Short Term Efficacy of a Starting Dose of 12.5 mg of Prednisone in Polymyalgia Rheumatica Patients
- Conditions
- Polymyalgia Rheumatica
- Registration Number
- NCT01169597
- Lead Sponsor
- University of Genova
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
- patients with PMR, diagnosed according to the criteria of Bird et al
- patients with arthritis
- patients with giant cell arteritis
- patients with Parkinson's disease
- patients with hypothyroidism
- patients with scapulohumeral periarthritis
- patients with fibromyalgia
- patients unable to cooperate
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method clinical remission within one month from the treatment initiation 1 month Remission was defined as at least a 70% global improvement of the signs and symptoms of PMR and normalization of ESR and CRP within the first month, allowing steroid tapering.
- Secondary Outcome Measures
Name Time Method to evaluate demographic features as possible predictive factors of response to 12.5 mg of prednisone 1 month age, sex, body weight measured at the time of the first visit were evaluated by logistic regression with response to 12.5 mg of prednison as independent variable
to evaluate characteristics of PMR as predictive factors of response to 12.5 mg of prednisone 1 month duration of disease, presence of fatigue, fever, and weight loss, duration of morning stiffness were assessed in multivariate analysis with response to 12.5 mg of prednisone as independent variable
to evaluate findings at clinical examination as predictive factors of response to 12.5 mg of prednisone 1 month presence of girdle tenderness, carpal tunnel syndrome, RS3PE, peripheral arthritis or tenosynovitis were studied by multivariate analysis with response to 12.5 mg prednisone as independent variable
to evaluate laboratory parameters as predictive factors of response to 12.5 mg of prednisone 1 month erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), and IgM rheumatoid factor (RF) were studied by multivariate analysis with response to 12.5 mg prednisone as independent variable
to evaluate results of US as possible predictors of response to 12.5 mg prednisone 1 month results of ultrasonography (US) of the shoulders were studied by multivariate analysis with response to 12.5 mh prednisone as independent variable
Trial Locations
- Locations (1)
Clinica Reumatologica, Dipartimento di medicina Interna, Università di Genova
🇮🇹Genova, Italy