Rheumatoid arthritis
Conditions
Interventions
None listed
Sponsors
The First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health, Japan
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Eligible patients are those who meet the 2010 ACR/EULAR RA classification criteria and have been diagnosed with RA. 2) Patients with a CDAI > 10.0 despite appropriate treatment with MTX in previous therapy are eligible. 3) For subjects in the OZR group, subjects who are able to provide written consent of their own volition (written consent) will be included. 4) Subjects must be at least 18 years of age. 5) Subjects must have no history of use of biologics and JAK inhibitors, for whom new OZR treatment will be initiated after the date of inclusion.
Exclusion criteria
Exclusion criteria: 1) Patients with severe infections 2) Patients with active TB 3) Patients with a history of hypersensitivity to OZR 4) Patients with a history of demyelinating disease 5) Patients with congestive heart failure 6) Patients for whom TNF inhibitors are contraindicated in the Guidance on the Use of TNF Inhibitors for Rheumatoid Arthritis (revised 2023) by the Japan College of Rheumatology. 7) Other patients deemed inappropriate for the study by the principal investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison of mean change in CDAI at 24 weeks in the Ozoralizumab and Certolizumab pegol groups | — |
Countries
Japan
Contacts
Public ContactMasanobu Ueno
University of Occupational and Environmental Health, Japan First Department of Internal Medicine
Outcome results
None listed