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Tacrolimus Versus Methotrexate as Rescue Therapy for Refractory Inflammatory Bowel Disease

NCT ID: NCT03204136

Last Updated: 2017-06-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-07-01

Study Completion Date

2019-12-01

Brief Summary

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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.

Detailed Description

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Conditions

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Inflammatory Bowel Diseases

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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tarcolimus

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

No interventions assigned to this group

methotrexate

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

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Tarcolimus or methotrexate was used in refractory inflammatory bowel disease patents

Exclusion Criteria

* Pregnant woman
Minimum Eligible Age

16 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

OTHER_GOV

Sponsor Role lead

Responsible Party

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Zhanghan Dai

attending physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Zhihua Ran, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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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 Municipality, China

Site Status

Countries

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China

Central Contacts

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Jun Shen, MD

Role: CONTACT

Phone: 8613651829887

Email: [email protected]

Facility Contacts

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Jun Shen, MD

Role: primary

Other Identifiers

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shrjibdc20170401

Identifier Type: -

Identifier Source: org_study_id