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Tacrolimus Versus Methotrexate as Rescue Therapy for Refractory Inflammatory Bowel Disease

Sponsor
Key Laboratory of Gastroenterology and Hepatology, Ministry of Health, China (Other)
Overall Status
Unknown status
CT.gov ID
NCT03204136
Collaborator
(none)
60
Enrollment
1
Location
29
Anticipated Duration (Months)
2.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Mesalazine, steroid, immunosuppressants and biologic agents are main medical treatments in treating inflammatory bowel diseases. Yet some patients develop severe side effects or initial invalid to conventional therapies. Some studies have already showed that tarcolimus and methotrexate are both effective in inducing and maintaining disease remission. Here we conduct a retrospective study to compare the efficancy of tarcolimus and methotrexate in treating refractory inflammatory bowel diseases as rescue therapy.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    60 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Retrospective
    Official Title:
    Tacrolimus Versus Methotrexate as Rescue Therapy for Refractory Inflammatory Bowel Disease: an Open-label, Retrospective Study
    Anticipated Study Start Date :
    Jul 1, 2017
    Anticipated Primary Completion Date :
    Apr 1, 2019
    Anticipated Study Completion Date :
    Dec 1, 2019

    Arms and Interventions

    Arm Intervention/Treatment
    tarcolimus

    refractory inflammatory bowel disease patents who used tarcolimus to induce and maintain remission
    methotrexate

    refractory inflammatory bowel disease patents who used methotrexate to induce and maintain remission

    Outcome Measures

    Primary Outcome Measures

    1. disease activity assessment after one year treatment [one year]

      Disease activity is assessed through blood test, radiology and clinical for both Crohn's disease and ulverative colitis. We evaluate clinical response based on Crohn's disease activity index (CDAI) for CD and Mayo score for UC at the end of one year observation.

    Secondary Outcome Measures

    1. The number of participants require surgical intervention during treatment and the number of participants with treatment-related adverse events. [one year]

      The number of participants require surgical intervention during treatment and the number of participants with treatment-related adverse events as assessed by CTCAE v4.0

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    16 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Tarcolimus or methotrexate was used in refractory inflammatory bowel disease patents
    Exclusion Criteria:
    • Pregnant woman

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Division of Gastroenterology and Hepatology, Key Laboratory of Gastroenterology and Hepatology, Ministry of Health；Shanghai Inflammatory Bowel Disease Research Center；Renji Hospital, School of Medicine, Shanghai Jiao Tong University Shanghai Shanghai China 200000

    Sponsors and Collaborators

    • Key Laboratory of Gastroenterology and Hepatology, Ministry of Health, China

    Investigators

    • Principal Investigator: Zhihua Ran, MD, Division of Gastroenterology and Hepatology, Key Laboratory of Gastroenterology and Hepatology, Ministry of Health；Shanghai Inflammatory Bowel Disease Research Center；Renji Hospital, School of Medicine, Shanghai Jiao Tong University; Shanghai Institute of

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Zhanghan Dai, attending physician, Key Laboratory of Gastroenterology and Hepatology, Ministry of Health, China
    ClinicalTrials.gov Identifier:
    NCT03204136
    Other Study ID Numbers:
    • shrjibdc20170401
    First Posted:
    Jun 29, 2017
    Last Update Posted:
    Jun 29, 2017
    Last Verified:
    Jun 1, 2017
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Intestinal Diseases
    Inflammatory Bowel Diseases

    Study Results

    No Results Posted as of Jun 29, 2017