MedTrace Logo

Comparison of Methotrexate vs Placebo in Corticosteroid-dependent Ulcerative Colitis

NCT00498589 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2015-02-05

No results posted yet for this study

Summary

* PHASE: II
* TYPE OF STUDY : With direct benefit
* DESCRIPTIVE: Multicenter, randomized, double-blind study
* INCLUSION CRITERIA: Steroid-dependent ulcerative colitis
* OBJECTIVES: To show superiority of methotrexate vs placebo in inducing steroid-free remission in steroid-dependent ulcerative colitis
* STUDY TREATMENTS: Methotrexate 1 intramuscular injection (25 mg) per week Placebo 1 intramuscular injection per week
* NUMBERS OF PATIENTS: 55 patients in each group, i.e. a total of 110 patients
* INCLUSION PERIOD: 24 months
* STUDY DURATION: 36 months
* EVALUATION CRITERIA: Remission without steroids, immunosuppressives and without colectomy at 16 weeks of treatment.

Conditions

Interventions

DRUG

methotrexate

25 mg per week IM or SC during 24 weeks

DRUG

placebo

one intramuscular injection per week

Sponsors & Collaborators

  • Centre Hospitalier Universitaire de Besancon

    lead OTHER

Principal Investigators

  • Franck Carbonnel · CHU Besançon

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-09-30
Primary Completion
2014-02-28
Completion
2014-06-30

Countries

  • Austria
  • Belgium
  • France
  • Israel
  • Italy
  • Netherlands

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00498589 on ClinicalTrials.gov