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

JRCT ID: jRCTs051240053

Registered date:07/06/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Rheumatoid arthritis
• Date of first enrollment: 22/08/2024
• Target sample size: 45
• Study type: Interventional

Intervention(s)

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

Outcome(s)

• Primary Outcome: DAS28-CRP at 12 weeks (Visit 4)

Secondary Outcome

(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

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

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

Exclude criteria

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 who have received any vaccine within 4 weeks prior to enrollment or will receive any vaccine during the study period
9) Patients receiving prednisolone (equivalent) >10 mg/day
10) Other patients who are judged by the principal investigator (subinvestigator) to be inappropriate to participate in this study

Related Information

• Primary Sponsor: Hashimoto Motomu
• Secondary Sponsor: Taisho Pharmaceutical Co., LTD.