A Retrospective Study Evaluating Cost-effectiveness of Leukocytapheresis and Anti-human TNF-alpha Monoclonal Antibody for Ulcerative Colitis.
Not Applicable
- Conditions
- lcerative colitis
- Registration Number
- JPRN-UMIN000036954
- Lead Sponsor
- Department of Nephrology, Endocrinology and Diabetology, Tokyo Bay Urayasu Ichikawa Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 12
Inclusion Criteria
Not provided
Exclusion Criteria
We excluded indeterminate colitis.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Rachmilewitz Clinical Activity Index (CAI) calculated by white blood cell counts, anemia, C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), as well as physical manifestations (e.g., bloody stool, abdominal cramps and fever) during the 12 months of the study period and the expense pertaining to the treatment over 12 months was calculated based on the costs for conventional drugs (e.g., mesalazine, prednisolone, azathiopurine), BP (infliximab, adalimumab) and apheresis devices (i.e., Cellsorba Ex).
- Secondary Outcome Measures
Name Time Method Adverse events during the treatment period.