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Crohn's DiseasePhase 4TAILORIXNCT01442025

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

A Phase 4 study testing Infliximab in people with Crohn's Disease, run by Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives at 12 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Crohn's Disease
What is being tested?
Infliximab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
121 participants
Where
12 sitesFrance
Study dates
Jun 2012to Jul 2015
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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
Show all 14Show fewer
  • 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.

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

France12 sites

  • Chu Amiens

    Amiens, 80054

  • Chu Clermont-Ferrand

    Clermont-Ferrand, 63003

  • Hopital Beaujon

    Clichy, 92110

  • CHRU Lille

    Lille

  • CHU NICE

    Nice, 06202

  • Hopital Saint Louis

    Paris, 75010

  • CHU Bordeaux - Pessac

    Pessac, 33700

  • Chu Reims

    Reims, 51000

  • Chu Rennes

    Rennes, 35033

  • Chu Toulouse

    Toulouse, 31403

  • Chu Tours

    Tours, 37044

  • Chu Nancy

    Vandœuvre-lès-Nancy, 54500

Other trials in France

About this study

Official title: 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.

Conditions
Crohn's Disease
Being tested
Infliximab
Keywords
Crohn's Disease, IFX trough level
Medical subject headings
Crohn Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • InfliximabDrug

    Also called IFX

    Perfusion of IFX 5mg/kg to be increased to 10 mg/kg based on clinical symptoms

  • InfliximabDrug

    Also called IFX

    Perfusion of IFX 5mg/kg or 10 mg/kg if dose increase criteria are met (biological)

  • InfliximabDrug

    Also called IFX

    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

Study groups in NCT01442025
Study groupRoleWhat they receive
Cohort 1 =Control GroupPlacebo comparatorthe 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.
Receives: Drug: Infliximab
Cohort 2Active comparatorDose 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
Receives: Drug: Infliximab
Cohort 3Active comparatorDose 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
Receives: Drug: Infliximab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Level of remission

    Proportion of patients with steroid-free remission (CDAI < 150) and endoscopic healing (absence of ulcers) at week 54 CDAI = Crohn's Disease Activity Index

    Measured: 54 weeks after Inclusion

Secondary outcomes (2)

  1. Clinical remission

    Clinical remission (CDAI <150) at each visit and the whole study period

    Measured: week 14 after inclusion

  2. Endoscopic evaluation

    • 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

    Measured: week 0, week 12 and week 54

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Sep 2011 (estimated)
  2. Study startJun 2012
  3. Primary completionJul 2015
  4. Study completionJul 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
121 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01442025
Sponsor's protocol ID
GETAID 2010-2
Acronym
TAILORIX
Status last verified
Aug 2015
First submitted
20 Sep 2011
Last updated
11 Aug 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • Hanauer SB, Feagan BG, Lichtenstein GR, Mayer LF, Schreiber S, Colombel JF, Rachmilewitz D, Wolf DC, Olson A, Bao W, Rutgeerts P; ACCENT I Study Group. Maintenance infliximab for Crohn's disease: the ACCENT I randomised trial. Lancet. 2002 May 4;359(9317):1541-9. doi: 10.1016/S0140-6736(02)08512-4.

    PubMed 12047962

  • Sands BE, Anderson FH, Bernstein CN, Chey WY, Feagan BG, Fedorak RN, Kamm MA, Korzenik JR, Lashner BA, Onken JE, Rachmilewitz D, Rutgeerts P, Wild G, Wolf DC, Marsters PA, Travers SB, Blank MA, van Deventer SJ. Infliximab maintenance therapy for fistulizing Crohn's disease. N Engl J Med. 2004 Feb 26;350(9):876-85. doi: 10.1056/NEJMoa030815.

    PubMed 14985485

  • Lemann M, Mary JY, Duclos B, Veyrac M, Dupas JL, Delchier JC, Laharie D, Moreau J, Cadiot G, Picon L, Bourreille A, Sobahni I, Colombel JF; Groupe d'Etude Therapeutique des Affections Inflammatoires du Tube Digestif (GETAID). Infliximab plus azathioprine for steroid-dependent Crohn's disease patients: a randomized placebo-controlled trial. Gastroenterology. 2006 Apr;130(4):1054-61. doi: 10.1053/j.gastro.2006.02.014.

    PubMed 16618399

  • D'Haens G, Baert F, van Assche G, Caenepeel P, Vergauwe P, Tuynman H, De Vos M, van Deventer S, Stitt L, Donner A, Vermeire S, Van De Mierop FJ, Coche JR, van der Woude J, Ochsenkuhn T, van Bodegraven AA, Van Hootegem PP, Lambrecht GL, Mana F, Rutgeerts P, Feagan BG, Hommes D; Belgian Inflammatory Bowel Disease Research Group; North-Holland Gut Club. Early combined immunosuppression or conventional management in patients with newly diagnosed Crohn's disease: an open randomised trial. Lancet. 2008 Feb 23;371(9613):660-667. doi: 10.1016/S0140-6736(08)60304-9.

    PubMed 18295023

  • Baert F, Moortgat L, Van Assche G, Caenepeel P, Vergauwe P, De Vos M, Stokkers P, Hommes D, Rutgeerts P, Vermeire S, D'Haens G; Belgian Inflammatory Bowel Disease Research Group; North-Holland Gut Club. Mucosal healing predicts sustained clinical remission in patients with early-stage Crohn's disease. Gastroenterology. 2010 Feb;138(2):463-8; quiz e10-1. doi: 10.1053/j.gastro.2009.09.056. Epub 2009 Oct 8.

    PubMed 19818785

  • 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

  • Rutgeerts P, Diamond RH, Bala M, Olson A, Lichtenstein GR, Bao W, Patel K, Wolf DC, Safdi M, Colombel JF, Lashner B, Hanauer SB. Scheduled maintenance treatment with infliximab is superior to episodic treatment for the healing of mucosal ulceration associated with Crohn's disease. Gastrointest Endosc. 2006 Mar;63(3):433-42; quiz 464. doi: 10.1016/j.gie.2005.08.011.

    PubMed 16500392

  • Colombel JF, Sandborn WJ, Reinisch W, Mantzaris GJ, Kornbluth A, Rachmilewitz D, Lichtiger S, D'Haens G, Diamond RH, Broussard DL, Tang KL, van der Woude CJ, Rutgeerts P; SONIC Study Group. Infliximab, azathioprine, or combination therapy for Crohn's disease. N Engl J Med. 2010 Apr 15;362(15):1383-95. doi: 10.1056/NEJMoa0904492.

    PubMed 20393175

  • Maser EA, Villela R, Silverberg MS, Greenberg GR. Association of trough serum infliximab to clinical outcome after scheduled maintenance treatment for Crohn's disease. Clin Gastroenterol Hepatol. 2006 Oct;4(10):1248-54. doi: 10.1016/j.cgh.2006.06.025. Epub 2006 Aug 22.

    PubMed 16931170

  • Seow CH, Newman A, Irwin SP, Steinhart AH, Silverberg MS, Greenberg GR. Trough serum infliximab: a predictive factor of clinical outcome for infliximab treatment in acute ulcerative colitis. Gut. 2010 Jan;59(1):49-54. doi: 10.1136/gut.2009.183095.

    PubMed 19651627

  • 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.

  • Louis E, Collard A, Oger AF, Degroote E, Aboul Nasr El Yafi FA, Belaiche J. Behaviour of Crohn's disease according to the Vienna classification: changing pattern over the course of the disease. Gut. 2001 Dec;49(6):777-82. doi: 10.1136/gut.49.6.777.

    PubMed 11709511

  • Vermeire S, van Assche G, Rutgeerts P. Review article: Altering the natural history of Crohn's disease--evidence for and against current therapies. Aliment Pharmacol Ther. 2007 Jan 1;25(1):3-12. doi: 10.1111/j.1365-2036.2006.03134.x.

    PubMed 17229216

  • Schnitzler F, Fidder H, Ferrante M, Noman M, Arijs I, Van Assche G, Hoffman I, Van Steen K, Vermeire S, Rutgeerts P. Mucosal healing predicts long-term outcome of maintenance therapy with infliximab in Crohn's disease. Inflamm Bowel Dis. 2009 Sep;15(9):1295-301. doi: 10.1002/ibd.20927.

    PubMed 19340881

  • D'haens G, Van Deventer S, Van Hogezand R, Chalmers D, Kothe C, Baert F, Braakman T, Schaible T, Geboes K, Rutgeerts P. Endoscopic and histological healing with infliximab anti-tumor necrosis factor antibodies in Crohn's disease: A European multicenter trial. Gastroenterology. 1999 May;116(5):1029-34. doi: 10.1016/s0016-5085(99)70005-3.

    PubMed 10220494

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Infliximab in people with Crohn's Disease, run by Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives at 12 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Level of remission (time frame: 54 weeks after Inclusion). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01442025, which also lists 17 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2015; AzTrials last refreshed its copy on 7 Nov 2026.

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