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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000024793
Receipt No. 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

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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
Institute Shiga University of Medical Science
Institute
Department

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
URL(English) https://upload.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


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