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