Giant Cell ArteritisNCT07084480
Giant Cell Arteritis - Ways to Precision Medicine
An observational study of Giant Cell Arteritis and Polymyalgia Rheumatic (PMR), run by Wuerzburg University Hospital at 1 site in Germany.
Trial summary
Long-term follow-up of aortal adverse events, as well as glucocortioid-associated adverse events in patients with polymyalgia rheumatica (PMR) and giant cell arteritis (GCA). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Giant Cell Arteritis, Polymyalgia Rheumatic (PMR)
- How many people
- 400 participants
- Where
- 1 siteGermany
- Study dates
- 14 Nov 2025to 31 Jul 2033
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: GCA and PMR patients will be recruited in the department of rheumatology of the university hospital of Würzburg
Who may be able to join
- Age greater or similar to 18 years
- Primary diagnosis of GCA or PMR
Who cannot join
- Age under 18 years
- lack of capacity to consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Riesenzellarteriitis - Wege Zur "Precision Medicine"
Long-term follow-up of aortal adverse events, as well as glucocortioid-associated adverse events in patients with polymyalgia rheumatica (PMR) and giant cell arteritis (GCA).
Read the detailed description
In this non-interventional cohort study the following aspects should be addressed:
- Can regular imaging procedures help to better assess the risk of aortic aneurysms and dissections over a period of 5-10 years after initial diagnosis of GCA?
- Which prognostic factors correlate with aortic events?
- What conclusions can be drawn about glucocorticoid-associated side effects over the longer (5-year) course?
- Can modern imaging in correlation with standardized clinical examination, serological markers and immunophenotypic testing define patient clusters within the clinically heterogeneous disease spectrum of GCA and PMR with the aim of individualizing therapy?
- What is the value of orbital MRI together with an ophthalmologic examination including fudoscopy and optical coherence tomography (OCT) in the detection of ischemic manifestations of GCA?
- Can a contrast agent-saving MRI technique (with 25 % less contrast agent) be used in GCA without impairing signal quality?
- Can rare lymphocyte populations be found by immunophenotyping, which provide information on the probability of recurrence or allow therapy control?
- Conditions
- Giant Cell Arteritis, Polymyalgia Rheumatic (PMR)
- Keywords
- non-interventional cohort study, aortic dilatation, innate lymhoid cells, optic coherence tomography, MRI
- Medical subject headings
- Giant Cell Arteritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Known patients | Patients, who are already known and had regular visits in the outpatient rheumatology department of the Würzburg university hospital. These patients already receive immunosuppressive therapy. | |
| New patients | Patients who have not yet been treated by the outpatient rheumatology department of the Würzburg university hospital, preferably but not limited to immunosuppressive therapy-naive patients. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of aortic adverse events
Aortic adverse events include new foramation or progress of aortic aneurysms, and aortic dissection
Measured: Within 5 years
Secondary outcomes (3)
Incidence of glucocorticoid-related adverse events
Assessment of the glucocorticoid toxicity index (GTI; excluding regular bone density measurements) to detect glucocorticoid-related adverse events.
The GIT includes 1) a cumulative worsening score, which includes the cumulative glucocorticoid toxicity over time (minimum value of 0 and a maximum value of 439, a decrease is not possible) and 2) an aggregate improvement score, which allows for decreases and increases of toxicity (range from -346 to 439, with negative values indicating improvement and positive values indicating worsening of glucocorticoid toxicity)
Measured: within 5 years
Detection of ischemic complications in the eyes
Is orbital MRI together with optic coherence tomography suitable to detect ischemic manifestations of GCA in the eye?
Measured: within 5 years
Performance of gadopiclenol in detecting vessel wall inflammation
The contrast agent gadopiclenol should be evaluated for its use in MR angiography, i.e. if it depicts (peri) vessel wall inflammation equally to older contrast agents. In a sub-cohort of 20 % of the patients , MR angiographies will be performed with 25% reduced gadoplicenol.
Measured: within 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2025
- Study start14 Nov 2025
- Primary completion31 Jul 2030 (estimated)
- Study completion31 Jul 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wuerzburg University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Gernert, Principal investigator, Wuerzburg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07084480
- Sponsor's protocol ID
- Riesenzellarteriitis-Register
- Status last verified
- Jul 2025
- First submitted
- 16 Jul 2025
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: single center study
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Riesenzellarteriitis - Wege Zur "Precision Medicine"
- ClinicalTrials.gov ID
- NCT07084480
- Acronym / sponsor ID
- Riesenzellarteriitis-Register
- Conditions
- Giant Cell Arteritis, Polymyalgia Rheumatic (PMR)
- Keywords
- non-interventional cohort study, aortic dilatation, innate lymhoid cells, optic coherence tomography, MRI
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Wuerzburg University HospitalUniversity, hospital or other
- Study start
- 14 Nov 2025 (actual)
- Primary completion
- 31 Jul 2030 (estimated)
- Study completion
- 31 Jul 2033 (estimated)
- First posted
- 24 Jul 2025 (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.
Long-term follow-up of aortal adverse events, as well as glucocortioid-associated adverse events in patients with polymyalgia rheumatica (PMR) and giant cell arteritis (GCA).
Detailed description
In this non-interventional cohort study the following aspects should be addressed:
- Can regular imaging procedures help to better assess the risk of aortic aneurysms and dissections over a period of 5-10 years after initial diagnosis of GCA?
- Which prognostic factors correlate with aortic events?
- What conclusions can be drawn about glucocorticoid-associated side effects over the longer (5-year) course?
- Can modern imaging in correlation with standardized clinical examination, serological markers and immunophenotypic testing define patient clusters within the clinically heterogeneous disease spectrum of GCA and PMR with the aim of individualizing therapy?
- What is the value of orbital MRI together with an ophthalmologic examination including fudoscopy and optical coherence tomography (OCT) in the detection of ischemic manifestations of GCA?
- Can a contrast agent-saving MRI technique (with 25 % less contrast agent) be used in GCA without impairing signal quality?
- Can rare lymphocyte populations be found by immunophenotyping, which provide information on the probability of recurrence or allow therapy control?
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Known patients | – | –Patients, who are already known and had regular visits in the outpatient rheumatology department of the Würzburg university hospital. These patients already receive immunosuppressive therapy. |
| New patients | – | –Patients who have not yet been treated by the outpatient rheumatology department of the Würzburg university hospital, preferably but not limited to immunosuppressive therapy-naive patients. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- GCA and PMR patients will be recruited in the department of rheumatology of the university hospital of Würzburg
Key inclusion criteria (2 listed)
- Age greater or similar to 18 years
- Primary diagnosis of GCA or PMR
Key exclusion criteria (2 listed)
- Age under 18 years
- lack of capacity to consent
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
Incidence of aortic adverse events
Time frame: Within 5 years
Aortic adverse events include new foramation or progress of aortic aneurysms, and aortic dissection
3 secondary outcomes
Incidence of glucocorticoid-related adverse events
Time frame: within 5 years
Detection of ischemic complications in the eyes
Time frame: within 5 years
Performance of gadopiclenol in detecting vessel wall inflammation
Time frame: within 5 years
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 22 Dec 2025.
- Individual participant dataSharing planned: No. single center study
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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.
Michael Gernert principal investigator
Wuerzburg University Hospital
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 Giant Cell Arteritis and Polymyalgia Rheumatic (PMR), run by Wuerzburg University Hospital at 1 site in Germany.
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 2 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 22 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 1 site in Germany. 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 Michael Gernert (+4993120140100, gernert_m1@ukw.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of aortic adverse events (time frame: Within 5 years). 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 22 Dec 2025.