Longitudinal Protocol for Granulomatosis With Polyangiitis (Wegener's) and Microscopic Polyangiitis - Full Text View

Sponsor:	Boston University
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 A. Merkel, Boston University
ClinicalTrials.gov Identifier:	NCT00315393

Purpose

Granulomatosis with polyangiitis (Wegener's) (GPA) 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 GPA or MPA.

Condition
Granulomatosis With Polyangiitis Microscopic Polyangiitis Wegener's

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Determining Disease Activity Biomarkers in Individuals With Granulomatosis With Polyangiitis (Wegener's) and Microscopic Polyangiitis

Resource links provided by NLM:

MedlinePlus related topics: Vasculitis

U.S. FDA Resources

Further study details as provided by Boston University:

Biospecimen Retention: Samples With DNA

Blood (serum and plasma), urine, and DNA

Estimated Enrollment:	600
Study Start Date:	April 2006
Estimated Study Completion Date:	April 2016
Estimated Primary Completion Date:	April 2016 (Final data collection date for primary outcome measure)

Detailed Description:

GPA and MPA are two autoimmune disorders that cause systemic vasculitis. GPA 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 GPA and MPA patients. These biomarkers may be used to help direct clinical care for GPA and MPA 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

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

Study Population

Individuals with granulomatosis with polyangiitis (Wegener's)and microscopic polyangiitis. Enrollment will be sequential and participants will have disease in various stages and of different duration.

Criteria

Inclusion Criteria:

Diagnosis of GPA or MPA. Widely accepted diagnostic criteria, as opposed to classification criteria or definitions, have not been developed for GPA and MPA.
For diagnosis of GPA, 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 GPA 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00315393

Locations

United States, Maryland
The Johns Hopkins Vasculitis Center	Recruiting
Baltimore, Maryland, United States, 21224
Contact: Lourdes P. Sejismundo 410-550-6818 lsejism1@jhmi.edu
Principal Investigator: Philip Seo, MD, MHS
United States, Massachusetts
Boston University School of Medicine	Recruiting
Boston, Massachusetts, United States, 02118
Contact: Rossie Clark-Cotton 617-414-2509 mrcc@bu.edu
Principal Investigator: Paul A. Monach, MD, PhD
United States, Minnesota
Mayo Clinic	Recruiting
Rochester, Minnesota, United States, 55905
Contact: Sara Biorn 507-284-4862 biorn.sara@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 Pittsburgh	Recruiting
Pittsburgh, Pennsylvania, United States, 15260
Contact: Dawn McBride, RN 412-586-3545 dlmc@pitt.edu
Principal Investigator: Kathleen Maksimowicz-McKinnon, DO
United States, Utah
University of Utah	Recruiting
Salt Lake City, Utah, United States, 84112
Contact: Julieanne Nielsen 801-585-0798 Julieanne.Nielsen@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, M5T 3L9
Contact: Julia Farquharson 416-586-8616 JFarquharson@mtsinai.on.ca
Principal Investigator: Simon Carette, MD

Sponsors and Collaborators

Boston University

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

Boston University

More Information

Additional Information:

Vasculitis Clinical Research Consortium This link exits the ClinicalTrials.gov site

Rare Diseases Clinical Research Consortium This link exits the ClinicalTrials.gov site

Publications:

Borgmann S, Haubitz M. Genetic impact of pathogenesis and prognosis of ANCA-associated vasculitides. Clin Exp Rheumatol. 2004;22(6 Suppl 36):S79-86. Review.

Cooley P, Taylor KH, Czika W, Seifer C, Taylor JF. Analysis of a biomarker for Wegener's granulomatosis. Int J Immunogenet. 2005 Aug;32(4):237-43.

Jagiello P, Gross WL, Epplen JT. Complex genetics of Wegener granulomatosis. Autoimmun Rev. 2005 Jan;4(1):42-7. Review.

Radice A, Sinico RA. Antineutrophil cytoplasmic antibodies (ANCA). Autoimmunity. 2005 Feb;38(1):93-103. Review.

Stone JH, Rajapakse VN, Hoffman GS, Specks U, Merkel PA, Spiera RF, Davis JC, St Clair EW, McCune J, Ross S, Hitt BA, Veenstra TD, Conrads TP, Liotta LA, Petricoin EF 3rd; Wegener's Granulomatosis Etanercept Trial Research Group. A serum proteomic approach to gauging the state of remission in Wegener's granulomatosis. Arthritis Rheum. 2005 Mar;52(3):902-10.

Responsible Party:	Peter A. Merkel, Professor, Boston University
ClinicalTrials.gov Identifier:	NCT00315393 History of Changes
Other Study ID Numbers:	RDCRN 5505, U54AR057319
Study First Received:	April 14, 2006
Last Updated:	February 2, 2012
Health Authority:	United States: Federal Government

Keywords provided by Boston University:

GPA
MPA
WG

Additional relevant MeSH terms:

Systemic Vasculitis
Microscopic Polyangiitis
Vasculitis
Vascular Diseases

Cardiovascular Diseases
Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on February 12, 2012