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UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000009839
Receipt No. 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 2019/12/13

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Basic information
Public title Cytapheresis (Leukocyte Apheresis) for remission maintenance therapy of ulcerative colitis: multicenter randomized controlled study.
Acronym CAPTAIN study
Scientific Title Cytapheresis (Leukocyte Apheresis) for remission maintenance therapy of ulcerative colitis: multicenter randomized controlled study.
Scientific Title:Acronym CAPTAIN study
Region
Japan

Condition
Condition Ulcerative Colitis
Classification by specialty
Medicine in general
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 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.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes 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.
Key secondary outcomes 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

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification YES
Dynamic allocation
Institution consideration
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 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.

Interventions/Control_2 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.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
12 years-old <=
Age-upper limit
85 years-old >=
Gender Male and Female
Key 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.
Key exclusion criteria Patients who are contraindicated use of Adacolumn or Cellsorba E.
Target sample size 200

Research contact person
Name of lead principal investigator
1st name Takanori
Middle name
Last name Takanori Kanai
Organization keio University Hospital
Division name Division of Gastroenterology Department of Internal Medicine
Zip code 1608582
Address 35 Shinanomachi Shinjuku Tokyo
TEL 03-3353-1211
Email takagast@z2.keio.jp

Public contact
Name of contact person
1st name Makoto
Middle name
Last name Naganuma
Organization Keio university hospital
Division name Division of Gastroenterology and Hepatology
Zip code 1608582
Address 35 Shinanomachi Shinjuku Tokyo
TEL 03-3353-1211
Homepage URL
Email maknaganuma@gmail.com

Sponsor
Institute Division of Gastroenterology Department of Internal Medicine, Keio university hospital
Institute
Department

Funding Source
Organization JIMRO Co., Ltd.
Asahi Kasei Medical Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Keio University School of Medicine
Address 35 Shinanomachi Shinjuku-ku, Tokyo
Tel 03-3353-1211
Email med-rinri-jimu@adst.keio.ac.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2013 Year 01 Month 23 Day

Related information
URL releasing protocol https://www.ncbi.nlm.nih.gov/pubmed/31811562
Publication of results Published

Result
URL related to results and publications https://www.ncbi.nlm.nih.gov/pubmed/31811562
Number of participants that the trial has enrolled 164
Results
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.
Results date posted
2019 Year 12 Month 13 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
See J Gastroenterol. 2019 Dec 6. doi: 10.1007
Participant flow
See J Gastroenterol. 2019 Dec 6. doi: 10.1007
Adverse events
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.
Outcome measures
The primary efficacy endpoint was the rate of cumulative
clinical remission at 12 months after enrolment.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Main results already published
Date of protocol fixation
2012 Year 12 Month 12 Day
Date of IRB
2012 Year 12 Month 20 Day
Anticipated trial start date
2013 Year 02 Month 01 Day
Last follow-up date
2018 Year 03 Month 31 Day
Date of closure to data entry
2018 Year 11 Month 18 Day
Date trial data considered complete
2019 Year 01 Month 30 Day
Date analysis concluded
2019 Year 03 Month 15 Day

Other
Other related information

Management information
Registered date
2013 Year 01 Month 22 Day
Last modified on
2019 Year 12 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011524

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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