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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   Information provided by Office of Rare Diseases (ORD)
First Received: April 14, 2006   Last Updated: June 1, 2009   History of Changes

April 14, 2006
June 1, 2009
April 2006
April 2011   (final data collection date for primary outcome measure)
 
 
Complete list of historical versions of study NCT00315393 on ClinicalTrials.gov Archive Site
 
 
 
Determining Disease Activity Biomarkers in Individuals With Wegener's Granulomatosis and Microscopic Polyangiitis
Longitudinal Protocol for Wegener's Granulomatosis and Microscopic Polyangiitis

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.

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.

 
Observational
Cohort, Prospective
  • Wegener's Granulomatosis
  • Microscopic Polyangiitis
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
300
April 2016
April 2011   (final data collection date for primary outcome measure)

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
Both
 
No
 
United States,   Canada
 
NCT00315393
Peter A. Merkey, MD, MPH, Boston University School of Medicine
RDCRN 5505, U54RR019497, VCRC 5505
Office of Rare Diseases (ORD)
Rare Diseases Clinical Research Network
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
Office of Rare Diseases (ORD)
June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP