RecruitingNot ApplicableNCT04973423

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


Sponsor

University Hospital, Clermont-Ferrand

Enrollment

180 participants

Start Date

Mar 21, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

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, hospitalization, intestinal resection). Fecal calprotectin, better accepted than colonoscopy, is a non-invasive biomarker of endoscopic inflammatory activity in CD. The CALM study recently showed that close follow-up with clinical and biological evaluation (assays of CRP and fecal calprotectin), called "tight control", associated with therapeutic intensification in the absence of clinical or biological remission, was associated with a better rate of endoscopic mucosal healing at 1 year than follow-up based solely on symptoms. Thus, the "CALM" strategy is considered to be the current benchmark. Transmural healing evaluated by MRI is also a promising objective associated with a reduced risk of progression (reappearance of symptoms, hospitalization, bowel resection). In addition, it could prevent intestinal destruction. A recent study by our team suggested that calprotectin (mucosal assessment) and MRI (transmural assessment) may be complementary and be a better therapeutic goal. We hypothesize that a "CALM + MRI" strategy concomitantly targeting transmural healing would be superior to the "CALM" strategy alone in maintaining clinical remission without corticosteroids in patients with CD treated with biotherapies.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating whether adding intestinal ultrasound (an external, non-invasive scan) to standard monitoring with a stool test (fecal calprotectin) provides a clearer picture of Crohn's disease activity in people starting a biologic therapy (e.g., a drug that targets the immune system). **You may be eligible if...** - You are 18 or older with confirmed Crohn's disease - You have active symptoms (Crohn's Disease Activity Index above 150) - You have objective evidence of bowel inflammation on both a stool test (calprotectin over 250) and an MRI scan - Your doctor recommends starting biologic therapy - You are affiliated with a Social Security scheme and able to give informed consent **You may NOT be eligible if...** - You have severe narrowings (strictures) causing intestinal obstruction - You have an uncontrolled abscess in the abdomen - You have a stoma (colostomy or ileostomy) or have had your entire colon removed - You are pregnant or breastfeeding - You have a contraindication to MRI Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONMRI

2 additional MRI will be done for the CALM + MRI group


Locations(17)

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

LILLE university hospital

Lille, France

Lyon Hospital, Hospices civils de Lyon

Lyon, France

Montluçon Hospital

Montluçon, France

Montpellier University hospital

Montpellier, France

Nancy University hospital

Nancy, France

Nice University hospital

Nice, France

Rennes University Hospital

Rennes, France

Saint Etienne University Hospital

Saint-Etienne, France

Thiers Hospital

Thiers, France

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NCT04973423


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