Ulcerative colitis
Conditions
Interventions
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 administ
Sponsors
Department of Internal Medicine, Division of Gastroenterology and Hepatology, Keio University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients who have an established diagnosis of ulcerative colitis and fulfill the criteria as described below: 1. Patients with moderate to severe activity defined by a DAI score of more than or equal to 6, AND an endoscopic sub-score of more than or equal to 2. 2. Patients showing steroid-resistance or steroid-dependence defined as below. 1) Steroid-resistance: No symptomatic improvement despite administration of oral prednisolone >= 30 mg for 2 weeks or i ntravenous prednisolone >= 30 mg for 1 week. 2) Steroid-dependence: Symptomatic worsening during steroid tapering or following discontinuation of steroids within 12 months.
Exclusion 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical response rate at week 10 according to the DAI score. | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical remission rate at week 10 DAI score at week 10 Endoscopic remission rate at week 10 | — |
Countries
Japan
Contacts
Public ContactToshifumi Hibi
Kitasato University Kitasato Institute Hospital Center for Advanced IBD Research and Treatment
Outcome results
None listed