A CONTROLLED, RANDOMISED,DOUBLE-BLIND, MULTICENTER STUDY, COMPARING METHOTREXATE VS PLACEBO IN STEROID-REFRACTORY ULCERATIVE COLITIS - METEOR

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2006-003607-40-AT
• Date of registration: 10/11/2008
• Prospective Registration: Yes
• Primary sponsor: Besancon University Hospitaö
• 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: 26/11/2008
• Recruitment status: Authorised-recruitment may be ongoing or finished
• 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

Countries of recruitment

Austria, Finland, Netherlands

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.
- Active or inactive disease, but the patient be treated with prednisone at a dose between 10 and 40mg, and clinically improved with this treatment
- Steroid-dependence defined by at least 1 unsuccessfull attempt to stop stystemic steroid therapy during the last 12 weeks (cf. ECCO Sonsensus for Crohn). Steroid therapy might have been completely stopped if it has been restarted within the last 30 days.
- 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:
-Patients refractory to oral steroids (no improvement after 2 weeks of 10 - 40mg of prednisone)
- 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.
- 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 - 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 base-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: Sanofi Aventis
Concentration unit: MBq/ml megabecquerel(s)/millilitre
Concentration type: equal
Concentration number: 25-25
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 < equal 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 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 ID(s)

2006-003607-40-NL

GETAID 2006-1