Clinical trial NCT05636501: Treat-to-target Prednisolon Taper in Patients with Polymyalgia Rheumatica
Official title: Dose Reduction and Discontinuation of Prednisolone Using Structured Treat-to-target Taper in Patients with Polymyalgia Rheumatica
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Polymyalgia Rheumatica
Lead sponsor: Aarhus University Hospital
Sponsor class: OTHER
Collaborators: name: Horsens Hospital
name: Regionshospitalet Silkeborg
name: Gødstrup Hospital
name: Regionshospital Nordjylland
name: Aalborg University Hospital
name: Frederiksberg University Hospital
First posted: 2022-12-05
Enrollment: 120
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Proportion of patients in prednisolone free remission 52 weeks from baseline
timeFrame: 52 weeks
Secondary outcomes:
measure: Change in prednisolone dose from baseline to week 52
timeFrame: 52 weeks
measure: Proportion of GCA patients diagnosed during the first 52 weeks
timeFrame: 52 weeks
measure: Self-reported number of relapses during the first 52 weeks
timeFrame: 52 weeks
measure: Change in patient-reported global visual analogue scale (VAS) from baseline to week 52
timeFrame: 52 weeks
measure: Change in polymyalgia rheumatica activity score (PMR-AS) from baseline to week 52
timeFrame: 52 weeks
measure: Proportion of patients with an undiagnosed vasculitis assessed by ultrasound at week 52 Proportion of patients with an undiagnosed vasculitis assessed by ultrasound at week 52
timeFrame: 52 weeks
measure: Changes in short form (SF)-36 mental component summary (MCS) from baseline to week 52
timeFrame: 52 weeks
measure: Changes in short form (SF)-36 physical component summary (PCS) from baseline to week 52
timeFrame: 52 weeks
measure: Changes in health assessment questionnaire disability index (HAQ-DI) from baseline to week 52
timeFrame: 52 weeks
measure: Changes in patient reported polymyalgia rheumatica visual analog scale (PMR VAS) from baseline to week 52
timeFrame: 52 weeks
measure: Changes in patient reported fatigue visal analog scale (VAS) from baseline to week 52
timeFrame: 52 weeks
measure: Changes in patient reported stiffness visual analog scale (VAS) from baseline to week 52
timeFrame: 52 weeks
measure: Changes in patient reported duration of morning stiffness from baseline to week 52
timeFrame: 52 weeks
measure: Proportion of patients where baseline DXA scan are performed during the first 3 months after baseline visit
timeFrame: 3 months
measure: Proportion of patients where HgbA1C blood samples are taken during the first 52 weeks
timeFrame: 52 weeks
measure: Frequency of patient reported adverse effects and comorbidities related to prednisolone treatment after 13, 26, 39 and 52 weeks
timeFrame: 52 weeks
measure: Proportion of patients with patient reported infections during the first 52 weeks
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Aalborg University Hospital
city: Aarhus
country: Denmark
facility: Aarhus University Hospital, Department of Rheumatology
city: Herning
country: Denmark
facility: Gødstrup Regional Hospital
city: Hjørring
country: Denmark
facility: Hjørring Regional Hospital
city: Horsens
country: Denmark
facility: Horsens Regional Hospital
city: Silkeborg
country: Denmark
facility: Silkeborg Regional Hospital
Study officials:
affiliation: Aarhus University Hospital
name: Kresten Keller
role: PRINCIPAL_INVESTIGATOR
References: