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STUDY OF THE ADDED VALUE OF A TRANSMURAL EVALUATION IN PATIENTS WITH CROHN'S DISEASE UNDER BIOTHERAPY WITH CLOSE FECAL CALPROTECTIN FOLLOW-UP

RecruitingNAAges 18 Years - anyAllUniversity Hospital, Clermont-Ferrand
NCT04973423 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Crohn's disease (CD) is a chronic inflammatory bowel disease (IBD) that can dramatically affect the quality of life of patients. Due to its transmural nature (involvement of the entire thickness of the intestinal wall), it naturally progresses to intestinal destruction (stenosis, fistula) which requires intestinal resection in approximately half of patients during their follow-up. The long-term goal for patients is to maintain a normal life, that is, without symptoms and without intestinal destruction. For this, the short and medium term therapeutic objectives have evolved in recent years. Clinical remission is not a sufficient goal since it has failed to alter the natural history of the disease. The current objective to be achieved is the combination of clinical remission and endoscopic mucosal healing since it is associated with a reduced risk of progression (reappearance of symptoms,

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📋 Eligibility rules (as published)
Inclusion Criteria: * Adult Crohn's disease (age ≥ 18 years) * Symptomatic with Crohn's disease activity index (CDAI)\> 150 * Presence of objective signs of inflammatory activity (fecal calprotectin\> 250 AND sign of MRI activity) * Requiring treatment with biotherapy according to the investigator * Able to give informed consent to participate in research * Affiliation to a Social Security scheme. Exclusion Criteria: * Severe obstructive symptoms * Uncontrolled intra-abdominal abscess * Isolated anoperineal lesions * Prevention of postoperative endoscopic recurrence * Temporary or definitive ostomy * Total colectomy * Contraindication to MRI * Pregnant or breastfeeding women * Protected adults (curatorship, guardianship, saving justice) * Refusal of participation
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What it tests

  • MRI
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Where

17 sites
Amiens university hospital
Amiens, France
Aurillac Hospital
Aurillac, France
Bayonne hospital
Bayonne, France
Bordeaux university hospital
Bordeaux, France
Chambery Hospital
Chambéry, France
Clermont-Ferrand University hospital
Clermont-Ferrand, France
Grenoble University Hospital
Grenoble, France
Issoire Hospital
Issoire, France

…and 9 more on ClinicalTrials.gov.

🤝 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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