The CURE - CD Trial

Brief summary (registry, in English)

A prospective randomized three-arms controlled trial of Crohn's Disease (CD) patients in remission of \<24 months duration. Patients will undergo screening by Magnetic Resonance Enterography (MRE) and patency capsule, and (if agreeing by separate consent) a baseline colonoscopy. Patients in whom patency of small bowel is proven will undergo video-capsule using the dedicated Inflammatory-Bowel Disease (IBD)-capsule (PillCam Crohn's). Patients with Lewis score\>350 for worst small bowel segment will be classified as high-risk and will be randomized for continued standard treatment or proactive treatment. Proactive treatment will consist of escalating/switching biologic treatment according to the pre-defined therapeutic drug monitoring (TDM)-based treatment-intensification protocol, or will consist of initiating biologic therapy in high-risk patients not receiving biologics at the time of enrollment. Both high-risk patients arms - the continued standard treatment and the proactive arm - will be followed up by clinic visits with physical examination, inflammatory and immune markers' assessment and microbiome analysis every 3 months and by serial video-capsule endoscopy (VCE) studies+ intestinal UltraSound (US) every six months. Patients who are classified as low-risk patients, as per Lewis score\<350 at baseline, will continue standard treatment and be similarly followed. All enrolled patients will undergo MRE at the end of the trial. All patients will undergo in addition blood and stool sampling for inflammatory markers, immune-phenotyping and microbiome analysis. All patients will undergo MRE at the end of the trial.

What you commit to

• Study type: Interventional
• Participants enrolled: 60
• From 3 Jul 2018 to the primary completion date, 26 Dec 2023
• 1 site in 1 country
• Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Who the study is looking for

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.