Switching to IL-6 inhibitors in Patients with Rheumatoid Arthritis Achieving Low Disease Activity with JAK Inhibitors
Conditions
Interventions
None listed
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Patients aged 18 years or older who have been diagnosed with rheumatoid arthritis by a physician based on the ACR/EULAR 2010 classification criteria and have been receiving a stable dose of JAK inhibitors for at least six months, with confirmed low disease activity (CDAI < 10) on at least two consecutive visits. This study includes patients who, after being informed of the benefits and risks of continuing JAK inhibitors versus switching to IL-6 inhibitors, opted to switch to IL-6 inhibitors based on shared decision-making.
Exclusion criteria
Exclusion criteria: Patients with a history of allergic reactions to IL-6 inhibitors will be excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of patients with rheumatoid arthritis maintaining low disease activity (CDAI < 10) at 24 weeks after switching to IL-6 inhibitors. | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in CDAI, HAQ, and EQ-5D at 12 and 24 weeks. Safety assessment of infections, malignancies, drug allergies, and other adverse events. Differences in the incidence of events between JAK inhibitor continuation group and IL-6 inhibitor switching group. | — |
Countries
Japan
Contacts
Kawasaki Medical School Department of Rheumatology