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

NCT ID: NCT05636501

Last Updated: 2025-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-12

Study Completion Date

2026-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Polymyalgia Rheumatica

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treat-to-target Prednisolone Taper

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.

Group Type ACTIVE_COMPARATOR

Treat-to-target Prednisolone Taper

Intervention Type OTHER

Systematic prednisolone taper

Usual Care

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.

Group Type PLACEBO_COMPARATOR

Usual care

Intervention Type OTHER

Prednisolone taper performed by discretion of the patient's general practitioner.

Interventions

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Treat-to-target Prednisolone Taper

Systematic prednisolone taper

Intervention Type OTHER

Usual care

Prednisolone taper performed by discretion of the patient's general practitioner.

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Horsens Hospital

OTHER

Sponsor Role collaborator

Regionshospitalet Silkeborg

OTHER

Sponsor Role collaborator

Gødstrup Hospital

OTHER

Sponsor Role collaborator

Regionshospital Nordjylland

OTHER_GOV

Sponsor Role collaborator

Aalborg University Hospital

OTHER

Sponsor Role collaborator

Frederiksberg University Hospital

OTHER

Sponsor Role collaborator

Aarhus University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Kresten Krarup Keller

MD associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kresten Keller

Role: PRINCIPAL_INVESTIGATOR

Aarhus University Hospital

Locations

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Aalborg University Hospital

Aalborg, , Denmark

Site Status

Aarhus University Hospital, Department of Rheumatology

Aarhus, , Denmark

Site Status

Gødstrup Regional Hospital

Herning, , Denmark

Site Status

Hjørring Regional Hospital

Hjørring, , Denmark

Site Status

Horsens Regional Hospital

Horsens, , Denmark

Site Status

Silkeborg Regional Hospital

Silkeborg, , Denmark

Site Status

Countries

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Denmark

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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T2T PMR

Identifier Type: -

Identifier Source: org_study_id