Tacrolimus Versus Methotrexate as Rescue Therapy for Refractory Inflammatory Bowel Disease

Tacrolimus Versus Methotrexate as Rescue Therapy for Refractory Inflammatory Bowel Disease: an Open-label, Retrospective Study

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.

Study Overview

• Status: Unknown
• Conditions: Inflammatory Bowel Diseases

• Study Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

• Study Contact: Name: Jun Shen, MD; Phone Number: 8613651829887; Email: shenjun@vip.163.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200000
      • 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
      • Contact: Jun Shen, MD; Phone Number: 8613651829887; Email: shenjun@vip.163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 75 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Pregnant woman

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
disease activity assessment after one year treatment	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.	one year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The number of participants require surgical intervention during treatment and the number of participants with treatment-related adverse events.	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	one year

Collaborators and Investigators

• Sponsor: 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 record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2017
• Primary Completion (Anticipated): April 1, 2019
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: June 11, 2017
• First Submitted That Met QC Criteria: June 27, 2017
• First Posted (Actual): June 29, 2017

Study Record Updates

• Last Update Posted (Actual): June 29, 2017
• Last Update Submitted That Met QC Criteria: June 27, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Intestinal Diseases
• Other Study ID Numbers: shrjibdc20170401

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No