UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028719
Receipt number R000029246
Scientific Title The study of the effect of cytapheresis against secondary failure of biologics therapy in inflammatory bowel disease maintenance therapy.
Date of disclosure of the study information 2017/09/01
Last modified on 2018/08/20 06:53:24

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Basic information

Public title

The study of the effect of cytapheresis against secondary failure of biologics therapy in inflammatory bowel disease maintenance therapy.

Acronym

CAPBIO

Scientific Title

The study of the effect of cytapheresis against secondary failure of biologics therapy in inflammatory bowel disease maintenance therapy.

Scientific Title:Acronym

CAPBIO

Region

Japan


Condition

Condition

Ulcerative colitis
Crohn's disease

Classification by specialty

Medicine in general 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 an Ada column, cell sorva 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


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

We judge combination therapy to have an effect with CRP, blood sedimentation, the improvement of the hemoglobin level by a blood test.
Also, in a practice range, we conduct a colonoscope or small intestine endoscopy and determine the difference of the effect with the control group by improvement of the endoscopic score (Rutgeerts score, Mayo score).

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

15 years-old <=

Age-upper limit

65 years-old >

Gender

Male and Female

Key inclusion criteria

The patients who would combine CAP therapy among the patients in maintenance administration with antiTNF - alpha antibody preparation (infliximab (Remicade), adalimumab (Humira)) among ulcerative colitis, patients with Crohn's disease with whole outpatient department and hospitalizing.

Key exclusion criteria

The patients who had the infection that the report based on the infection method needs.

Target sample size

20


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-cho, Otsu

TEL

0775482217

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-cho, Otsu

TEL

0775482217

Homepage URL


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

2017 Year 09 Month 01 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

Open public recruiting

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 06 Month 30 Day

Date trial data considered complete

2020 Year 09 Month 30 Day

Date analysis concluded

2021 Year 03 Month 31 Day


Other

Other related information

None


Management information

Registered date

2017 Year 08 Month 18 Day

Last modified on

2018 Year 08 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029246


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name