Actively Recruiting
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
Eligibility Criteria
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.
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
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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