UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000024793
Receipt number R000028526
Scientific Title Examination about the effect of the cytapheresis combination therapy for patients with inflammatory bowel disease during biologics induction and maintenance administration.
Date of disclosure of the study information 2016/11/10
Last modified on 2018/11/20 21:57:26

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Basic information

Public title

Examination about the effect of the cytapheresis combination therapy for patients with inflammatory bowel disease during biologics induction and maintenance administration.

Acronym

CAPBiologics

Scientific Title

Examination about the effect of the cytapheresis combination therapy for patients with inflammatory bowel disease during biologics induction and maintenance administration.

Scientific Title:Acronym

CAPBiologics

Region

Japan


Condition

Condition

Crohn's disease
Ulcerative colitis

Classification by specialty

Gastroenterology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The choice of the therapy has CAP therapy, and it has been already known that it is effective for treatment to use this together, but the synergistic detailed mechanism is not apparent.
The CAP therapy is able to remove granular leukocyte cell sorva an Ada column together, but cell sorva is able to remove lymphocytes.
B cells and the plasma cells are included in lymphocytes other than T cells and are aimed for the collection of of the data base about the effect that the removal of antibody forming cells gives in an antibiological preparation antibody level.

Basic objectives2

PK,PD

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

When we show the change of the anti-drug antibody with the CAP therapy, CAP therapy and anti-TNF antibody preparation combination may produce a synergistic effect.

Key secondary outcomes



Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


Interventions/Control_2


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

16 years-old <=

Age-upper limit

70 years-old >

Gender

Male and Female

Key inclusion criteria

(1) Crohn's disease made maintenance therapy with infliximab or adalimumab, the patients with ulcerative colitis.
(2) The patients who used CAP combination therapy.

Key exclusion criteria

none

Target sample size

40


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hirotsugu Imaeda

Organization

Shiga University of Medical Science

Division name

Division of Gastroenterology, Department of Medicine

Zip code


Address

Setatsukinowa, Otsu

TEL

077-548-2217

Email

imaeda@belle.shiga-med.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hirotsugu Imaeda

Organization

Shiga University of Medical Science

Division name

Division of Gastroenterology, Department of Medicine

Zip code


Address

Setatsukinowa, Otsu

TEL

077-548-2217

Homepage URL

http://www.ninai-sums.jp/study/gastrointestinal-medicine

Email

imaeda@belle.shiga-med.ac.jp


Sponsor or person

Institute

Shiga University of Medical Science

Institute

Department

Personal name



Funding Source

Organization

Ministry of Health, Labour and Welfare

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

2016 Year 11 Month 10 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Terminated

Date of protocol fixation

2015 Year 05 Month 12 Day

Date of IRB


Anticipated trial start date

2015 Year 06 Month 01 Day

Last follow-up date

2020 Year 03 Month 31 Day

Date of closure to data entry

2020 Year 03 Month 31 Day

Date trial data considered complete

2020 Year 03 Month 31 Day

Date analysis concluded

2021 Year 03 Month 31 Day


Other

Other related information

Effective


Management information

Registered date

2016 Year 11 Month 10 Day

Last modified on

2018 Year 11 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028526


Research Plan
Registered date File name
2017/01/12 研究実施計画書等修正報告書 (1).pdf

Research case data specifications
Registered date File name

Research case data
Registered date File name