Unique ID issued by UMIN | UMIN000009839 |
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Receipt number | R000011524 |
Scientific Title | Cytapheresis (Leukocyte Apheresis) for remission maintenance therapy of ulcerative colitis: multicenter randomized controlled study. |
Date of disclosure of the study information | 2013/01/23 |
Last modified on | 2023/02/10 05:07:44 |
Cytapheresis (Leukocyte Apheresis) for remission maintenance therapy of ulcerative colitis: multicenter randomized controlled study.
CAPTAIN study
Cytapheresis (Leukocyte Apheresis) for remission maintenance therapy of ulcerative colitis: multicenter randomized controlled study.
CAPTAIN study
Japan |
Ulcerative Colitis
Medicine in general |
Others
NO
The aim of this multicenter randomized controlled study is to clarify the efficacy of the Cytapheresis (Leukocyte Apheresis) with Adacolum© or Cellsorba E© as a maintenance therapy for Ulcerative Colitis patients who achieved remission with a series of Leukocyte Apheresis sessions.
Safety,Efficacy
Confirmatory
Explanatory
Not applicable
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.
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
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
No treatment
YES
YES
Central registration
2
Treatment
Device,equipment |
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.
II. Control group: Assigned patients are not intervened by Cytapheresis (Leukocyte Apheresis) for their maintenance therapy. They continue conventional pharmacological therapy as their maintenance therapy.
12 | years-old | <= |
85 | years-old | >= |
Male and Female
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.
Patients who are contraindicated use of Adacolumn or Cellsorba E.
200
1st name | Takanori |
Middle name | |
Last name | Takanori Kanai |
keio University Hospital
Division of Gastroenterology Department of Internal Medicine
1608582
35 Shinanomachi Shinjuku Tokyo
03-3353-1211
takagast@z2.keio.jp
1st name | Makoto |
Middle name | |
Last name | Naganuma |
Keio university hospital
Division of Gastroenterology and Hepatology
1608582
35 Shinanomachi Shinjuku Tokyo
03-3353-1211
maknaganuma@gmail.com
Division of Gastroenterology Department of Internal Medicine, Keio university hospital
JIMRO Co., Ltd.
Asahi Kasei Medical Co., Ltd.
Profit organization
Japan
Keio University School of Medicine
35 Shinanomachi Shinjuku-ku, Tokyo
03-3353-1211
med-rinri-jimu@adst.keio.ac.jp
NO
2013 | Year | 01 | Month | 23 | Day |
https://www.ncbi.nlm.nih.gov/pubmed/31811562
Published
https://www.ncbi.nlm.nih.gov/pubmed/31811562
164
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.
2019 | Year | 12 | Month | 13 | Day |
See J Gastroenterol. 2019 Dec 6. doi: 10.1007
See J Gastroenterol. 2019 Dec 6. doi: 10.1007
A total of nine treatment-related AEs (11.3%) were
identified in the apheresis group.
Most of the AEs were associated
with anticoagulant-intolerance, such as headache,
skin rash, or general fatigue. All events were
reversible, with no severe AEs observed in either group
over the period of observation.
The primary efficacy endpoint was the rate of cumulative
clinical remission at 12 months after enrolment.
Completed
2012 | Year | 12 | Month | 12 | Day |
2012 | Year | 12 | Month | 20 | Day |
2013 | Year | 02 | Month | 01 | Day |
2018 | Year | 03 | Month | 31 | Day |
2018 | Year | 11 | Month | 18 | Day |
2019 | Year | 01 | Month | 30 | Day |
2019 | Year | 03 | Month | 15 | Day |
2013 | Year | 01 | Month | 22 | Day |
2023 | Year | 02 | Month | 10 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011524
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