Validation of the PMR Activity Score and Evolution of Patient-reported Outcomes in Patients With Polymyalgia Rheumatica

NCT05542316 | Completed

• 1 other identifier: S66638
• Study Type: observational
• Target: 133
• Locations: 1 country
• Sites: 1

Brief Summary

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. 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.

Conditions

Polymyalgia Rheumatica

Outcome Measures

Primary Outcomes (1)

• Determination of the sensitivity and specificity of the PMR-activity score and the optimal cut-off point to discriminate between disease remission and active disease

  52 weeks

Secondary Outcomes (20)

• Determination of the sensitivity and specificity of morning stiffness time and the optimal cut-off point to discriminate between disease remission and active disease

  52 weeks

• Determination of the sensitivity and specificity of ability to elevate the upper limbs and the optimal cut-off point to discriminate between disease remission and active disease

  52 weeks

• Determination of the sensitivity and specificity of physician's global assessment using a visual analogue scale and the optimal cut-off point to discriminate between disease remission and active disease

  52 weeks

• Determination of the sensitivity and specificity of patient's assessment of pain using a visual analogue scale and the optimal cut-off point to discriminate between disease remission and active disease

  52 weeks

• Determination of the sensitivity and specificity of C-reactive protein and the optimal cut-off point to discriminate between disease remission and active disease

  52 weeks

Study Arms (1)

Patients with a final diagnosis of PMR

Eligibility Criteria

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

Study Population

Diagnosis of PMR

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

University Hospitals Leuven

Leuven, Belgium

Location

Related Publications (4)

• Leeb BF, Bird HA. A disease activity score for polymyalgia rheumatica. Ann Rheum Dis. 2004 Oct;63(10):1279-83. doi: 10.1136/ard.2003.011379.

  PMID: 15361387 BACKGROUND

• Mackie SL, Twohig H, Neill LM, Harrison E, Shea B, Black RJ, Kermani TA, Merkel PA, Mallen CD, Buttgereit F, Mukhtyar C, Simon LS, Hill CL; OMERACT PMR Working Group. The OMERACT Core Domain Set for Outcome Measures for Clinical Trials in Polymyalgia Rheumatica. J Rheumatol. 2017 Oct;44(10):1515-1521. doi: 10.3899/jrheum.161109. Epub 2017 Aug 1.

  PMID: 28765246 BACKGROUND

• Twohig H, Owen C, Muller S, Mallen CD, Mitchell C, Hider S, Hill C, Shea B, Mackie SL. Outcomes Measured in Polymyalgia Rheumatica and Measurement Properties of Instruments Considered for the OMERACT Core Outcome Set: A Systematic Review. J Rheumatol. 2021 Jun;48(6):883-893. doi: 10.3899/jrheum.200248. Epub 2020 Aug 1.

  PMID: 32739892 BACKGROUND

• Twohig H, Mitchell C, Mallen CD, Muller S. Development and psychometric evaluation of the PMR-Impact Scale: a new patient reported outcome measure for polymyalgia rheumatica. Rheumatology (Oxford). 2023 Feb 1;62(2):758-765. doi: 10.1093/rheumatology/keac317.

  PMID: 35639659 BACKGROUND

MeSH Terms

Conditions

Polymyalgia Rheumatica

Condition Hierarchy (Ancestors)

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

Study Officials

• Steven Vanderschueren, MD, PhD

  Universitaire Ziekenhuizen KU Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2022
• First Posted: September 15, 2022
• Study Start: July 1, 2022
• Primary Completion: December 9, 2024
• Study Completion: December 9, 2024
• Last Updated: March 30, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)