None listed
Conditions
Brief summary
Despite the fact that Polymyalgia Rheumatica (PMR) is the most common inflammatory rheumatic disease of the elderly, it is poorly understood. With no diagnostic tests available, diagnosis is dependent upon a history of muscle pain and stiffness in the hip and shoulder regions, combined with raised inflammation levels in the blood. Treatment consists of Prednisolone (commonly referred to as “cortisone”) prescribed in a “one size fits all” approach. However, the way in which PMR patients’ symptoms respond is very variable; some improve almost overnight, whilst other individuals require higher doses for much longer periods of time. Unfortunately, such long-term Prednisolone use can result in many complications including osteoporosis, weight gain, high blood pressure and diabetes. Similarly, uncontrolled PMR is associated with increased risk of heart attacks and stroke. This project aims to identify the characteristics of patients that fail to respond adequately to Prednisolone treatment. It is hypothesized that this information will delineate a distinct subset of “refractory” PMR patients, thereby permitting further study of alternate therapy in this group and minimizing the side effects of Prednisolone use long-term.
Interventions
This study will prospectively evaluate patients with a new diagnosis of Polymyalgia Rheumatica (PMR) as they are treated with a standard weaning course of Prednisolone (duration 46 weeks). The demographic, clinical, laboratory and radiologic characteristics (on musculoskeletal ultrasound and whole body PET/CT scan [in selected cases]) of patients whose disease relapses (defined by the PMR-Activity Score) will be compared with those in sustained disease remission. Identification of this "refracto
This study will prospectively evaluate patients with a new diagnosis of Polymyalgia Rheumatica (PMR) as they are treated with a standard weaning course of Prednisolone (duration 46 weeks). The demographic, clinical, laboratory and radiologic characteristics (on musculoskeletal ultrasound and whole body PET/CT scan [in selected cases]) of patients whose disease relapses (defined by the PMR-Activity Score) will be compared with those in sustained disease remission. Identification of this "refractory" subset of patients will permit future treatment to be tailored to individual risk of disease relapse and prevent complications from unnecessarily prolonged glucocorticoid therapy.
Sponsors
Austin Health
Eligibility
Sex/Gender
All
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
New diagnosis of Polymyalgia Rheumatica as defined by the 2012 EULAR/ACR Classification Criteria: - Age >= 50 years; AND - Bilateral shoulder aching; AND - Abnormal ESR and/or CRP; PLUS a score of >=4 based upon a scoring algorithm: - Morning stiffness duration >45 mins (2 points); - Hip pain or limited range of movement (1 point); - Negative rheumatoid factor and/or ACPA (2 points); - Absence of peripheral joint pain (1 point).
Exclusion criteria
- Inability to provide informed consent; - Symptoms suggestive of Giant Cell Arteritis (headache, jaw claudication, scalp tenderness or visual disturbance); - Cancer within the past 5 years; - Neuromuscular disease; - Active infection; - Other inflammatory conditions eg. RA; - Chronic pain syndromes; - Uncontrolled psychiatric conditions, hypertension or diabetes; - Treatment with glucocorticoids for >7 days prior to screening or a dose >15mg/day. - Treatment with concomitant Disease Modifying Anti-Rheumatic Drugs.
Outcome results
None listed