Evaluating MRI's role in managing Crohn's disease with biotherapy
STUDY OF THE ADDED VALUE OF A TRANSMURAL EVALUATION IN PATIENTS WITH CROHN'S DISEASE UNDER BIOTHERAPY WITH CLOSE FECAL CALPROTECTIN FOLLOW-UP
This study is testing if adding MRI scans to the treatment plan helps people with Crohn's disease on biotherapy feel better and heal more effectively compared to standard follow-ups.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 180 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Clermont-Ferrand Academic / other |
| Locations | 17 sites (Amiens and 16 other locations) |
| Trial ID | NCT04973423 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of adding MRI evaluations to the management of Crohn's disease patients undergoing biotherapy. It compares two therapeutic strategies: one with regular follow-up based on clinical and laboratory criteria, and another that incorporates additional MRI assessments to guide treatment intensification. Patients will be monitored over a period of 152 weeks, with the aim of achieving both clinical remission and endoscopic mucosal healing. The study utilizes a randomized, open-label design to ensure robust data collection and analysis.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with active Crohn's disease requiring biotherapy and showing signs of inflammatory activity.
Not a fit: Patients with severe obstructive symptoms, uncontrolled intra-abdominal abscesses, or those who cannot undergo MRI will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to better management of Crohn's disease, reducing the risk of disease progression and the need for surgical interventions.
How similar studies have performed: Previous studies have shown promise in using MRI for monitoring Crohn's disease, but this specific approach is novel in its combination with biotherapy management.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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 this trial is running
Amiens and 16 other locations
- Amiens university hospital — Amiens, France (Not_yet_recruiting)
- Aurillac Hospital — Aurillac, France (Not_yet_recruiting)
- Bayonne hospital — Bayonne, France (Not_yet_recruiting)
- Bordeaux university hospital — Bordeaux, France (Not_yet_recruiting)
- Chambery Hospital — Chambéry, France (Not_yet_recruiting)
- Clermont-Ferrand University hospital — Clermont-Ferrand, France (Recruiting)
- Grenoble University Hospital — Grenoble, France (Not_yet_recruiting)
- Issoire Hospital — Issoire, France (Not_yet_recruiting)
- LILLE university hospital — Lille, France (Not_yet_recruiting)
- Lyon Hospital, Hospices civils de Lyon — Lyon, France (Not_yet_recruiting)
- Montluçon Hospital — Montluçon, France (Not_yet_recruiting)
- Montpellier University hospital — Montpellier, France (Not_yet_recruiting)
- Nancy University hospital — Nancy, France (Not_yet_recruiting)
- Nice University hospital — Nice, France (Not_yet_recruiting)
- Rennes University Hospital — Rennes, France (Not_yet_recruiting)
- Saint Etienne University Hospital — Saint-Etienne, France (Not_yet_recruiting)
- Thiers Hospital — Thiers, France (Not_yet_recruiting)
Study contacts
- Study coordinator: Lise Laclautre
- Email: promo_interne_drci@chu-clermontferrand.fr
- Phone: 04 73 75 11 95
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.