- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00441961
Treatment With High Dose Methotrexate in Patients With Eosinophilic Fasciitis
August 10, 2011 updated by: Radboud University Medical Center
Evaluate the effect of high dose MTX on skin induration in patients with eosinophilic fascia.
Study Overview
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 Type
Interventional
Enrollment (Actual)
6
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Nijmegen, Netherlands, 6500 HB
- Radboud University Nijmegen Medical Centre
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Efficacy is evaluated after 6 months.
Time Frame: December 2008
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December 2008
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: H. Knaapen, MD, Radboud University Medical Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2006
Primary Completion (Actual)
December 1, 2010
Study Completion (Actual)
June 1, 2011
Study Registration Dates
First Submitted
February 28, 2007
First Submitted That Met QC Criteria
February 28, 2007
First Posted (Estimate)
March 1, 2007
Study Record Updates
Last Update Posted (Estimate)
August 11, 2011
Last Update Submitted That Met QC Criteria
August 10, 2011
Last Verified
July 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Musculoskeletal Diseases
- Fasciitis
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Antirheumatic Agents
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Dermatologic Agents
- Reproductive Control Agents
- Abortifacient Agents, Nonsteroidal
- Abortifacient Agents
- Folic Acid Antagonists
- Methotrexate
Other Study ID Numbers
- mtx in eosinophilic fasciitis
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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