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Tacrolimus Versus Methotrexate as Rescue Therapy for Refractory Inflammatory Bowel Disease

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ClinicalTrials.gov Identifier: NCT03204136
Recruitment Status : Not yet recruiting
First Posted : June 29, 2017
Last Update Posted : June 29, 2017
Sponsor:
Information provided by (Responsible Party):
Zhanghan Dai, Key Laboratory of Gastroenterology and Hepatology, Ministry of Health, China

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
Inflammatory Bowel Diseases

Study Type : Observational
Estimated 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
Estimated Study Start Date : July 1, 2017
Estimated Primary Completion Date : April 1, 2019
Estimated Study Completion Date : December 1, 2019

Resource links provided by the National Library of Medicine


Group/Cohort
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



Primary Outcome Measures :
  1. disease activity assessment after one year treatment [ Time Frame: 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. [ Time Frame: 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



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Ages Eligible for Study:   16 Years to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Inflammatory bowel disease patients who are refractory or intolerance to conventional therapy (including mesalazine, steroid, azathioprine and biological agents). Tarcolimus or methotrexate was used in these patients.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Pregnant woman

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): NCT03204136


Contacts
Contact: Jun Shen, MD 8613651829887 shenjun@vip.163.com

Locations
China, Shanghai
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 Not yet recruiting
Shanghai, Shanghai, China, 200000
Contact: Jun Shen, MD    8613651829887    shenjun@vip.163.com   
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

Responsible Party: Zhanghan Dai, attending physician, Key Laboratory of Gastroenterology and Hepatology, Ministry of Health, China
ClinicalTrials.gov Identifier: NCT03204136     History of Changes
Other Study ID Numbers: shrjibdc20170401
First Posted: June 29, 2017    Key Record Dates
Last Update Posted: June 29, 2017
Last Verified: June 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
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Methotrexate
Tacrolimus
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors
Calcineurin Inhibitors