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

N/AActive Not RecruitingNCT05636501

Aarhus University Hospital120 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

120

Conditions

Polymyalgia Rheumatica

Interventions

Eligibility

Sex: ALLMin age: 50 Years

Medical Language ↔ Plain English

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)

Locations (6)

Aalborg University Hospital

Aalborg, Denmark

Aarhus University Hospital, Department of Rheumatology

Aarhus, Denmark

Gødstrup Regional Hospital

Herning, Denmark

Hjørring Regional Hospital

Hjørring, Denmark

Horsens Regional Hospital

Horsens, Denmark

Silkeborg Regional Hospital

Silkeborg, Denmark

Outcomes

Primary Outcomes

Proportion of patients in prednisolone free remission 52 weeks from baseline

Time frame: 52 weeks

Secondary Outcomes

Change in prednisolone dose from baseline to week 52

Change in prednisolone dose from baseline to week 52. Key secondary.

Time frame: 52 weeks

Proportion of GCA patients diagnosed during the first 52 weeks

Proportion of GCA patients diagnosed during the first 52 weeks. Key secondary

Time frame: 52 weeks

Self-reported number of relapses during the first 52 weeks

Self-reported number of relapses during the first 52 weeks (assessed by increase in symptoms and an increase in prednisolone dosage). Key secondary

Time frame: 52 weeks

Change in patient-reported global visual analogue scale (VAS) from baseline to week 52

Change in patient-reported global VAS from baseline to week 52. Scale 0-10, 10 is worse. Key secondary

Time frame: 52 weeks

Change in polymyalgia rheumatica activity score (PMR-AS) from baseline to week 52

Change in PMR-AS from baseline to week 52. scale 0-indefinitely. High score is worse. Secondary

Time frame: 52 weeks

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

Proportion of patients with an undiagnosed vasculitis assessed by ultrasound at week 52. Secondary

Time frame: 52 weeks

Changes in short form (SF)-36 mental component summary (MCS) from baseline to week 52

Changes in SF-36 MCS from baseline to week 52. Secondary

Time frame: 52 weeks

Changes in short form (SF)-36 physical component summary (PCS) from baseline to week 52

Changes in SF-36 PCS from baseline to week 52. Secondary

Time frame: 52 weeks

Changes in health assessment questionnaire disability index (HAQ-DI) from baseline to week 52

Changes in HAQ-DI from baseline to week 52. High score is worse. Secondary

Time frame: 52 weeks

Changes in patient reported polymyalgia rheumatica visual analog scale (PMR VAS) from baseline to week 52

Changes in patient reported PMR VAS from baseline to week 52. High score is worse. Secondary

Time frame: 52 weeks

Changes in patient reported fatigue visal analog scale (VAS) from baseline to week 52

Changes in patient reported fatigue VAS from baseline to week 52. Higher is worse. Secondary

Time frame: 52 weeks

Changes in patient reported stiffness visual analog scale (VAS) from baseline to week 52

Changes in patient reported stiffness VAS from baseline to week 52. Higher is worse. Secondary

Time frame: 52 weeks

Changes in patient reported duration of morning stiffness from baseline to week 52

Changes in patient reported duration of morning stiffness from baseline to week 52. Secondary

Time frame: 52 weeks

Proportion of patients where baseline DXA scan are performed during the first 3 months after baseline visit

Proportion of patients where baseline DXA scan are performed during the first 3 months after baseline visit. Secondary

Time frame: 3 months

Proportion of patients where HgbA1C blood samples are taken during the first 52 weeks

Proportion of patients where HgbA1C blood samples are taken during the first 52 weeks. Secondary

Time frame: 52 weeks

Frequency of patient reported adverse effects and comorbidities related to prednisolone treatment after 13, 26, 39 and 52 weeks

Frequency of patient reported adverse effects and comorbidities related to prednisolone treatment after 13, 26, 39 and 52 weeks. Secondary.

Time frame: 52 weeks

Proportion of patients with patient reported infections during the first 52 weeks

Proportion of patients with patient reported infections during the first 52 weeks. Secondary.

Time frame: 52 weeks