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UMIN ID: UMIN000054683

Registered date:17/06/2024

The effect of ozoralizumab on glucocorticoid reduction and its safety in patients with rheumatoid arthritis

Basic Information

Recruitment status	Pending
Health condition(s) or Problem(s) studied	Rheumatoid arthritis
Date of first enrollment	2024/06/19
Target sample size	40
Countries of recruitment	Japan
Study type	Observational
Intervention(s)

TO Original Data: UMIN

Outcome(s)

Primary Outcome	Change in glucocorticoid dose from the start of OZR administration at 12 weeks
Secondary Outcome	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)

Primary Outcome

Change in glucocorticoid dose from the start of OZR administration at 12 weeks

Secondary Outcome

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)

Key inclusion & exclusion criteria

Age minimum	18years-old
Age maximum	Not applicable
Gender	Male and Female
Include criteria
Exclude 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.

Related Information

Primary Sponsor	Graduate School of Medicine, Kyoto University
Secondary Sponsor	Nagahama City Hospital, Toyooka Hospital, Tango Central Hospital
Source(s) of Monetary Support	Taisho Pharmaceutical Co., Ltd.
Secondary ID(s)

Contact

public contact
Name	Akira Onishi
Address	54, Kawahara-cho, Shogoin, Sakyo-ku, Kyoto Japan 606-8507
Telephone	075-751-3877
E-mail	aonishi@kuhp.kyoto-u.ac.jp
Affiliation	Graduate School of Medicine, Kyoto University Department of Advanced Medicine for Rheumatic Diseases
scientific contact
Name	Akira Onishi
Address	54, Kawahara-cho, Shogoin, Sakyo-ku, Kyoto Japan
Telephone	075-751-3877
E-mail	aonishi@kuhp.kyoto-u.ac.jp
Affiliation	Graduate School of Medicine, Kyoto University Department of Advanced Medicine for Rheumatic Diseases

TO Original Data: UMIN