NCT00315497

Brief Summary

Giant cell arteritis (GCA), also known as temporal arteritis, is a disease that usually only occurs in older adults. GCA causes inflammation of blood vessels, or vasculitis. In order to properly treat this disease, it is critical that the level of disease activity can be determined over the course of the disease. The purpose of this study is to determine new biological markers, or biomarkers, that may be used to assess the severity of disease in people with GCA.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
426

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2006

Longer than P75 for all trials

Geographic Reach
2 countries

9 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

April 1, 2006

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

April 14, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 18, 2006

Completed
13.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

July 12, 2022

Status Verified

July 1, 2022

Enrollment Period

13.7 years

First QC Date

April 14, 2006

Last Update Submit

July 11, 2022

Conditions

Temporal Arteritis

Keywords

Giant Cell Arteritis

Outcome Measures

Primary Outcomes (1)

  • Discover biomarkers in Giant cell arteritis capable of measuring disease activity and response to treatment.

    Study completion

Secondary Outcomes (1)

  • Measure the predictive value of biomarkers for clinical outcome in Giant cell arteritis.

    Study completion.

Eligibility Criteria

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

Adults with giant cell arteritis. Enrollment will be sequential and participants will have disease in various stages and of different duration.

You may qualify if:

  • Diagnosis of GCA, meeting at least 3 of the following 5 American College of Rheumatology (ACR) criteria for the diagnosis of GCA:
  • At least 50 years of age at disease onset
  • New onset or new type of localized pain in the head
  • Temporal artery abnormality (i.e., temporal artery tenderness to palpation or decreased pulsation unrelated to arteriosclerosis of cervical arteries)
  • ESR of greater than 40 mm in the first hour by the Westergren method
  • Temporal artery biopsy showing vasculitis characterized by a predominance of mononuclear cell infiltration or granulomatous inflammation, usually with multinucleated giant cells

You may not qualify if:

  • Unable to give informed consent and sign the consent form

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Boston University School of Medicine

Boston, Massachusetts, 02118, United States

Location

Mayo Clinic College of Medicine

Rochester, Minnesota, 55905, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15222, United States

Location

University of Utah

Salt Lake City, Utah, 84122, United States

Location

St. Joseph's Healthcare

Hamilton, Ontario, Canada

Location

Mount Sinai Hospital

Toronto, Ontario, M5T 3L9, Canada

Location

Related Publications (4)

  • Gonzalez-Gay MA, Amoli MM, Garcia-Porrua C, Ollier WE. Genetic markers of disease susceptibility and severity in giant cell arteritis and polymyalgia rheumatica. Semin Arthritis Rheum. 2003 Aug;33(1):38-48. doi: 10.1053/sarh.2002.50025.

    PMID: 12920695BACKGROUND

  • Goronzy JJ, Weyand CM. Cytokines in giant-cell arteritis. Cleve Clin J Med. 2002;69 Suppl 2:SII91-4. doi: 10.3949/ccjm.69.suppl_2.sii91.

    PMID: 12086274BACKGROUND

  • Weyand CM, Fulbright JW, Hunder GG, Evans JM, Goronzy JJ. Treatment of giant cell arteritis: interleukin-6 as a biologic marker of disease activity. Arthritis Rheum. 2000 May;43(5):1041-8. doi: 10.1002/1529-0131(200005)43:53.0.CO;2-7.

    PMID: 10817557BACKGROUND

  • Weyand CM, Goronzy JJ. Giant-cell arteritis and polymyalgia rheumatica. Ann Intern Med. 2003 Sep 16;139(6):505-15. doi: 10.7326/0003-4819-139-6-200309160-00015.

    PMID: 13679329BACKGROUND

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Blood (serum and plasma), urine, and DNA

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

  • 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
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 14, 2006

First Posted

April 18, 2006

Study Start

April 1, 2006

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

July 12, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations

US(7)CA(2)