Rituximab Effect on Decreasing glUcoCorticoid Exposition in PolyMyalgia Rheumatica Patients Experiencing a PMR Relapse

Launched by SINT MAARTENSKLINIEK · Sep 6, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a medication called Rituximab (RTX) in patients with Polymyalgia Rheumatica (PMR) who are experiencing a relapse of their symptoms. PMR is a condition that particularly affects older adults, causing pain and stiffness, especially in the shoulders and hips. The usual treatment involves glucocorticoids, which are steroid medications, but they can have significant side effects. This trial aims to see if Rituximab can help patients achieve remission from PMR without needing to rely heavily on glucocorticoids.

To participate in this study, individuals must have a confirmed diagnosis of PMR and be experiencing a relapse, meaning their symptoms have returned and certain blood tests show increased inflammation. They should also be unable to lower their glucocorticoid dose below 5 mg per day. Participants will receive either Rituximab or a placebo (a harmless substance that looks like the real drug) and will be monitored over a longer period to better understand how effective Rituximab is in reducing the need for glucocorticoids. This trial is currently recruiting participants of all genders, aged 18 and older.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Polymyalgia rheumatica (PMR) diagnosis fulfilling the 2012 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) classification criteria
• • Experiencing a PMR relapse, defined as recurring of symptoms and increase in erythrocyte sedimentation rate (ESR)/ C reactive protein (CRP)
• • Unable to reduce glucocorticoid dose below 5mg/day prednisolone or equivalent
• • Informed consent
• Exclusion Criteria:
• • Treatment with systemic immunosuppressants (other than GC, MTX, leflunomide and azathioprine) 3 months prior to inclusion;
• • (clinical) suspect concomitant giant cell arteritis or other rheumatic inflammatory diseases;
• • concomitant conditions that might significantly interfere with PMR pain or movement evaluation as judged by the investigator;
• • previous hypersensitivity for RTX or contra-indications to RTX.