NCT01442025

Study Investigating Tailored Treatment With Infliximab for Active Crohn's Disease

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 121 (actual)
• Sponsor: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Crohn's Disease

Interventions

Type	Name	Description
DRUG	Infliximab	Perfusion of IFX 5mg/kg to be increased to 10 mg/kg based on clinical symptoms
DRUG	Infliximab	Perfusion of IFX 5mg/kg or 10 mg/kg if dose increase criteria are met (biological)
DRUG	Infliximab	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

Timeline

• Start date: 2012-06-01
• Primary completion: 2015-07-01
• Completion: 2015-07-01
• First posted: 2011-09-28
• Last updated: 2015-08-11

Locations

12 sites across 1 country: France