Giant Cell ArteritisDANIVASNCT05935709
DANIsh VASculitis Database (DANIVAS)
An observational study of Giant Cell Arteritis and Polymyalgia Rheumatica, run by Aarhus University Hospital at 2 sites in Denmark.
Trial summary
The aim of this national pragmatic observational study is to investigate whether the use of new diagnostic imaging modalities facilitates disease stratification that can potentially predict treatment response, relapse risk and complications and hence guide management strategies to improve disease control and reduce… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Giant Cell Arteritis, Polymyalgia Rheumatica
- How many people
- 3,000 participants
- Where
- 2 sitesDenmark
- Study dates
- 10 Nov 2023to 31 Dec 2051
- How long will I take part?
- 10 Years
- Phase
- Observational
- 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
Study population: Patients can be included at any time during the disease course. Patients will be registered as either incident (newly diagnosed within the last 3 months) or prevalent (included during routine follow-up > 3 months after diagnosis) cases.
Who may be able to join
- Are diagnosed with GCA or PMR within the last 5 years
- Diagnosis is established by or confirmed by a rheumatologist (clinical expert opinion)
- Speak and understand Danish
- Are able to give signed and dated informed consent
Who cannot join
- Denies or are not able to give informed consent
- Are diagnosed with other systemic autoimmune diseases that out-rules the diagnosis of GCA or PMR
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Kresten Krarup Keller, Ass prof contact
Denmark2 sites, 2 recruiting
- Recruiting
Led og Bindevævssygdomme, Aarhus University Hospital
Aarhus, 8200
Kresten Krarup Keller, Ass Prof
- Recruiting
Medicinsk klinik 2, Regionshospitalet Horsens
Horsens, 8700
Berit Dalsgaard Nielsen, Ass Prof
About this study
Official title: Disease Stratification in GCA and PMR to Inform Management and Reduce Disease and Treatment-related Damage
The aim of this national pragmatic observational study is to investigate whether the use of new diagnostic imaging modalities facilitates disease stratification that can potentially predict treatment response, relapse risk and complications and hence guide management strategies to improve disease control and reduce disease and treatment related damage.
Read the detailed description
BACKGROUND Giant cell arteritis (GCA) is the most common vasculitis of the elderly. The concomitant disease polymyalgia rheumatica (PMR) is characterised by pain of the proximal muscles, general symptoms, and raised inflammatory markers. Only limited research has previously been performed nationally and internationally in GCA and PMR. To explore clinical practice, biomarkers, disease subsets, comorbidities, and long-term effectiveness of new treatments the establishment of large registries are highly warranted.
OBJECTIVES Primary objective: To compare cumulative GC doses in patients with c-GCA as compared to Large vessel (LV) -GCA
Key secondary objectives:
- To compare cumulative GC doses in patients with pure PMR compared to PMR patients with subclinical LV-GCA
- To compare the incidence of aortic dilatation 2 years after diagnosis in patients with c-GCA as compared to LV-GCA
- In the subpopulation of patients whom a diagnostic Fluor-Deoxy-Glucose Positron Emissions Tomography ( FDG- PET)/CT was performed, to evaluate the risk of aortic complications (aneurisms and dissections) in GCA patients with aortic involvement as compared to patients without aortic involvement.
Once the database is established nationally, the database will be the basis for additional research projects in the future.
METHODS Using RedCap database infrastructure, clinical data including imaging will be documented in the individual Case Report Form developed by the project steering group.
The study population can be enrolled at any point during disease course and registered as either incidents ( up until 3 months from diagnosis) or prevalent. The treatment and follow up will be performed according to the National Danish GCA and PMR guidelines. At some of the visits data entry to the database will be performed: Enrollment visit, response visit(after 2 months), routine visit(after 6 months for incident patients and every year following), screening visit(2 years after diagnosis) and withdrawal visits. The aim is to include all rheumatic departments in Denmark.
Data audit to secure a high completeness will be performed regularly by a project manager the first two years and thereafter by a datamanager. Linkage of data across nationwide medical and administrative registries at the individual level will be performed. Blood samples will be collected by the infrastructure of the clinical biobank Danish ReumaBiobank (DRB).
- Conditions
- Giant Cell Arteritis, Polymyalgia Rheumatica
- Medical subject headings
- Giant Cell Arteritis, Polymyalgia Rheumatica
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative glucocorticoid doses compared between patients with cranial GCA and patients with Large Vessel-GCA
based on redeemed prescriptions
Measured: From date of diagnosis with GCA until one year after. Assessed yearly up to 120 months
Secondary outcomes (3)
Comparison of cumulative glucocorticoid doses in patients with pure PMR compared to PMR with subclinical LV-GCA
based on redeemed prescriptions
Measured: From date of diagnosis with PMR until one year after. Assessed yearly up to 120 months
Incidence of aortic dilatation in patients with c-GCA as compared to LV-GCA
Aortic dilatation is defined as diameters above the 90th percentile of the respective aortic region.The angiography can be performed as either CT or MR angiography and will be performed according to local set-up and imaging acquisition protocols.
Measured: 2 years after diagnosis
Risk of aortic complications (aneurisms and dissections) in GCA patients with aortic involvement as compared to patients without aortic involvement.
The PET/CT scan at diagnosis compared to scan at year 2
Measured: 2 years after diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2023
- Study start10 Nov 2023
- Primary completion31 Dec 2034 (estimated)
- Study completion31 Dec 2051 (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 Giant Cell ArteritisStudies 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
- 3,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Regionshospitalet Horsens, Aalborg University Hospital, Odense University Hospital, Esbjerg Hospital - University Hospital of Southern Denmark, Holbaek Sygehus, Copenhagen University Hospital, Rigshospitalet, Zealand University Hospital
- Responsible party
- Sponsor
- Investigators
- Berit Dalsgaard Nielsen, Ass prof, Principal investigator, Led og Bindevæv, Aarhus University Hospital, Palle Juul-Jensens Boulevard 59, 8200 Aarhus N, DK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05935709
- Sponsor's protocol ID
- DANIVAS
- Acronym
- DANIVAS
- Status last verified
- Apr 2023
- First submitted
- 1 Jun 2023
- Last updated
- 24 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nielsen BD, Kristensen S, Donskov A, Terslev L, Dreyer LW, Colic A, Hetland ML, Hojgaard P, Ellingsen T, Hauge EM, Chrysidis S, Keller KK. The DANIsh VASculitis cohort study: protocol for a national multicenter prospective study including incident and prevalent patients with giant cell arteritis and polymyalgia rheumatica. Front Med (Lausanne). 2024 Jul 3;11:1415076. doi: 10.3389/fmed.2024.1415076. eCollection 2024.
PubMed 39026552
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Disease Stratification in GCA and PMR to Inform Management and Reduce Disease and Treatment-related Damage
- ClinicalTrials.gov ID
- NCT05935709
- Acronym / sponsor ID
- DANIVAS / DANIVAS
- Conditions
- Giant Cell Arteritis, Polymyalgia Rheumatica
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Collaborators
- Regionshospitalet Horsens, Aalborg University Hospital, Odense University Hospital, Esbjerg Hospital - University Hospital of Southern Denmark, Holbaek Sygehus, Copenhagen University Hospital, Rigshospitalet, Zealand University Hospital
- Study start
- 10 Nov 2023 (actual)
- Primary completion
- 31 Dec 2034 (estimated)
- Study completion
- 31 Dec 2051 (estimated)
- First posted
- 7 Jul 2023 (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.
The aim of this national pragmatic observational study is to investigate whether the use of new diagnostic imaging modalities facilitates disease stratification that can potentially predict treatment response, relapse risk and complications and hence guide management strategies to improve disease control and reduce disease and treatment related damage.
Detailed description
BACKGROUND Giant cell arteritis (GCA) is the most common vasculitis of the elderly. The concomitant disease polymyalgia rheumatica (PMR) is characterised by pain of the proximal muscles, general symptoms, and raised inflammatory markers. Only limited research has previously been performed nationally and internationally in GCA and PMR. To explore clinical practice, biomarkers, disease subsets, comorbidities, and long-term effectiveness of new treatments the establishment of large registries are highly warranted.
OBJECTIVES Primary objective: To compare cumulative GC doses in patients with c-GCA as compared to Large vessel (LV) -GCA
Key secondary objectives:
- To compare cumulative GC doses in patients with pure PMR compared to PMR patients with subclinical LV-GCA
- To compare the incidence of aortic dilatation 2 years after diagnosis in patients with c-GCA as compared to LV-GCA
- In the subpopulation of patients whom a diagnostic Fluor-Deoxy-Glucose Positron Emissions Tomography ( FDG- PET)/CT was performed, to evaluate the risk of aortic complications (aneurisms and dissections) in GCA patients with aortic involvement as compared to patients without aortic involvement.
Once the database is established nationally, the database will be the basis for additional research projects in the future.
METHODS Using RedCap database infrastructure, clinical data including imaging will be documented in the individual Case Report Form developed by the project steering group.
The study population can be enrolled at any point during disease course and registered as either incidents ( up until 3 months from diagnosis) or prevalent. The treatment and follow up will be performed according to the National Danish GCA and PMR guidelines. At some of the visits data entry to the database will be performed: Enrollment visit, response visit(after 2 months), routine visit(after 6 months for incident patients and every year following), screening visit(2 years after diagnosis) and withdrawal visits. The aim is to include all rheumatic departments in Denmark.
Data audit to secure a high completeness will be performed regularly by a project manager the first two years and thereafter by a datamanager. Linkage of data across nationwide medical and administrative registries at the individual level will be performed. Blood samples will be collected by the infrastructure of the clinical biobank Danish ReumaBiobank (DRB).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients can be included at any time during the disease course. Patients will be registered as either incident (newly diagnosed within the last 3 months) or prevalent (included during routine follow-up > 3 months after diagnosis) cases.
Key inclusion criteria (4 listed)
- Are diagnosed with GCA or PMR within the last 5 years
- Diagnosis is established by or confirmed by a rheumatologist (clinical expert opinion)
- Speak and understand Danish
- Are able to give signed and dated informed consent
Key exclusion criteria (2 listed)
- Denies or are not able to give informed consent
- Are diagnosed with other systemic autoimmune diseases that out-rules the diagnosis of GCA or PMR
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cumulative glucocorticoid doses compared between patients with cranial GCA and patients with Large Vessel-GCA
Time frame: From date of diagnosis with GCA until one year after. Assessed yearly up to 120 months
based on redeemed prescriptions
3 secondary outcomes
Comparison of cumulative glucocorticoid doses in patients with pure PMR compared to PMR with subclinical LV-GCA
Time frame: From date of diagnosis with PMR until one year after. Assessed yearly up to 120 months
Incidence of aortic dilatation in patients with c-GCA as compared to LV-GCA
Time frame: 2 years after diagnosis
Risk of aortic complications (aneurisms and dissections) in GCA patients with aortic involvement as compared to patients without aortic involvement.
Time frame: 2 years after diagnosis
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 24 Jan 2024.
- Derived from this study: PubMed 39026552Nielsen BD, Kristensen S, Donskov A, Terslev L, Dreyer LW, Colic A, Hetland ML, Hojgaard P, Ellingsen T, Hauge EM, Chrysidis S, Keller KK. The DANIsh VASculitis cohort study: protocol for a national multicenter prospective study including incident and prevalent patients with giant cell arteritis and polymyalgia rheumatica. Front Med (Lausanne). 2024 Jul 3;11:1415076. doi: 10.3389/fmed.2024.1415076. eCollection 2024.
- 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.
Kresten Krarup Keller, Ass prof contact
Berit Dalsgaard Nielsen, Ass prof principal investigator
Led og Bindevæv, Aarhus University Hospital, Palle Juul-Jensens Boulevard 59, 8200 Aarhus N, DK
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Giant Cell Arteritis and Polymyalgia Rheumatica, run by Aarhus University Hospital at 2 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 2 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: looking for participants now, as of the sponsor's last update on 24 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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. 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?
Contact Agnete Overgaard Donskov, MD (+4530225709, agnead@rm.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative glucocorticoid doses compared between patients with cranial GCA and patients with Large Vessel-GCA (time frame: From date of diagnosis with GCA until one year after. Assessed yearly up to 120 months). 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 NCT05935709, 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 24 Jan 2024.