FasciitisNCT00441961
Treatment With High Dose Methotrexate in Patients With Eosinophilic Fasciitis
A study testing methotrexate in people with Fasciitis, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
Evaluate the effect of high dose MTX on skin induration in patients with eosinophilic fascia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fasciitis
- What is being tested?
- methotrexate
- How many people
- 6 participants
- Where
- 1 siteNetherlands
- Study dates
- Oct 2006to Jun 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Radboud University Nijmegen Medical Centre
Nijmegen, 6500 HB
About this study
Evaluate the effect of high dose MTX on skin induration in patients with eosinophilic fascia.
Read the 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.
- Conditions
- Fasciitis
- Being tested
- methotrexate
- Keywords
- Eosinophilic fasciitis, Shulman's syndrome, methotrexate
- Medical subject headings
- Fasciitis, Eosinophilic Fasciitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
methotrexateDrug
methotrexate
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy is evaluated after 6 months.
Measured: December 2008
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2007 (estimated)
- Study startOct 2006
- Primary completionDec 2010
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FasciitisStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- H. Knaapen, MD, Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00441961
- Sponsor's protocol ID
- mtx in eosinophilic fasciitis
- Status last verified
- Jul 2010
- First submitted
- 28 Feb 2007
- Last updated
- 11 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 27541801
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment With High Dose Methotrexate in Patients With Eosinophilic Fasciitis
- ClinicalTrials.gov ID
- NCT00441961
- Acronym / sponsor ID
- mtx in eosinophilic fasciitis
- Conditions
- Fasciitis
- Keywords
- Eosinophilic fasciitis, Shulman's syndrome, methotrexate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- Oct 2006
- Primary completion
- Dec 2010 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 1 Mar 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Eosinophilic fasciitis as defined by clinical judgement of an expert,
- Histologically confirmed with a skin-fascia-muscle biopsy, and in additon:
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| methotrexatemethotrexate | Drug | – |
Primary outcome
Efficacy is evaluated after 6 months.
Time frame: December 2008
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2011.
- Derived from this study: PubMed 27541801Mertens 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
H. Knaapen, MD principal investigator
Radboud University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing methotrexate in people with Fasciitis, run by Radboud University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy is evaluated after 6 months. (time frame: December 2008). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00441961, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2011.