Evaluating MRI's role in managing Crohn's disease with biotherapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Clermont-Ferrand University hospital
  Clermont-Ferrand, France Recruiting
• 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

Study contacts

• Study coordinator: Lise Laclautre
• Email: promo_interne_drci@chu-clermontferrand.fr
• Phone: 04 73 75 11 95

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.