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

Status: Recruiting
Location: See all (17) locations...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
France
Amiens university hospital
NOT_YET_RECRUITING
Amiens
Aurillac Hospital
NOT_YET_RECRUITING
Aurillac
Bayonne hospital
NOT_YET_RECRUITING
Bayonne
Bordeaux university hospital
NOT_YET_RECRUITING
Bordeaux
Chambery Hospital
NOT_YET_RECRUITING
Chambéry
Clermont-Ferrand University hospital
RECRUITING
Clermont-ferrand
Grenoble University Hospital
NOT_YET_RECRUITING
Grenoble
Issoire Hospital
NOT_YET_RECRUITING
Issoire
LILLE university hospital
NOT_YET_RECRUITING
Lille
Lyon Hospital, Hospices civils de Lyon
NOT_YET_RECRUITING
Lyon
Montluçon Hospital
NOT_YET_RECRUITING
Montluçon
Montpellier University hospital
NOT_YET_RECRUITING
Montpellier
Nancy University hospital
NOT_YET_RECRUITING
Nancy
Nice University hospital
NOT_YET_RECRUITING
Nice
Rennes University Hospital
NOT_YET_RECRUITING
Rennes
Saint Etienne University Hospital
NOT_YET_RECRUITING
Saint-etienne
Thiers Hospital
NOT_YET_RECRUITING
Thiers
Contact Information
Primary
Lise Laclautre
promo_interne_drci@chu-clermontferrand.fr
04 73 75 11 95
Time Frame
Start Date: 2022-03-21
Estimated Completion Date: 2027-08-21
Participants
Target number of participants: 180
Treatments
No_intervention: CALM
Tight control of inflammatory activity by calprotectin.
Other: CALM + IRM
Tight control of inflammatory activity by calprotectin associated with transmural evaluation.
Sponsors
Leads: University Hospital, Clermont-Ferrand

This content was sourced from clinicaltrials.gov