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 Purpose

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 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

Recruitment Criteria

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Accepts Healthy Volunteers
No

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Study Type
Interventional
Eligible Ages 18 Years - 65 Years
Gender All
More Inclusion & Exclusion 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 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:

    - 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 - Steroid use ≤6 months prior to screening - Currently receiving steroids, immunosuppressive agents (other than purine, methotrexate), biologic treatment (other than infliximab) or thalidomide

Trial Details

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

Trial ID:
NCT02177071

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase
Phase 4

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Lead Sponsor
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

The person who is responsible for the scientific and technical direction of the entire clinical study.

Principal Investigator
Benjamin PARIENTE, doctor
Principal Investigator Affiliation Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Agency Class
OtherOther
Overall Status Recruiting
Countries Australia, Belgium, France

The disease, disorder, syndrome, illness, or injury that is being studied.

Conditions
Crohn's Disease
Additional Details

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 than 6 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 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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Chu Nancy, Vandoeuvre Les Nancy, France

Status

Recruiting

Address

Chu Nancy

Vandoeuvre Les Nancy, , 54500

Site Contact

LAURENT PEYRIN BIROULET, MD,PhD

edouard.louis@ulg.ac.be

+33383153354

Chr Valencienne, Valencienne, France

Status

Not yet recruiting

Address

Chr Valencienne

Valencienne, , 59300

Site Contact

MEDINA BOUALIT, MD

edouard.louis@ulg.ac.be

0033142494988

Chu Tours, Tours, France

Status

Recruiting

Address

Chu Tours

Tours, , 37044

Site Contact

Laurence PICON, MD

l.picon@chu-tours.fr

+33247475916

Ch Gustave Dron, Tourcoing, France

Status

Withdrawn

Address

Ch Gustave Dron

Tourcoing, , 59208

Chu Toulouse, Toulouse, France

Status

Recruiting

Address

Chu Toulouse

Toulouse, , 31403

Site Contact

Jacques MOREAU, MD

moreau.j@chu-toulouse.fr

+33561322764

Chu Strasbourg, Strasbourg, France

Status

Withdrawn

Address

Chu Strasbourg

Strasbourg, , 67091

Chu Saint Etienne, St Etienne, France

Status

Recruiting

Address

Chu Saint Etienne

St Etienne, , 42270

Site Contact

Xavier ROBLIN, MD

xavier.roblin@chu-st-etienne.fr

+33 4 77 82 83 20

Chu Rouen, Rouen, France

Status

Not yet recruiting

Address

Chu Rouen

Rouen, , 76031

Site Contact

Eric LEREBOURS, MD,PhD

eric.lerebours@chu-rouen.fr

+33232888101

Chu Rennes, Rennes, France

Status

Recruiting

Address

Chu Rennes

Rennes, , 35033

Site Contact

Guillaume BOUGUEN, MD

guillaume.bouguen@chu-rennes.fr

+33299284347

Chu Reims, Reims, France

Status

Active, not recruiting

Address

Chu Reims

Reims, ,

CHU LYON, Pierre Benite, France

Status

Recruiting

Address

CHU LYON

Pierre Benite, , 69495

Site Contact

Bernard FLOURIE, MD,PhD

bernard.flourie@chu-lyon.fr

+33478861288

CHU Bordeaux - Pessac, Pessac, France

Status

Recruiting

Address

CHU Bordeaux - Pessac

Pessac, , 33700

Site Contact

David LAHARIE, MD

david.laharie@chu-bordeaux.fr

0033142494988

Montsouris Mutualist Institute, Paris, France

Status

Recruiting

Address

Montsouris Mutualist Institute

Paris, , 75674

Hopital Saint Joseph, Paris, France

Status

Recruiting

Address

Hopital Saint Joseph

Paris, , 75014

Site Contact

ELISE CHANTELOUP, MD

echanteloup@hpsj.fr

0033142494988

Hopital Cochin, Paris, France

Status

Not yet recruiting

Address

Hopital Cochin

Paris, , 75014

Site Contact

Vered ABITBOL, MD

vered@club-internet.fr

+33158411967

Hopital St Antoine, Paris, France

Status

Recruiting

Address

Hopital St Antoine

Paris, , 75012

Site Contact

Jacques COSNES, MD, PhD

jacques.cosnes@sat.aphp.fr

+33 1 49 28 31 70

Hopital Saint Louis, Paris, France

Status

Recruiting

Address

Hopital Saint Louis

Paris, , 75010

Site Contact

Matthieu ALLEZ, MD, PhD

matthieu.allez@sls.aphp.fr

33 1 42 49 95 97

CHU NICE, Nice, France

Status

Recruiting

Address

CHU NICE

Nice, , 06202

Site Contact

Xavier HEBUTERNE, MD,PhD

hebuterne.x@chu-nice.fr

+33492066168

Chu Nantes, Nantes, France

Status

Recruiting

Address

Chu Nantes

Nantes, , 44093

Site Contact

Arnaud BOURREILLE, MD

arnaud.boureille@chu-nantes.fr

+33202400830

Chu Montpellier, Montpellier, France

Status

Not yet recruiting

Address

Chu Montpellier

Montpellier, , 34295

Site Contact

ROMAIN ALTWEGG, MD

edouard.louis@ulg.ac.be

+33467337394

Ch Le Raincy Montfermeil, Montfermeil, France

Status

Withdrawn

Address

Ch Le Raincy Montfermeil

Montfermeil, , 93370

Chu Lille, Lille, France

Status

Recruiting

Address

Chu Lille

Lille, ,

Site Contact

Maria NACHURY, MD

edouard.louis@ulg.ac.be

0033142494988

Hopital Bicetre, Le Kremlin Bicetre, France

Status

Recruiting

Address

Hopital Bicetre

Le Kremlin Bicetre, , 94275

Site Contact

Franck CARBONNEL, MD,PhD

franck.carbonnel@bct.aphp.fr

+33 1 45 21 37 22

Chu Kremlin Bicetre, Kremlin Bicetre, France

Status

Recruiting

Address

Chu Kremlin Bicetre

Kremlin Bicetre, ,

Hopital Henri Mondor, Creteil, France

Status

Not yet recruiting

Address

Hopital Henri Mondor

Creteil, , 94010

Site Contact

Jean-Charles DELCHIER, MD,PhD

jean-charles.delchier@hmn.aphp.fr

+33149812351

Hopital Beaujon, Clichy, France

Status

Recruiting

Address

Hopital Beaujon

Clichy, , 92110

Site Contact

Yoram BOUHNIK, MD,PhD

yoram.bouhnik@bjn.aphp.fr

+33 1 40 87 56 00

Chu Clermont-Ferrand, Clermont-ferrand, France

Status

Recruiting

Address

Chu Clermont-Ferrand

Clermont-ferrand, , 63003

Site Contact

Gilles BOMMELAER, MD,PhD

gbommelaer@chu-clermontferrand.fr

+33473750523

Caen Unversity Hospital, Caen, France

Status

Recruiting

Address

Caen Unversity Hospital

Caen, , 14033

Chu Besancon, Besancon, France

Status

Recruiting

Address

Chu Besancon

Besancon, , 25030

Site Contact

LUCINE VUITON, MD

edouard.louis@ulg.ac.be

0033142494988

Chu Amiens, Amiens, France

Status

Recruiting

Address

Chu Amiens

Amiens, , 80054

Site Contact

Jean-Louis DUPAS, MD,PhD

dupas.jean-louis@chu-amiens.fr

+33 3 22 66 82 08

CHU LIEGE - Sart Tilman, Liege, Belgium

Status

Recruiting

Address

CHU LIEGE - Sart Tilman

Liege, , 4000

Site Contact

Edouard LOUIS, MD,PhD

Edouard.Louis@ulg.ac.be

+32436667889

Gent University Hospital, Gent, Belgium

Status

Recruiting

Address

Gent University Hospital

Gent, , 9000

Site Contact

Martine DE VOS, MD,PhD

martine.devos@uzgent.be

003292402371

St Vincent Hospital, Melbourne, Australia

Status

Recruiting

Address

St Vincent Hospital

Melbourne, ,

Site Contact

NIK DONG, MD

Nik.DING@svha.org.au

0033142494988

The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation. For a full description of terms please refer to our Terms, Conditions & Privacy.