Short Term Efficacy of a Starting Dose of 12.5 mg of Prednisone in Polymyalgia Rheumatica Patients
Primary Purpose
Polymyalgia Rheumatica
Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
prednisone
Sponsored by
About this trial
This is an interventional treatment trial for Polymyalgia Rheumatica focused on measuring polymyalgia rheumatica, prednisone, clinical examination, remission, ultrasonography
Eligibility 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
Sites / Locations
- Clinica Reumatologica, Dipartimento di medicina Interna, Università di Genova
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
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
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
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
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01169597
Brief Title
Short Term Efficacy of a Starting Dose of 12.5 mg of Prednisone in Polymyalgia Rheumatica Patients
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 Type
Interventional
2. Study Status
Record Verification Date
June 2010
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
May 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Genova
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polymyalgia Rheumatica
Keywords
polymyalgia rheumatica, prednisone, clinical examination, remission, ultrasonography
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
prednisone
Intervention Description
prednisone 12.5 mg daily po
Primary Outcome Measure Information:
Title
clinical remission within one month from the treatment initiation
Description
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.
Time Frame
1 month
Secondary Outcome Measure Information:
Title
to evaluate demographic features as possible predictive factors of response to 12.5 mg of prednisone
Description
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
Time Frame
1 month
Title
to evaluate characteristics of PMR as predictive factors of response to 12.5 mg of prednisone
Description
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
Time Frame
1 month
Title
to evaluate findings at clinical examination as predictive factors of response to 12.5 mg of prednisone
Description
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
Time Frame
1 month
Title
to evaluate laboratory parameters as predictive factors of response to 12.5 mg of prednisone
Description
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
Time Frame
1 month
Title
to evaluate results of US as possible predictors of response to 12.5 mg prednisone
Description
results of ultrasonography (US) of the shoulders were studied by multivariate analysis with response to 12.5 mh prednisone as independent variable
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Clinica Reumatologica, Dipartimento di medicina Interna, Università di Genova
City
Genova
ZIP/Postal Code
16132
Country
Italy
12. IPD Sharing Statement
Citations:
PubMed Identifier
19910443
Citation
Dasgupta B, Borg FA, Hassan N, Barraclough K, Bourke B, Fulcher J, Hollywood J, Hutchings A, Kyle V, Nott J, Power M, Samanta A; BSR and BHPR Standards, Guidelines and Audit Working Group. BSR and BHPR guidelines for the management of polymyalgia rheumatica. Rheumatology (Oxford). 2010 Jan;49(1):186-90. doi: 10.1093/rheumatology/kep303a. Epub 2009 Nov 12. No abstract available.
Results Reference
background
PubMed Identifier
21569559
Citation
Cimmino MA, Parodi M, Montecucco C, Caporali R. The correct prednisone starting dose in polymyalgia rheumatica is related to body weight but not to disease severity. BMC Musculoskelet Disord. 2011 May 14;12(1):94. doi: 10.1186/1471-2474-12-94.
Results Reference
derived
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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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