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Efficacy of additional Calcineurin inhibitors in anti TNF-alfa antibody refractory Ulcerative colitis

Not Applicable
Recruiting
Conditions
lcerative colitis
Registration Number
JPRN-UMIN000024936
Lead Sponsor
Keio University Gastroenterology and Hepatology
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
30
Inclusion Criteria

Not provided

Exclusion Criteria

1 Patients with severe Ulcerative colitis. 2 Patients with colitis except for Ulcerative colitis. 3 Patients with gastrointestinal obstruction. 4 Preoperation patients. 5 Patients with severe infection. 6 Patients with severe heart disease. 7 Patients with serum creatinine above 1.2. 8 Patients with serum total Bilirubin above 2.0, AST above 50, ALT above 50. 9 Patients with malignancy or history of malignancy. 10 Patients with neuropsychiatric disorder. 11 women who are or may be pregnant, nursing women and woman who desire to bear children. 12 Inappropriate patients by doctor's judgement. 13 Patients who received a part of other UC therapies.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
primary outcome is efficacy at 6 months. Effective is partial Mayo score <3.
Secondary Outcome Measures
NameTimeMethod
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