The CURE - CD Trial

NCT03555058 | Completed

• 1 other identifier: 4945-18-SMC
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

CD - Crohn's Disease

Outcome Measures

Primary Outcomes (1)

• Rate of disease flares/complications in high-risk patients

  The rate of disease flares/complications in high-risk patients allocated to the Proactive arm versus the high-risk patients allocated to standard treatment

  24 months

Secondary Outcomes (3)

• Rate of disease flares/complications in low-risk patients

  24 months

• Rate of mucosal healing

  24 months

• Rate of disease flares/complications compared to a previous similar study

  24 months

Study Arms (3)

High risk- TDM

OTHER

Treatment escalation per TDM and physician's decision.

Other: Treatment escalation

High risk- Follow Up

NO INTERVENTION

Patients randomized to this arm will keep with the follow-up regime. Treatment escalation will occur only upon worsening of symptoms.

Low risk

NO INTERVENTION

Control group. Patients will be assigned to this group based on VCE results and will not undergo randomization.

Interventions

Treatment escalation OTHER

Treatment escalation per TDM and physician's decision.

High risk- TDM

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• CD patients in steroid-free remission for at least 3 months, but no more than 2 years.
• CDAI \< 150.

You may not qualify if:

• Clinical remission for more than 2 years.
• Patients on a second/third line of biologic class of treatment.

Sponsors & Collaborators

• Sheba Medical Center: lead

Study Sites (1)

Sheba_Medical_Center

Tel Litwinsky, 52961, Israel

Location

Related Publications (2)

• Margalit Yehuda R, Davidov Y, Selinger L, Ungar B, Lahat A, Yablecovitch D, Neuman S, Kopylov U, Ben Horin S, Eliakim R; Israeli IBD Research Nucleus (IIRN). The Visibility and Performance of Small Bowel Video Capsule Endoscopy With and Without Pre-Procedural Purge Preparation in the Same Patients. J Gastroenterol Hepatol. 2025 Jun;40(6):1485-1491. doi: 10.1111/jgh.16954. Epub 2025 Apr 3.

  PMID: 40176636 DERIVED

• Ben-Horin S, Lahat A, Ungar B, Ukashi O, Yablecovitch D, Amitai MM, Haberman Y, Selinger L, Talan-Asher A, Kriger-Sharabi O, Naftali T, Ron Y, Yanai H, Dotan I, Kopylov U, Eliakim R; Israeli IBD Research Nucleus (IIRN). Capsule Endoscopy-Guided Proactive Treat-to-Target Versus Continued Standard Care in Patients With Quiescent Crohn's Disease: A Randomized Controlled Trial. Gastroenterology. 2025 Jul;169(1):85-93.e3. doi: 10.1053/j.gastro.2025.02.031. Epub 2025 Mar 17.

  PMID: 40107519 DERIVED

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Abraham Eliakim, Prof.

  Sheba Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: May 27, 2018
• First Posted: June 13, 2018
• Study Start: July 3, 2018
• Primary Completion: December 26, 2023
• Study Completion: December 26, 2023
• Last Updated: February 14, 2024

Record last verified: 2024-02

Locations

IL (1)