Rheumatoid arthritis
Conditions
Interventions
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 grea
Sponsors
Hashimoto Motomu
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion 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
Exclusion criteria
Exclusion 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 (10 mg/day 11) Other patients who are judged by the principal investigator (subinvestigator) to be inappropriate to participate in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| DAS28-CRP at 12 weeks (Visit 4) | — |
Secondary
| Measure | Time frame |
|---|---|
| (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 | — |
Contacts
Public ContactRyu Watanabe
Osaka Metropolitan University Hospital
Outcome results
None listed