Polymyalgia Rheumatica Clinical Trial
Official title:
Short Term Study on the Effect of a Fixed Dose of 12.5 mg of Prednisone as Starting Dose in Polymyalgia Rheumatica
Polymyalgia rheumatica (PMR) is a common inflammatory condition affecting elderly people and
involving the girdles. The mainstay of treatment is oral glucocorticoids (GC), with the
recent BSR-BHPR guidelines suggesting an initial prednisone dose comprised between 15 and 20
mg as appropriate. However, probably because of the dramatic response of PMR to GC,
randomized controlled trials of treatment are lacking. As a result, there is no evidence
from controlled studies on the efficacy of different initial doses or drug tapering.
Objective of the study: to test if 12.5 mg prednisone/day is an adequate starting dose in
polymyalgia rheumatica (PMR) and to evaluate clinical predictors of drug response.
Methods: 60 consecutive PMR patients will be treated with a starting dose of 12,5 mg/day
prednisone. Clinical, laboratory, and ultrasonographic features will be recorded as possible
predictors of response to prednisone. Remission is defined as disappearance of at least 75%
of the signs and symptoms of PMR and normalization of ESR and CRP within the first month, a
scenario allowing steroid tapering.
n/a
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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