Polymyalgia RheumaticaNCT02985424
Polymyalgia Rheumatica and Giant Cell Arteritis
An observational study of Polymyalgia Rheumatica and Giant Cell Arteritis, run by Svendborg Hospital at 1 site in Denmark.
Trial summary
The purpose of this study is to delineate the association of the 18F-Fluorodeoxyglucose Positron Emission Tomography/Computed Tomography (18F-FDG PET/CT) detected vasculitis pattern of the large vessels (PET positivity) and the clinical picture of Polymyalgia Rheumatica (PMR)/Giant Cell Arteritis (GCA) . Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Polymyalgia Rheumatica, Giant Cell Arteritis
- What is being tested?
- 18F-FDG PET/CT
- How many people
- 80 participants
- Where
- 1 siteDenmark
- Study dates
- May 2017to Feb 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All new patients with clinical suspicion of PMR/GCA.
Who may be able to join
- At least five (A-E) components of the PMR diagnostic criteria, including:
- A. Age ≥50 years,
- B. Bilateral shoulder or hip pain,
- C. Morning stiffness lasting >45 min,
- D. Elevated erythrocyte sedimentation rate (ESR),
- E. Elevated C-reactive protein (CRP),
- F. Disease duration >2weeks, should be met to suspect PMR.
- For GCA following criteria's must be seen: Age > 50 years, ESR/CRP > 50, as well as at least two symptoms related to vasculitis (scalp tenderness, vision disturbances, headache (new or changed), jaw claudication, tenderness of the temporal arteria) if patients do not simultaneously have PMR. If the patient is suspected for PMR, one cranial symptom is enough to suspect GCA.
Who cannot join
- Dementia
- Inability to communicate in Danish
- Infections or malignancy when prednisolone is permanently unsuitable
- Contraindication to imaging studies (allergy to contrast materials, reduced kidney function, pregnancy and Blood Sugar (BS) >8 mmol/l after 6 hours fasting)
- Initiation of steroid treatment before the PET scan
- Inability to provide informed consent
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Rheumatology, Odense University Hospital, Svendborg Hospital
Svendborg, 5700
Inger Marie Jensen Hansen, PhD, DMSci, +45 63202506, inger.marie.jensen.hansen@rsyd.dk
About this study
Official title: Polymyalgia Rheumatica and Giant Cell Arteritis - Three Challenges - Consequences of the Vasculitis Process, Osteoporosis and Malignancy: A Prospective Cohort Study Protocol
The purpose of this study is to delineate the association of the 18F-Fluorodeoxyglucose Positron Emission Tomography/Computed Tomography (18F-FDG PET/CT) detected vasculitis pattern of the large vessels (PET positivity) and the clinical picture of Polymyalgia Rheumatica (PMR)/Giant Cell Arteritis (GCA) .
Read the detailed description
Introduction:
Polymyalgia Rheumatica (PMR) and Giant Cell Arteritis (GCA) are common inflammatory conditions. The diagnosis of PMR/GCA poses many challenges since there are no specific diagnostic tests. Recent literature emphasizes the ability of 18F-Fluorodeoxyglucose Positron Emission Tomography/Computed Tomography (18F-FDG PET/CT) to assess global disease activity and/or inflammation burden. 18F-FDG PET/CT may lead to make diagnosis at an earlier stage than conventional imaging and assess response to therapy. With respect to the management of PMR/GCA, there are three significant areas of concern as follows: Vasculitis process/vascular stiffness, malignancy and osteoporosis.
Methods and Analysis:
Patients: All patients with the suspicion of PMR/GCR will be offered to participate in the study. The current protocol consists of 4 separate studies including: I) The association of clinical picture of PMR/GCA with PET detected vasculitis II) Evaluating validity of 18F-FDG PET/CT scan for diagnosis of PMR/GCA compared to temporal artery biopsy III) Incidence of new diagnosed malignancies in patients with PMR/GCA, or PMR like syndrome with the aim of PET/CT scan and Chest X ray/Abdominal ultrasound IV) Impact of disease process as well as steroid treatment on bone mineral density, body composition and vasculitis/vascular stiffness in PMR/GCA patients.
- Conditions
- Polymyalgia Rheumatica, Giant Cell Arteritis
- Being tested
- 18F-FDG PET/CT
- Medical subject headings
- Polymyalgia Rheumatica, Giant Cell Arteritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-FDG PET/CTOther
18F-Fluorodeoxyglucose Positron Emission Tomography/Computed Tomography
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulated prednisolone dose within the first year after treatment initiation in patients with and without vasculitis in the large vessels
Measured: One year
Secondary outcomes (23)
Patient reported global visual analogue scale (VAS) in patients with vasculitis in the large vessels (positive PET)
Patient global assessment of disease severity as measured on a visual analogue scale (VAS) that ranges from 0 to 100, in patients with vasculitis in the large vessels detected by PET scan
Measured: One year
Physician reported visual analogue scale (VAS) in patients with vasculitis in the large vessels (positive PET)
Physician assessment of disease severity as measured on a visual analogue scale (VAS) that ranges from 0 to 100 in patients with vasculitis in the large vessels detected by PET scan.
Measured: One year
Patient reported pain in patients with vasculitis in the large vessels (positive PET)
Patient assessment of pain intensity as measured on a visual analogue scale (VAS) that ranges from 0 to 100, in patients with vasculitis in the large vessels detected by PET scan
Measured: One year
Morning stiffness (minute) in patients with vasculitis in the large vessels (positive PET)
Measured: One year
Biochemistry results in patients with vasculitis in the large vessels (positive PET)
ESR, CRP and fibrinogen
Measured: One year
Number of relapses in patients with vasculitis in the large vessels (positive PET)
Measured: One year
Proportion of PET positivity (vasculitis in the large vessels as well as findings compatible with PMR) in patients with temporal artery biopsy positive.
Measured: One year
Proportion of PET negativity (no signs of vasculitis in the large vessels) in patients with temporal artery biopsy negative.
Measured: One year
Incidence of malignancies in the included patients detected by the aim of 18F-FDG PET/CT scan.
Measured: One year
Incidence of malignancies in the included patients detected by the aim of Chest X Ray plus abdominal Ultrasound.
Measured: One year
Impact of disease process and steroid treatment on Aortic Pulse Wave Velocity (PWV)
Measured: One year
Impact of disease process and steroid treatment on upper limb PWV
Measured: One year
Impact of disease process and steroid treatment on Aortic augmentation index
Measured: One year
Impact of disease process and steroid treatment on Body Mass Index
Measured: One year
Impact of disease process and steroid treatment on T score
Measured: One year
Impact of disease process and steroid treatment on Z score
Measured: One year
Impact of disease process and steroid treatment on Lean Body Mass
Measured: One year
Impact of disease process and steroid treatment on Fat Mass
Measured: One year
Impact of disease process and steroid treatment on Bone Mineral Density
Measured: One year
Impact of disease process and steroid treatment on Bone Mineral Content
Measured: One year
Impact of disease process and steroid treatment on Fat Free Mass
Measured: One year
Impact of disease process and steroid treatment on Fat Free Mass Index
Measured: One year
Impact of disease process and steroid treatment on Fat Mass Index
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2016 (estimated)
- Study startMay 2017 (estimated)
- Primary completionFeb 2018 (estimated)
- Study completionFeb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Polymyalgia RheumaticaStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Svendborg Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Odense University Hospital
- Responsible party
- Principal investigator, Amir Emamifar, Svendborg Hospital
- Investigators
- Inger Marie Jensen Hansen, Phd, DMSci, Study chair, Department of Rheumatology, Odense University Hospital, Svendborg Hospital, Svendborg, Denmark.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02985424
- Sponsor's protocol ID
- S-20160098
- Other IDs
- 16/40522
- Status last verified
- Apr 2017
- First submitted
- 1 Dec 2016
- Last updated
- 25 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Emamifar A, Hess S, Ellingsen T, Gerke O, Ahangarani Farahani Z, Syrak Hansen P, Jensen Hansen IM, Thye-Ronn P. Clinical presentation and treatment response in patients with polymyalgia rheumatica and giant cell arteritis during a 40-week follow-up. Rheumatol Adv Pract. 2021 Nov 24;5(3):rkab091. doi: 10.1093/rap/rkab091. eCollection 2021.
PubMed 34909566
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Polymyalgia Rheumatica and Giant Cell Arteritis - Three Challenges - Consequences of the Vasculitis Process, Osteoporosis and Malignancy: A Prospective Cohort Study Protocol
- ClinicalTrials.gov ID
- NCT02985424
- Acronym / sponsor ID
- S-20160098
- Conditions
- Polymyalgia Rheumatica, Giant Cell Arteritis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Svendborg HospitalUniversity, hospital or other
- Collaborators
- Odense University Hospital
- Study start
- May 2017 (estimated)
- Primary completion
- Feb 2018 (estimated)
- Study completion
- Feb 2020 (estimated)
- First posted
- 7 Dec 2016 (estimated)
- 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.
The purpose of this study is to delineate the association of the 18F-Fluorodeoxyglucose Positron Emission Tomography/Computed Tomography (18F-FDG PET/CT) detected vasculitis pattern of the large vessels (PET positivity) and the clinical picture of Polymyalgia Rheumatica (PMR)/Giant Cell Arteritis (GCA) .
Detailed description
Introduction:
Polymyalgia Rheumatica (PMR) and Giant Cell Arteritis (GCA) are common inflammatory conditions. The diagnosis of PMR/GCA poses many challenges since there are no specific diagnostic tests. Recent literature emphasizes the ability of 18F-Fluorodeoxyglucose Positron Emission Tomography/Computed Tomography (18F-FDG PET/CT) to assess global disease activity and/or inflammation burden. 18F-FDG PET/CT may lead to make diagnosis at an earlier stage than conventional imaging and assess response to therapy. With respect to the management of PMR/GCA, there are three significant areas of concern as follows: Vasculitis process/vascular stiffness, malignancy and osteoporosis.
Methods and Analysis:
Patients: All patients with the suspicion of PMR/GCR will be offered to participate in the study. The current protocol consists of 4 separate studies including: I) The association of clinical picture of PMR/GCA with PET detected vasculitis II) Evaluating validity of 18F-FDG PET/CT scan for diagnosis of PMR/GCA compared to temporal artery biopsy III) Incidence of new diagnosed malignancies in patients with PMR/GCA, or PMR like syndrome with the aim of PET/CT scan and Chest X ray/Abdominal ultrasound IV) Impact of disease process as well as steroid treatment on bone mineral density, body composition and vasculitis/vascular stiffness in PMR/GCA patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All new patients with clinical suspicion of PMR/GCA.
Key inclusion criteria (8 listed)
- At least five (A-E) components of the PMR diagnostic criteria, including:
- For GCA following criteria's must be seen: Age > 50 years, ESR/CRP > 50, as well as at least two symptoms related to vasculitis (scalp tenderness, vision disturbances, headache (new or changed), jaw claudication, tenderness of the temporal arteria) if patients do not simultaneously have PMR. If the patient is suspected for PMR, one cranial symptom is enough to suspect GCA.
Key exclusion criteria (6 listed)
- Dementia
- Inability to communicate in Danish
- Infections or malignancy when prednisolone is permanently unsuitable
- Contraindication to imaging studies (allergy to contrast materials, reduced kidney function, pregnancy and Blood Sugar (BS) >8 mmol/l after 6 hours fasting)
- Initiation of steroid treatment before the PET scan
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 |
|---|---|---|
| 18F-FDG PET/CT18F-Fluorodeoxyglucose Positron Emission Tomography/Computed Tomography | Other | – |
Primary outcome
Cumulated prednisolone dose within the first year after treatment initiation in patients with and without vasculitis in the large vessels
Time frame: One year
23 secondary outcomes
Patient reported global visual analogue scale (VAS) in patients with vasculitis in the large vessels (positive PET)
Time frame: One year
Physician reported visual analogue scale (VAS) in patients with vasculitis in the large vessels (positive PET)
Time frame: One year
Patient reported pain in patients with vasculitis in the large vessels (positive PET)
Time frame: One year
Morning stiffness (minute) in patients with vasculitis in the large vessels (positive PET)
Time frame: One year
Biochemistry results in patients with vasculitis in the large vessels (positive PET)
Time frame: One year
Number of relapses in patients with vasculitis in the large vessels (positive PET)
Time frame: One year
Proportion of PET positivity (vasculitis in the large vessels as well as findings compatible with PMR) in patients with temporal artery biopsy positive.
Time frame: One year
Proportion of PET negativity (no signs of vasculitis in the large vessels) in patients with temporal artery biopsy negative.
Time frame: One year
Incidence of malignancies in the included patients detected by the aim of 18F-FDG PET/CT scan.
Time frame: One year
Incidence of malignancies in the included patients detected by the aim of Chest X Ray plus abdominal Ultrasound.
Time frame: One year
Impact of disease process and steroid treatment on Aortic Pulse Wave Velocity (PWV)
Time frame: One year
Impact of disease process and steroid treatment on upper limb PWV
Time frame: One year
Impact of disease process and steroid treatment on Aortic augmentation index
Time frame: One year
Impact of disease process and steroid treatment on Body Mass Index
Time frame: One year
Impact of disease process and steroid treatment on T score
Time frame: One year
Impact of disease process and steroid treatment on Z score
Time frame: One year
Impact of disease process and steroid treatment on Lean Body Mass
Time frame: One year
Impact of disease process and steroid treatment on Fat Mass
Time frame: One year
Impact of disease process and steroid treatment on Bone Mineral Density
Time frame: One year
Impact of disease process and steroid treatment on Bone Mineral Content
Time frame: One year
Impact of disease process and steroid treatment on Fat Free Mass
Time frame: One year
Impact of disease process and steroid treatment on Fat Free Mass Index
Time frame: One year
Impact of disease process and steroid treatment on Fat Mass Index
Time frame: One year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2017.
- Derived from this study: PubMed 34909566Emamifar A, Hess S, Ellingsen T, Gerke O, Ahangarani Farahani Z, Syrak Hansen P, Jensen Hansen IM, Thye-Ronn P. Clinical presentation and treatment response in patients with polymyalgia rheumatica and giant cell arteritis during a 40-week follow-up. Rheumatol Adv Pract. 2021 Nov 24;5(3):rkab091. doi: 10.1093/rap/rkab091. eCollection 2021.
- Individual participant dataSharing planned: No
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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.
Inger Marie Jensen Hansen, Phd, DMSci study chair
Department of Rheumatology, Odense University Hospital, Svendborg Hospital, Svendborg, Denmark.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Polymyalgia Rheumatica and Giant Cell Arteritis, run by Svendborg Hospital at 1 site 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 8 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 25 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amir Emamifar, MD (+45 71399718, amir.emamifar@rsyd.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulated prednisolone dose within the first year after treatment initiation in patients with and without vasculitis in the large vessels (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02985424, which also lists 1 linked publication.
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 25 Apr 2017.