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Evaluation of Molecular Mechanisms of Non-response to Therapy in Patients With Inflammatory Bowel Disease

RecruitingNAAges 18 Years - anyAllCentral Hospital, Nancy, France
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In plain words

What the trial is, and whether it could suit you

Inflammatory bowel diseases (IBD) represent a group of immune-mediated disorders, in which currently unidentified trigger factors drive the manifestation of chronic relapsing- remitting destructive inflammatory episodes in the gut. IBD comprise two main disease entities, ulcerati\\ie colitis (UC) and Crohn s disease (CD). The diseases differ in anatomical distribution, with continuous, uniform inflammation restricted to the colon in UC, and multifocal inflammation extended throughout the entire gastrointestinal tract from mouth to anus in CD. Clinical symptoms of IBD may include bloody stools, abdominal pain, fatigue, diarrhoea, fever and weight loss. Extra-intestinal symptoms occurring in up to 40% of patients, e.g. anaemia, skin lesions (e.g. erythema nodosum, pyoderma), arthritis and uveitis, and other complications directly related to the disease organ, such as fistula in CD are cons

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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.
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What it tests

  • Samples
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Where

1 site
CHRU of Nancy
Vandœuvre-lès-Nancy, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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