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

Polymyalgia Rheumatica Clinical Trial

Official title:

Short Term Study on the Effect of a Fixed Dose of 12.5 mg of Prednisone as Starting Dose in Polymyalgia Rheumatica

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01169597
• Other study ID #: PMR-PDN001
• Status: Completed
• Phase: Phase 4
• First received: July 21, 2010
• Last updated: July 23, 2010
• Start date: January 2009
• Est. completion date: May 2010

Study information

• Verified date: June 2010
• Source: University of Genova
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Giant Cell Arteritis
• Polymyalgia Rheumatica

Intervention

Drug:
• prednisone
prednisone 12.5 mg daily po

Locations

Country	Name	City	State
Italy	Clinica Reumatologica, Dipartimento di medicina Interna, Università di Genova	Genova

Sponsors (1)

Lead Sponsor	Collaborator
University of Genova

Country where clinical trial is conducted

Italy, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	to evaluate demographic features as possible predictive factors of response to 12.5 mg of prednisone	age, sex, body weight measured at the time of the first visit were evaluated by logistic regression with response to 12.5 mg of prednison as independent variable	1 month	No
Secondary	to evaluate characteristics of PMR as predictive factors of response to 12.5 mg of prednisone	duration of disease, presence of fatigue, fever, and weight loss, duration of morning stiffness were assessed in multivariate analysis with response to 12.5 mg of prednisone as independent variable	1 month	No
Secondary	to evaluate findings at clinical examination as predictive factors of response to 12.5 mg of prednisone	presence of girdle tenderness, carpal tunnel syndrome, RS3PE, peripheral arthritis or tenosynovitis were studied by multivariate analysis with response to 12.5 mg prednisone as independent variable	1 month	No
Secondary	to evaluate laboratory parameters as predictive factors of response to 12.5 mg of prednisone	erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), and IgM rheumatoid factor (RF) were studied by multivariate analysis with response to 12.5 mg prednisone as independent variable	1 month	No
Secondary	to evaluate results of US as possible predictors of response to 12.5 mg prednisone	results of ultrasonography (US) of the shoulders were studied by multivariate analysis with response to 12.5 mh prednisone as independent variable	1 month	No