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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000054683

Enrollment

Registered

2024-06-17

Start date

2024-06-19

Completion date

Unknown

Last updated

2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid arthritis

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Change in glucocorticoid dose from the start of OZR administration at 12 weeks	—

Secondary

Measure	Time frame
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)	—

Measure

Time frame

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)

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Countries

Japan

Contacts

Public ContactAkira Onishi

Graduate School of Medicine, Kyoto University Department of Advanced Medicine for Rheumatic Diseases

aonishi@kuhp.kyoto-u.ac.jp075-751-3877

Outcome results