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Register:	EUCTR
Last refreshed on:	19 March 2012
Main ID:	EUCTR2006-003607-40-NL
Date of registration:	13/08/2008
Prospective Registration:	Yes
Primary sponsor:	Besancon University Hospital
Public title:	A CONTROLLED, RANDOMISED, DOUBLE-BLIND, MULTICENTER STUDY, COMPARING METHOTREXATE VS PLACEBO IN STEROID-REFRACTORY ULCERATIVE COLITIS - METEOR
Scientific title:	A CONTROLLED, RANDOMISED, DOUBLE-BLIND, MULTICENTER STUDY, COMPARING METHOTREXATE VS PLACEBO IN STEROID-REFRACTORY ULCERATIVE COLITIS - METEOR
Date of first enrolment:	13/11/2008
Target sample size:	110
Recruitment status:	Not Recruiting
URL:	https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-003607-40
Study type:	Interventional clinical trial of medicinal product
Study design:	Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no
Phase:

Countries of recruitment
Austria	Finland	Netherlands

Contacts

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Affiliation:

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Key inclusion & exclusion criteria

Inclusion criteria:
- Between 18 and 75 years of age.
- UC diagnosed according to the Lennard-Jones criteria (Appendix 1) with endoscopic colorectal lesions, whatever their extension may be.
- A Mayo Disease Activity Index ? 4, with no item >1 for the clinical part of the score and from 0 to 2 for the endoscopic part at the time of inclusion.
- Steroid-dependence defined by at least 1 unsuccessful attempt to stop systemic steroid therapy during the last 12 weeks. (cf. ECCO Consensus for Crohn). Steroid therapy might have been completely stopped if it has been restarted within the last 30 days.
- To be receiving a treatment of prednisone at a dose between 10 and 40mg, stable for at least 2 weeks at the time of inclusion.
- Under an adequate contraception for male or female subjects of childbearing potential: barrier methods of contraception (condom, female condom, diaphragm, spermicidal gel) and oral contraception started at least 15 days before inclusion. This contraception will be continued throughout the study duration and at least 3 months after study termination.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
- Indication to a colectomy.
- Pregnant or breast-feeding female subjects.
- No efficacious contraception.
- NSAIDS or cotrimoxazole intake upon inclusion, or probenecide intake within 1 month prior to inclusion.
- Anti-TNF? treatment within 2 months prior to inclusion.
- Azathioprine, mercaptopurine, cyclosporin or thalidomide within 1 month prior to inclusion.
- Modification of mesalazine or olsalazine dosage within 1 month prior to inclusion.
- Chronic (broncho) pneumopathy.
- Renal failure (creatininaemia > upper limit of normal laboratory values limit).
- Liver disease apart from primary sclerosing cholangitis.
- Unexplained rise higher than twice the normal level for transaminases, alkaline phosphatases and/or bilirubin.
- Folate level < normal level.
- Infection by HIV, HBV (except in case of positive antibodies anti-HBs), HCV with serologies not older than 3 months.
- Past history of malignant condition (including leukaemia, lymphoma and myelodysplasia) except for baso-cellular cutaneous cancers.
- Obesity (BMI>30).

Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Steroid-dependent ulcerative colitis

Intervention(s)

Trade Name: methotrexate bellon
Product Name: methotrexate bellon 25mg/ml
Pharmaceutical Form: Solution for injection
INN or Proposed INN: methotrexate bellon 25mg/ml
CAS Number: 59 05 2
Current Sponsor code: Sonifi Aventis
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 25-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Intramuscular use

Primary Outcome(s)

Primary end point(s): Success at the 16th and the 24th week of treatment is the main criteria.
The success is measured by:
- Remission according to a Mayo Disease Activity Index ? 2 with no items >1* (see appendix 3),
and
- complete stop of prednisone or prednisolone for 7 days or more.
and
- no other immunosuppressive or colectomy between inclusion and the 24th week

Main Objective: Success at the 16th and the 24th week of treatment is the main criteria.
The success is measured by:
- Remission according to a Mayo Disease Activity Index ? 2 with no items >1
and
- complete stop of prednisone or prednisolone for 7 days or more.
and
- no other immunosuppressive or colectomy between inclusion and the 24th week

Secondary Objective: Success on the 16th week
Success on the 16th and 24th weeks
Clinical remission on each visit

Secondary Outcome(s)

Secondary ID(s)

GETAID 2006-1

Source(s) of Monetary Support

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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