UMIN-CTR Clinical Trial

Basic information
Public title	A Retrospective Study Evaluating Cost-effectiveness of Leukocytapheresis and Anti-human TNF-alpha Monoclonal Antibody for Ulcerative Colitis.
Acronym	A Retrospective Study Evaluating Cost-effectiveness of Leukocytapheresis and Anti-human TNF-alpha Monoclonal Antibody for Ulcerative Colitis.
Scientific Title	A Retrospective Study Evaluating Cost-effectiveness of Leukocytapheresis and Anti-human TNF-alpha Monoclonal Antibody for Ulcerative Colitis.
Scientific Title:Acronym	A Retrospective Study Evaluating Cost-effectiveness of Leukocytapheresis and Anti-human TNF-alpha Monoclonal Antibody for Ulcerative Colitis.
Region	Japan

Condition
Condition	Ulcerative colitis
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Although leukocytapheresis (LCAP) and anti-TNF-alpha monoclonal antibody (biological preparation; BP) have been used commonly for refractory cases of ulcerative colitis (UC), it has not been determined hitherto whether these therapeutic tools have similar beneficial impact on the disease activity. Furthermore, the costs accompanying the treatment with these two modalities have not been compared. We therefore evaluated retrospectively the cost-effectiveness as well as the adverse events entailing the treatment with LCAP and BP.
Basic objectives2	Others
Basic objectives -Others	Cost-effectiveness
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Rachmilewitz Clinical Activity Index (CAI) calculated by white blood cell counts, anemia, C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), as well as physical manifestations (e.g., bloody stool, abdominal cramps and fever) during the 12 months of the study period and the expense pertaining to the treatment over 12 months was calculated based on the costs for conventional drugs (e.g., mesalazine, prednisolone, azathiopurine), BP (infliximab, adalimumab) and apheresis devices (i.e., Cellsorba Ex).
Key secondary outcomes	Adverse events during the treatment period.

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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	We enrolled patients who had been diagnosed as UC in Tokyo Bay Urayasu Ichikawa Medical Center between April 2013 and December 2018. Endoscopic and histological diagnosis of UC was made in all patients. These patients had Rachmilewitz Clinical Activity Index (CAI) 5 or greater and most of the patients had been treated with conventional therapies, including mesalazine and corticosteroids. These patients were then treated with either LCAP or BP.
Key exclusion criteria	We excluded indeterminate colitis.
Target sample size	12

Research contact person
Name of lead principal investigator	1st name Toshihiko Middle name Last name Suzuki
Organization	Tokyo Bay Urayasu Ichikawa Medical Center
Division name	Department of Nephrology, Endocrinology and Diabetology
Zip code	2790001
Address	3-4-32, Todaijima, Urayasu, Chiba
TEL	+81-47-351-3101
Email	suzutoshibay@gmail.com

Public contact
Name of contact person	1st name Masahiro Middle name Last name Sakai
Organization	Tokyo Bay Urayasu Ichikawa Medical Center
Division name	Department of Nephrology, Endocrinology and Diabetology
Zip code	2790001
Address	3-4-32, Todaijima, Urayasu, Chiba
TEL	+81-47-351-3101
Homepage URL
Email	masahirosa@jadecom.jp

Sponsor
Institute	Department of Nephrology, Endocrinology and Diabetology, Tokyo Bay Urayasu Ichikawa Medical Center
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Tokyo Bay Urayasu Ichikawa Medical Center
Address	3-4-32, Todaijima, Urayasu, Chiba
Tel	+81-47-351-3101
Email	masahirosa@jadecom.jp

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	東京ベイ・浦安市川医療センター

Other administrative information
Date of disclosure of the study information	2019 Year 06 Month 04 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	12
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	Completed
Date of protocol fixation	2018 Year 10 Month 01 Day
Date of IRB	2018 Year 11 Month 14 Day
Anticipated trial start date	2018 Year 11 Month 15 Day
Last follow-up date	2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Retrospective study

Management information
Registered date	2019 Year 06 Month 04 Day
Last modified on	2019 Year 06 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039362