UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037797 |
|---|---|
| Receipt number | R000043104 |
| Scientific Title | Prevention of sarcopenia by biologic agents and JAK inhibitors in rheumatoid arthritis; PRESENT study |
| Date of disclosure of the study information | 2019/08/30 |
| Last modified on | 2025/02/28 11:15:12 |
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Basic information
Public title
Prevention of sarcopenia by biologic agents and JAK inhibitors in rheumatoid arthritis; PRESENT study
Acronym
PRESENT study
Scientific Title
Prevention of sarcopenia by biologic agents and JAK inhibitors in rheumatoid arthritis; PRESENT study
Scientific Title:Acronym
PRESENT study
Region
| Japan |
Condition
Condition
Rheumatoid arthritis, Sarcopenia
Classification by specialty
| Clinical immunology | Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the incidence rate of sarcopeia, falls, and fractures between biologic agents or JAK inhibitors group and DMARDs additional group by multicenter study.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
Incidence rate of sarcopenia at 52 weeks
Key secondary outcomes
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
1.Rheumatoid arthritis patients fulfilled ACR/EULAR 2010 classification
2.Uncontrolled disease patients using conventional DMARDs over 12 weeks. Uncontrolled disease was defined below 3 conditions.
.Swelling joint count over 6
.Tender joint count over 6
.CRP over 2.0mg/dl or ESR over 28mm/hr
If the patients do not fulfilled,
.Progressive bone erosion on X-ray
.DAS28-ESR over 3.2
3.Included all disease duration
Key exclusion criteria
1.Complicated with sever complication patients
2.Autoimmune disease patients effected inflammation except rheumatoid arthritis
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Mashiro |
| Middle name | |
| Last name | Tada |
Organization
Osaka City General Hospital
Division name
Orthopaedic surgery
Zip code
534-0021
Address
2-13-22, Miyakojimahondori, Miyakajimaku, Osaka
TEL
06-6929-1221
m-tada@med.osaka-cu.ac.jp
Public contact
Name of contact person
| 1st name | Mashiro |
| Middle name | |
| Last name | Tada |
Organization
Osaka City General Hospital
Division name
Orthopaedic surgery
Zip code
534-0021
Address
2-13-22, Miyakojimahondori, Miyakajimaku, Osaka
TEL
06-6929-1221
Homepage URL
m-tada@med.osaka-cu.ac.jp
Sponsor or person
Institute
Department of Orthopaedic surgery, Osaka City General Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of Orthopaedic surgery, Osaka City General Hospital
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
Osaka City General Hospital Research Ethics Review Board
Address
2-13-22, Miyakojimahondori, Miyakajimaku, Osaka
Tel
06-6929-1221
xc0017@osakacity-hp.or.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
| 2019 | Year | 08 | Month | 30 | 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
| 2019 | Year | 08 | Month | 26 | Day |
Date of IRB
| 2019 | Year | 12 | Month | 13 | Day |
Anticipated trial start date
| 2019 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2025 | Year | 06 | Month | 30 | Day |
Other
Other related information
To compare the incidence rate of sarcopeia, falls, and fractures between biologic agents or JAK inhibitors group and DMARDs additional group by multicenter study.
Management information
Registered date
| 2019 | Year | 08 | Month | 26 | Day |
Last modified on
| 2025 | Year | 02 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043104
