A proSpective Randomized Controlled Trial comParing infliximAb-antimetabolites Combination Therapy to Anti-metabolites monotheRapy and Infliximab monothErapy in Crohn's Disease Patients in Sustained Steroid-free Remission on Combination Therapy
NCT ID: NCT02177071
Last Updated: 2022-08-03
Study Results
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Basic Information
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COMPLETED
PHASE4
211 participants
INTERVENTIONAL
2015-10-09
2021-10-31
Brief Summary
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Design : Prospective, open-label, randomized three-arms study
Main Inclusion criteria Luminal Crohn's disease patients with steroid free remission for at least 6 months and a combination therapy with infliximab and anti-metabolites for at least 8 months
Primary objective To demonstrate that Infliximab scheduled maintenance with or without antimetabolites is superior to antimetabolites alone to maintain sustained steroid-free remission over 2 years, while the latter is non inferior with regards to the mean time spent in remission over the same duration
Main co-primary end points Clinical relapse rate at 2 years Mean remission duration within 2 years Study treatment Infliximab, Mercaptopurine, azathioprine, methotrexate.
Number of subjects 225 randomized patients (75 per arm)
Study duration: 3 + 2 years Enrollment: 3 years Follow-up: 2 years
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Detailed Description
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* To identify baseline predictive factors of relapse in the three study groups.
* To assess the ability of blood CRP and fecal calprotectin to predict short term relapse in the three groups.
* To assess time spent inclinical remission in the three groups.
* To assess the rate of treatment failure in the three study groups.
* To assess the time to treatment failure in the three study groups.
* To assess progression of bowel damage in the three groups.
* To assess the safety and efficacy of infliximab retreatment in the antimetabolites group.
* To assess safety in the three study groups.
* To assess the health related quality of life in the three study groups.
* To assess direct and indirect costs in the three study groups.
* To assess evolution of blood CRP and fecal calprotectin in the three study groups.
* To assess evolution of infliximab trough levels and ATI in the two infliximab scheduled maintenance groups.
* To assess genetic association with the various clinical and biological outcomes.
* To assess the impact of 6TGN levels on the various clinical and biological outcomes in the purine treated patients 4. STUDY POPULATION 4.1. Selection of study population Patients to be included are those who have been in steroid free remission for at least 6 months and with scheduled infliximab/antimetabolites combination therapy for at least 8 months, with a scheduled infliximab treatment administrated every 8 weeks for the last 4 months.
4.2. Source of recruitment Patients are recruited from participating GETAID IBD-centers in France, Belgium and SOIBD IBD-centers in Sweden, and selected centres in UK, Germany, Netherland and Australia 4.3. Inclusion criteria
To be eligible all of the following criteria must be met:
* Diagnosis of Crohn's disease.
* Male or female, age \> 18 years.
* Currently treated with a combination therapy with infliximab and anti-metabolites for luminal Crohn's disease.
* Combined therapy with scheduled infliximab and anti-metabolites for at least 8 months.
* Scheduled administration of infliximab 5 mg/Kg every 8 weeks over the last 4 months.
* Antimetabolites administered at a stable dosage for the last 3 months: at least 1 mg/Kg or 2 mg/Kg for mercaptopurine and azathioprine, respectively, or the highest tolerated dosage if intolerance to standard dose;(lower dose than standard dose is also allowed if 6 TGN \> 235 pmol) ; at least 15 mg/week subcutaneously for methotrexate.
* Patients in steroid free clinical remission for at least 6 months according to retrospective assessment of the patients' files.
* CDAI \< 150 at baseline.
* A contraceptive during the whole study
* Patients able to understand the information provided to them and to give written informed consent for the study
4.4. Exclusion criteria
* Patients who have presented a severe acute or delayed reaction to infliximab.
* Perianal fistulae as the main indication for infliximab treatment
* Active perianal/abdominal fistulae at time of inclusion, defined by active drainage
* Patients with ostomy or ileoanal pouch
* Pregnancy or planned pregnancy during the study
* Inability to follow study procedures as judged by the investigator
* Non-compliant subjects.
* Participation in another therapeutic study
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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INFLIXIMAB AND ANTI METABOLITE
continuing scheduled infliximab treatment and anti-metabolite
No interventions assigned to this group
STOP INFLIXIMAB CONTINUING ANTI METABOLITE
discontinuing infliximab and continuing the anti-metabolite
INFLIXIMAB
CONTINUING INFLIXIMAB AND discontinuing anti-metabolites
CONTINUING INFLIXIMAB AND DISCONTINUING ANTI METABOLITE
AZATHIOPRINE
MERCAPTOPURINE
Methotrexate
Interventions
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INFLIXIMAB
AZATHIOPRINE
MERCAPTOPURINE
Methotrexate
Eligibility Criteria
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Inclusion Criteria
* Male or female, age \> 18 years.
* Currently treated with a combination therapy with infliximab and anti-metabolites for luminal Crohn's disease.
* Combined therapy with scheduled infliximab and anti-metabolites for at least 8 months.
* Scheduled administration of infliximab 5 mg/Kg every 8 weeks over the last 4 months.
* Antimetabolites administered at a stable dosage for the last 3 months: at least 1 mg/Kg or 2 mg/Kg for mercaptopurine and azathioprine, respectively, or the highest tolerated dosage if intolerance to standard dose; at least 15 mg/week subcutaneously for methotrexate.
* Patients in steroid free clinical remission for at least 6 months according to retrospective assessment of the patients' files.
* CDAI \< 150 at baseline.
* A contraceptive during the whole study for childbearing potential female patients.
* Patients able to understand the information provided to them and to give written informed consent for the study
Exclusion Criteria
* Perianal fistulae as the main indication for infliximab treatment
* Active perianal/abdominal fistulae at time of inclusion, defined by active drainage
* Patients with ostomy or ileoanal pouch
* Pregnancy or planned pregnancy during the study
* Inability to follow study procedures as judged by the investigator
* Non-compliant subjects.
* Participation in another therapeutic study
* Steroid use ≤6 months prior to screening
* Currently receiving steroids, immunosuppressive agents (other than purine, methotrexate), biologic treatment (other than infliximab) or thalidomide
18 Years
65 Years
ALL
No
Sponsors
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Saint-Louis Hospital, Paris, France
OTHER
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
OTHER
Responsible Party
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Principal Investigators
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David Laharie
Role: PRINCIPAL_INVESTIGATOR
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
Locations
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St Vincent Hospital
Melbourne, , Australia
CHU LIEGE - Sart Tilman
Liège, Province De Liège, Belgium
Gent University Hospital
Ghent, , Belgium
Chu Clermont-Ferrand
Clermont-Ferrand, Auvergne-Rhône-Alpes, France
CHU LYON
Pierre-Bénite, Auvergne-Rhône-Alpes, France
Chu Saint Etienne
Saint-Etienne, Auvergne-Rhône-Alpes, France
Chu Besancon
Besançon, Bourgogne-Franche-Comté, France
Chu Rennes
Rennes, Brittany Region, France
Chu Tours
Tours, Centre-Val de Loire, France
Chu Reims
Reims, Grand Est, France
Chu Nancy
Vandœuvre-lès-Nancy, Grand Est, France
Chu Amiens
Amiens, Hauts-de-France, France
Chu Lille
Lille, Hauts-de-France, France
Chr Valencienne
Valenciennes, Hauts-de-France, France
Caen Unversity Hospital
Caen, Normandy, France
CHU Bordeaux - Pessac
Pessac, Nouvelle-Aquitaine, France
Chu Montpellier
Montpellier, Occitanie, France
Chu Toulouse
Toulouse, Occitanie, France
Chu Nantes
Nantes, Pays de la Loire Region, France
CHU NICE
Nice, Provences Alpes Cote d'Azur, France
Hopital Saint Joseph
Paris, , France
Hopital Beaujon
Clichy, Île-de-France Region, France
Chu Kremlin Bicetre
Le Kremlin-Bicêtre, Île-de-France Region, France
Hopital Bicetre
Le Kremlin-Bicêtre, Île-de-France Region, France
Hopital Saint Louis
Paris, Île-de-France Region, France
Hopital St Antoine
Paris, Île-de-France Region, France
Montsouris Mutualist Institute
Paris, Île-de-France Region, France
Countries
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References
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Pierre N, Huynh-Thu VA, Baiwir D, Mazzucchelli G, Fleron M, Trzpiot L, Eppe G, De Pauw E, Laharie D, Satsangi J, Bossuyt P, Vuitton L, Vieujean S, Colombel JF, Meuwis MA, Louis E; GETAID and the SPARE-Biocycle research group. External validation of serum biomarkers predicting short-term and mid/long-term relapse in patients with Crohn's disease stopping infliximab. Gut. 2024 Nov 11;73(12):1965-1973. doi: 10.1136/gutjnl-2024-332648.
Louis E, Resche-Rigon M, Laharie D, Satsangi J, Ding N, Siegmund B, D'Haens G, Picon L, Bossuyt P, Vuitton L, Irving P, Viennot S, Lamb CA, Pollok R, Baert F, Nachury M, Fumery M, Gilletta C, Almer S, Ben-Horin S, Bouhnik Y, Colombel JF, Hertervig E; GETAID and the SPARE-Biocycle research group. Withdrawal of infliximab or concomitant immunosuppressant therapy in patients with Crohn's disease on combination therapy (SPARE): a multicentre, open-label, randomised controlled trial. Lancet Gastroenterol Hepatol. 2023 Mar;8(3):215-227. doi: 10.1016/S2468-1253(22)00385-5. Epub 2023 Jan 11.
Hirten RP, Lakatos PL, Halfvarson J, Colombel JF. Reply. Clin Gastroenterol Hepatol. 2021 Jun;19(6):1301-1302. doi: 10.1016/j.cgh.2020.07.061. Epub 2020 Nov 26. No abstract available.
Other Identifiers
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GETAID 2014-03
Identifier Type: -
Identifier Source: org_study_id
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