CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 120 enrolled
Drug / intervention
early immunosuppressants (azathioprine, methotrexate)drug
Likely dose
early immunosuppressants (azathioprine, methotrexate) 2.5 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00546546
NCT00546546Phase 4Completed

Effect of Early Prescription of Immunosuppressants on First Three-year Course of Crohn's Disease

Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives·interventional·Posted Oct 19, 2007·Updated Apr 28, 2015

In Brief

A Phase 4 clinical trial evaluating early immunosuppressants (azathioprine, methotrexate) for Crohn's Disease. Completed, enrolled 120 participants across 26 sites.

Detailed Summary

Pluricentric randomized study comparing two therapeutic strategies at beginning of Crohn's disease: early immunosuppressants (prescription within the six first months following diagnosis) vs. conventional strategy (immunosuppressants given only in case of steroid failure, in a selected group of patients being at high risk of disabling course. The hypothesis is that immunosuppressants given early may improve the disease course during the 3 following years in this subset of patients.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCrohn's Disease
CountriesFrance

Timeline

Phase 4CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 19, 2007
Enrollment StartJul 1, 2005
Primary CompletionDec 1, 2012
Study CompletionJun 1, 2013
TodayJul 2, 2026
Enrollment to primary: 7.4 yearsPosted 18.7 years ago

Interventions

early immunosuppressants (azathioprine, methotrexate)drug

azathioprine 2.5 mg/kg/day SC methotrexate 25 mg/week if aza not tolerated