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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

Tracking Information
First Submitted Date  ICMJE July 21, 2010
First Posted Date  ICMJE July 26, 2010
Last Update Posted Date July 26, 2010
Study Start Date  ICMJE January 2009
Actual Primary Completion Date January 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 23, 2010)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 23, 2010)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Short Term Efficacy of a Starting Dose of 12.5 mg of Prednisone in Polymyalgia Rheumatica Patients
Official Title  ICMJE Short Term Study on the Effect of a Fixed Dose of 12.5 mg of Prednisone as Starting Dose in Polymyalgia Rheumatica
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Polymyalgia Rheumatica
Intervention  ICMJE Drug: prednisone
prednisone 12.5 mg daily po
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 23, 2010)
60
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2010
Actual Primary Completion Date January 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01169597
Other Study ID Numbers  ICMJE PMR-PDN001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Prof. Marco A Cimmino, Dept. of Internal Medicine, University of Genova, Italy
Study Sponsor  ICMJE University of Genova
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Genova
Verification Date June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP