Ulcerative Colitis
Conditions
Interventions
I. Intervention group: Assigned patients are treated 2 times per month Cytapheresis (Leukocyte Apheresis) for 1 year for their maintenance therapy with the same device as remission induction therapy.
Sponsors
Division of Gastroenterology Department of Internal Medicine, Keio university hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: This study is conducted for ulcerative colitis patients who achieved remission induction with a series of Cytapheresis (Leukocyte Apheresis) sessions. These patients should meet the inclusion criteria and also should not meet the exclusive criteria as below. The remission induction therapy with Cytapheresis (Leukocyte Apheresis) should be within a flame of health insurance of Japan.
Exclusion criteria
Exclusion criteria: Patients who are contraindicated use of Adacolumn or Cellsorba E.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactMakoto Naganuma
Keio university hospital Division of Gastroenterology and Hepatology
Outcome results
None listed