Evaluation of Molecular Mechanisms of Non-response to Therapy in Patients With Inflammatory Bowel Disease (3TR)
Crohn's Disease, Ulcerative Colitis
About this trial
This is an interventional other trial for Crohn's Disease focused on measuring biomarkers, Crohn's disease, ulcerative colitis, disease activity, therapy reponse
Eligibility Criteria
Inclusion Criteria: Male and female patients ≥ 18 years of age (at the time of signing the Informed Consent) Person informed about study organization and having signed the informed consent. Established diagnosis of Crohn's dsease or ulcerative colitis with a minimum disease duration 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 to baseline, dosage ≤ 20 mg prednisone Indication for colonoscopy for the assessment of disease activity as for standards of care and current guidelines Person affiliated to or beneficiary of a social security plan Exclusion Criteria: Diagnosis of indeterminate colitis, microscopic colitis, ischaemic colitis, infectious colitis, radiation colitis Absolute contraindications to colonoscopy procedures, complication during previous endoscopy 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 Health Code: 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 under psychiatric care as referred in articles L. 3212-1 and L. 3213-1.
Sites / Locations
- CHRU of NancyRecruiting
Arms of the Study
Arm 1
Other
Samples
The intervention is to collect blood; urine; saliva and stool samples but also mucosal biopsies at each protocol visits (baseline and follow up visits).