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

August 10, 2015 updated by: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

121

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Amiens, France, 80054
        • CHU Amiens
      • Clermont-ferrand, France, 63003
        • CHU Clermont-Ferrand
      • Clichy, France, 92110
        • Hopital Beaujon
      • Lille, France
        • CHRU Lille
      • Nice, France, 06202
        • CHU Nice
      • Paris, France, 75010
        • Hopital Saint Louis
      • Pessac, France, 33700
        • CHU Bordeaux - Pessac
      • Reims, France, 51000
        • CHU Reims
      • Rennes, France, 35033
        • CHU Rennes
      • Toulouse, France, 31403
        • CHU Toulouse
      • Tours, France, 37044
        • Chu Tours
      • Vandoeuvre Les Nancy, France, 54500
        • Chu Nancy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Cohort 1 =Control Group
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.
Drug: Infliximab
Perfusion of IFX 5mg/kg to be increased to 10 mg/kg based on clinical symptoms
Other Names:
  • IFX
Drug: Infliximab
Perfusion of IFX 5mg/kg or 10 mg/kg if dose increase criteria are met (biological)
Other Names:
  • IFX
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
Other Names:
  • IFX
ACTIVE_COMPARATOR: Cohort 2
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
Drug: Infliximab
Perfusion of IFX 5mg/kg to be increased to 10 mg/kg based on clinical symptoms
Other Names:
  • IFX
Drug: Infliximab
Perfusion of IFX 5mg/kg or 10 mg/kg if dose increase criteria are met (biological)
Other Names:
  • IFX
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
Other Names:
  • IFX
ACTIVE_COMPARATOR: Cohort 3
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
Drug: Infliximab
Perfusion of IFX 5mg/kg to be increased to 10 mg/kg based on clinical symptoms
Other Names:
  • IFX
Drug: Infliximab
Perfusion of IFX 5mg/kg or 10 mg/kg if dose increase criteria are met (biological)
Other Names:
  • IFX
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
Other Names:
  • IFX

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Level of remission
Time Frame: 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
54 weeks after Inclusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical remission
Time Frame: week 14 after inclusion
Clinical remission (CDAI <150) at each visit and the whole study period
week 14 after inclusion
Endoscopic evaluation
Time Frame: 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
week 0, week 12 and week 54

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

Investigators

  • Study Director: Geert D'Haens, PhD, Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (ACTUAL)

July 1, 2015

Study Completion (ACTUAL)

July 1, 2015

Study Registration Dates

First Submitted

September 20, 2011

First Submitted That Met QC Criteria

September 26, 2011

First Posted (ESTIMATE)

September 28, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

August 11, 2015

Last Update Submitted That Met QC Criteria

August 10, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GETAID 2010-2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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