Clinical trial NCT01169597: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Polymyalgia Rheumatica
Keywords: polymyalgia rheumatica
prednisone
clinical examination
remission
ultrasonography
Lead sponsor: University of Genova
Sponsor class: OTHER
First posted: 2010-07-26
Enrollment: 60
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: clinical remission within one month from the treatment initiation
timeFrame: 1 month
Secondary outcomes:
measure: to evaluate demographic features as possible predictive factors of response to 12.5 mg of prednisone
timeFrame: 1 month
measure: to evaluate characteristics of PMR as predictive factors of response to 12.5 mg of prednisone
timeFrame: 1 month
measure: to evaluate findings at clinical examination as predictive factors of response to 12.5 mg of prednisone
timeFrame: 1 month
measure: to evaluate laboratory parameters as predictive factors of response to 12.5 mg of prednisone
timeFrame: 1 month
measure: to evaluate results of US as possible predictors of response to 12.5 mg prednisone
timeFrame: 1 month
Other outcomes:
Locations:
city: Genova
country: Italy
facility: Clinica Reumatologica, Dipartimento di medicina Interna, Università di Genova
Study officials:
References:
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.
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.