Treat-to-target Prednisolon Taper in Patients With Polymyalgia Rheumatica

Aarhus University Hospital

Status: Active, not recruiting

Conditions: Polymyalgia Rheumatica

Treatments: Other: Treat-to-target Prednisolone Taper; Other: Usual care

Study type: Interventional

Funder types: Other

Identifiers

NCT05636501

T2T PMR

Details and patient eligibility

About

Polymyalgia rheumatica (PMR) has an incidence of approximately 1000/10^6 for persons more than 50 years. Treatment with prednisolone carries several significant adverse effects, and it is therefore essential to taper prednisolone as fast as possible. Systematic treatment strategies (treat-to-target) is the most important improvement of disease management for other rheumatic diseases such as rheumatoid arthritis in the last decades. Thus, the purpose is to investigate benefits and harms associated with a nurce led systematic prednisolone taper strategy at the department of rheumatology compared to individual treatment by discretion of the general practitioner. It is a 1-year open label randomised trial with a 1-year extension in 120 treatment naïve patients with PMR.

Enrollment: 120 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients newly diagnosed with PMR according to the EULAR criteria for PMR.
• No sign of GCA on ultrasonography of the temporal and axillary arteries.
• Age over 50 years.
• Danish spoken and written language skills sufficient to fill out questionnaires.

Exclusion criteria

• Peroral, intraarticular or intramuscular application of glucocorticoids within the last month.
• Previous prednisolone treatment for GCA/PMR.
• Unable to give consent.
• Symptoms of GCA (newly onset-headache, tenderness of the temporal artery, jaw claudication, vision disturbances).
• Active malignant cancers within the last 5 years (except basal cell carcinoma).
• Other inflammatory rheumatic diseases (eg. rheumatoid arthritis, polymyositis, spondyloarthritis, psoriatic arthritits, gout).
• Uncontrolled diseases (eg severe active asthma, cardiac disease with NYHA class IV)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups, including a placebo group

Treat-to-target Prednisolone Taper

Active Comparator group

Description:

Patients randomized to the "Treat-to-target" group is prescribed with a systematic prednisolone taper according to a specific scheme. The starting dose can be increased if remission is not reached initially or in case of relapse, folloved by taper according to the specific scheme. A nurse will make a minimum of 5 phone consultations the first year, and hereafter minimum every 3 months.

Treatment:

Other: Treat-to-target Prednisolone Taper

Usual Care

Placebo Comparator group

Description:

Patients randomized to "usual care" are dismissed from the hospital after the diagnosis and the prednisolone taper are subsequently performed by discretion of the patient's general practitioner.

Treatment:

Other: Usual care