Tacrolimus Versus Methotrexate as Rescue Therapy for Refractory Inflammatory Bowel Disease

Inflammatory Bowel Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03204136
• Other study ID #: shrjibdc20170401
• Status: Not yet recruiting
• Phase: N/A
• First received: June 11, 2017
• Last updated: June 27, 2017
• Start date: July 1, 2017
• Est. completion date: December 1, 2019

Study information

• Verified date: June 2017
• Source: Key Laboratory of Gastroenterology and Hepatology, Ministry of Health, China
• Contact: Jun Shen, MD
• Phone: 8613651829887
• Email: shenjun[@]vip.163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 1, 2019
• Est. primary completion date: April 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 75 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Pregnant woman

Related Conditions & MeSH terms

• Inflammatory Bowel Diseases
• Intestinal Diseases

Locations

Country	Name	City	State
China	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

Sponsors (1)

Lead Sponsor	Collaborator
Key Laboratory of Gastroenterology and Hepatology, Ministry of Health, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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