The patients with moderate to severe active refractory ulcerative colitis
Conditions
Interventions
Group of remission maintenance therapy for 48 weeks with immunomodulator at from 2 to 4 weeks following remission induction with tacrolimus,
Group of no remission maintenance therapy with immunomodula
Sponsors
Osaka City University, Graduate School of Medicine,Department of Gastroenterology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)The patients with ulcerative colitis of left side colitis or pancolitis type 2)Moderate to severe active ulcerative colitis (more than 6 points for DAI) 3)Steroid refractory or dependent case
Exclusion criteria
Exclusion criteria: 1)The treatment with immunomodulator or anti-TNF alpha agents within 12 weeks before administration of tacrolimus 2)The treatment with cytapheresis within 12 weeks before administration of tacrolimus 3)The patients who are not suitable for treatment of immunomodulator 4)The patients after colectomy 5)the patients with renal disorder
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Remission rate at 48 weeks after the administration of tacrolimus | — |
Countries
Japan
Contacts
Public ContactKenji Watanabe
Osaka City University, Graduate School of Medicine Gastroenterology
Outcome results
None listed