NCT05935709

Brief Summary

The aim of this national pragmatic observational study is to investigate whether the use of new diagnostic imaging modalities facilitates disease stratification that can potentially predict treatment response, relapse risk and complications and hence guide management strategies to improve disease control and reduce disease and treatment related damage.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
3,000

participants targeted

Target at P75+ for all trials

Timeline
313mo left

Started Nov 2023

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

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

Study Progress9%
Nov 2023Dec 2051

First Submitted

Initial submission to the registry

June 1, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 7, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

November 10, 2023

Completed
11.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2034

Expected
17 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2051

Last Updated

January 24, 2024

Status Verified

April 1, 2023

Enrollment Period

11.1 years

First QC Date

June 1, 2023

Last Update Submit

January 22, 2024

Conditions

Giant Cell ArteritisPolymyalgia Rheumatica

Outcome Measures

Primary Outcomes (1)

  • Cumulative glucocorticoid doses compared between patients with cranial GCA and patients with Large Vessel-GCA

    based on redeemed prescriptions

    From date of diagnosis with GCA until one year after. Assessed yearly up to 120 months

Secondary Outcomes (3)

  • Comparison of cumulative glucocorticoid doses in patients with pure PMR compared to PMR with subclinical LV-GCA

    From date of diagnosis with PMR until one year after. Assessed yearly up to 120 months

  • Incidence of aortic dilatation in patients with c-GCA as compared to LV-GCA

    2 years after diagnosis

  • Risk of aortic complications (aneurisms and dissections) in GCA patients with aortic involvement as compared to patients without aortic involvement.

    2 years after diagnosis

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients can be included at any time during the disease course. Patients will be registered as either incident (newly diagnosed within the last 3 months) or prevalent (included during routine follow-up \> 3 months after diagnosis) cases.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Led og Bindevævssygdomme, Aarhus University Hospital

Aarhus, 8200, Denmark

RECRUITING

Medicinsk klinik 2, Regionshospitalet Horsens

Horsens, 8700, Denmark

RECRUITING

Related Publications (1)

  • Nielsen BD, Kristensen S, Donskov A, Terslev L, Dreyer LW, Colic A, Hetland ML, Hojgaard P, Ellingsen T, Hauge EM, Chrysidis S, Keller KK. The DANIsh VASculitis cohort study: protocol for a national multicenter prospective study including incident and prevalent patients with giant cell arteritis and polymyalgia rheumatica. Front Med (Lausanne). 2024 Jul 3;11:1415076. doi: 10.3389/fmed.2024.1415076. eCollection 2024.

    PMID: 39026552DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

blood samples

MeSH Terms

Conditions

Giant Cell ArteritisPolymyalgia Rheumatica

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 DiseasesMuscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue Diseases

Study Officials

  • Berit Dalsgaard Nielsen, Ass prof

    Led og Bindevæv, Aarhus University Hospital, Palle Juul-Jensens Boulevard 59, 8200 Aarhus N, DK

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Agnete Overgaard Donskov, MD

CONTACT

+4530225709agnead@rm.dk

Kresten Krarup Keller, Ass prof

CONTACT

kreskell@rm.dk

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 1, 2023

First Posted

July 7, 2023

Study Start

November 10, 2023

Primary Completion (Estimated)

December 31, 2034

Study Completion (Estimated)

December 31, 2051

Last Updated

January 24, 2024

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

DK(2)