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Determining Disease Activity Biomarkers in Individuals With Eosinophilic Granulomatosis With Polyangiitis (Churg-Strauss)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2016 by University of Pennsylvania
Sponsor:
Collaborators:
Office of Rare Diseases (ORD)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Rare Diseases Clinical Research Network
Information provided by (Responsible Party):
Peter Merkel, University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT00315380
First received: April 14, 2006
Last updated: November 11, 2016
Last verified: November 2016
  Purpose
Eosinophilic granulomatosis with polyangiitis (Churg-Strauss) (EGPA) is a rare immune system disorder that causes asthma, an excessive number of eosinophils (a type of white blood cell) in the blood, and the inflammation of blood vessels, or vasculitis. In order to properly treat EGPA, 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 this disease in people with EGPA.

Condition
Eosinophilic Granulomatosis With Polyangiitis
Churg-Strauss Syndrome

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Longitudinal Protocol for Eosinophilic Granulomatosis With Polyangiitis (Churg-Strauss)

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • Discover biomarkers in EGPA capable of measuring disease activity and response to treatment [ Time Frame: Study completion ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Measure the predictive value of biomarkers for clinical outcome in EGPA [ Time Frame: Study completion. ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA
Blood (serum and plasma), urine, and DNA

Estimated Enrollment: 500
Study Start Date: April 2006
Estimated Study Completion Date: April 2019
Estimated Primary Completion Date: April 2019 (Final data collection date for primary outcome measure)
Detailed Description:

EGPA, also known as allergic granulomatosis angiitis, is a systemic vasculitis. EGPA is marked by three distinct symptoms: asthma; eosinophilia, evidenced by an excessive number of eosinophils in the blood and tissues; and vasculitis involving the skin, lungs, nerves, kidneys, and other organs. Nerve involvement may also occur in EGPA, causing pain, tingling, numbness, and muscle wasting in the hands and feet. Because EGPA patients may not show any visible signs of active disease, current methods of monitoring disease progression usually represent a period of extended inflammation and disease activity. Thus, patients may go untreated during a period of undetectable disease when damage might be preventable. This study will use novel scientific methods to identify new biomarkers that can be used to monitor disease activity in EGPA patients. These biomarkers may be used to help direct clinical care for EGPA 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.

  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Individuals with eosinophilic granulomatosis with polyangiitis (Churg-Strauss). Enrollment will be sequential and participants will have disease in various stages and of different duration.
Criteria

Inclusion Criteria:

  • Documented evidence of small vessel vasculitis and at least 4 of the following 6 American College of Rheumatology (ACR) criteria for the diagnosis of eosinophilic granulomatosis with polyangiitis (Churg-Strauss):

    1. Asthma
    2. Peak peripheral blood eosinophilia of greater than 10% of total white blood cell count
    3. Peripheral neuropathy attributable to vasculitis
    4. Transient pulmonary infiltrates on chest imaging studies
    5. Paranasal sinus abnormalities or nasal polyposis
    6. Eosinophilic inflammation on tissue biopsy
  • Parent or guardian willing to provide informed consent, if applicable

Exclusion Criteria:

  • Granulomatosis with polyangiitis (Wegener's)
  • Microscopic polyangiitis
  • Drug-induced vasculitis
  • Hypereosinophilic syndrome
  • Sarcoidosis
  • Infectious forms of vasculitis
  • Takayasu's arteritis
  • Giant cell arteritis
  • Cogan's syndrome
  • Behcet's disease
  • Kawasaki disease
  • Cryoglobulinemic vasculitis
  • Systemic lupus erythematosus
  • Rheumatoid arthritis
  • Mixed connective tissue disease or any overlapping autoimmune syndrome
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00315380

Locations
United States, Massachusetts
Boston University School of Medicine Recruiting
Boston, Massachusetts, United States, 02118
Contact: Naomi Amudala, NP    617-414-2512    namudala@bu.edu   
Principal Investigator: Paul A. Monach, MD, PhD         
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Cindy Beinhorn       beinhorn.cynthia@mayo.edu   
Principal Investigator: Ulrich Specks, MD         
Principal Investigator: Steven R. Ytterberg, MD         
United States, Ohio
Cleveland Clinic Foundation Recruiting
Cleveland, Ohio, United States, 44195
Contact: Katie Gartner    216-445-1397    gartnek@ccf.org   
Principal Investigator: Carol A. Langford, MD, MHS         
United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Jacquelyn Thomas    215-614-4406    jacquelyn.thomas@uphs.upenn.edu   
Principal Investigator: Peter Merkel, MD, MPH         
University of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15260
Contact: Laurie Hope       hopelk@upmc.edu   
Principal Investigator: Larry Moreland, MD         
United States, Utah
University of Utah Recruiting
Salt Lake City, Utah, United States, 84112
Contact: Jessica gonzalez       jessica.gonzalez@hsc.utah.edu   
Principal Investigator: Curry Koening, MD, MHS         
Canada, Ontario
St. Joseph's Healthcare Recruiting
Hamilton, Ontario, Canada
Contact: Sandra Messier    905-522-1155 ext 35873    smessier@stjoes.ca   
Principal Investigator: Nader A. Khalidi, MD         
Mount Sinai Hospital Recruiting
Toronto, Ontario, Canada
Contact: Samyukta Jagadeesh    416-586-8616    sjagadeesh@mtsinai.on.ca   
Principal Investigator: Simon Carette, MD         
Sponsors and Collaborators
University of Pennsylvania
Office of Rare Diseases (ORD)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Rare Diseases Clinical Research Network
Investigators
Study Chair: Peter A. Merkel, MD, MPH University of Pennsylvania
  More Information

Additional Information:
Publications:
Responsible Party: Peter Merkel, Professor, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00315380     History of Changes
Other Study ID Numbers: RDCRN 5506  U54AR057319 
Study First Received: April 14, 2006
Last Updated: November 11, 2016
Health Authority: United States: Federal Government
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by University of Pennsylvania:
EGPA
CSS

Additional relevant MeSH terms:
Systemic Vasculitis
Granulomatosis with Polyangiitis
Churg-Strauss Syndrome
Vasculitis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases, Interstitial
Lung Diseases
Respiratory Tract Diseases
Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
Autoimmune Diseases
Immune System Diseases
Granuloma
Lymphoproliferative Disorders
Lymphatic Diseases

ClinicalTrials.gov processed this record on December 05, 2016