NCT02985424

Brief Summary

The purpose of this study is to delineate the association of the 18F-Fluorodeoxyglucose Positron Emission Tomography/Computed Tomography (18F-FDG PET/CT) detected vasculitis pattern of the large vessels (PET positivity) and the clinical picture of Polymyalgia Rheumatica (PMR)/Giant Cell Arteritis (GCA) .

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

December 1, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 7, 2016

Completed
5 months until next milestone

Study Start

First participant enrolled

May 1, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2020

Completed
Last Updated

April 25, 2017

Status Verified

April 1, 2017

Enrollment Period

9 months

First QC Date

December 1, 2016

Last Update Submit

April 24, 2017

Conditions

Polymyalgia RheumaticaGiant Cell Arteritis

Outcome Measures

Primary Outcomes (1)

  • Cumulated prednisolone dose within the first year after treatment initiation in patients with and without vasculitis in the large vessels

    One year

Secondary Outcomes (23)

  • Patient reported global visual analogue scale (VAS) in patients with vasculitis in the large vessels (positive PET)

    One year

  • Physician reported visual analogue scale (VAS) in patients with vasculitis in the large vessels (positive PET)

    One year

  • Patient reported pain in patients with vasculitis in the large vessels (positive PET)

    One year

  • Morning stiffness (minute) in patients with vasculitis in the large vessels (positive PET)

    One year

  • Biochemistry results in patients with vasculitis in the large vessels (positive PET)

    One year

  • +18 more secondary outcomes

Interventions

18F-FDG PET/CTOTHER

18F-Fluorodeoxyglucose Positron Emission Tomography/Computed Tomography

Eligibility Criteria

Age18 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All new patients with clinical suspicion of PMR/GCA.

You may qualify if:

  • At least five (A-E) components of the PMR diagnostic criteria, including:
  • A. Age ≥50 years,
  • B. Bilateral shoulder or hip pain,
  • C. Morning stiffness lasting \>45 min,
  • D. Elevated erythrocyte sedimentation rate (ESR),
  • E. Elevated C-reactive protein (CRP),
  • F. Disease duration \>2weeks, should be met to suspect PMR.
  • For GCA following criteria's must be seen: Age \> 50 years, ESR/CRP \> 50, as well as at least two symptoms related to vasculitis (scalp tenderness, vision disturbances, headache (new or changed), jaw claudication, tenderness of the temporal arteria) if patients do not simultaneously have PMR. If the patient is suspected for PMR, one cranial symptom is enough to suspect GCA.

You may not qualify if:

  • Dementia
  • Inability to communicate in Danish
  • Infections or malignancy when prednisolone is permanently unsuitable
  • Contraindication to imaging studies (allergy to contrast materials, reduced kidney function, pregnancy and Blood Sugar (BS) \>8 mmol/l after 6 hours fasting)
  • Initiation of steroid treatment before the PET scan
  • Inability to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Rheumatology, Odense University Hospital, Svendborg Hospital

Svendborg, 5700, Denmark

Location

Related Publications (1)

  • Emamifar A, Hess S, Ellingsen T, Gerke O, Ahangarani Farahani Z, Syrak Hansen P, Jensen Hansen IM, Thye-Ronn P. Clinical presentation and treatment response in patients with polymyalgia rheumatica and giant cell arteritis during a 40-week follow-up. Rheumatol Adv Pract. 2021 Nov 24;5(3):rkab091. doi: 10.1093/rap/rkab091. eCollection 2021.

    PMID: 34909566DERIVED

MeSH Terms

Conditions

Polymyalgia RheumaticaGiant Cell Arteritis

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesVasculitis, Central Nervous SystemAutoimmune Diseases of the Nervous SystemNervous System DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesVascular DiseasesCardiovascular DiseasesArteritisVasculitisSkin Diseases, VascularSkin DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Inger Marie Jensen Hansen, Phd, DMSci

    Department of Rheumatology, Odense University Hospital, Svendborg Hospital, Svendborg, Denmark.

    STUDY CHAIR

Central Study Contacts

Amir Emamifar, MD

CONTACT

+45 71399718amir.emamifar@rsyd.dk

Inger Marie Jensen Hansen, PhD, DMSci

CONTACT

+45 63202506inger.marie.jensen.hansen@rsyd.dk

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor of Medicine

Study Record Dates

First Submitted

December 1, 2016

First Posted

December 7, 2016

Study Start

May 1, 2017

Primary Completion

February 1, 2018

Study Completion

February 1, 2020

Last Updated

April 25, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)