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

December 12, 2025 updated by: Kresten Krarup Keller, Aarhus University Hospital

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

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Kresten Keller, MD, PhD
  • Phone Number: +45 40384984
  • Email: krekel@rm.dk

Study Locations

  • Denmark
      • Aalborg, Denmark
        • Aalborg University Hospital
      • Aarhus, Denmark
        • Aarhus University Hospital, Department of Rheumatology
      • Herning, Denmark
        • Gødstrup Regional Hospital
      • Hjørring, Denmark
        • Hjørring Regional Hospital
      • Horsens, Denmark
        • Horsens Regional Hospital
      • Silkeborg, Denmark
        • Silkeborg Regional Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: 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.
Other: Treat-to-target Prednisolone Taper
Systematic prednisolone taper
Placebo Comparator: 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.
Other: Usual care
Prednisolone taper performed by discretion of the patient's general practitioner.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Proportion of patients in prednisolone free remission 52 weeks from baseline
Time Frame: 52 weeks
Proportion of patients in prednisolone free remission 52 weeks from baseline
52 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in prednisolone dose from baseline to week 52
Time Frame: 52 weeks
Change in prednisolone dose from baseline to week 52. Key secondary.
52 weeks
Proportion of GCA patients diagnosed during the first 52 weeks
Time Frame: 52 weeks
Proportion of GCA patients diagnosed during the first 52 weeks. Key secondary
52 weeks
Self-reported number of relapses during the first 52 weeks
Time Frame: 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
Change in patient-reported global visual analogue scale (VAS) from baseline to week 52
Time Frame: 52 weeks
Change in patient-reported global VAS from baseline to week 52. Scale 0-10, 10 is worse. Key secondary
52 weeks
Change in polymyalgia rheumatica activity score (PMR-AS) from baseline to week 52
Time Frame: 52 weeks
Change in PMR-AS from baseline to week 52. scale 0-indefinitely. High score is worse. Secondary
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
Time Frame: 52 weeks
Proportion of patients with an undiagnosed vasculitis assessed by ultrasound at week 52. Secondary
52 weeks
Changes in short form (SF)-36 mental component summary (MCS) from baseline to week 52
Time Frame: 52 weeks
Changes in SF-36 MCS from baseline to week 52. Secondary
52 weeks
Changes in short form (SF)-36 physical component summary (PCS) from baseline to week 52
Time Frame: 52 weeks
Changes in SF-36 PCS from baseline to week 52. Secondary
52 weeks
Changes in health assessment questionnaire disability index (HAQ-DI) from baseline to week 52
Time Frame: 52 weeks
Changes in HAQ-DI from baseline to week 52. High score is worse. Secondary
52 weeks
Changes in patient reported polymyalgia rheumatica visual analog scale (PMR VAS) from baseline to week 52
Time Frame: 52 weeks
Changes in patient reported PMR VAS from baseline to week 52. High score is worse. Secondary
52 weeks
Changes in patient reported fatigue visal analog scale (VAS) from baseline to week 52
Time Frame: 52 weeks
Changes in patient reported fatigue VAS from baseline to week 52. Higher is worse. Secondary
52 weeks
Changes in patient reported stiffness visual analog scale (VAS) from baseline to week 52
Time Frame: 52 weeks
Changes in patient reported stiffness VAS from baseline to week 52. Higher is worse. Secondary
52 weeks
Changes in patient reported duration of morning stiffness from baseline to week 52
Time Frame: 52 weeks
Changes in patient reported duration of morning stiffness from baseline to week 52. Secondary
52 weeks
Proportion of patients where baseline DXA scan are performed during the first 3 months after baseline visit
Time Frame: 3 months
Proportion of patients where baseline DXA scan are performed during the first 3 months after baseline visit. Secondary
3 months
Proportion of patients where HgbA1C blood samples are taken during the first 52 weeks
Time Frame: 52 weeks
Proportion of patients where HgbA1C blood samples are taken during the first 52 weeks. Secondary
52 weeks
Frequency of patient reported adverse effects and comorbidities related to prednisolone treatment after 13, 26, 39 and 52 weeks
Time Frame: 52 weeks
Frequency of patient reported adverse effects and comorbidities related to prednisolone treatment after 13, 26, 39 and 52 weeks. Secondary.
52 weeks
Proportion of patients with patient reported infections during the first 52 weeks
Time Frame: 52 weeks
Proportion of patients with patient reported infections during the first 52 weeks. Secondary.
52 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Aarhus University Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Frederiksberg University Hospital
Aalborg University Hospital
Gødstrup Hospital
Horsens Hospital
Regionshospitalet Silkeborg
Regionshospital Nordjylland

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Kresten Keller, Aarhus University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 12, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 9, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 10, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 1, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 5, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 18, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 12, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • T2T PMR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All IPD that underlie results in the publications

IPD Sharing Time Frame

Starting 6 months after publication, and 2 years.

IPD Sharing Access Criteria

By resonably request.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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