The Predictive Factors for Refractory Status and Readmission after Tacrolimus Treatment in Patients with Active Ulcerative Colitis

The Predictive Factors for Refractory Status and Readmission after Tacrolimus Treatment in Patients with Active Ulcerative Colitis - The Predictive Factors for Refractory Status and Readmission after Tacrolimus Treatment in Patients with Active Ulcerative Colitis

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000009664

Enrollment

Registered

2012-12-29

Start date

2009-12-01

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

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Inclusion criteria Patients who meets all criteria 1 and 2. 1. Patients with moderate to severe active disease Lichtiger's clinical activity index (CAI) >= 9 2.Eligible patients were aged 20 to 65 years old

Exclusion criteria

Exclusion criteria: Exclusion criteria 1.Patients with serious infectious disease 2.Patients with serious heart disease 3.Patients with serious kidney disease 4.Patients with serious liver disease 5.Patients with diabetes 6.Patients who are pregnant or have the possibility of pregnancy 7.Patients with malignancy 8.Patients who had adverse effect and/or high risk in administration thiopurine 9.Patients who judged as "non-eligible" for this study by responsible doctors

Design outcomes

Primary

Measure	Time frame
The predictors for refractory to Tacrolimus The predictors for readmission after Tacrolimus therapy Refractory tacrolimus is defined a patient who underwent surgery or changed to alternative treatment during TAC therapy with high trough level (10-15ng/ml, at least 7 days) Relapse is defined as UC-related readmission within 6 months after Tacrolimus therapy	—

Secondary

Measure	Time frame
1.The cumulative colectomy-free survival over 6 months 2.Duration of maintaining as the state of non-relapsing* *State of non-relapse is defined by Lichtiger's clinical activity index (CAI) score: Total score<=3 3.State of mucosal healing defined by elements of endoscopic findings in Mayo score 4.Ratio of patients who can achieve steroid withdrawal and the duration for steroid withdrawal 5.Decrease of concentration of C-reactive protein as an inflammatory marker 6.Overall safety during maintenance therpy	—

Measure

Time frame

1.The cumulative colectomy-free survival over 6 months 2.Duration of maintaining as the state of non-relapsing* *State of non-relapse is defined by Lichtiger's clinical activity index (CAI) score: Total score<=3 3.State of mucosal healing defined by elements of endoscopic findings in Mayo score 4.Ratio of patients who can achieve steroid withdrawal and the duration for steroid withdrawal 5.Decrease of concentration of C-reactive protein as an inflammatory marker 6.Overall safety during maintenance therpy

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Countries

Japan

Contacts

Public ContactYoko Yokoyama

Hyogo College of Medicine Internal Medicine, Lower Gastroenterology

yoko0502@hyo-med.ac.jp0798-45-6662

Outcome results