Short Term Efficacy of a Starting Dose of 12.5 mg of Prednisone in Polymyalgia Rheumatica Patients

NCT01169597 | Completed Phase 4

• 1 other identifier: PMR-PDN001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Polymyalgia Rheumatica

Keywords

polymyalgia rheumatica; prednisone; clinical examination; remission; ultrasonography

Outcome Measures

Primary Outcomes (1)

• 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.

  1 month

Secondary Outcomes (5)

• to evaluate demographic features as possible predictive factors of response to 12.5 mg of prednisone

  1 month

• to evaluate characteristics of PMR as predictive factors of response to 12.5 mg of prednisone

  1 month

• to evaluate findings at clinical examination as predictive factors of response to 12.5 mg of prednisone

  1 month

• to evaluate laboratory parameters as predictive factors of response to 12.5 mg of prednisone

  1 month

• to evaluate results of US as possible predictors of response to 12.5 mg prednisone

  1 month

Interventions

prednisone DRUG

prednisone 12.5 mg daily po

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with PMR, diagnosed according to the criteria of Bird et al

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Genova: lead

Study Sites (1)

Clinica Reumatologica, Dipartimento di medicina Interna, Università di Genova

Genova, 16132, Italy

Location

Related Publications (2)

• 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.

  PMID: 19910443 BACKGROUND

• 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.

  PMID: 21569559 DERIVED

MeSH Terms

Conditions

Polymyalgia Rheumatica

Interventions

Prednisone

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 21, 2010
• First Posted: July 26, 2010
• Study Start: January 1, 2009
• Primary Completion: January 1, 2010
• Study Completion: May 1, 2010
• Last Updated: July 26, 2010

Record last verified: 2010-06

Locations

IT (1)