Using Novel Imaging to Rethink Diagnostic and Treatment Strategies for Polymyalgia Rheumatica (REMAP PMR)

Kresten Krarup Keller

Status: Enrolling

Conditions: Polymyalgia Rheumatica (PMR)

Treatments: Diagnostic Test: PET/CT with 18-FDG; Diagnostic Test: PET/MRI

Study type: Observational

Funder types: Other

Identifiers

NCT07010484

1-10-72-69-25

NNF24OC0094827 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 149 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

149 participants in 1 patient group

Patients with and suspected of polymyalgia rheumatica

Description:

The study 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 polymyalgia rheumatica (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 (estimated 64 from the 111 patients with suspected PMR, and additionally 38 diagnosed with PMR of which approximately 34 will have PMR without concurrent giant cell arteritis). Patients with a clinical diagnosis of PMR and a negative PET will not be started in routine treatment, but receive intramuscular glucocorticoids, which can be followed by oral prednisolone 15 mg tapered during a maximum of 3 month after diagnosis at discretion of the investigator.

Treatment:

Diagnostic Test: PET/MRI

Diagnostic Test: PET/CT with 18-FDG