NCT00744952

Brief Summary

Assessing disease activity in people with Takayasu's arteritis is difficult, as most people with the disease do not exhibit visible, measurable symptoms. Combination positron emission tomography/computed axial tomography (PET/CT) is a particularly sensitive, accurate scanning method that may improve researchers' ability to evaluate people with the disease. This study will determine the effectiveness of PET/CT in assessing disease activity in people with Takayasu's arteritis.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
26

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2008

Longer than P75 for all trials

Geographic Reach
2 countries

5 active sites

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

Study Start

First participant enrolled

August 1, 2008

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

August 29, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 1, 2008

Completed
10.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2018

Completed
Last Updated

October 19, 2018

Status Verified

October 1, 2018

Enrollment Period

10.2 years

First QC Date

August 29, 2008

Last Update Submit

October 18, 2018

Conditions

Takayasu Arteritis

Keywords

Large-vessel vasculitis

Outcome Measures

Primary Outcomes (1)

  • Disease activity

    Measured throughout the study

Eligibility Criteria

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

Participants in this study will have been diagnosed with Takayasu's arteritis and will be currently enrolled in the Vasculitis Clinical Research Consortium (VCRC) Longitudinal Study #5503.

You may qualify if:

  • Diagnosis of Takayasu's arteritis, as defined by the VCRC Longitudinal Study #5503
  • Currently enrolled in the VCRC Longitudinal Study #5503
  • Active disease has occurred in conjunction with a disease relapse within 2 weeks before study entry (A detailed definition of "active disease" is available in the study protocol.)
  • Willing and able to comply with the schedule for imaging studies and follow-up procedures

You may not qualify if:

  • Pregnant or breastfeeding
  • Unable to comply with study guidelines
  • Unable to safely undergo MRI scanning

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Boston University School of Medicine

Boston, Massachusetts, 02118, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

St. Joseph's Healthcare

Hamilton, Ontario, Canada

Location

Mount Sinai Hospital, Toronto

Toronto, Ontario, M5L 3L9, Canada

Location

Related Publications (5)

  • Numano F. The story of Takayasu arteritis. Rheumatology (Oxford). 2002 Jan;41(1):103-6. doi: 10.1093/rheumatology/41.1.103. No abstract available.

    PMID: 11792888BACKGROUND

  • Stone JH, Hoffman GS, Merkel PA, Min YI, Uhlfelder ML, Hellmann DB, Specks U, Allen NB, Davis JC, Spiera RF, Calabrese LH, Wigley FM, Maiden N, Valente RM, Niles JL, Fye KH, McCune JW, St Clair EW, Luqmani RA; International Network for the Study of the Systemic Vasculitides (INSSYS). A disease-specific activity index for Wegener's granulomatosis: modification of the Birmingham Vasculitis Activity Score. International Network for the Study of the Systemic Vasculitides (INSSYS). Arthritis Rheum. 2001 Apr;44(4):912-20. doi: 10.1002/1529-0131(200104)44:43.0.CO;2-5.

    PMID: 11318006BACKGROUND

  • Weyand CM, Goronzy JJ. Medium- and large-vessel vasculitis. N Engl J Med. 2003 Jul 10;349(2):160-9. doi: 10.1056/NEJMra022694. No abstract available.

    PMID: 12853590BACKGROUND

  • Tso E, Flamm SD, White RD, Schvartzman PR, Mascha E, Hoffman GS. Takayasu arteritis: utility and limitations of magnetic resonance imaging in diagnosis and treatment. Arthritis Rheum. 2002 Jun;46(6):1634-42. doi: 10.1002/art.10251.

    PMID: 12115196BACKGROUND

  • Hoffman GS, Merkel PA, Brasington RD, Lenschow DJ, Liang P. Anti-tumor necrosis factor therapy in patients with difficult to treat Takayasu arteritis. Arthritis Rheum. 2004 Jul;50(7):2296-304. doi: 10.1002/art.20300.

    PMID: 15248230BACKGROUND

Related Links

MeSH Terms

Conditions

Takayasu Arteritis

Condition Hierarchy (Ancestors)

Aortic Arch SyndromesAortic DiseasesVascular DiseasesCardiovascular DiseasesArteritisVasculitisSkin Diseases, VascularSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Peter A. Merkel, MD, MPH

    University of Pennsylvania

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 29, 2008

First Posted

September 1, 2008

Study Start

August 1, 2008

Primary Completion

September 30, 2018

Study Completion

September 30, 2018

Last Updated

October 19, 2018

Record last verified: 2018-10

Locations

US(3)CA(2)