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

Polymyalgia Rheumatica Clinical Trial

Official title:

Dose Reduction and Discontinuation of Prednisolone Using Structured Treat-to-target Taper in Patients With Polymyalgia Rheumatica

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05636501
• Other study ID #: T2T PMR
• Status: Recruiting
• Phase: N/A
• Start date: January 12, 2023
• Est. completion date: November 2026

Study information

• Verified date: January 2023
• Source: Aarhus University Hospital
• Contact: Kresten Keller, MD, PhD
• Phone: +45 40384984
• Email: krekel[@]rm.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: November 2026
• Est. primary completion date: November 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Giant Cell Arteritis
• Polymyalgia Rheumatica

Intervention

Other:
• Treat-to-target Prednisolone Taper
Systematic prednisolone taper
• Usual care
Prednisolone taper performed by discretion of the patient's general practitioner.

Locations

Country	Name	City	State
Denmark	Aalborg University Hospital	Aalborg
Denmark	Aarhus University Hospital, Department of Rheumatology	Aarhus
Denmark	Esbjerg Regional Hospital	Esbjerg
Denmark	Gødstrup Regional Hospital	Herning
Denmark	Hjørring Regional Hospital	Hjørring
Denmark	Horsens Regional Hospital	Horsens
Denmark	Randers Regional Hospital	Randers
Denmark	Silkeborg Regional Hospital	Silkeborg

Sponsors (9)

Lead Sponsor	Collaborator
Aarhus University Hospital	Aalborg University Hospital, Frederiksberg University Hospital, Herning Hospital, Horsens Hospital, Hospital of South West Jutland, North Denmark Regional Hospital, Randers Regional Hospital, Regionshospitalet Silkeborg

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients in prednisolone free remission 52 weeks from baseline	Proportion of patients in prednisolone free remission 52 weeks from baseline	52 weeks
Secondary	Change in prednisolone dose from baseline to week 52	Change in prednisolone dose from baseline to week 52. Key secondary.	52 weeks
Secondary	Proportion of GCA patients diagnosed during the first 52 weeks	Proportion of GCA patients diagnosed during the first 52 weeks. Key secondary	52 weeks
Secondary	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	52 weeks
Secondary	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	52 weeks
Secondary	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	52 weeks
Secondary	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	52 weeks
Secondary	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	52 weeks
Secondary	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	52 weeks
Secondary	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	52 weeks
Secondary	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	52 weeks
Secondary	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	52 weeks
Secondary	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	52 weeks
Secondary	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	52 weeks
Secondary	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	3 months
Secondary	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	52 weeks
Secondary	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.	52 weeks
Secondary	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.	52 weeks