Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT04973423

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

Led by University Hospital, Clermont-Ferrand · Updated on 2022-04-26

180

Participants Needed

17

Research Sites

282 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult Crohn's disease (age 218 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.
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

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Trial Site Locations

Total: 17 locations

1

Amiens university hospital

Amiens, France

Not Yet Recruiting

2

Aurillac Hospital

Aurillac, France

Not Yet Recruiting

3

Bayonne hospital

Bayonne, France

Not Yet Recruiting

4

Bordeaux university hospital

Bordeaux, France

Not Yet Recruiting

5

Chambery Hospital

Chambéry, France

Not Yet Recruiting

6

Clermont-Ferrand University hospital

Clermont-Ferrand, France

Actively Recruiting

7

Grenoble University Hospital

Grenoble, France

Not Yet Recruiting

8

Issoire Hospital

Issoire, France

Not Yet Recruiting

9

LILLE university hospital

Lille, France

Not Yet Recruiting

10

Lyon Hospital, Hospices civils de Lyon

Lyon, France

Not Yet Recruiting

11

Montluçon Hospital

Montluçon, France

Not Yet Recruiting

12

Montpellier University hospital

Montpellier, France

Not Yet Recruiting

13

Nancy University hospital

Nancy, France

Not Yet Recruiting

14

Nice University hospital

Nice, France

Not Yet Recruiting

15

Rennes University Hospital

Rennes, France

Not Yet Recruiting

16

Saint Etienne University Hospital

Saint-Etienne, France

Not Yet Recruiting

17

Thiers Hospital

Thiers, France

Not Yet Recruiting

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Research Team

L

Lise Laclautre

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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