A Randomized, Multicenter Open Label Study Comparing Early Administration of Azathioprine Plus IF… (NCT02425852) | Clinical Trial Compass
CompletedPhase 4
A Randomized, Multicenter Open Label Study Comparing Early Administration of Azathioprine Plus IFX to Steroids Plus Azathioprine for Acute Severe Colitis
France65 participantsStarted 2016-12
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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-H…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percentage of patients with treatment failure at week 52.
Timeframe: Week 52
Trial details
NCT IDNCT02425852
SponsorGroupe d'Etude Therapeutique des Affections Inflammatoires Digestives