Determining Disease Activity Biomarkers in Individuals With Giant Cell Arteritis

Brief Title

Determining Disease Activity Biomarkers in Individuals With Giant Cell Arteritis

Official Title

Longitudinal Protocol for Giant Cell Arteritis

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.
    

Detailed Description

      GCA is a rare autoimmune disorder and is the most common type of inflammation of medium- to
      large-sized blood vessels in the body. It usually only occurs in older adults. The most
      common symptoms of GCA include headache, pain in the shoulders and hips (polymyalgia
      rheumatica), pain in the jaw (jaw claudication), fever, and blurred vision. Organ-specific
      markers of injury or damage as well as direct markers of vascular damage and inflammation are
      currently used by clinicians to assess GCA disease progression; however, these markers are
      not very useful in guiding treatment. There are also blood tests that clinicians use to
      monitor GCA activity, such as erythrocyte sedimentation rate (ESR) and C-reactive protein
      (CRP), but these tests lack specificity and sensitivity. Most treatments available now for
      GCA are toxic, therefore if other markers indicating disease activity can be found, it may
      lead to the development of less toxic treatments. This study will use new scientific methods
      to identify new biomarkers that can be used to monitor disease activity in GCA patients.
      These biomarkers may be used to help direct clinical care for GCA patients and assist in
      future drug development.

      Study visits will occur monthly for the first year, then every 3 months thereafter for the
      remainder of the study. Blood and urine collection will occur at every visit. A physical exam
      and medical and medication history will occur every 3 months; also, participants will be
      asked to complete several questionnaires to assess disease activity, health status, and
      tobacco, alcohol, and drug use. Participants may have additional study visits if a disease
      flare or disease-related complications occur during the study.
    


Study Type

Observational


Primary Outcome

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

Secondary Outcome

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

Condition

Temporal Arteritis



Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

500

Start Date

April 2006

Completion Date

September 2022

Primary Completion Date

September 2022

Eligibility Criteria

        Inclusion Criteria:

          -  Diagnosis of GCA, meeting at least 3 of the following 5 American College of
             Rheumatology (ACR) criteria for the diagnosis of GCA:

               1. At least 50 years of age at disease onset

               2. New onset or new type of localized pain in the head

               3. Temporal artery abnormality (i.e., temporal artery tenderness to palpation or
                  decreased pulsation unrelated to arteriosclerosis of cervical arteries)

               4. ESR of greater than 40 mm in the first hour by the Westergren method

               5. Temporal artery biopsy showing vasculitis characterized by a predominance of
                  mononuclear cell infiltration or granulomatous inflammation, usually with
                  multinucleated giant cells

        Exclusion Criteria:

          -  Unable to give informed consent and sign the consent form
      

Gender

All

Ages

50 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Peter A. Merkel, MD, MPH, , 

Location Countries

Canada

Location Countries

Canada

Administrative Informations


NCT ID

NCT00315497

Organization ID

VCRC5502

Secondary IDs

U54AR057319

Responsible Party

Principal Investigator

Study Sponsor

University of Pennsylvania

Collaborators

 Office of Rare Diseases (ORD)

Study Sponsor

Peter A. Merkel, MD, MPH, Study Chair, University of Pennsylvania


Verification Date

May 2021