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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000028719
Receipt No. 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

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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
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
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
URL(English) https://upload.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


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