Short Term Efficacy of a Starting Dose of 12.5 mg of Prednisone in Polymyalgia Rheumatica Patients
Information source: University of Genova
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Polymyalgia Rheumatica
Intervention: prednisone (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: University of Genova
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.
Clinical Details
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 design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: clinical remission within one month from the treatment initiation
Secondary outcome: to evaluate demographic features as possible predictive factors of response to 12.5 mg of prednisoneto evaluate characteristics of PMR as predictive factors of response to 12.5 mg of prednisone to evaluate findings at clinical examination as predictive factors of response to 12.5 mg of prednisone to evaluate laboratory parameters as predictive factors of response to 12.5 mg of prednisone to evaluate results of US as possible predictors of response to 12.5 mg prednisone
Eligibility
Minimum age: 50 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Clinica Reumatologica, Dipartimento di medicina Interna, Università di Genova, Genova 16132, Italy
Additional Information
Related publications: 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.
Starting date: January 2009
Last updated: July 23, 2010
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