CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 121 enrolled
Drug / intervention
Infliximab +2 moredrug
Likely dose
Infliximab 5mg/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/NCT01442025
NCT01442025Phase 4Completed
CompareCT.gov

A Randomized Controlled Trial Investigating Tailored Treatment With Infliximab for Active Luminal Crohn's Disease

Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives·interventional·Posted Sep 28, 2011·Updated Aug 11, 2015

In Brief

A Phase 4 clinical trial evaluating Infliximab for Crohn's Disease. Completed, enrolled 121 participants across 12 sites.

Detailed Summary

To investigate whether sustained trough levels of IFX can be achieved using IFX (Infliximab) trough level measurements and adjustment of dosing based upon these levels by means of two different standardized algorithms in comparison with 'standard of care' IFX treatment and its effects on clinical and endoscopic outcomes.

Study Details

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

Timeline

Phase 4CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedSep 28, 2011
Enrollment StartJun 1, 2012
Primary CompletionJul 1, 2015
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 14.8 years ago

Interventions

Infliximabdrug

Perfusion of IFX 5mg/kg to be increased to 10 mg/kg based on clinical symptoms

Infliximabdrug

Perfusion of IFX 5mg/kg or 10 mg/kg if dose increase criteria are met (biological)

Infliximabdrug

Perfusion of IFX 5mg/kg or 7,5 mg/kg if dose increase criteria are met (biological)and 10mg/kg if dose increase criteria are met for a second time