Validation of the PMR Activity Score and Evolution of Patient-reported Outcomes in Patients With Polymyalgia Rheumatica
Key facts
- Who runs it
- Universitaire Ziekenhuizen KU Leuven
- Where
- Belgium1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Completed
- People taking part
- 133 people enrolled
- Started
- 1 Jul 2022
- Ended
- 9 Dec 2024
- Type of study
- Observational
- Record updated
- 30 March 2025
Who can take part
- Age
- 50 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
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Who can take part
- Diagnosis of PMR based on the judgment of an experienced clinician (affiliated with the general internal medicine or rheumatology department), taking into account all available information (clinical symptoms, biochemical, radiological, and PET results)
- Able to give informed consent
- Understanding and able to write Dutch, English or French
Who cannot take part
- Concomitant diagnosis of giant cell arteritis (new diagnosis or being treated for giant cell arteritis)
- Concurrent rheumatoid arthritis, other inflammatory arthritis or other connective tissue disease
- Patients on glucocorticoids or other immunosuppressive drugs for another indication
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
Polymyalgia rheumatica (PMR) is a systemic inflammatory disease that affects elderly people. It is characterized by pain and morning stiffness in the shoulders, pelvic girdles and neck. Glucocorticoids are the mainstay of the treatment. In clinical practice, the disease activity of PMR and corresponding treatment changes are based on the presence of symptoms and inflammatory markers. The interpretation of these abnormalities can be surprisingly difficult, especially when they are not consistent. In 2004, Leeb and Bird developed a composite score for measurement of disease activity in PMR, called the polymyalgia rheumatica activity score. It consists of 5 domains: morning stiffness time, ability to elevate the upper limbs, physician's global assessment, pain and CRP level. However, high-quality evidence on the measurement properties is lacking and there is still no consensus on the optimal cut off point.
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Based on a Delphi study with physicians and patients OMERACT defines laboratory markers of systemic inflammation, pain, stiffness and physical function as the four inner core of domains considered mandatory for clinical trials of PMR, most frequently measured by erythrocyte sedimentation rate (ESR) and/or C-reactive protein (CRP), visual analogue scale (VAS) for pain, morning stiffness time and Health Assessment Questionnaire-Disability Index (HAQ-DI) respectively. Patient's global fatigue was strongly recommended to measure in PMR as well. Recently, a PMR-specific patient-reported outcome measure was developed, called the PMR impact scale. However, outcome measures in PMR studies lack consistency and there is no high-quality evidence on the measurement properties. In addition, the evolution of these patient reported outcomes is not known.
The group in the trial
- Patients with a final diagnosis of PMR
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Validation of the Polymyalgia Rheumatica Activity Score for Determination of Disease Activity
- Record updated
- 30 March 2025