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

Phase 4

Completed

• Conditions: Crohn's Disease
• Interventions: Drug: Infliximab

• Registration Number: NCT01442025
• Lead Sponsor: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-09-20
• Study First Submitted QC: 2011-09-26
• Study First Posted: 2011-09-28
• Study Start: 2012-06
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-10
• Last Update Posted: 2015-08-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 121

Inclusion Criteria

• Age > 18 years
• Active CD (CDAI>220) and signs of active inflammation as evidenced by elevated serum hsCRP levels (>5 mg/L) and/or elevated fecal calprotectin levels (>250 µg/g) and endoscopically visible ulcers.
• Patients must be naïve to biologics with indication for starting anti-TNF therapy in accordance with national reimbursement criteria.
• Patients must be naïve to thiopurines or have failed therapy with thiopurines (in which case AZA will be continued).
• Ongoing steroids are allowed if at stable dose for at least 2 weeks and at a maximum of prednisone 40 mg/d or budesonide 9 mg/day.
• Patients who consent to receiving Infliximab 5 mg/kg at week 0, 2 and 6 and further on every 8 weeks in conjunction with azathioprine (2,5 mg/kg/day). Patients who develop AZA intolerance during the trial are continued in the trial without AZA (ie IFX monotherapy).

Exclusion Criteria

• Absence of endoscopically visible ulcers
• Prior exposure to infliximab (other biologics allowed)
• Ongoing steroid therapy at doses > 40 mg/d prednisolone equivalent
• Previous intolerance to azathioprine leading to drug discontinuation
• Ongoing infections
• Positive tuberculosis screen per local guidelines
• Serious other diseases including cancer in the 5 years prior to inclusion excluding non-melanoma skin cancer
• Indication for immediate surgery
• Pregnant or breast-feeding woman.
• Positive fecal culture for Salmonella, Shigella, Yersinia and Campylobacter and/or presence of Clostridium difficile B toxin in the stools
• Active tuberculosis
• Untreated latent tuberculosis (see national recommendations. Appendix 2).
• Non-compliant subjects.
• Participation in another therapeutic study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort 2	Infliximab	Dose of IFX will be increased by 2.5 mg/kg (maximally 2 times) if the following criteria are met A dose increase is maintained for the following infusions
Cohort 1 =Control Group	Infliximab	the dose of IFX will be increased by 5 mg/kg (maximally 1 time) based on symptom relapse (usual clinical practice) Dose will be kept stable ofr the rest of the trial Dose decreases will not be allowed.
Cohort 3	Infliximab	Dose of IFX will be increased by 5 mg/kg (maximally 1 time) if the following criteria are met A dose increase is maintained for the following infusions

Primary Outcome Measures

Name	Time	Method
Level of remission	54 weeks after Inclusion	Proportion of patients with steroid-free remission (CDAI \< 150) and endoscopic healing (absence of ulcers) at week 54 CDAI = Crohn's Disease Activity Index

Secondary Outcome Measures

Name	Time	Method
Clinical remission	week 14 after inclusion	Clinical remission (CDAI \<150) at each visit and the whole study period
Endoscopic evaluation	week 0, week 12 and week 54	* percentage of patients in each group with absence of ulcers; * percentage of patients in each group with \>50% improvement in CDEIS (Crohn's Disease Endoscopic Index Score

Trial Locations

Locations (12)

Hopital Beaujon; 🇫🇷 Clichy, France

Chu Toulouse; 🇫🇷 Toulouse, France

CHRU Lille; 🇫🇷 Lille, France

Chu Nancy; 🇫🇷 Vandoeuvre Les Nancy, France

CHU NICE; 🇫🇷 Nice, France

CHU Bordeaux - Pessac; 🇫🇷 Pessac, France

Chu Reims; 🇫🇷 Reims, France

Chu Clermont-Ferrand; 🇫🇷 Clermont-ferrand, France

Chu Rennes; 🇫🇷 Rennes, France

Chu Tours; 🇫🇷 Tours, France

Hopital Saint Louis; 🇫🇷 Paris, France

Chu Amiens; 🇫🇷 Amiens, France