Delayed release prednisone in PMR
A randomized, open-label, dose-ranging study of oral delayed release prednisone in patients with untreated polymyalgia rheumatica (PMR).
What is PMR?
PMR is a systemic inflammatory rheumatological condition of unknown pathogenesis. Although synovitis and arthritis are not features of PMR, both PMR and rheumatoid arthritis (RA) show a characteristic and marked circadian variation in symptoms. PMR has a lifetime risk of 2.43% in women and 1.66% in men, compared to 3.64% and 1.68% respectively as estimated in RA . PMR is twice as common in women as men, seldom occurs in people below the age of 50, and is usually seen in people above 60.
Who can participate?
All patients newly diagnosed with PMR at each of the participating sites are potential candidates. Patients will give fully informed consent after being provided details of the study and all questions have been answered. Written informed consent will be provided before any screening procedures can be initiated. Overall in the entire study, 10-15 patients in each arm (30-45 in total) will be recruited. We anticipate 25-50% of patients to agree to participate in the study.
What will happen during the study?
A four-week, randomized, controlled, open-label trial of DR prednisone in which patients receive in period 1 one of three-night time doses of treatment (4mg, 7mg or 10mg) for two weeks followed in period 2 by treatment with 15mg IR prednisone in the morning for two weeks. Period 1 is randomized and open-label and period 2 is open label. Before enrollment and randomization patient diagnosis and responsiveness to 15mg IR prednisone in the morning is established. 45 patients will be randomized, 15 patients in each treatment arm.
How do I sign up?
Interested in helping doctors find groundbreaking solutions to reducing joint pain? Complete and submit the registration form, and we’ll send you an email regarding the next steps of your participation.