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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000024936
Enrollment
30
Registered
2016-11-22
Start date
2016-11-30
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ulcerative colitis

Interventions

patients who received Infliximab continued to treat every 8 week and who received Adalimumab continued to treat every 2 week. Patients received Tacrolimus 0.5mg2Cap par day at day0. Day0 is day of

Sponsors

Keio University Gastroenterology and Hepatology
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1 Patients were diagnosed as Ulcerative colitis. 2 pMayo above 2 3 Patients to obtain consent for this study. 4 Over 16years old. 5 Patients received anti TNF-alfa antibody.

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
primary outcome is efficacy at 6 months. Effective is partial Mayo score <3.

Countries

Japan

Contacts

Public ContactMakoto Naganuma

Keio University Gastroenterology and Hepatology

maknaganuma@gmail.com03-3353-1211

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026