UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045786 |
|---|---|
| Receipt number | R000052269 |
| Scientific Title | Estimated number of patients with chronic refractory gout using real-world data from the United States |
| Date of disclosure of the study information | 2021/10/18 |
| Last modified on | 2025/06/04 10:52:36 |
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Basic information
Public title
Estimated number of patients with chronic refractory gout using real-world data from the United States
Acronym
Estimated number of patients with chronic refractory gout
Scientific Title
Estimated number of patients with chronic refractory gout using real-world data from the United States
Scientific Title:Acronym
Estimated number of patients with chronic refractory gout
Region
| Japan | North America |
Condition
Condition
Gout
Classification by specialty
| Medicine in general | Cardiology | Endocrinology and Metabolism |
| Nephrology | Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to estimate the number of patients with chronic refractory gout in clinical practice using real-world data from the United States.
It also aims to investigate the characteristics, treatment status and disease burden of patients with chronic refractory gout.
Basic objectives2
Others
Basic objectives -Others
Epidemiology
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Number of patients with chronic refractory gout and its proportion to the population
Key secondary outcomes
Number of gout patients and its proportion to the population
Characteristics, treatment status and disease burden of patients with gout and chronic refractory gout
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Analysis target population is patients with chronic refractory gout.
Analysis for gout patients will also be performed.
The definitions of analysis target population in the MarketScan Commercial database are as follows.
1. Patients with gout in 2019, and
2. Patients with continuous insurance coverage, and
3. Patients aged 0-64 at the end of 2019, and
4. Patients with chronic refractory gout
Analysis target population in the Medicare 5% sample databases is gout diagnosed patients aged 65 years or older.
Key exclusion criteria
N.A.
Target sample size
0
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Sugiyama |
Organization
Teijin Pharma Limited
Division name
Medical Science Department
Zip code
100-8585
Address
2-1, Kasumigaseki 3-chome, Chiyoda-ku, Tokyo
TEL
03-3506-4140
tpm-com@umin.ac.jp
Public contact
Name of contact person
| 1st name | Ruriko |
| Middle name | |
| Last name | Koto |
Organization
Teijin Pharma Limited
Division name
Medical Science Department
Zip code
100-8585
Address
2-1, Kasumigaseki 3-chome, Chiyoda-ku, Tokyo
TEL
03-3506-4140
Homepage URL
tpm-com@umin.ac.jp
Sponsor or person
Institute
Teijin Pharma Limited
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Teijin Pharma Limited
Address
2-1, Kasumigaseki 3-chome, Chiyoda-ku, Tokyo
Tel
03-3506-4140
tpm-com@umin.ac.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
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 10 | Month | 18 | 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
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
| 2021 | Year | 09 | Month | 30 | Day |
Date of IRB
| 2021 | Year | 09 | Month | 30 | Day |
Anticipated trial start date
| 2021 | Year | 10 | Month | 29 | Day |
Last follow-up date
| 2021 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is a retrospective descriptive study using two US real-world data, the MarketScan Commertial database and the Medicare 5% Sample database.
Management information
Registered date
| 2021 | Year | 10 | Month | 18 | Day |
Last modified on
| 2025 | 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=R000052269
