A comparative study of the efficacy of tacrolimus with infliximab in intractable ulcerative colitis

• Register: JPRN
• Last refreshed on: 17 October 2023
• Main ID: JPRN-UMIN000010612
• Date of registration: 01/05/2013
• Prospective Registration: Yes
• Primary sponsor: Department of Internal Medicine, Division of Gastroenterology and Hepatology, Keio University School of Medicine
• Public title: A comparative study of the efficacy of tacrolimus with infliximab in intractable ulcerative colitis
• Scientific title: A comparative study of the efficacy of tacrolimus with infliximab in intractable ulcerative colitis - A comparison of the efficacy of tacrolimus with infliximab in ulcerative colitis
• Date of first enrolment: 2013/05/01
• Target sample size: 130
• Recruitment status: Complete: follow-up complete
• URL: https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012376
• Study type: Interventional
• Study design: Parallel Randomized
• Phase: Phase IV

Countries of recruitment

Japan

Contacts

• Name: Toshifumi Hibi
• Affiliation: Kitasato University Kitasato Institute Hospital Center for Advanced IBD Research and Treatment

• Name: Toshifumi Hibi
• Affiliation: Kitasato University Kitasato Institute Hospital Center for Advanced IBD Research and Treatment

Key inclusion & exclusion criteria

Inclusion criteria:
Exclusion criteria: 1. Patients with only proctitis. 2. Patients having contraindications to tacrolimus including current use of cyclosporine, bozentan, or potassium-sparing diuretics. 3. Patients having contraindications to infliximab including serious infection (sepsis), active tuberculosis infection, allergy to murine-derive proteins. 4. Patients who have been administered anti-TNF agents, tacrolimus, or cyclosporine. 5. Concomitant medication: 1) Changed the dose of oral 5-aminosalicylate (ASA) agents within 1 week. 2) Used topical 5-ASA agents or topical steroid agents within 1 week. 3) Underwent cytapheresis within 1 week. 4) Started an immunomodulator (azathioprine, mercaptopurine) within 12 weeks or changed the dose of the agent within 4 weeks. 5) Changed the dose of oral prednisolone within 1 week. 6) Changed the dose of intravenous prednisolone within 1 week. 6. Patients who have a serious infection or are suspected to have it. 7. Patients who have a serious cardiovascular disease. 8. Patients who have a serious renal disease (Serum Cr >= 2.0 mg/dl) 9. Patients who have a serious hepatic disease (Total bilirubin >= 3.0 mg/dl or AST or ALT >= 200 IU/ml) 10. Patients who are pregnant, possible to be pregnant, or want to be during the study period, or are breastfeeding. 11. Patients who have a neoplasm or had a neoplasm. 12. Patients who have a psychological disorder. 13. Patients who underwent resection of the colon (excluding appendectomy) 14. Patients who are judged to be exclusive by investigators for a certain reason.

Age minimum: 20years-old
Age maximum: Not applicable
Gender: Male and Female

Health Condition(s) or Problem(s) studied

Ulcerative colitis

Intervention(s)

Tacrolimus will be administered orally for 10 weeks at the trough level of 10-15 ng/ml for the first 2 weeks following that of 5-10 ng/ml for the rest of the study period.
Infliximab will be administered intravenously at the dose of 5 mg/kg at 0, 2, 6 weeks.

Primary Outcome(s)

Clinical response rate at week 10 according to the DAI score.

Secondary Outcome(s)

Clinical remission rate at week 10 DAI score at week 10 Endoscopic remission rate at week 10

Source(s) of Monetary Support

Research group of intractable inflammatory bowel disease subsidized by the Ministry of Health, Labour and Welfare of Japan

Ethics review

Status: YES
Approval date:
Contact: