Polymyalgia RheumaticaNCT05636501
Treat-to-target Prednisolon Taper in Patients With Polymyalgia Rheumatica
A study testing Treat-to-target Prednisolone Taper in people with Polymyalgia Rheumatica, run by Aarhus University Hospital at 6 sites in Denmark.
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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Polymyalgia Rheumatica
- What is being tested?
- Treat-to-target Prednisolone Taper
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 6 sitesDenmark
- Study dates
- 12 Jan 2023to Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Denmark6 sites
Aalborg University Hospital
Aalborg
Aarhus University Hospital, Department of Rheumatology
Aarhus
Gødstrup Regional Hospital
Herning
Hjørring Regional Hospital
Hjørring
Horsens Regional Hospital
Horsens
Silkeborg Regional Hospital
Silkeborg
About this study
Official title: 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.
- Conditions
- Polymyalgia Rheumatica
- Being tested
- Treat-to-target Prednisolone Taper, Usual care
- Medical subject headings
- Polymyalgia Rheumatica
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treat-to-target Prednisolone TaperOther
Systematic prednisolone taper
Usual careOther
Prednisolone taper performed by discretion of the patient's general practitioner.
| Study group | Role | What they receive |
|---|---|---|
| Treat-to-target Prednisolone Taper | Active comparator | 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. Receives: Other: Treat-to-target Prednisolone Taper |
| Usual Care | Placebo comparator | 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. Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients in prednisolone free remission 52 weeks from baseline
Proportion of patients in prednisolone free remission 52 weeks from baseline
Measured: 52 weeks
Secondary outcomes (17)
Change in prednisolone dose from baseline to week 52
Change in prednisolone dose from baseline to week 52. Key secondary.
Measured: 52 weeks
Proportion of GCA patients diagnosed during the first 52 weeks
Proportion of GCA patients diagnosed during the first 52 weeks. Key secondary
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2022
- Study start12 Jan 2023
- Primary completion9 Oct 2025
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polymyalgia RheumaticaStudies of the same condition, open and under way.
- More trials run by Aarhus University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Horsens Hospital, Regionshospitalet Silkeborg, Gødstrup Hospital, Regionshospital Nordjylland, Aalborg University Hospital, Frederiksberg University Hospital
- Responsible party
- Principal investigator, Kresten Krarup Keller, Aarhus University Hospital
- Investigators
- Kresten Keller, Principal investigator, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05636501
- Sponsor's protocol ID
- T2T PMR
- Status last verified
- Oct 2025
- First submitted
- 10 Nov 2022
- Last updated
- 18 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in the publications
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose Reduction and Discontinuation of Prednisolone Using Structured Treat-to-target Taper in Patients With Polymyalgia Rheumatica
- ClinicalTrials.gov ID
- NCT05636501
- Acronym / sponsor ID
- T2T PMR
- Conditions
- Polymyalgia Rheumatica
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Collaborators
- Horsens Hospital, Regionshospitalet Silkeborg, Gødstrup Hospital, Regionshospital Nordjylland, Aalborg University Hospital, Frederiksberg University Hospital
- Study start
- 12 Jan 2023 (actual)
- Primary completion
- 9 Oct 2025 (actual)
- Study completion
- Nov 2026 (estimated)
- First posted
- 5 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treat-to-target Prednisolone Taper | Active comparator | Other: Treat-to-target Prednisolone TaperPatients 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. |
| Usual Care | Placebo comparator | Other: Usual carePatients 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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treat-to-target Prednisolone TaperSystematic prednisolone taper | Other | Treat-to-target Prednisolone Taper |
| Usual carePrednisolone taper performed by discretion of the patient's general practitioner. | Other | Usual Care |
Primary outcome
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
17 secondary outcomes
Change in prednisolone dose from baseline to week 52
Time frame: 52 weeks
Proportion of GCA patients diagnosed during the first 52 weeks
Time frame: 52 weeks
Self-reported number of relapses during the first 52 weeks
Time frame: 52 weeks
Change in patient-reported global visual analogue scale (VAS) from baseline to week 52
Time frame: 52 weeks
Change in polymyalgia rheumatica activity score (PMR-AS) from baseline to week 52
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
Time frame: 52 weeks
Changes in short form (SF)-36 mental component summary (MCS) from baseline to week 52
Time frame: 52 weeks
Changes in short form (SF)-36 physical component summary (PCS) from baseline to week 52
Time frame: 52 weeks
Changes in health assessment questionnaire disability index (HAQ-DI) from baseline to week 52
Time frame: 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 fatigue visal analog scale (VAS) from baseline to week 52
Time frame: 52 weeks
Changes in patient reported stiffness visual analog scale (VAS) from baseline to week 52
Time frame: 52 weeks
Changes in patient reported duration of morning stiffness from baseline to week 52
Time frame: 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 HgbA1C blood samples are taken during the first 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
Time frame: 52 weeks
Proportion of patients with patient reported infections during the first 52 weeks
Time frame: 52 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2025.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in the publications
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kresten Keller principal investigator
Aarhus University Hospital
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treat-to-target Prednisolone Taper in people with Polymyalgia Rheumatica, run by Aarhus University Hospital at 6 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients in prednisolone free remission 52 weeks from baseline (time frame: 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2025.