Rheumatoid arthritis Rheumatoid arthritis
Conditions
Interventions
fMRI imaging before and after ozoralizumab administration (two times in total).
fMRI
Sponsors
Kono Michihito
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1 Patients who are 18 years of age or older at the time of obtaining consent 2 Patients who have received a full explanation of their participation in this study and who have given their consent of their own free will based on a full understanding of the study 3 Patients with rheumatoid arthritis diagnosed according to the 2010 ACR/EULAR rheumatoid arthritis classification criteria 4 Patients with inadequate response or intolerance to treatment with at least one conventional synthetic DMARD (csDMARD) 5 Patients with moderately or more active rheumatoid arthritis (DAS28-CRP greater than or equal to 3.2)
Exclusion criteria
Exclusion criteria: The following patients will be excluded from this study if they meet any of the following criteria 1Pregnant and lactating patients 2Patients who meet the contraindications in the ozoralizumab electronic package insert 3Patients with strongly suspected cerebral organic factors 4Patients with serious physical illnesses (cardiac, hepatic, renal, etc) 5Patients who are unable to undergo MRI examination 6Patients with infectious diseases requiring systemic treatment 7Other patients who are judged to be inappropriate as research subjects by the principal investigator or the physician in charge of the research (hereafter referred to as investigator in charge of the research
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in FC from baseline to 12 weeks after ozoralizumab administration | — |
Secondary
| Measure | Time frame |
|---|---|
| Assessment of absolute values. (i) Disease activity: number of swollen and painful joints (28 joints), DAS28-CRP, DAS28-ESR, CDAI and SDAI (Visit1,2,3 and 4) (ii) Patient pain VAS (Visit 1, 2, 3, 4 and Day 1), patient general VAS (Visit 1, 2, 3 and 4), mHAQ, EQ5D, JFIQR, FACIT-F and CFS (Visit 1 and 4) (iii) FC, BOLD signal (Visit0 and 4) Assessment of change (i) Disease activity: number of swollen and painful joints (28 joints), DAS28-ESR, CDAI, SDAI (change from Visit 1 to Visit 2, 3 and 4), DAS28-CRP, (change from Visit 1 to Visit 2 and 3) (ii) Patient pain VAS (change from Visit 1 to Visit 2, 3, 4 and Day 1), patient general VAS (change from Visit 1 to Visit 2, 3 and 4), mHAQ, EQ5D, JFIQR, FACIT-F, CFS (change from Visit 1 to Visit 4) (iii) FC, BOLD signal (amount of change from Visit0 to Visit4) Translated with DeepL.com (free version) | — |
Contacts
Public ContactYuichiro Fujieda
Hokkaido University Hospital
Outcome results
None listed