Inflammatory Bowel Diseases Clinical Trial
Official title:
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Key Laboratory of Gastroenterology and Hepatology, Ministry of Health, China |
China,
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 |
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