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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
Sponsor:
Information provided by:
University of Genova

Study Description
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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.


Condition or disease Intervention/treatment Phase
Polymyalgia Rheumatica Drug: prednisone Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Drug Information available for: Prednisone

Arms and Interventions
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Intervention Details:
  • Drug: prednisone
    prednisone 12.5 mg daily po

Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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


Eligibility Criteria
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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01169597


Locations
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Italy
Clinica Reumatologica, Dipartimento di medicina Interna, Università di Genova
Genova, Italy, 16132
Sponsors and Collaborators
University of Genova
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Prof. Marco A Cimmino, Dept. of Internal Medicine, University of Genova, Italy
ClinicalTrials.gov Identifier: NCT01169597    
Other Study ID Numbers: PMR-PDN001
First Posted: July 26, 2010    Key Record Dates
Last Update Posted: July 26, 2010
Last Verified: June 2010
Keywords provided by University of Genova:
polymyalgia rheumatica
prednisone
clinical examination
remission
ultrasonography
Additional relevant MeSH terms:
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Polymyalgia Rheumatica
Giant Cell Arteritis
Muscular Diseases
Musculoskeletal Diseases
Nervous System Diseases
Rheumatic Diseases
Connective Tissue Diseases
Vasculitis, Central Nervous System
Autoimmune Diseases of the Nervous System
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
 Arteritis
Vasculitis
Skin Diseases, Vascular
Skin Diseases
Autoimmune Diseases
Immune System Diseases
Prednisone
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents