Tacrolimus (FK506) P-III, Open-label Study in Refractory Ulcerative Colitis Patients

Study Overview
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Brief Summary
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Patients with severe refractory ulcerative colitis (UC) or those who received placebo in study F506-CL-1107 will receive tacrolimus for a maximum of 12 weeks. Safety and efficacy will be evaluated.

Detailed Description
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Patients with severe refractory ulcerative colitis (UC) or those who received placebo in study F506-CL-1107 study can participate in this study. Patients will receive tacrolimus for a maximum of 12 weeks in an open-label study manner. Improvement of Disease Activity Index (DAI) score and other efficacy scores will be evaluated during the drug administration period.

Official Title
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Tacrolimus (FK506) P-III, Open-label Study in Severe Refractory Ulcerative Colitis Patients or Patients Who Attended and Received Placebo in F506-CL-1107 Study

Conditions
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Ulcerative Colitis

Intervention / Treatment
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* Drug: Tacrolimus


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Severe refractory UC patients who meets the following criteria Disease activity: more than 6 times of stool a day, bloody stool, moderate to severe endoscopic finding Steroid resistant or dependent OR Moderate to severe refractory UC patients who participated and received placebo in F506-CL-1107 study Exclusion Criteria: Mild or fulminant type Renal failure patients, hepatic failure patients Patients taking 6-mercaptopurine, cyclosporin or other immunosuppressants within 12 weeks prior to entry Patients who received LCAP or GCAP within 2 weeks prior to entry Patients who changed the dose of steroid or started steroid within 2 weeks prior to entry Patients who changed the dose of steroid or started steroid within 1 week prior to entry in case they received more than 40 mg/ day or 1mg/kg/day of steroid just before the study

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Tacrolimus<br>* Oral<br>* Other names: FK506;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of Disease Activity Index score (DAI score) |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of DAI score ( Total & each item) |  | 2 weeks | 
| Changes of clinical severity and symptom |  | 12 weeks | 
| Endoscopic finding |  | 12 weeks | 
| Patients impression |  | 12 weeks | 
| Amount of steroid |  | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ulcerative colitis, Tacrolimus, FK506, Treatment outcome