Short Term Efficacy of a Starting Dose of 12.5 mg of Prednisone in Polymyalgia Rheumatica Patients

Study Overview
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Brief Summary
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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.

Official Title
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Short Term Study on the Effect of a Fixed Dose of 12.5 mg of Prednisone as Starting Dose in Polymyalgia Rheumatica

Conditions
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Polymyalgia Rheumatica

Intervention / Treatment
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* Drug: prednisone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with PMR, diagnosed according to the criteria of Bird et al Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: prednisone|prednisone 12.5 mg daily po|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical remission within one month from the treatment initiation | 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. | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to evaluate demographic features as possible predictive factors of response to 12.5 mg of prednisone | 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 | 1 month | 
| to evaluate characteristics of PMR as predictive factors of response to 12.5 mg of prednisone | 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 | 1 month | 
| to evaluate findings at clinical examination as predictive factors of response to 12.5 mg of prednisone | 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 | 1 month | 
| to evaluate laboratory parameters as predictive factors of response to 12.5 mg of prednisone | 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 | 1 month | 
| to evaluate results of US as possible predictors of response to 12.5 mg prednisone | results of ultrasonography (US) of the shoulders were studied by multivariate analysis with response to 12.5 mh prednisone as independent variable | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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polymyalgia rheumatica, prednisone, clinical examination, remission, ultrasonography