UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000036954
Receipt number 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 15:28:42

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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 or person

Institute

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

Institute

Department

Personal name



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

Value
https://center6.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