NCT07010484 Using Novel Imaging to Rethink Diagnostic and Treatment Strategies for Polymyalgia Rheumatica
| NCT ID | NCT07010484 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Kresten Krarup Keller |
| Condition | Polymyalgia Rheumatica (PMR) |
| Study Type | OBSERVATIONAL |
| Enrollment | 149 participants |
| Start Date | 2025-08-21 |
| Primary Completion | 2028-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 149 participants in total. It began in 2025-08-21 with a primary completion date of 2028-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Polymyalgia rheumatica (PMR) is the most common chronic inflammatory rheumatic disease among the elderly and is characterized by proximal extremity pain and fatigue. Treatment with prednisolone carries several significant adverse effects, and it is therefore essential to avoid unnecessary treatment. However, clinical diagnosis and even imaging such as positron emission tomography and computed tomography (PET/CT) has low diagnostic accuracy, which decrease after start of prednisolone. The purpose is to evaluate a new method to diagnose PMR with PET/CT using magnetic resonance imaging (MRI) for informing the interpretation of PET in 111 patients suspected of PMR at baseline and after 8 weeks prednisolone treatment. In addition, a treatment initiation strategy guided by clinical diagnosis combined with PET will be evaluated in 100 patients with newly diagnosed PMR.
Eligibility Criteria
Inclusion Criteria: 1. Patients suspected of PMR seen at the Department of Rheumatology/internal medicine in Aarhus, Silkeborg, Horsens, Gødstrup, Randers, and Svendborg. 2. Age above 50. 3. Proximal extremity pain. Exclusion Criteria: 1. Oral, intravenous, intra-articular or intramuscular glucocorticoids within the last 2 months. 2. Previous prednisolone treatment for GCA/PMR. 3. Unable to give consent. 4. Proximal extremity pain duration for more than one year. 5. Symptoms of GCA (headache, scalp tenderness, jaw or tongue claudication, vision disturbances attributable to GCA, limb claudication). 6. Active malignant cancers within the last 5 years (except basal cell carcinoma). 7. Other known inflammatory rheumatic diseases (e.g. rheumatoid arthritis, polymyositis, spondyloarthritis, psoriatic arthritis, gout). 8. Uncontrolled diseases (e.g. severe active asthma, cardiac disease with NYHA class IV) 9. For MRI: Implants contraindicating MRI and BMI\>150 kg.
Contact & Investigator
Kresten K Keller, MD, PhD
PRINCIPAL INVESTIGATOR
Department of Rheumatology, Aarhus University Hospital
Frequently Asked Questions
Who can join the NCT07010484 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, studying Polymyalgia Rheumatica (PMR). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07010484 currently recruiting?
Yes, NCT07010484 is actively recruiting participants. Contact the research team at krekel@rm.dk for enrollment information.
Where is the NCT07010484 trial being conducted?
This trial is being conducted at Aarhus, Denmark, Gødstrup, Denmark, Horsens, Denmark, Odense, Denmark and 3 additional locations.
Who is sponsoring the NCT07010484 clinical trial?
NCT07010484 is sponsored by Kresten Krarup Keller. The principal investigator is Kresten K Keller, MD, PhD at Department of Rheumatology, Aarhus University Hospital. The trial plans to enroll 149 participants.