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Completed

NCT Number: NCT01169597

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

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.

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Clinica Reumatologica, Dipartimento di medicina Interna, Università di Genova

Genova, 16132, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prednisone

Drug

prednisone 12.5 mg daily po

Primary outcomes

  1. clinical remission within one month from the treatment initiation

    Time frame: 1 month

    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.

Secondary outcomes

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

    Time frame: 1 month

    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

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

    Time frame: 1 month

    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

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

    Time frame: 1 month

    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

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

    Time frame: 1 month

    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

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

    Time frame: 1 month

    results of ultrasonography (US) of the shoulders were studied by multivariate analysis with response to 12.5 mh prednisone as independent variable

Sponsors and collaborators

Lead sponsor

University of Genova

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jul 26, 2010
Registry last updated
Jul 26, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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