An observational study in Polymyalgia Rheumatica, sponsored by Universitaire Ziekenhuizen KU Leuven. Completed at 1 site in Belgium. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2025-03-30.
Sponsored by Universitaire Ziekenhuizen KU Leuven · Observational
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.
The primary objective of this prospective observational trial is to validate the PMR-activity score and to determine the optimal cut-off point to discriminate between disease remission and active disease. The secondary objective is to assess the evolution of the patient reported outcomes during the disease course and their relation with disease activity.
The investigators intend to perform a 12-month, observational prospective trial in patients with recently diagnosed PMR. Patients will be followed and treated as standard of care. Follow-up visits will be planned at 8 weeks, 16 weeks, 26 weeks and 52 weeks. As in standard of care, additional visits can be planned if necessary, e.g. in case of symptoms suggestive of relapse. Each visit ESR, CRP, morning stiffness time, ability to elevate the upper limbs, physician's global assessment and VAS for pain as components of the PMR-activity score and VAS for global health, pain, stiffness and fatigue, HAQ-DI, Short Form Health survey (SF36) and PMR impact scale as patient-reported outcomes will be collected.
68 studies on the registry are indexed under Polymyalgia Rheumatica; 22 are open to participants now.
This study's enrollment of 133 is close to the median of 133 across 27 observational studies indexed under Polymyalgia Rheumatica.
Browse Polymyalgia Rheumatica studies →Universitaire Ziekenhuizen KU Leuven is the lead sponsor of 963 studies on the registry; 267 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Diagnosis of PMR
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Time frame: 52 weeks
Determination of the sensitivity and specificity of morning stiffness time and the optimal cut-off point to discriminate between disease remission and active disease
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 52 weeks
Determination of the sensitivity and specificity of the change in the PMR-activity score between two visits and the optimal cut-off point to discriminate between disease remission and active disease
Time frame: 52 weeks
Determination of the sensitivity and specificity of the change in morning stiffness between two visits and the optimal cut-off point to discriminate between disease remission and active disease
Time frame: 52 weeks
Determination of the sensitivity and specificity of the change in ability to elevate the upper limbs between two visits and the optimal cut-off point to discriminate between disease remission and active disease
Time frame: 52 weeks
Determination of the sensitivity and specificity of the change in physician's global assessment using a visual analogue scale between two visits and the optimal cut-off point to discriminate between disease remission and active disease
Time frame: 52 weeks
Determination of the sensitivity and specificity of the change in patient's assessment of pain using a visual analogue scale between two visits and the optimal cut-off point to discriminate between disease remission and active disease
Time frame: 52 weeks
Determination of the sensitivity and specificity of the change in C-reactive protein between two visits and the optimal cut-off point to discriminate between disease remission and active disease
Time frame: 52 weeks
Evolution of Health Assessment Questionnaire-Disability Index (HAQ-DI) over the disease course and the relation with disease activity
Time frame: 52 weeks
Evolution of the ability to elevate the upper limbs over the disease course and the relation with disease activity
Time frame: 52 weeks
Evolution of the patient's assessment of pain using a visual analogue scale over the disease course and the relation with disease activity
Time frame: 52 weeks
Evolution of the patient's assessment of global health using a visual analogue scale over the disease course and the relation with disease activity
Time frame: 52 weeks
Evolution of the patient's assessment of fatigue using a visual analogue scale over the disease course and the relation with disease activity
Time frame: 52 weeks
Evolution of the patient's assessment of stiffness using a visual analogue scale over the disease course and the relation with disease activity
Time frame: 52 weeks
Evolution of morning stiffness time over the disease course and the relation with disease activity
Time frame: 52 weeks
Evolution of 36-item Short Form Health Survey (SF36) over the disease course and the relation with disease activity
Time frame: 52 weeks
Evolution of the PMR impact scale over the disease course and the relation with disease activity
Time frame: 52 weeks
Plan to share: No
Ran from Jul 2022 to primary completion in Dec 2024, 29 months.
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This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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