Checks Crohn's disease inflammation with MRI during biologic treatment
Tests added MRI scans to stool tests in adults with Crohn's disease on biologic drugs.
Key facts
- Who runs it
- University Hospital, Clermont-Ferrand
- Where
- Amiens, Aurillac, Bayonne, Bordeaux, Chambéry, Clermont-Ferrand, Grenoble, Issoire, Lille, Lyon, Montluçon, Montpellier, Nancy, Nice, Rennes, Saint-Etienne, and Thiers, FranceSee the 17 sites
- Trial code
- Registry title
- 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
- People taking part
- 180 people, planned
- Started
- 21 Mar 2022
- Expected to end
- 21 Aug 2027
- Type of study
- Interventional, 2 groupsOne group gets no study treatment, for comparison.
- Treatments tested
- MRI
- Record updated
- 30 July 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with active, symptomatic Crohn's disease who need a biologic treatment and show signs of inflammation on stool tests and MRI.
- Age
- 18 years or older
- Sex
- All sexes can join.
- Disease stage
- Active Crohn's disease with symptoms (CDAI above 150) and signs of inflammation: fecal calprotectin above 250 and MRI signs of activity.
- Earlier treatment
- Needs treatment with a biotherapy, according to the investigator.
- Biomarker or test result
- Fecal calprotectin above 250 together with MRI signs of inflammatory activity.
Main reasons for not taking part
- Severe obstructive symptoms
- Uncontrolled abscess inside the abdomen
- Isolated lesions around the anus only
- Ostomy (temporary or permanent) or total colectomy
- Pregnant or breastfeeding women
The registry criteria, word for word
Show all 16 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
Where in France
- Amiens University HospitalAmiens, FranceContact: MAthurin FUMERY (principal investigator)Not yet recruiting
- Aurillac HospitalAurillac, FranceContact: Clément PASTAUD (principal investigator)Not yet recruiting
- Bayonne HospitalBayonne, FranceContact: Félix GOUTORBE (principal investigator)Not yet recruiting
- Bordeaux University HospitalBordeaux, FranceContact: David LAHARIE (principal investigator)Not yet recruiting
- Chambery HospitalChambéry, FranceContact: Christophe Allimant (principal investigator)Not yet recruiting
- Clermont-Ferrand University HospitalClermont-Ferrand, FranceContact: Anthony BUISSON (principal investigator)Taking people
- Grenoble University HospitalGrenoble, FranceContact: Nicolas MATHIEU (principal investigator)Not yet recruiting
- Issoire HospitalIssoire, FranceContact: Camille Sautel (principal investigator)Not yet recruiting
- Lille University HospitalLille, FranceContact: Maria NACHURY (principal investigator)Not yet recruiting
- Lyon Hospital, Hospices civils de LyonLyon, FranceContact: Stéphane NANCEY (principal investigator)Not yet recruiting
- Montluçon HospitalMontluçon, FranceContact: Cédric DURON (principal investigator)Not yet recruiting
- Montpellier University HospitalMontpellier, FranceContact: Romain ALTWEGG (principal investigator)Not yet recruiting
- Nancy University HospitalNancy, FranceContact: Laurent PEYRIN-BIROULET (principal investigator)Not yet recruiting
- Nice University HospitalNice, FranceContact: Xavier HEBUTERNE (principal investigator)Not yet recruiting
- Rennes University HospitalRennes, FranceContact: Guillaume BOUGUEN (principal investigator)Not yet recruiting
- Saint-Etienne University HospitalSaint-Etienne, FranceContact: Xavier ROBLIN (principal investigator)Not yet recruiting
- Thiers HospitalThiers, FranceContact: Julien SCANZI (principal investigator)Not yet recruiting
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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.
The 2 groups in the trial
- CALMNo study treatment, for comparison
Tight control of inflammatory activity by calprotectin.
- CALM + IRMOther group
Tight control of inflammatory activity by calprotectin associated with transmural evaluation.
Treatment: MRI
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- 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
- Plain-language title
- Checks Crohn's disease inflammation with MRI during biologic treatmentGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 30 July 2026