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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 24 August 2015
Main ID:  NCT01442025
Date of registration: 20/09/2011
Prospective Registration: Yes
Primary sponsor: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
Public title: Study Investigating Tailored Treatment With Infliximab for Active Crohn's Disease TAILORIX
Scientific title: A Randomized Controlled Trial Investigating Tailored Treatment With Infliximab for Active Luminal Crohn's Disease
Date of first enrolment: June 2012
Target sample size: 121
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT01442025
Study type:  Interventional
Study design:  Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment  
Phase:  Phase 4
Countries of recruitment
France
Contacts
Name:     David Laharie
Address: 
Telephone:
Email:
Affiliation:  Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
Name:     Geert D'Haens, PhD
Address: 
Telephone:
Email:
Affiliation:  Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both
Health Condition(s) or Problem(s) studied
Crohn's Disease
Intervention(s)
Drug: Infliximab
Primary Outcome(s)
Level of remission [Time Frame: 54 weeks after Inclusion]
Secondary Outcome(s)
Clinical remission [Time Frame: week 14 after inclusion]
Endoscopic evaluation [Time Frame: week 0, week 12 and week 54]
Secondary ID(s)
GETAID 2010-2
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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