Cytapheresis (Leukocyte Apheresis) for remission maintenance therapy of ulcerative colitis: multicenter randomized controlled study.
Not Applicable
- Conditions
- lcerative Colitis
- Registration Number
- JPRN-UMIN000009839
- Lead Sponsor
- Division of Gastroenterology Department of Internal Medicine, Keio university hospital
- Brief Summary
The cumulative remission rate at 12 months was 46.6% in the apheresis group and 36.4% in the control group (p=0.1621). The rate of endoscopic remission at 12 months was significantly higher in the apheresis group than in the control group (42.5% vs. 25.9%) p=0.0480). No severe adverse events were observed in either group.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 164
Inclusion Criteria
Not provided
Exclusion Criteria
Patients who are contraindicated use of Adacolumn or Cellsorba E.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary efficacy endpoint was the rate of cumulative clinical remission at 12 months after enrolment. Clinical remission was defined as a Mayo score of2 or less and no subscores with a value greater than 1. Definition of non-remission (relapse): Mayo score 3 or more (If endoscopy is difficult at the time of relapse, Mayo endoscopic score is calculated as 2.
- Secondary Outcome Measures
Name Time Method Before we completed the data analysis, the following secondary endpoints were added : The main secondary endpoint was described as below. 1) the clinical remission and the steroid-free clinical remission at 6 and 12 months, 2) the rate of clinical remission with no bleeding at 12 months, 3) the rates of mucosal healing and complete mucosal healing at 12 months, 4) the rate of cumulative steroid discontinuation at 12 months were analysed. 5) safety