An observational study in Inflammatory Bowel Diseases, sponsored by Key Laboratory of Gastroenterology and Hepatology, Ministry of Health, China. Status unknown at 1 site in China. Open to participants aged 16 Years to 75 Years. Per ClinicalTrials.gov, last updated 2017-06-29.
Sponsored by Key Laboratory of Gastroenterology and Hepatology, Ministry of Health, China · Observational
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.
963 studies on the registry are indexed under Intestinal Diseases; 174 are open to participants now.
This study's planned enrollment of 60 is below the median of 140 across 377 observational studies indexed under Intestinal Diseases.
Browse Intestinal Diseases studies →This is the only study on the registry with Key Laboratory of Gastroenterology and Hepatology, Ministry of Health, China as lead sponsor.
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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.
Exclusion Criteria:
refractory inflammatory bowel disease patents who used tarcolimus to induce and maintain remission
refractory inflammatory bowel disease patents who used methotrexate to induce and maintain remission
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.
Time frame: one year
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
Time frame: one year
This study is status unknown, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.
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