chronic inflammation of the joints Rheumatoid arthritis
Conditions
Interventions
Conventional low dose: 1 × 1000 mg
Patients allocated to the conventional low dose group will receive a single
1000 mg RTX infusion according to the standard protocol for infusion of
rituximab
Ult
Sponsors
Sint Maartenskliniek
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Rheumatoid arthritis: either 2010 ACR RA and/or 1987 RA criteria and/or clinical diagnosis of the treating rheumatologist, fulfilled at any time point between start of the disease and inclusion. - RTX retreatment: at least once RTX in the last 18 months for RA in a dose of 1 × 1000 mg, 2 × 1000 mg or 2 × 500 mg and no other biologicals received after last RTX dose. Patients treated with innovator RTX (MabThera) as well as registered biosimilars will be included. - At least 6 months of stable, low disease activity after the last RTX infusion (operationalized by either DAS28-CRP
Exclusion criteria
Exclusion criteria: - Patients with known (non-)response to ultra-low dose RTX (below 1 × 1000 mg) - Current corticosteroid dosing above 10 mg per day prednisolone equivalent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease activity measured with the DAS28-CRP at baseline, 3 and 6 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Baseline characteristics: demographics, disease characteristics, treatment characteristics, joint damage, patient and rheumatologist expectations of lower dose. - Functioning: measured with HAQ-DI at baseline, 3 and 6 months - Quality of life: measured with EuroQolEQ5D-5L at baseline, 3 and 6 months - Adverse events: occurrence of adverse events during study period. - Medication use: use of DMARDs, corticosteroids, NSAIDs during study period - Pharmacokinetics: serum RTX, serum anti-RTX at four time points: before infusion, after infusion, after 3 and after 6 months. - Pharmacodynamics: To be able to study the pharmacodynamics of RTX in patients and possible predictors of response, we will analyze at baseline, 3 months and 6 months: CD19+ B-cell count (baseline only), serum free light chains, S100A8/9. - Costs - Process evaluation: study integrity | — |
Countries
Netherlands
Outcome results
None listed