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Efficacy and safety of the anti-TNF multivalent NANOBODY compound ozoralizumab in RA patients with high titers of rheumatoid factor (OHZORA High study) (OHZORA High study)

Efficacy and safety of the anti-TNF multivalent NANOBODY compound ozoralizumab in RA patients with high titers of rheumatoid factor (OHZORA High study) (OHZORA High study)

Hashimoto Motomu

Osaka Metropolitan University Hospital

1-5-7 Asahimachi, Abeno-ku, Osaka

motomu.hashimoto@omu.ac.jp

Watanabe Ryu

Osaka Metropolitan University Hospital

1-5-7 Asahimachi, Abeno-ku, Osaka

+81-6-6645-3891

doctorwatanaberyu7@gmail.com

Recruiting

June. 07, 2024

Interventional

non-randomized controlled trial

open(masking not used)

active control

parallel assignment

treatment purpose

The study will enroll those who meet all of the following inclusion criteria
(1) Patients who have given informed consent to participate in this study
2) Japanese rheumatoid arthritis patients who have been treated with one or more csDMARDs, including MTX, for at least 4 weeks at the time of consent without dose modification or addition of concomitant medications
3) Patients with moderately active disease (DAS28-CRP = or >3.2) during the previous observation period (Visit 0)
4) Patients who are at least 18 years of age at the time of consent
5) Patients who are able to make outpatient visits according to the study schedule

1) Patients on dialysis
2) Pregnant and lactating patients
3) Patients with severe hepatic impairment (Child-Pugh Classification C)
4) Patients with serious infections or active tuberculosis
5) Patients with either neutropenia (<1000/mm3), lymphopenia (<500/mm3), or anemia (hemoglobin <8 g/dL) at enrollment
6) Patients with congenital or acquired immunodeficiency
7) Patients with demyelinating diseases (multiple sclerosis, etc.) or a history of the diseases
8) Patients with congestive heart failure
9) Patients who have received any vaccine within 4 weeks prior to enrollment or will receive any vaccine during the study period
10) Patients receiving prednisolone (equivalent) >10 mg/day
11) Other patients who are judged by the principal investigator (subinvestigator) to be inappropriate to participate in this study

Both

Rheumatoid arthritis

Group 1: Patients with rheumatoid arthritis and rheumatoid factor (RF) less than 15 IU/mL at enrollment receive 30 mg ozoralizumab every 4 weeks
Group 2: Patients with rheumatoid arthritis and RF greater than 15 IU/mL and less than 150 IU/mL at enrollment receive 30 mg ozoralizumab every 4 weeks
Group 3: Patients with rheumatoid arthritis and RF greater than 150 IU/mL at enrollment receive 30 mg ozoralizumab every 4 weeks

DAS28-CRP at 12 weeks (Visit 4)

(1) RF titer, changes in RF titer, anti-CCP antibody titer, changes in anti-CCP antibody titer
(2) HAQ, Patients' global VAS, Patients' pain VAS, Physicians' global VAS, changes in HAQ, changes in Patients' global VAS, changes in Patients' pain VAS, changes in Physicians' global VAS
(3) CDAI, SDAI, DAS28-ESR, DAS28-CRP (except Visit 4), changes in CDAI, changes in SDAI, changes in DAS28-ESR, changes in DAS28-CRP

+81-6-6645-3456

May. 27, 2024

Yes

When sending samples to the research institution (SRL) , only the case number, age, and sex registered in the Osaka Metropolitan University Hospital EDC system (REDCap) will be given. The data linking the case number and stratification will be stored in REDCap.

none