Treatment With High Dose Methotrexate in Patients With Eosinophilic Fasciitis

• Sponsor: Radboud University Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT00441961
• Collaborator: (none)
• Enrollment: 6
• Location: 1
• Duration (Months): 56
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

Evaluate the effect of high dose MTX on skin induration in patients with eosinophilic fascia.

Condition or Disease	Intervention/Treatment	Phase
Fasciitis	Drug: methotrexate	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 6 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Treatment With High Dose Methotrexate in Patients With Eosinophilic Fasciitis
• Study Start Date: Oct 1, 2006
• Actual Primary Completion Date: Dec 1, 2010
• Actual Study Completion Date: Jun 1, 2011

Outcome Measures

Primary Outcome Measures

1. Efficacy is evaluated after 6 months. [December 2008]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Radboud University Nijmegen Medical Centre	Nijmegen		Netherlands	6500 HB

Sponsors and Collaborators

• Radboud University Medical Center

Investigators

• Principal Investigator: H. Knaapen, MD, Radboud University Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00441961
• Other Study ID Numbers: mtx in eosinophilic fasciitis
• First Posted: Mar 1, 2007
• Last Update Posted: Aug 11, 2011
• Last Verified: Jul 1, 2010

• Keywords provided by , ,: Eosinophilic fasciitis, Shulman's syndrome, methotrexate
• Additional relevant MeSH terms: Fasciitis; Methotrexate

Study Results

No Results Posted as of Aug 11, 2011