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RECRUITING
NCT04973423
NA

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

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

180

Start Date

2022-03-21

Completion Date

2027-08-21

Last Updated

2022-04-26

Healthy Volunteers

No

Interventions

RADIATION

MRI

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