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Study identifier: NCT04973423 Synced from ClinicalTrials.gov · July 29, 2026
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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

Condition: Crohn Disease · Calprotectin · MRI  ·  Sponsor: University Hospital, Clermont-Ferrand

PhaseNA
Planned participants180
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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.…

This description comes directly from the study's public registry record.

Talk to the study team

Lise Laclautre  ·  04 73 75 11 95  ·  promo_interne_drci@chu-clermontferrand.fr

Always discuss trial participation with your own doctor first.

Locations (17)

Amiens university hospitalAmiens, FranceNot Yet Recruiting
Aurillac HospitalAurillac, FranceNot Yet Recruiting
Bayonne hospitalBayonne, FranceNot Yet Recruiting
Bordeaux university hospitalBordeaux, FranceNot Yet Recruiting
Chambery HospitalChambéry, FranceNot Yet Recruiting
Clermont-Ferrand University hospitalClermont-Ferrand, FranceRecruiting
Grenoble University HospitalGrenoble, FranceNot Yet Recruiting
Issoire HospitalIssoire, FranceNot Yet Recruiting
LILLE university hospitalLille, FranceNot Yet Recruiting
Lyon Hospital, Hospices civils de LyonLyon, FranceNot Yet Recruiting
Montluçon HospitalMontluçon, FranceNot Yet Recruiting
Montpellier University hospitalMontpellier, FranceNot Yet Recruiting

+ 5 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT04973423