Health TrialsbyHealthPanel

Giant Cell Arteritis - Ways to Precision Medicine

ConditionsGiant Cell ArteritisPolymyalgia Rheumatic (PMR)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorWuerzburg University Hospital

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age greater or similar to 18 years

Primary diagnosis of GCA or PMR

Disqualifiers

Age under 18 years

lack of capacity to consent

Trial population

GCA and PMR patients will be recruited in the department of rheumatology of the university hospital of Würzburg

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

400 Participants
are grouped into 2 trial groups
Group A: Known patients
Group B: New patients

Trial outcomes

Primary outcomes

1

Incidence of aortic adverse events

Aortic adverse events include new foramation or progress of aortic aneurysms, and aortic dissection

Time frame
Within 5 years

Secondary outcomes

1

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)

Time frame
within 5 years
2

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?

Time frame
within 5 years
3

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.

Time frame
within 5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Wuerzburg University Hospital

Lead sponsor

Source ClinicalTrials.gov
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