Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
In this non-interventional cohort study the following aspects should be addressed:
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of aortic adverse events | Aortic adverse events include new foramation or progress of aortic aneurysms, and aortic dissection | Within 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
GCA and PMR patients will be recruited in the department of rheumatology of the university hospital of Würzburg
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michael Gernert | Contact | +4993120140100 | gernert_m1@ukw.de | |
| Hannah Labinsky | Contact | +4993120140100 | Labinsky_h@ukw.de |
| Name | Affiliation | Role |
|---|---|---|
| Michael Gernert | Wuerzburg University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitätsklinikum Würzburg | Recruiting | Würzburg | Germany |
single center study
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D013700 | Giant Cell Arteritis |
| ID | Term |
|---|---|
| D020293 | Vasculitis, Central Nervous System |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D002561 | Cerebrovascular Disorders |
Not provided
Not provided
Not provided
Not provided
Not provided
| 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? | 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. | within 5 years |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001167 | Arteritis |
| D014657 | Vasculitis |
| D017445 | Skin Diseases, Vascular |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |