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Determining Disease Activity Biomarkers in Individuals With Wegener's Granulomatosis and Microscopic Polyangiitis

This study is currently recruiting participants.
Study NCT00315393.   Last updated on September 10, 2008.   Information provided by Office of Rare Diseases (ORD)

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Descriptive Information Fields
Brief Title  Determining Disease Activity Biomarkers in Individuals With Wegener's Granulomatosis and Microscopic Polyangiitis
Official Title  Longitudinal Protocol for Wegener's Granulomatosis and Microscopic Polyangiitis
Brief Summary

Wegener's granulomatosis (WG) and microscopic polyangiitis (MPA) are two rare immune system disorders that cause the inflammation of blood vessels, or vasculitis. In order to properly treat these diseases, 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 WG or MPA.

Detailed Description

WG and MPA are two autoimmune disorders that cause systemic vasculitis. WG commonly affects the upper respiratory tract, the lungs, and the kidneys. MPA is marked by kidney inflammation, weight loss, skin lesions, nerve damage, and fever. Many patients with WG or MPA show no visible symptoms of active disease; it is known that underlying subclinical disease activity leads to long-term damage in these patients. Also, because it is difficult to monitor WG and MPA disease activity, it is difficult for clinicians to know when and how to treat these patients. This study will use new scientific methods to identify new biomarkers that can be used to monitor disease activity in WG and MPA patients. These biomarkers may be used to help direct clinical care for WG and MPA 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-related complications occur during the study.

Study Phase
Study Type  Observational
Study Design  Cohort, Prospective
Primary Outcome Measure 
Secondary Outcome Measure 
Condition  Wegener's Granulomatosis
Microscopic Polyangiitis
Intervention 
MEDLINE PMIDs 15675141,   16026591,   15652778,   15804710,   15751091
Links
Recruitment Information Fields
Recruitment Status  Recruiting
Enrollment  300
Start Date  April 2006
Completion Date April 2016
Eligibility Criteria 

Inclusion Criteria:

  • Diagnosis of WG or MPA. Widely accepted diagnostic criteria, as opposed to classification criteria or definitions, have not been developed for WG and MPA.
  • For diagnosis of WG, meets at least 2 of the following 5 modified American College of Rheumatology (ACR) criteria:

    1. Nasal or oral inflammation with oral ulcers or nasal discharge with pus or blood
    2. Abnormal chest radiograph with nodules, fixed infiltrates, or cavities
    3. Urinary sediment with microhematuria or red cell casts
    4. Granulomatous inflammation within the wall of an artery or in the perivascular area on biopsy
    5. Antineutrophil cytoplasmic antibody (ANCA) positive by enzyme immunoassay for either PR3- or MPO-ANCA
  • For diagnosis of MPA, meets the Chapel Hill Consensus Conference Definition for MPA:

    1. Necrotizing vasculitis, with few or no immune deposits, that affects small vessels (i.e., capillaries, venules, arterioles)
    2. Necrotizing arteritis involving small- and medium-sized arteries may be present
    3. Necrotizing glomerulonephritis is very common
    4. Pulmonary capillaritis often occurs
  • Parent or guardian willing to provide informed consent, if applicable

Exclusion Criteria:

  • Simultaneous diagnoses of both WG and MPA
  • Churg-Strauss syndrome
  • Takayasu's arteritis
  • Giant cell arteritis
  • Polyarteritis nodosa
  • Cogan's syndrome
  • Behcet's disease
  • Sarcoidosis
  • Kawasaki's disease
  • Tuberculosis or any atypical mycobacterial infections
  • Deep fungal infections
  • Lymphoma, lymphomatoid granulomatosis, or any other type of cancer that mimics anti-neutrophil cytoplasmic antibody-associated vasculitis (AAVs)
  • Cryoglobulinemic vasculitis
  • Systemic lupus erythematosus
  • Rheumatoid arthritis
  • Mixed connective tissue disease or any overlapping autoimmune syndrome
Gender Both
Ages
Accepts Healthy Volunteers No
Contacts ††
Location Countries  United States,   Canada
Administrative Information Fields
NCT ID  NCT00315393
Organization ID RDCRN 5505
Secondary IDs †† U54RR019497, VCRC 5505
Study Sponsor  Office of Rare Diseases (ORD)
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    
Information Provided By Office of Rare Diseases (ORD)
Verification Date September 2008
First Received Date  April 14, 2006
Last Updated Date September 10, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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