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

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ClinicalTrials.gov Identifier: NCT01442025
Recruitment Status : Completed
First Posted : September 28, 2011
Last Update Posted : August 11, 2015
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Crohn's Disease Drug: Infliximab Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 121 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial Investigating Tailored Treatment With Infliximab for Active Luminal Crohn's Disease
Study Start Date : June 2012
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease
Drug Information available for: Infliximab

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 Name: 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 or 10 mg/kg if dose increase criteria are met (biological)
Other Name: 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 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 Name: IFX




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Clinical remission [ Time Frame: week 14 after inclusion ]
    Clinical remission (CDAI <150) at each visit and the whole study period

  2. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01442025


Locations
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France
Chu Amiens
Amiens, France, 80054
Chu Clermont-Ferrand
Clermont-ferrand, France, 63003
Hopital Beaujon
Clichy, France, 92110
CHRU Lille
Lille, France
CHU NICE
Nice, France, 06202
Hopital Saint Louis
Paris, France, 75010
CHU Bordeaux - Pessac
Pessac, France, 33700
Chu Reims
Reims, France, 51000
Chu Rennes
Rennes, France, 35033
Chu Toulouse
Toulouse, France, 31403
Chu Tours
Tours, France, 37044
Chu Nancy
Vandoeuvre Les Nancy, France, 54500
Sponsors and Collaborators
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
Investigators
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Study Director: Geert D'Haens, PhD Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
Principal Investigator: David Laharie Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

Additional Information:
Publications:
Louis E, Vernier-Massouille G, Grimaud JC, et al. Infliximab discontinuation in Crohn's disease patients in stable remission on combined therapy with immunosuppressors: a prospective ongoing cohort study. Gastroenterology 2009, 136:A-146
Van Moerkercke W, Ackaert C, Compernolle G, Jürgens M, Cleynen I, Van Assche G, Rutgeerts P, Gils A, Vermeire S. High infliximab trough levels are associated with mucosal healing in Crohn's disease. Gastroenterology 2010; 138 (Supp 1), S-60.

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Responsible Party: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
ClinicalTrials.gov Identifier: NCT01442025     History of Changes
Other Study ID Numbers: GETAID 2010-2
First Posted: September 28, 2011    Key Record Dates
Last Update Posted: August 11, 2015
Last Verified: August 2015

Keywords provided by Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives:
Crohn's Disease
IFX trough level

Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Infliximab
Dermatologic Agents
Gastrointestinal Agents
Antirheumatic Agents