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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000036954
Receipt No. R000039362
Scientific Title A Retrospective Study Evaluating Cost-effectiveness of Leukocytapheresis and Anti-human TNF-alpha Monoclonal Antibody for Ulcerative Colitis.
Date of disclosure of the study information 2019/06/04
Last modified on 2019/06/04

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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

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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