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
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
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
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
