi: 10.1001/jamadermatol.2016.2873.
Results Reference
derived
Learn more about this trial
Treatment With High Dose Methotrexate in Patients With Eosinophilic Fasciitis
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