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The CURE - CD Trial

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ClinicalTrials.gov Identifier: NCT03555058
Recruitment Status : Recruiting
First Posted : June 13, 2018
Last Update Posted : October 3, 2019
Sponsor:
Information provided by (Responsible Party):
Prof. Shomron BenHorin, Sheba Medical Center

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.

Condition or disease Intervention/treatment Phase
CD - Crohn's Disease Other: Treatment escalation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Comprehensive individUalized pRoactive ThErapy of Crohn's Disease Trial: The CURE-CD Trial
Actual Study Start Date : July 3, 2018
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : August 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

Arm Intervention/treatment
High risk- TDM
Treatment escalation per TDM and physician's decision.
Other: Treatment escalation
Treatment escalation per TDM and physician's decision.

No Intervention: High risk- Follow Up
Patients randomized to this arm will keep with the follow-up regime. Treatment escalation will occur only upon worsening of symptoms.
No Intervention: Low risk
Control group. Patients will be assigned to this group based on VCE results and will not undergo randomization.



Primary Outcome Measures :
  1. Rate of disease flares/complications in high-risk patients [ Time Frame: 24 months ]
    The rate of disease flares/complications in high-risk patients allocated to the Proactive arm versus the high-risk patients allocated to standard treatment


Secondary Outcome Measures :
  1. Rate of disease flares/complications in low-risk patients [ Time Frame: 24 months ]
    The rate of disease flares/complications in low-risk patients continuing their treatment unaltered compared to the high-risk patients allocated to the standard treatment arm.

  2. Rate of mucosal healing [ Time Frame: 24 months ]
    The rate of mucosal healing, defined as LS<350 for worst segment and LS<450 for total small bowel in the two high risk arms at 24 months

  3. Rate of disease flares/complications compared to a previous similar study [ Time Frame: 24 months ]
    The rate of disease flares/complications in low-risk and high-risk patients continuing their treatment unaltered compared to the rate in the patients enrolled in Sheba-IIRN previously completed study.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03555058


Contacts
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Contact: Abraham Eliakim, Prof. +972-3-5307072 abraham.eliakim@sheba.health.gov.il
Contact: Limor Selinger limor.selinger@sheba.health.gov.il

Locations
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Israel
Sheba_Medical_Center Recruiting
Tel-Hashomer, Israel, 52961
Contact: Limor Selinger         
Principal Investigator: Shomron Ben-Horin, MD         
Sponsors and Collaborators
Sheba Medical Center
Investigators
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Principal Investigator: Abraham Eliakim, Prof. Sheba Medical Center
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Responsible Party: Prof. Shomron BenHorin, Prof., Sheba Medical Center
ClinicalTrials.gov Identifier: NCT03555058    
Other Study ID Numbers: 4945-18-SMC
First Posted: June 13, 2018    Key Record Dates
Last Update Posted: October 3, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases