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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 prednisone

to 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

Page last updated: August 23, 2015

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