Tacrolimus Versus Methotrexate as Rescue Therapy for Refractory Inflammatory Bowel Disease

NCT03204136 | Unknown

• 1 other identifier: shrjibdc20170401
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Inflammatory Bowel Diseases

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• The number of participants require surgical intervention during treatment and the number of participants with treatment-related adverse events.

  one year

Study Arms (2)

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

Eligibility Criteria

• Age: 16 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Pregnant woman

Sponsors & Collaborators

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

Study Sites (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 Municipality, 200000, China

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jun Shen, MD

CONTACT

8613651829887; shenjun@vip.163.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: attending physician

Study Record Dates

• First Submitted: June 11, 2017
• First Posted: June 29, 2017
• Study Start: July 1, 2017
• Primary Completion: April 1, 2019
• Study Completion: December 1, 2019
• Last Updated: June 29, 2017

Record last verified: 2017-06

Locations

CN (1)