UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054683 |
|---|---|
| Receipt number | R000062380 |
| Scientific Title | The effect of ozoralizumab on glucocorticoid reduction and its safety in patients with rheumatoid arthritis |
| Date of disclosure of the study information | 2024/06/17 |
| Last modified on | 2025/12/18 09:53:16 |
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Basic information
Public title
The effect of ozoralizumab on glucocorticoid reduction and its safety in patients with rheumatoid arthritis
Acronym
The effect of ozoralizumab on glucocorticoid reduction and its safety in patients with rheumatoid arthritis
Scientific Title
The effect of ozoralizumab on glucocorticoid reduction and its safety in patients with rheumatoid arthritis
Scientific Title:Acronym
The effect of ozoralizumab on glucocorticoid reduction and its safety in patients with rheumatoid arthritis
Region
| Japan |
Condition
Condition
Rheumatoid arthritis
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the impact of ozoralizumab (OZR) on glucoccorticoid reduction in patients with inadequate response or intolerance to the use of conventional synthetic anti-rheumatic drugs (csDMARDs) and who must be treated with glucocorticoid
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Change in glucocorticoid dose from the start of OZR administration at 12 weeks
Key secondary outcomes
1. Change in glucocoticoid dose (4, 8, 16, 20, 24, 48 weeks)
2. Percentage of glucocorticoid discontinuation (12, 24, 48 weeks)
3. Change in disease activity based on CDAI, DAS28-ESR, and DAS28-CRP (4, 8, 12, 16, 20, 24, 48 weeks)
4. Percentage of low disease activity and remission (4, 8, 12, 16, 20, 24, 48 weeks) 5.
5. Percentage of patients with low disease activity/remission and achieved prednisone reduction of at least 2.5 mg/day (12, 24, 48 weeks)
6. Change in HAQ (4, 8, 12, 16, 20, 24, 48 weeks)
7. Overall patient assessment VAS (1, 2, 3 days, 1, 2, 3, 4, 8, 12, 16, 20, 24, 48 weeks)
8. mHAQ change (1, 2, 3 days, 1, 2, 3, 4, 8, 12, 16, 20, 24, 48 weeks)
9. FACIT-F (4, 8, 12, 24, and 48 weeks)
10. RAID (4, 8, 12, 24, 48 weeks)
11. Patient pain assessment VAS (1, 2, 3 days, 1, 2, 3, 4, 8, 12, 16, 20, 24, 48 weeks)
12. RAPID3 (1, 2, 3 days, 1, 2, 3, 4, 8, 12, 16, 20, 24, 48 weeks)
13. Adverse events (AE) of interest: steroid withdrawal syndrome, infection (12, 24, 48 weeks)
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
(1) Patients who are at least 18 years old.
(2) Patients diagnosed with rheumatoid arthritis based on ACR classification criteria (1987) or ACR/EULAR classification criteria for rheumatoid arthritis(2010).
(3) Patients who have been treated with csDMARD for at least 3 months and have inadequate response or intolerance.
(4) Patients receiving 5 mg/day or more prednisone equivalent of glucocorticoid.
(5) Patients with moderate or high disease activity (DAS28-ESR>3.2).
(6) Patients who are scheduled to initiate OZR.
Key exclusion criteria
(1) Patients with contraindications to OZR.
(2) Patients who have undergone surgical procedures for rheumatoid arthritis within 8 weeks prior to initiation of OZR or are scheduled to undergo procedures during the study period.
(3) Patients who are judged by the study investigator to be inappropriate for the subject of this study.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Akira |
| Middle name | |
| Last name | Onishi |
Organization
Graduate School of Medicine, Kyoto University
Division name
Department of Advanced Medicine for Rheumatic Diseases
Zip code
606-8507
Address
54, Kawahara-cho, Shogoin, Sakyo-ku, Kyoto
TEL
075-751-3877
aonishi@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Akira |
| Middle name | |
| Last name | Onishi |
Organization
Graduate School of Medicine, Kyoto University
Division name
Department of Advanced Medicine for Rheumatic Diseases
Zip code
606-8507
Address
54, Kawahara-cho, Shogoin, Sakyo-ku, Kyoto
TEL
075-751-3877
Homepage URL
aonishi@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Graduate School of Medicine, Kyoto University
Institute
Department
Personal name
Akira Onishi
Funding Source
Organization
Taisho Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Nagahama City Hospital, Toyooka Hospital, Tango Central Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address
Konoe-cho, Yoshida, Sakyo-ku, Kyoto
Tel
075-753-4680
ethcom@kuhp.kyoto-u.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
京都大学病院（京都府）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 06 | Month | 17 | 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
| 2024 | Year | 01 | Month | 31 | Day |
Date of IRB
| 2024 | Year | 04 | Month | 05 | Day |
Anticipated trial start date
| 2024 | Year | 06 | Month | 19 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2024 | Year | 06 | Month | 17 | Day |
Last modified on
| 2025 | Year | 12 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062380
