NCT00498589

Brief 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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Sep 2007

Longer than P75 for phase_2

Geographic Reach
6 countries

22 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 9, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 10, 2007

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2007

Completed
6.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

February 5, 2015

Status Verified

February 1, 2015

Enrollment Period

6.4 years

First QC Date

July 9, 2007

Last Update Submit

February 4, 2015

Conditions

Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

  • Remission without steroids, immunosuppressives and without colectomy

    week 16

Study Arms (2)

1

PLACEBO COMPARATOR

Methotrexate IM or SC 25 mg/week vs placebo IM or SC for 24 weeks

Drug: methotrexate

2

PLACEBO COMPARATOR

1 IM or SC of placebo per week during 24 weeks

Drug: placebo

Interventions

methotrexateDRUG

25 mg per week IM or SC during 24 weeks

1
placeboDRUG

one intramuscular injection per week

2

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • UC diagnosed according to the Lennard-Jones criteria (Appendix 1) with endoscopic colorectal lesions, whatever their extension may be
  • Steroid-dependence defined by at least 1 unsuccessful attempt to stop systemic steroid therapy during the last 12 weeks. 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

You may not qualify if:

  • Indication to a colectomy.
  • Alcoholism (more than 21 glasses per week for male subjects and 14 glasses per week for female subjects). 1 glass corresponds to 3 cl of strong alcohol, 10 cl glass of wine or a half pint of beer.
  • Pregnant or breast-feeding female subjects.
  • No efficacious contraception.
  • Chronic (broncho) pneumopathy.
  • Renal failure (creatinaemia \> 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.
  • Past history of malignant condition (including leukaemia, lymphoma and myelodysplasia) except for baso-cellular cutaneous cancers.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (22)

University Hospital of Vienna

Vienna, 1090, Austria

Location

ULB - Cliniques Saint Luc

Brussels, 1200, Belgium

Location

CHU Amiens - Hôpital Nord

Amiens, 84000, France

Location

CH Avignon

Avignon, 84000, France

Location

Centre Hospitalier Universitaire de Besançon

Besançon, 25000, France

Location

CHU Clermont-Ferrand - Hôpital Hotel Dieu

Clermont-Ferrand, 63000, France

Location

APHP - Hôpital Beaujon

Clichy, 92110, France

Location

APHP - Hôpital Bicêtre

Le Kremlin-Bicêtre, 94270, France

Location

CHRU Lille - Hôpital Huriez

Lille, 59037, France

Location

CHU Nantes - Hôpital Hôtel Dieu

Nantes, 44000, France

Location

CHU Nice - Hôpital de l'Archet 2

Nice, 06202, France

Location

APHP - Hôpital Saint Louis

Paris, 75010, France

Location

APHP - Hôpital Saint Antoine

Paris, 75012, France

Location

APHP - Hôpital Cochin

Paris, 75014, France

Location

CHU Bordeaux - Hôpital Haut L'Eveque

Pessac, 33604, France

Location

CHU Rouen - Hôpital Charles Nicolle

Rouen, 76000, France

Location

CHU St Etienne - Hôpital NOrd

Saint-Priest, 42270, France

Location

CHU Toulouse - Hôpital Rangueil

Toulouse, 31403, France

Location

Sheba Medical Center

Tel Aviv, 52621, Israel

Location

Istituto Clinico Humanitas

Rozzano , Milano, 20089, Italy

Location

Ospedale Casa Sollievo Della Sofferenza

San Giovanni Rotondo, 71013, Italy

Location

LUMC

Leiden, 2333, Netherlands

Location

Related Publications (1)

  • Carbonnel F, Colombel JF, Filippi J, Katsanos KH, Peyrin-Biroulet L, Allez M, Nachury M, Novacek G, Danese S, Abitbol V, Bossa F, Moreau J, Bommelaer G, Bourreille A, Fumery M, Roblin X, Reinisch W, Bouhnik Y, Brixi H, Seksik P, Malamut G, Farkkila M, Coulibaly B, Dewit O, Louis E, Deplanque D, Michetti P, Sarter H, Laharie D; European Crohn's and Colitis Organisation; Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives. Methotrexate Is Not Superior to Placebo for Inducing Steroid-Free Remission, but Induces Steroid-Free Clinical Remission in a Larger Proportion of Patients With Ulcerative Colitis. Gastroenterology. 2016 Feb;150(2):380-8.e4. doi: 10.1053/j.gastro.2015.10.050. Epub 2015 Nov 26.

    PMID: 26632520DERIVED

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

Methotrexate

Condition Hierarchy (Ancestors)

ColitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesInflammatory Bowel DiseasesColonic DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

AminopterinPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Franck Carbonnel

    CHU Besançon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PU-PH

Study Record Dates

First Submitted

July 9, 2007

First Posted

July 10, 2007

Study Start

September 1, 2007

Primary Completion

February 1, 2014

Study Completion

June 1, 2014

Last Updated

February 5, 2015

Record last verified: 2015-02

Locations

IL(1)IT(2)BE(1)NL(1)AU(1)FR(16)