NCT05248906

Brief Summary

Giant cell arteritis - Optimization of diagnostics

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 3, 2020

Completed
5 months until next milestone

Study Start

First participant enrolled

March 19, 2021

Completed
11 months until next milestone

First Posted

Study publicly available on registry

February 21, 2022

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2024

Completed
Last Updated

April 2, 2025

Status Verified

February 1, 2022

Enrollment Period

2.8 years

First QC Date

November 3, 2020

Last Update Submit

March 27, 2025

Conditions

Giant Cell Arteritis

Keywords

Temporal artery biopsy,Giant cell arteritisUltrasound18F-FDG PET/CT

Outcome Measures

Primary Outcomes (1)

  • Giant cell arteritis

    Clinical verification of giant cell arteritis diagnosis as evaluated with a combination of ultrasound, biopsy and PET/CT.

    Week 26

Interventions

Giant cell arteritisDIAGNOSTIC_TEST

Ultrasound 18F-fluorodeoxyglucose (18F-FDG) Positron Emission Tomography Temporal artery biopsy

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Clinical suspicion of giant cell arteritis

You may qualify if:

  • Clinical suspicion of giant cell arteritis
  • Meets the American College of Rheumatology Criteria:
  • Age at disease onset =\> 50 years New headache Temporal artery abnormality Elevated erythrocyte sedimentation rate \>=50 mm/hour Abnomal artery biopsy

You may not qualify if:

  • Active cancer Use of steroid for more than a week (the prior 6 months)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rigshospitalet

Copenhagen, Denmark

Location

Related Publications (1)

  • Klefter ON, Hansen MS, Lykkebirk L, Subhi Y, Brittain JM, Jensen MR, Dohn UM, Fana V, Wiencke AK, Heegaard S, Terslev L, Hamann S. Combining Paracentral Acute Middle Maculopathy and Peripapillary Fluid as Biomarkers in Anterior Ischemic Optic Neuropathy. Am J Ophthalmol. 2025 Mar;271:329-336. doi: 10.1016/j.ajo.2024.12.001. Epub 2024 Dec 6.

    PMID: 39645178DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples for DNA analysis will be collected.

MeSH Terms

Conditions

Giant Cell Arteritis

Condition Hierarchy (Ancestors)

Vasculitis, Central Nervous SystemAutoimmune Diseases of the Nervous SystemNervous System DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesVascular DiseasesCardiovascular DiseasesArteritisVasculitisSkin Diseases, VascularSkin DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Steffen Hamann, MD, PhD,FEBO

    Rigshospitalet, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 3, 2020

First Posted

February 21, 2022

Study Start

March 19, 2021

Primary Completion

January 1, 2024

Study Completion

January 1, 2024

Last Updated

April 2, 2025

Record last verified: 2022-02

Locations

DK(1)