STUDY OF THE ADDED VALUE OF A TRANSMURAL EVALUATION IN PATIENTS WITH CROHN'S DISEASE UNDER BIOTHERAPY WITH CLOSE FECAL CALPROTECTIN FOLLOW-UP
Deeper
1 other identifier
interventional
180
1 country
17
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2022
Longer than P75 for not_applicable
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 13, 2021
CompletedFirst Posted
Study publicly available on registry
July 22, 2021
CompletedStudy Start
First participant enrolled
March 21, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 21, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 21, 2027
April 26, 2022
April 1, 2022
5 years
July 13, 2021
April 19, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Proportion of months spent in clinical remission
Proportion of months (4 week period) spent in clinical remission without corticosteroids according to PRO-2 (\<3 very soft or watery stools per day and no moderate to severe abdominal pain).
Between week 24 and week 76.
Study Arms (2)
CALM
NO INTERVENTIONTight control of inflammatory activity by calprotectin.
CALM + IRM
OTHERTight control of inflammatory activity by calprotectin associated with transmural evaluation.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 13, 2021
First Posted
July 22, 2021
Study Start
March 21, 2022
Primary Completion (Estimated)
March 21, 2027
Study Completion (Estimated)
August 21, 2027
Last Updated
April 26, 2022
Record last verified: 2022-04