Phase
Condition
Ulcerative Colitis
Colic
Inflammatory Bowel Disease
Treatment
Samples
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Male and female patients ≥ 18 years of age (at the time of signing the InformedConsent)
Person informed about study organization and having signed the informed consent.
Established diagnosis of Crohn's dsease or ulcerative colitis with a minimum diseaseduration of 3 months
Moderate to severe disease activity
UC : Mayo Score ≥ 6 including endoscopy score of ≥ 2
CD : CDAI score betwenn 220 and 450 (inclusive)
Indication to start any biological or small molecule agent (anti-TNF, anti-IL 21/23,anti-integrin and JAK-inhibitors)
In case of treatment with corticosteroid : stable dose for at least 3 weeks prior tobaseline, dosage ≤ 20 mg prednisone
Indication for colonoscopy for the assessment of disease activity as for standardsof care and current guidelines
Person affiliated to or beneficiary of a social security plan
Exclusion
Exclusion Criteria:
Diagnosis of indeterminate colitis, microscopic colitis, ischaemic colitis,infectious colitis, radiation colitis
Absolute contraindications to colonoscopy procedures, complication during previousendoscopy
Bleeding disorders
Indication for surgery for UC
Rectal topical therapy (enemas or suppositories) ≤ 2 weeks prior to baseline
Treatment with > 20 mg prednisone within 3 weeks prior to baseline
Anaemia (haemoglobbin < 10g/dl) at baseline
Subject unable to comply with the study procedures
Person referred in articles L.1121-5, L. 1121-7 and L.1121-8 of the Public HealthCode:
Pregnant, parturient or breastfeeding woman
Minor person (non-emancipated)
Adult person under legal protection (any form of public guardianship)
Adult person incapable of giving consent and not under legal protection
Person deprived of liberty for judicial or administrative decision, person underpsychiatric care as referred in articles L. 3212-1 and L. 3213-1.
Study Design
Connect with a study center
CHRU of Nancy
Vandoeuvre Les Nancy, CHRU De Nancy 54511
FranceActive - Recruiting
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