Tacrolimus Versus Methotrexate as Rescue Therapy for Refractory Inflammatory Bowel Disease

• Conditions: Inflammatory Bowel Diseases

• Registration Number: NCT03204136
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2017-06
• Study First Submitted: 2017-06-11
• Study First Submitted QC: 2017-06-27
• Last Update Submitted: 2017-06-27
• Study First Posted: 2017-06-29
• Last Update Posted: 2017-06-29
• Study Start: 2017-07-01
• Primary Completion: 2019-04-01
• Study Completion: 2019-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

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

Exclusion Criteria

• Pregnant woman

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
disease activity assessment after one year treatment	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

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

Trial Locations

Locations (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, China