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

Primary Purpose

Polymyalgia Rheumatica

Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Treat-to-target Prednisolone Taper
Usual care
Sponsored by
Aarhus University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Polymyalgia Rheumatica

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Aalborg University Hospital
  • Aarhus University Hospital, Department of RheumatologyRecruiting
  • Esbjerg Regional Hospital
  • Gødstrup Regional HospitalRecruiting
  • Hjørring Regional Hospital
  • Horsens Regional HospitalRecruiting
  • Randers Regional HospitalRecruiting
  • Silkeborg Regional HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Treat-to-target Prednisolone Taper

Usual Care

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Proportion of patients in prednisolone free remission 52 weeks from baseline
Proportion of patients in prednisolone free remission 52 weeks from baseline

Secondary Outcome Measures

Change in prednisolone dose from baseline to week 52
Change in prednisolone dose from baseline to week 52. Key secondary.
Proportion of GCA patients diagnosed during the first 52 weeks
Proportion of GCA patients diagnosed during the first 52 weeks. Key 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
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
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
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
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
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
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
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
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
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
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
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
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
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.
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.

Full Information

First Posted
November 10, 2022
Last Updated
January 31, 2023
Sponsor
Aarhus University Hospital
Collaborators
Randers Regional Hospital, Horsens Hospital, Regionshospitalet Silkeborg, Herning Hospital, North Denmark Regional Hospital, Aalborg University Hospital, Hospital of South West Jutland, Frederiksberg University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05636501
Brief Title
Treat-to-target Prednisolon Taper in Patients With Polymyalgia Rheumatica
Official Title
Dose Reduction and Discontinuation of Prednisolone Using Structured Treat-to-target Taper in Patients With Polymyalgia Rheumatica
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 12, 2023 (Actual)
Primary Completion Date
November 2025 (Anticipated)
Study Completion Date
November 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aarhus University Hospital
Collaborators
Randers Regional Hospital, Horsens Hospital, Regionshospitalet Silkeborg, Herning Hospital, North Denmark Regional Hospital, Aalborg University Hospital, Hospital of South West Jutland, Frederiksberg University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polymyalgia Rheumatica

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treat-to-target Prednisolone Taper
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Usual Care
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Treat-to-target Prednisolone Taper
Intervention Description
Systematic prednisolone taper
Intervention Type
Other
Intervention Name(s)
Usual care
Intervention Description
Prednisolone taper performed by discretion of the patient's general practitioner.
Primary Outcome Measure Information:
Title
Proportion of patients in prednisolone free remission 52 weeks from baseline
Description
Proportion of patients in prednisolone free remission 52 weeks from baseline
Time Frame
52 weeks
Secondary Outcome Measure Information:
Title
Change in prednisolone dose from baseline to week 52
Description
Change in prednisolone dose from baseline to week 52. Key secondary.
Time Frame
52 weeks
Title
Proportion of GCA patients diagnosed during the first 52 weeks
Description
Proportion of GCA patients diagnosed during the first 52 weeks. Key secondary
Time Frame
52 weeks
Title
Self-reported number of relapses during the first 52 weeks
Description
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
Title
Change in patient-reported global visual analogue scale (VAS) from baseline to week 52
Description
Change in patient-reported global VAS from baseline to week 52. Scale 0-10, 10 is worse. Key secondary
Time Frame
52 weeks
Title
Change in polymyalgia rheumatica activity score (PMR-AS) from baseline to week 52
Description
Change in PMR-AS from baseline to week 52. scale 0-indefinitely. High score is worse. Secondary
Time Frame
52 weeks
Title
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
Description
Proportion of patients with an undiagnosed vasculitis assessed by ultrasound at week 52. Secondary
Time Frame
52 weeks
Title
Changes in short form (SF)-36 mental component summary (MCS) from baseline to week 52
Description
Changes in SF-36 MCS from baseline to week 52. Secondary
Time Frame
52 weeks
Title
Changes in short form (SF)-36 physical component summary (PCS) from baseline to week 52
Description
Changes in SF-36 PCS from baseline to week 52. Secondary
Time Frame
52 weeks
Title
Changes in health assessment questionnaire disability index (HAQ-DI) from baseline to week 52
Description
Changes in HAQ-DI from baseline to week 52. High score is worse. Secondary
Time Frame
52 weeks
Title
Changes in patient reported polymyalgia rheumatica visual analog scale (PMR VAS) from baseline to week 52
Description
Changes in patient reported PMR VAS from baseline to week 52. High score is worse. Secondary
Time Frame
52 weeks
Title
Changes in patient reported fatigue visal analog scale (VAS) from baseline to week 52
Description
Changes in patient reported fatigue VAS from baseline to week 52. Higher is worse. Secondary
Time Frame
52 weeks
Title
Changes in patient reported stiffness visual analog scale (VAS) from baseline to week 52
Description
Changes in patient reported stiffness VAS from baseline to week 52. Higher is worse. Secondary
Time Frame
52 weeks
Title
Changes in patient reported duration of morning stiffness from baseline to week 52
Description
Changes in patient reported duration of morning stiffness from baseline to week 52. Secondary
Time Frame
52 weeks
Title
Proportion of patients where baseline DXA scan are performed during the first 3 months after baseline visit
Description
Proportion of patients where baseline DXA scan are performed during the first 3 months after baseline visit. Secondary
Time Frame
3 months
Title
Proportion of patients where HgbA1C blood samples are taken during the first 52 weeks
Description
Proportion of patients where HgbA1C blood samples are taken during the first 52 weeks. Secondary
Time Frame
52 weeks
Title
Frequency of patient reported adverse effects and comorbidities related to prednisolone treatment after 13, 26, 39 and 52 weeks
Description
Frequency of patient reported adverse effects and comorbidities related to prednisolone treatment after 13, 26, 39 and 52 weeks. Secondary.
Time Frame
52 weeks
Title
Proportion of patients with patient reported infections during the first 52 weeks
Description
Proportion of patients with patient reported infections during the first 52 weeks. Secondary.
Time Frame
52 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kresten Keller, MD, PhD
Phone
+45 40384984
Email
krekel@rm.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kresten Keller
Organizational Affiliation
Aarhus University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aalborg University Hospital
City
Aalborg
Country
Denmark
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Salome Kristensen
Facility Name
Aarhus University Hospital, Department of Rheumatology
City
Aarhus
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kresten Keller
Phone
40384984
Email
krekel@rm.dk
Facility Name
Esbjerg Regional Hospital
City
Esbjerg
Country
Denmark
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stavros Chrysidis
Facility Name
Gødstrup Regional Hospital
City
Herning
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Line Moll
Facility Name
Hjørring Regional Hospital
City
Hjørring
Country
Denmark
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lone Hansen
Facility Name
Horsens Regional Hospital
City
Horsens
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Berit Nielsen
Facility Name
Randers Regional Hospital
City
Randers
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sidsel Aabo
Facility Name
Silkeborg Regional Hospital
City
Silkeborg
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jesper Blegvad Nissen

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

Learn more about this trial

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

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