National database for Giant Cell Arteritis and Polymyalgia Rheumatica
Disease Stratification in GCA and PMR to Inform Management and Reduce Disease and Treatment-related Damage
University of Aarhus · NCT05935709
This study is trying to see how new imaging techniques can help doctors better manage Giant Cell Arteritis and Polymyalgia Rheumatica by looking at treatment responses and risks in patients.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 3000 (estimated) |
| Ages | 50 Years and up |
| Sex | All |
| Sponsor | University of Aarhus (other) |
| Locations | 2 sites (Aarhus and 1 other locations) |
| Trial ID | NCT05935709 on ClinicalTrials.gov |
What this trial studies
This observational study aims to establish a national database to investigate the impact of new diagnostic imaging techniques on the management of Giant Cell Arteritis (GCA) and Polymyalgia Rheumatica (PMR). It will compare treatment responses, relapse risks, and complications among patients diagnosed with these conditions. The study will utilize the RedCap database to document clinical data and imaging results, facilitating future research projects. By exploring clinical practices and biomarkers, the study seeks to improve disease control and reduce treatment-related damage.
Who should consider this trial
Good fit: Ideal candidates are individuals diagnosed with GCA or PMR within the last five years who can provide informed consent and speak Danish.
Not a fit: Patients with other systemic autoimmune diseases that preclude a diagnosis of GCA or PMR will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management strategies for patients with GCA and PMR, enhancing treatment outcomes and reducing complications.
How similar studies have performed: While limited research has been conducted on GCA and PMR, the establishment of large registries has shown promise in similar contexts, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Where this trial is running
Aarhus and 1 other locations
- Led og Bindevævssygdomme, Aarhus University Hospital — Aarhus, Denmark (RECRUITING)
- Medicinsk klinik 2, Regionshospitalet Horsens — Horsens, Denmark (RECRUITING)
Study contacts
- Principal investigator: Berit Dalsgaard Nielsen, Ass prof — Led og Bindevæv, Aarhus University Hospital, Palle Juul-Jensens Boulevard 59, 8200 Aarhus N, DK
- Study coordinator: Agnete Overgaard Donskov, MD
- Email: agnead@rm.dk
- Phone: +4530225709
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Giant Cell Arteritis, Polymyalgia Rheumatica