Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Determining Disease Activity Biomarkers in Individuals With Churg-Strauss Syndrome
This study is currently recruiting participants.
Verified by Office of Rare Diseases (ORD), September 2008
Sponsors and Collaborators: Office of Rare Diseases (ORD)
Rare Diseases Clinical Research Network
Information provided by: Office of Rare Diseases (ORD)
ClinicalTrials.gov Identifier: NCT00315380
  Purpose

Churg-Strauss Syndrome (CSS) 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 CSS, 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 CSS.


Condition
Churg-Strauss Syndrome

MedlinePlus related topics: Vasculitis
U.S. FDA Resources
Study Type: Observational
Study Design: Cohort, Prospective
Official Title: Longitudinal Protocol for Churg-Strauss Syndrome

Further study details as provided by Office of Rare Diseases (ORD):

Biospecimen Retention:   Samples With DNA

Biospecimen Description:

Blood (serum and plasma), urine, and DNA


Estimated Enrollment: 96
Study Start Date: April 2006
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Detailed Description:

CSS, also known as allergic granulomatosis angiitis, is a systemic vasculitis. CSS 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 CSS, causing pain, tingling, numbness, and muscle wasting in the hands and feet. Because CSS 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 CSS patients. These biomarkers may be used to help direct clinical care for CSS patients and assist in future drug development.

This study will last 5 years. 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-releated complications occur during the study.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Individuals with Churg-Strauss Syndrome. 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 Churg-Strauss syndrome:

    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:

  • Wegener's granulomatosis
  • 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's disease
  • Cryoglobulinemic vasculitis
  • Systemic lupus erythematosus
  • Rheumatoid arthritis
  • Mixed connective tissue disease or any overlapping autoimmune syndrome
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00315380

Locations
United States, Maryland
The Johns Hopkins Vasculitis Center Recruiting
Baltimore, Maryland, United States, 21224
Contact: Cynthia Bethea     410-550-4390     cbethea3@jhmi.edu    
Principal Investigator: Philip Seo, MD, MHS            
United States, Massachusetts
Boston University School of Medicine Recruiting
Boston, Massachusetts, United States, 02118
Contact: Jessica Martin     617-414-2507     jmartin@bu.edu    
Principal Investigator: Peter A. Merkel, MD, MPH            
Principal Investigator: Paul A. Monach, MD            
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Kathy Mieras     507-284-9187     mieras.kathleen@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: Katherine Tuthill     216-444-5257     TUTHILLK@ccf.org    
Principal Investigator: Carol A. Langford, MD, MHS            
Canada, Ontario
Mount Sinai Hospital Recruiting
Toronto, Ontario, Canada
Contact: Sara Sutherland     416-586-8616     SSutherland2@mtsinai.on.ca    
Principal Investigator: Simon Carette, MD            
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            
Sponsors and Collaborators
Rare Diseases Clinical Research Network
Investigators
Study Chair: Peter A. Merkel, MD, MPH Boston University
Principal Investigator: Carol A. Langford, MD, MHS The Cleveland Clinic
Principal Investigator: Philip Seo, MD, MHS Johns Hopkins Vasculitis Center
Principal Investigator: Ulrich Specks, MD Mayo Clinic
Principal Investigator: Steven R. Yetterberg, MD Mayo Clinic
  More Information

Publications:
Responsible Party: Boston University School of Medicine ( Peter A. Merkey, MD, MPH )
Study ID Numbers: RDCRN 5506, U54RR019497, VCRC 5506
Study First Received: April 14, 2006
Last Updated: September 10, 2008
ClinicalTrials.gov Identifier: NCT00315380  
Health Authority: United States: Federal Government

Keywords provided by Office of Rare Diseases (ORD):
CSS

Study placed in the following topic categories:
Lymphatic Diseases
Vasculitis
Churg-Strauss Syndrome
Churg-Strauss syndrome
Vascular Diseases
Lymphoproliferative Disorders
Granuloma

Additional relevant MeSH terms:
Pathologic Processes
Disease
Syndrome
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009