RITUXIMAB for Polymyalgia rheumatica

Inclusion criteria

• {"criterion_text":"- A clinical diagnoses of PMR according to the 2012 EULAR/ACR classification criteria"}
• {"criterion_text":"- Re-emerging PMR symptoms and elevated ESR or CRP levels"}
• {"criterion_text":"- Unable to reduce glucocorticoid dose below 5mg/day prednisolone or equivalent."}

Exclusion criteria

• {"criterion_text":"- Treatment with systemic immunosuppressants (other than GC, MTX, leflunomide and azathioprine) 3 months prior to inclusion"}
• {"criterion_text":"- (clinical) suspect concomitant giant cell arteritis or other rheumatic inflammatory disease"}
• {"criterion_text":"- Concomitant conditions that might significantly interfere with evaluation of PMR pain or movement as judged by the investigator"}
• {"criterion_text":"- Previous hypersensitivity for RTX or contra-indications to RTX"}
• {"criterion_text":"- Not being able to speak, read or write Dutch"}

Primary endpoints

• {"endpoint_text":"- The proportion of patients in GC free remission one year after RTX treatment compared to placebo","definition_or_measurement_approach":""}

Secondary endpoints

• {"endpoint_text":"- Proportion of patients in GC free remission at week 21","definition_or_measurement_approach":""}
• {"endpoint_text":"- Proportion of patients with low dose GC (≤5mg/day) remission at week 21, week 52, 1.5 year and 2 years.","definition_or_measurement_approach":""}
• {"endpoint_text":"- PMR-AS at each visit","definition_or_measurement_approach":""}
• {"endpoint_text":"- The number of disease relapses/recurrences up to week 52","definition_or_measurement_approach":""}
• {"endpoint_text":"- The proportion of patients with a disease relapse/recurrence at week 52","definition_or_measurement_approach":""}
• {"endpoint_text":"- The time from baseline to GC free remission and to relapse","definition_or_measurement_approach":""}
• {"endpoint_text":"- GC cumulative dose at 52 weeks, 1.5 and 2 years.","definition_or_measurement_approach":""}
• {"endpoint_text":"- Proportion of patients with RTX/PCB retreatment","definition_or_measurement_approach":""}
• {"endpoint_text":"- Proportion of patients who start methotrexate, leflunomide, tocilizumab or sarilumab or possible other bDMARD being registered for PMR","definition_or_measurement_approach":""}
• {"endpoint_text":"- Sex differences in frequencies of GC-remission and adverse events","definition_or_measurement_approach":""}
• {"endpoint_text":"- Changes in patient reported outcomes, concerning pain, fatigue, stiffness and physical function (as recommended by the OMERACT)","definition_or_measurement_approach":""}
• {"endpoint_text":"- Medical consumption and productivity loss","definition_or_measurement_approach":""}
• {"endpoint_text":"- (Changes in) modified glucocorticoid toxicity index (which excludes bone mineral density scan to improve feasibility)","definition_or_measurement_approach":""}
• {"endpoint_text":"- Frequency, types, proportion of patients with, and total numbers of ( especially GC- and RTX-related) AE during the 52 week study","definition_or_measurement_approach":""}
• {"endpoint_text":"- Proportion of patients in GC free remission 1.5 years after RTX/PCB infusion","definition_or_measurement_approach":""}
• {"endpoint_text":"- Proportion of patients in GC free remission 2 years after RTX/PCB infusion","definition_or_measurement_approach":""}
• {"endpoint_text":"- The number of disease relapses/recurrences up to 2 years.","definition_or_measurement_approach":""}
• {"endpoint_text":"- The proportion of patients with a disease relapse/recurrence at 2 years.","definition_or_measurement_approach":""}
• {"endpoint_text":"- The proportion of patients lost-to follow-up and the reason for loss to follow-up at 1.5 and 2 years","definition_or_measurement_approach":""}
• {"endpoint_text":"- The proportion of patients that had a (different) DMARD started (and reason for starting the DMARD) at 1.5 and 2 years","definition_or_measurement_approach":""}
• {"endpoint_text":"- The proportion (and number) of patients in which a (concomitant) rheumatic (inflammatory) disease was diagnosed at 1.5 and 2 years","definition_or_measurement_approach":""}

Netherlands

Earliest CTIS Part Ii Submission Date

24-06-2024

Latest Decision Or Authorization Date

05-03-2025

Processing Time Days

254

Number Of Sites

9

Number Of Participants

174

Primary sponsor

Full Name

Sint Maartenskliniek Stichting

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands