Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
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.
|Eligible Ages||18 Years and Over|
- - 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.
- - 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.
- - 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.
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.
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.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Aurélien Amiot, MDLaurent Peyrin-Biroulet, MD, PhD|
|Principal Investigator Affiliation||Groupe 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.
The disease, disorder, syndrome, illness, or injury that is being studied.
NUMBER OF PATIENTS : 73 patients in each group i.e. a total of 146patients. RECRUITMENT PERIOD : 36 months STUDY DURATION : 12 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.
Active Comparator: Combination therapy arm
Infliximab 5 mg/kg plus Azathioprine 2-2.5 mg/kg/day. Azathioprine will be introduced at day 5-7 and continued until week 52. Azathioprine dose regimen will be between 2 and 2.5 mg/kg/d, as close as possible to 2.5 mg/kg/d, or to 1.5 mg/kg/d for 6-mercaptopurine, in one daily intake.
Active Comparator: Azathioprine arm
Intravenous steroids will be continue until day 2. Then, steroid therapy will be orally administered at a dose of 40-60 mg/day ou 1 mg/kg/day prednisolone (or equivalent) and progressively reduced by 10mg step every week to 20mg per day, and then reduced by 5mg step every week until stopped. Hydrocortisone intake to prevent steroid weaning will be authorized until supradrenal function normalization. In patients with clinical response at day 7, Azathioprine will be introduced at day 5-7 and continued until week 52. Azathioprine dose regimen will be between 2 and 2.5 mg/kg/d, as close as possible of 2.5 mg/kg/d, or of 1.5 mg/kg/d for 6-mercaptopurine, in one daily intake.
Drug: - Azathioprine
Azathioprine alone versus Azathioprine and IFX
Drug: - Infliximab
Drug: - Prednisolone
Drug: - Hydrocortisone
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.
Besancon, , 25030
LUCINE VUITON, MD
CHU de CLERMONT FERRAND- Hopital Estain
Clermont-Ferrand, , 67000
Anthony BUISSON, MD
APHP- Hopital BEAUJON
Clichy, , 92110
YORAM BOUHNIK, MD
Henri Mondor Hospital
Creteil, , 94010
Chu Kremlin Bicetre
Le Kremlin-Bicêtre, ,
Benjamin PARIENTE, MD, PhD
CHU de NICE- Hopital Archet 2
Nice, , 06200
JEROME FILLIPI, MD
Hopital Saint Joseph
Paris, , 75014
ELISE CHANTELOUP, MD
CHU RENNES - Hopital Pontchaillou
GUILLAUME BOUGUEN, MD