UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The study of the effect of cytapheresis against secondary failure of biologics therapy in inflammatory bowel disease maintenance therapy.
Title of the study (Brief title)	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	Hirotsugu Imaeda
Organization	Shiga University of Medical Science
Division name	Division of Gastroenterology, Department of Medicine
Address	Setatsukinowa-cho, Otsu
TEL	0775482217
Email	imaeda@belle.shiga-med.ac.jp

Public contact
Name of contact person	Hirotsugu Imaeda
Organization	Shiga University of Medical Science
Division name	Division of Gastroenterology, Department of Medicine
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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2015 Year 05 Month 12 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000029246