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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

Information source: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Crohn's Disease

Intervention: INFLIXIMAB (Drug); AZATHIOPRINE (Drug); MERCAPTOPURINE (Drug); Methotrexate (Drug)

Phase: Phase 4

Status: Not yet recruiting

Sponsored by: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

Official(s) and/or principal investigator(s):
Benjamin PARIENTE, doctor, Principal Investigator, Affiliation: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

Overall contact:
Edouard LOUIS, PHD, Phone: 0033142494988, Email: edouard.louis@ulg.ac.be

Summary

Phase IV 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 1 year 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 300 randomized patients (100 per arm) Study duration: 2 + 2 years Enrollment: 2 years Follow-up: 2 years

Clinical Details

Official title: 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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: co-primary efficacy end points

Secondary outcome:

relapse in each arm.

Sustained clinical remission

Treatment failure

Tissue damage progression

Detailed description: 3. STUDY OBJECTIVES 3. 1. Primary objective To assess the effect of two withdrawal strategies over two years in patients with stable remission for more than6 months on combination therapy with infliximab and antimetabolites, and demonstrate that continued combination of infliximab and antimetabolites or continued monotherapy with infliximab are both superior to antimetabolites alone for maintaining sustained steroid-free clinical remission, while antimetabolites alone are non-inferior with regards to the mean time spent in remission 3. 2. Secondary objectives

- 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 1 year, with a scheduled infliximab treatment administrated every 8 weeks for the last 6 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 the USA. 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 12 months.

- Scheduled administration of infliximab 5 mg/Kg every 8 weeks over the last 6 months.

- Antimetabolites administered at a stable dosage for the last 6 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

- 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

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- 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 12

months.

- Scheduled administration of infliximab 5 mg/Kg every 8 weeks over the last 6 months.

- Antimetabolites administered at a stable dosage for the last 6 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

- Patients able to understand the information provided to them and to give written

informed consent for the study 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

Locations and Contacts

Edouard LOUIS, PHD, Phone: 0033142494988, Email: edouard.louis@ulg.ac.be

Gent University Hospital, Gent 9000, Belgium

CHU LIEGE - Sart Tilman, Liege 4000, Belgium

Chu Amiens, Amiens 80054, France

Chu Besancon, Besancon 25030, France; Not yet recruiting
LUCINE VUITON, MD
LUCINE VUITON, MD, Principal Investigator

Caen Unversity Hospital, Caen 14033, France

Chu Clermont-Ferrand, Clermont-ferrand 63003, France

Hopital Beaujon, Clichy 92110, France

Hopital Louis Mourier, Colombes 92700, France

Hopital Henri Mondor, Creteil 94010, France

Chu Kremlin Bicetre, Kremlin Bicetre, France; Not yet recruiting
FRANCK CARBONNEL, MD, Sub-Investigator

Hopital Bicetre, Le Kremlin Bicetre 94275, France

Chu Lille, Lille, France; Not yet recruiting
Maria NACHURY, MD
Maria NACHURY, MD, Principal Investigator

Chu Marseille - Hopital Nord, Marseille 13915, France

Ch Le Raincy Montfermeil, Montfermeil 93370, France

Chu Montpellier, Montpellier 34295, France; Not yet recruiting
ROMAIN ALTWEGG, MD, Phone: +33467337394
ROMAIN ALTWEGG, MD, Sub-Investigator

Chu Nantes, Nantes 44093, France

CHU NICE, Nice 06202, France

Georges Pompidou European Hospital, Paris 75015, France

Hopital Bichat, Paris 75018, France

Hopital Cochin, Paris 75014, France

Hopital Lariboisiere, Paris 75010, France

Hopital Saint Louis, Paris 75010, France

Hopital St Antoine, Paris 75012, France

Montsouris Mutualist Institute, Paris 75674, France

CHU Bordeaux - Pessac, Pessac 33700, France

CHU LYON, Pierre Benite 69495, France

Chu Reims, Reims, France

Chu Rennes, Rennes 35033, France

Chu Rouen, Rouen 76031, France

Chu Saint Etienne, St Etienne 42270, France

Chu Strasbourg, Strasbourg 67091, France; Not yet recruiting
Bernard DUCLOS, MD,PhD, Phone: +33388127442, Email: bduclos@noos.fr
Bernard DUCLOS, MD,PhD, Principal Investigator
JEAN MARIE REIMUND, MDPHD, Sub-Investigator

Chu Toulouse, Toulouse 31403, France

Ch Gustave Dron, Tourcoing 59208, France; Not yet recruiting
GUENOLA VERNIER, MD
GWENOLA VERNIER, MD, Principal Investigator

Chu Tours, Tours 37044, France

Chr Valencienne, Valencienne 59300, France; Not yet recruiting
MEDINA BOUALIT, MD
MEDINA BOUALIT, MD, Principal Investigator

Chu Nancy, Vandoeuvre Les Nancy 54500, France; Not yet recruiting
LAURENT PEYRIN BIROULET, MD,PhD, Phone: +33383153354
Laurent PEYRIN-BIROULET, MD,PhD, Principal Investigator

Additional Information

Starting date: April 2015
Last updated: April 26, 2015

Page last updated: August 23, 2015

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