rheumatoid arthritis
Conditions
Interventions
None listed
Sponsors
Sanofi K.K.
Outsource: Asahi Kasei Pharma Corporation, Scope of works to be outsourced: Request and contract procedure to medical institution, Request for case registration, entering CRF and answering inquiries,and progress management
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Patients with rheumatoid arthritis who have had an inadequate response to conventional treatments -Patients who newly start receiving the treatment with KEVZARA -Patients provided informed consent on a voluntary basis
Exclusion criteria
Exclusion criteria: -
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety: Incidence rates of adverse drug reactions and important risks (Serious infection including tuberculosis, intestinal perforation, serious hypersensitivity, interstitial pneumonia, reactivation of hepatitis B virus, serious hematologic disorder, hepatic disorder, malignancy, cardiovascular event) Effectiveness: DAS28-CRP | — |
Countries
Japan
Contacts
Public ContactPublic contact for Drug use surveillance -
Sanofi K.K. Post-authorization regulatory studies, Medical Affairs
Outcome results
None listed