UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057385 |
|---|---|
| Receipt number | R000065277 |
| Scientific Title | Switching to IL-6 inhibitors in Patients with Rheumatoid Arthritis Achieving Low Disease Activity with JAK Inhibitors |
| Date of disclosure of the study information | 2025/03/24 |
| Last modified on | 2026/02/06 09:20:02 |
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Basic information
Public title
Switching to IL-6 inhibitors in Patients with Rheumatoid Arthritis Achieving Low Disease Activity with JAK Inhibitors
Acronym
Switching to IL-6 inhibitors in Patients with Rheumatoid Arthritis Achieving Low Disease Activity with JAK Inhibitors
Scientific Title
Switching to IL-6 inhibitors in Patients with Rheumatoid Arthritis Achieving Low Disease Activity with JAK Inhibitors
Scientific Title:Acronym
Switching to IL-6 inhibitors in Patients with Rheumatoid Arthritis Achieving Low Disease Activity with JAK Inhibitors
Region
| Japan |
Condition
Condition
Switching to IL-6 inhibitors in Patients with Rheumatoid Arthritis Achieving Low Disease Activity with JAK Inhibitors
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the maintenance rate of low disease activity and the safety of switching to IL-6 inhibitors over 24 weeks in adult rheumatoid arthritis patients who have maintained low disease activity with JAK inhibitors.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The proportion of patients with rheumatoid arthritis maintaining low disease activity (CDAI < 10) at 24 weeks after switching to IL-6 inhibitors.
Key secondary outcomes
Changes in CDAI, HAQ, and EQ-5D at 12 and 24 weeks.
Safety assessment of infections, malignancies, drug allergies, and other adverse events.
Differences in the incidence of events between JAK inhibitor continuation group and IL-6 inhibitor switching group.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients aged 18 years or older who have been diagnosed with rheumatoid arthritis by a physician based on the ACR/EULAR 2010 classification criteria and have been receiving a stable dose of JAK inhibitors for at least six months, with confirmed low disease activity (CDAI < 10) on at least two consecutive visits. This study includes patients who, after being informed of the benefits and risks of continuing JAK inhibitors versus switching to IL-6 inhibitors, opted to switch to IL-6 inhibitors based on shared decision-making.
Key exclusion criteria
Patients with a history of allergic reactions to IL-6 inhibitors will be excluded.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Shunichi |
| Middle name | |
| Last name | Fujita |
Organization
Kawasaki Medical School
Division name
Department of rheumatology
Zip code
701-0192
Address
577 Matsushima, Kurashiki city, Okayama, Japan
TEL
086-462-1111
shunichi@med.kawasaki-m.ac.jp
Public contact
Name of contact person
| 1st name | Shunichi |
| Middle name | |
| Last name | Fujita |
Organization
Kawasaki Medical School
Division name
Department of Rheumatology
Zip code
701-0192
Address
577 Matsushima, Kurashiki city, Okayama, Japan
TEL
086-462-1111
Homepage URL
shunichi@med.kawasaki-m.ac.jp
Sponsor or person
Institute
Kawasaki Medical School
Institute
Department
Personal name
Funding Source
Organization
Kawasaki Medical School
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
Kawasaki Medical School
Address
577 Matsushima, Kurashiki city, Okayama, Japan
Tel
086-462-1111
shunichi@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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 03 | Month | 24 | 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
Enrolling by invitation
Date of protocol fixation
| 2025 | Year | 03 | Month | 24 | Day |
Date of IRB
| 2025 | Year | 05 | Month | 19 | Day |
Anticipated trial start date
| 2025 | Year | 05 | Month | 20 | Day |
Last follow-up date
| 2028 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
No additional information.
Management information
Registered date
| 2025 | Year | 03 | Month | 24 | Day |
Last modified on
| 2026 | Year | 02 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065277
