Short Term Efficacy of a Starting Dose of 12.5 mg of Prednisone in Polymyalgia Rheumatica Patients
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|ClinicalTrials.gov Identifier: NCT01169597|
Recruitment Status : Completed
First Posted : July 26, 2010
Last Update Posted : July 26, 2010
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.
|Condition or disease||Intervention/treatment||Phase|
|Polymyalgia Rheumatica||Drug: prednisone||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Short Term Study on the Effect of a Fixed Dose of 12.5 mg of Prednisone as Starting Dose in Polymyalgia Rheumatica|
|Study Start Date :||January 2009|
|Actual Primary Completion Date :||January 2010|
|Actual Study Completion Date :||May 2010|
- Drug: prednisone
prednisone 12.5 mg daily po
- clinical remission within one month from the treatment initiation [ Time Frame: 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.
- to evaluate demographic features as possible predictive factors of response to 12.5 mg of prednisone [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 1 month ]results of ultrasonography (US) of the shoulders were studied by multivariate analysis with response to 12.5 mh prednisone as independent variable
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01169597
|Clinica Reumatologica, Dipartimento di medicina Interna, Università di Genova|
|Genova, Italy, 16132|