Status:
COMPLETED
Treatment With High Dose Methotrexate in Patients With Eosinophilic Fasciitis
Lead Sponsor:
Radboud University Medical Center
Conditions:
Fasciitis
Eligibility:
All Genders
18+ years
Phase:
NA
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 wit...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT00441961
Start Date
October 1 2006
End Date
June 1 2011
Last Update
August 11 2011
Active Locations (1)
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1
Radboud University Nijmegen Medical Centre
Nijmegen, Netherlands, 6500 HB