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

This study has been completed.
Sponsor:
Information provided by:
University of Genova
ClinicalTrials.gov Identifier:
NCT01169597
First received: July 21, 2010
Last updated: July 23, 2010
Last verified: June 2010
  Purpose

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 Intervention Phase
Polymyalgia Rheumatica
Drug: prednisone
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University of Genova:

Primary Outcome Measures:
  • clinical remission within one month from the treatment initiation [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    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:
  • to evaluate demographic features as possible predictive factors of response to 12.5 mg of prednisone [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    results of ultrasonography (US) of the shoulders were studied by multivariate analysis with response to 12.5 mh prednisone as independent variable


Enrollment: 60
Study Start Date: January 2009
Study Completion Date: May 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: prednisone
    prednisone 12.5 mg daily po
  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
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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Please refer to this study by its ClinicalTrials.gov identifier: NCT01169597

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

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Prof. Marco A Cimmino, Dept. of Internal Medicine, University of Genova, Italy
ClinicalTrials.gov Identifier: NCT01169597     History of Changes
Other Study ID Numbers: PMR-PDN001
Study First Received: July 21, 2010
Last Updated: July 23, 2010
Health Authority: Italy: Ethics Committee

Keywords provided by University of Genova:
polymyalgia rheumatica
prednisone
clinical examination
remission
ultrasonography

Additional relevant MeSH terms:
Giant Cell Arteritis
Polymyalgia Rheumatica
Arteritis
Autoimmune Diseases
Autoimmune Diseases of the Nervous System
Brain Diseases
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Connective Tissue Diseases
Immune System Diseases
Muscular Diseases
Musculoskeletal Diseases
Nervous System Diseases
Rheumatic Diseases
Skin Diseases
Skin Diseases, Vascular
Vascular Diseases
Vasculitis
Vasculitis, Central Nervous System
Prednisone
Anti-Inflammatory Agents
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014