A Randomized, Multicenter Open Label Study Comparing Early Administration of Azathioprine Plus IFX to Steroids Plus Azathioprine for Acute Severe Colitis

Study Purpose

PHASE : IV TYPE OF STUDY : With direct benefit. DESCRIPTIVE : Multicentre, randomized, open label study. INCLUSION CRITERIA : Acute severe ulcerative colitis. OBJECTIVES : To compare the efficacy and safety of early administration of the combination therapy with infliximab and azathioprine with steroids and azathioprine in patients with acute severe ulcerative colitis treated with intravenous steroids. STUDY TREATMENTS : All patients : Intravenous steroids (0.8 mg/kg/day of methylprednisolone or equivalent) for 5 days. Combination therapy arm: Infliximab 5 mg/kg plus Azathioprine 2-2.5 mg/kg/day. Azathioprine arm: Steroids tapering for 3 months and Azathioprine 2-2.5 mg/kg/day.

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 and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Age > 18 years.
  • - Diagnosis of UC according to Lennard-Jones criteria (Appendix 1).
  • - Endoscopically demonstrated colorectal lesions localized above the anal margin and extending at least up to 15cm proximally (Endoscopic Mayo subscore ≥ 2).
  • - Acute flare requiring hospitalization - Severe acute flare of UC with a Lichtiger Index score > 10 at Day -3 - Adequate contraception for male or female subjects of childbearing potential, which will be continued throughout the study and at least 3 months after study termination.
3.2 EXCLUSION CRITERIA
  • - Pregnant or breast-feeding woman.
  • - Previous treatment with infliximab.
  • - Treatment with adalimumab or golimumab within 8 weeks before randomization - Treatment with vedolizumab within 4 weeks before randomization - Azathioprine or 6-mercaptopurine treatment initiated more than 4 weeks before screening.
  • - Ongoing intravenous steroids for more than 96 hours at time of the screening - Contraindication for anti-TNF therapy - Indication for immediate surgery.
  • - History of colorectal dysplasia.
  • - Diagnosis of Crohn's disease or indeterminate colitis - Positive stool tests for amoebiasis and/or positive bacteriological culture for Salmonella, Shigella, Yersinia and Campylobacter and/or presence of Clostridium difficile B toxin in the stools.
  • - Renal failure (creatininemia > upper limit of normal laboratory value).
  • - Uncontrolled high blood pressure.
  • - HIV, HBV viral infection (except the presence of positive anti-HBs antibodies) with serology not older than 3 months.
  • - Uncontrolled bacterial or active viral infection.
  • - Past medical history of malignant condition in the last 5 years (including leukaemia, lymphoma and myelodysplasia) except for baso-cellular cutaneous cancers.
  • - Past medical history of myocardial infarction or heart failure.
  • - Intradermal reaction to Tuberculin (Tubertest® 5 units) > 5mm or positive interferon-gamma release assay (Quantiferon®) - Active tuberculosis - Untreated latent tuberculosis (see national recommendations.
Appendix 2).
  • - Abnormal blood count with polynuclear neutrophils < 1,500 G/L or white cells < 3,000, or platelets < 100,000 G/L.
  • - Unexplained rise higher than 3 times the normal level for transaminases, alkaline phosphatases and/or higher than twice the normal level for bilirubin.
  • - Severe acute or chronic medical or psychiatric condition that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in judgement of the investigator, would make the subject inappropriate for entry in this study.
  • - Subjects who, in the opinion of the investigator, will be uncooperative or unable to comply with study procedures.
  • - Participation in another clinical trial.

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:
NCT02425852

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
Aurélien Amiot, MDLaurent Peyrin-Biroulet, MD , PhDXavier Roblin, MD
Principal Investigator Affiliation Groupe d'Etude Therapeutique des Affections Inflammatoires DigestivesGroupe d'Etude Therapeutique des Affections Inflammatoires DigestivesGroupe d'Etude Therapeutique des Affections Inflammatoires Digestives

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

Agency Class
Other
Overall Status Recruiting
Countries France

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

Conditions
Ulcerative Colitis
Additional Details

NUMBER OF PATIENTS : 75 patients in each group i.e. a total of 150 patients. RECRUITMENT PERIOD : 24 months STUDY DURATION : 36 months PRIMARY END POINT : Treatment failure is defined by: - Absence of steroid-free remission at W52 according to the total Mayo Disease Activity Index score - OR Absence of mucosal healing (Mayo endoscopic subscore 0-1) - OR Adverse event leading to treatment interruption - OR Colectomy - OR Death - OR Infliximab withdrawal in the combination therapy group OR Infliximab introduction in the azathioprine group SECONDARY END POINT: - Clinical response and remission at D7, W14 and W52 (according to Lichtiger score and total Mayo Disease Activity Index score) - Endoscopic and histological response - Mucosal healing (partial endoscopic Mayo subscore 0) - Colectomy rate - Adverse events rate - Fecal calprotectin - Health-economic outcome

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 Besancon, Besancon, France

Status

Recruiting

Address

Chu Besancon

Besancon, , 25030

Site Contact

LUCINE VUITON, MD

CHU de CLERMONT FERRAND- Hopital Estain, Clermont-Ferrand, France

Status

Recruiting

Address

CHU de CLERMONT FERRAND- Hopital Estain

Clermont-Ferrand, , 67000

Site Contact

GILLES BOMMELAER, MD

gbommelaer@chu-clermontferrand.fr

APHP- Hopital BEAUJON, Clichy, France

Status

Recruiting

Address

APHP- Hopital BEAUJON

Clichy, , 92110

Site Contact

YORAM BOUHNIK, MD

yoram.bouhnik@gmail.com

Hopital Louis Mourrier, Colombes, France

Status

Recruiting

Address

Hopital Louis Mourrier

Colombes, , 92700

Site Contact

Benoit COFFIN, MD,PhD

benoit.coffin@lmr.ap-hop-paris.fr

+33147606061

Henri Mondor Hospital, Creteil, France

Status

Recruiting

Address

Henri Mondor Hospital

Creteil, , 94010

Chu Kremlin Bicetre, Le Kremlin-Bicêtre, France

Status

Recruiting

Address

Chu Kremlin Bicetre

Le Kremlin-Bicêtre, ,

CHRU Lille, Lille, France

Status

Recruiting

Address

CHRU Lille

Lille, ,

Site Contact

Benjamin PARIENTE, MD, PhD

Chu Montpellier, Montpellier, France

Status

Recruiting

Address

Chu Montpellier

Montpellier, , 34295

Site Contact

ROMAIN ALTWEGG, MD

+33467337394

CHU de NICE- Hopital Archet 2, Nice, France

Status

Recruiting

Address

CHU de NICE- Hopital Archet 2

Nice, , 06200

Site Contact

JEROME FILLIPI, MD

filippi.j@chu-nice.fr

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

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 Joseph, Paris, France

Status

Recruiting

Address

Hopital Saint Joseph

Paris, , 75014

Site Contact

ELISE CHANTELOUP, MD

echanteloup@hpsj.fr

CHU RENNES - Hopital Pontchaillou, Rennes, France

Status

Recruiting

Address

CHU RENNES - Hopital Pontchaillou

Rennes, ,

Site Contact

GUILLAUME BOUGUEN, MD

Chu Rouen, Rouen, France

Status

Recruiting

Address

Chu Rouen

Rouen, , 76031

Site Contact

Eric LEREBOURS, MD,PhD

eric.lerebours@chu-rouen.fr

+33232888101

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 NANCY - Hopital Brabois, Vandoeuvre Les Nancy, France

Status

Recruiting

Address

CHU NANCY - Hopital Brabois

Vandoeuvre Les Nancy, , 54500

Site Contact

LAURENT PEYRIN BIROULET, MD,PhD

peyrinbiroulet@gmail.com

+33383153354

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