Treatment With High Dose Methotrexate in Patients With Eosinophilic Fasciitis

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00441961

Enrollment

Registered

2007-03-01

Start date

2006-10-31

Completion date

2011-06-30

Last updated

2011-08-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fasciitis

Keywords

Eosinophilic fasciitis, Shulman's syndrome, methotrexate

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.

Interventions

DRUGmethotrexate

methotrexate

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Efficacy is evaluated after 6 months.	December 2008

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026