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Therapeutic Optimization Study Based on MR Enterocolonography in Patients With Crohn's Disease | Clinical Trials | Clareo Health

UNKNOWNPHASE3

Therapeutic Optimization Study Based on MR Enterocolonography in Patients With Crohn's Disease

NCT02332356•Tokyo Medical and Dental University

View on ClinicalTrials.gov

Summary

This randomized, controlled study aims to evaluate the impact of therapeutic intervention (step up) for the patients who are clinical remission with Magnetic Resonance Enterocolonography (MREC) active. In addition, to evaluate the impact of therapeutic step down for the patients who archived clinical and MREC remission. The primary endpoint is the rate of clinical remission at 104 weeks.

Eligibility

Age

16 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Clinical diagnosis of Crohn's and proven history of disease with clinical remission (CDAI\<150)
•Signed written consent form to enroll the study (Need agreement from deputy for patients under 20years old)

Exclusion Criteria

•Contraindication for infliximab, adalimumab, or azathioprine
•Lactating woman
•Presence of malignancy
•Within 3 month from intestinal surgery
•Presence of an end stoma
•Planned surgery

Locations (1)

Gastroenterology and Hepatology, Tokyo Medical and Dental UNIV

Tokyo, Japan

Key Dates

Start Date

September 1, 2014

Primary Completion Date

March 1, 2024

Completion Date

March 1, 2024

Last Updated

November 27, 2023

Enrollment

100

ACTUAL participants

Conditions

Crohn Disease

Interventions

azathioprine or adalimumab and infliximab

DRUG

Switching to the IL-23 Inhibitor Guselkumab for People With Active IBD Who Previously Used Ustekinumab (SHIFT-IBD)

NCT07245394

Inflammatory Bowel Disease (IBD)Crohn Disease (CD)+2 more

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RECRUITING

ALPCO/Calprotectin CLIA Assay: Expected Values of Calprotectin in Healthy Subjects

NCT07089420

IBD (Inflammatory Bowel Disease)IBS - Irritable Bowel Syndrome+2 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 27, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Therapeutic Optimization Study Based on MR Enterocolonography in Patients With Crohn's Disease

Inclusion Criteria

Exclusion Criteria

Switching to the IL-23 Inhibitor Guselkumab for People With Active IBD Who Previously Used Ustekinumab (SHIFT-IBD)

ALPCO/Calprotectin CLIA Assay: Expected Values of Calprotectin in Healthy Subjects

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