UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050387 |
|---|---|
| Receipt number | R000057362 |
| Scientific Title | Study of the effectiveness and safety of switching from JAK inhibitors to non-TNF biologics in elderly patients with rheumatoid arthritis |
| Date of disclosure of the study information | 2023/04/01 |
| Last modified on | 2023/08/22 17:22:16 |
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Basic information
Public title
Study of the effectiveness and safety of switching from JAK inhibitors to non-TNF biologics in elderly patients with rheumatoid arthritis
Acronym
Switching from JAK inhibitors to non-TNF biologics in elderly RA patients
Scientific Title
Study of the effectiveness and safety of switching from JAK inhibitors to non-TNF biologics in elderly patients with rheumatoid arthritis
Scientific Title:Acronym
Switching from JAK inhibitors to non-TNF biologics in elderly RA patients
Region
| Japan |
Condition
Condition
Rheumatoid arthritis
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess effectiveness and safety 24 weeks after switching to non-TNF biologics in elderly RA patients aged 65 years and older who maintain low disease activity with JAK-inhibitor
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Percentage of Participants with low disease activity (CDAI <10) 24 weeks after switching to non-TNF biologics
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Non-TNF biologics
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Elderly RA patients aged 65 years and older who maintain low disease activity with JAK-inhibitor
Key exclusion criteria
none
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Kazuhisa |
| Middle name | |
| Last name | Nakano |
Organization
Kawasaki Medical School
Division name
Department of Rheumatology
Zip code
701-0192
Address
577 Matsushima, Kurashiki, Okayama, Japan
TEL
0864621111
nakanok@med.kawasaki-m.ac.jp
Public contact
Name of contact person
| 1st name | Kazuhisa |
| Middle name | |
| Last name | Nakano |
Organization
Kawasaki Medical School
Division name
Department of Rheumatology
Zip code
701-0192
Address
577 Matsuhima, Kurashiki, Okayama, Japan
TEL
0864621111
Homepage URL
nakanok@med.kawasaki-m.ac.jp
Sponsor or person
Institute
Kawasaki Medical School
Institute
Department
Personal name
Kazuhisa Nakano
Funding Source
Organization
Kawasaki Medical School
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kawasaki Medical School
Address
577, Matsushima, Kurashiki, Okayama, Japan
Tel
0864621111
nakanok@med.kawasaki-m.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
川崎医科大学附属病院
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 04 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 02 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 02 | Month | 20 | Day |
Last modified on
| 2023 | Year | 08 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057362
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
