Ignite Creation Date:
2024-05-05 @ 10:41 PM
Last Modification Date:
2024-10-26 @ 10:23 AM
Study NCT ID:
NCT01169597
Status:
COMPLETED
Last Update Posted:
2010-07-26
First Post:
2010-07-21
Brief Title:
Short Term Efficacy of a Starting Dose of 125 mg of Prednisone in Polymyalgia Rheumatica Patients
Sponsor:
University of Genova
Organization:
University of Genova
Study Overview
Official Title:
Short Term Study on the Effect of a Fixed Dose of 125 mg of Prednisone as Starting Dose in Polymyalgia Rheumatica
Status:
COMPLETED
Status Verified Date:
2010-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 125 mg prednisoneday 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 125 mgday 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
Methods 60 consecutive PMR patients will be treated with a starting dose of 125 mgday 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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None