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

Phase 3

Completed

• Conditions: Ulcerative Colitis
• Interventions: Drug: Tacrolimus

• Registration Number: NCT00643071
• Lead Sponsor: Astellas Pharma Inc

Brief Summary

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

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.

Study Timeline

• Study Start: 2006-09
• Study First Submitted: 2008-03-20
• Study First Submitted QC: 2008-03-20
• Study First Posted: 2008-03-26
• Primary Completion: 2008-05
• Study Completion: 2008-05
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-25
• Last Update Posted: 2014-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Tacrolimus	-

Primary Outcome Measures

Name	Time	Method
Improvement of Disease Activity Index score (DAI score)	12 weeks

Secondary Outcome Measures

Name	Time	Method
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