Phase
Condition
Inflammatory Bowel Disease
Crohn's Disease
Treatment
Infliximab
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Admission with acute severe UC (defined patients with bloody diarrhoea ≥ 6/day andany signs of systemic toxicity (pulse > 90/min, temperature > 37.8°C, haemoglobin < 105 g/l, erythrocyte sedimentation rate [ESR] > 30 mm/h, or C-reactive protein [CRP] > 30 mg/l)
Failure to intravenous steroid treatment as defined by the Oxford criteria (morethan 8 stools/d or 3-8 stools/d and CRP≥45) and a Lichtiger score ≥ 10 on day 3after starting iv steroid treatment
Patients going through baseline endoscopy and biopsy sampling (including CMV) beforestarting on IFX treatment
In the opinion of the investigator, the subject is capable of understanding andcomplying with protocol requirements.
The subject signs and dates a written, informed consent form and any requiredprivacy authorization prior to the initiation of any study procedures.
Male or non-pregnant, non-lactating females. Females of child bearing potential musthave a negative serum pregnancy test prior to randomization, and must use a hormonal (oral, implantable or injectable) or barrier method of birth control throughout week
Females unable to bear children must have documentation of such in the sourcerecords (i.e., tubal ligation, hysterectomy, or post-menopausal [defined as aminimum of one year since the last menstrual period]).
Exclusion
Exclusion Criteria:
Patients at imminent need of surgery as judged by the treating clinician
Previous use of IFX
Enteric pathogens (such as Salmonella, Shigella, Yershinia, Campylobacter and C.difficile) detected by stool analysis within 2 weeks prior to enrollment or atscreening
Active participation in another interventional trial
Patients with Crohn's disease or IBD-U
Patients with abdominal abscess
Patients with colonic stricture
Patients with a history of colon cancer or colonic dysplasia, unless sporadicadenoma, which has been removed
Active or latent tuberculosis (screening according to national guidelines)
Cardiac failure in NYHA stage III-IV
History of demyelinating disease
Recent live vaccination
Patients with ongoing acute/chronic infection (including but not limited to HIV,hepatitis B and C) with the exception of chronic herpes labialis or cervical HPV
History of cancer in the last 5 years with the exception of non-melanoma skin cancer
A history of alcohol or illicit drug use that in the opinion of the principalinvestigator (PI) would interfere with study procedures
Patients with psychiatric problems that in the opinion of the PI would interferewith study procedures
Patients unable to attend all study visits
Patients with a history of non-compliance with clinical study protocols
Contraindication for endoscopy
Patients who received any investigational drug in the past 30 days or 5 half-lives,whichever is longer
Patients who received cyclosporine in the previous 14 days
Pregnancy and lactation
Study Design
Study Description
Connect with a study center
St Vincent's University Hospital
Dublin,
IrelandSite Not Available
Academic Medical Center
Amsterdam,
NetherlandsSite Not Available
OLVG Oost
Amsterdam,
NetherlandsSite Not Available
Radboud UMC
Nijmegen,
NetherlandsSite Not Available
Klinikk Baerum Sykehus
Bærums Verk,
NorwaySite Not Available
Akerhus University Hospital
Lørenskog,
NorwaySite Not Available
Helse Stavanger
Stavanger,
NorwaySite Not Available
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