UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000009839
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

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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 or person

Institute

Division of Gastroenterology Department of Internal Medicine, Keio university hospital

Institute

Department

Personal name



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

Completed

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

2023 Year 02 Month 10 Day



Link to view the page

Value
https://center6.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