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Longitudinal Protocol for Granulomatosis With Polyangiitis (Wegener's) and Microscopic Polyangiitis
This study is currently recruiting participants.
Verified February 2017 by Peter Merkel, University of Pennsylvania
Sponsor:
University of Pennsylvania
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:
NCT00315393
First received: April 14, 2006
Last updated: February 21, 2017
Last verified: February 2017
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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:
Genetics Home Reference related topics:
granulomatosis with polyangiitis
MedlinePlus related topics:
Granulomatosis with Polyangiitis
Genetic and Rare Diseases Information Center resources:
Granulomatosis With Polyangiitis
Microscopic Polyangiitis
ANCA-associated Vasculitis
U.S. FDA Resources
Further study details as provided by Peter Merkel, University of Pennsylvania:
Primary Outcome Measures:
- Discover biomarkers in GPA/MPA capable of measuring disease activity and response to treatment. [ Time Frame: Study completion ]
Secondary Outcome Measures:
- Measure the predictive value of biomarkers for clinical outcome in GPA/MPA [ Time Frame: Study completion. ]
Biospecimen Retention: Samples With DNA
Blood (serum and plasma), urine, and DNA
| Estimated Enrollment: | 1200 |
| 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) |
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| Ages Eligible for Study: | Child, Adult, Senior |
| Sexes Eligible for Study: | All |
| 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:
- Nasal or oral inflammation with oral ulcers or nasal discharge with pus or blood
- Abnormal chest radiograph with nodules, fixed infiltrates, or cavities
- Urinary sediment with microhematuria or red cell casts
- Granulomatous inflammation within the wall of an artery or in the perivascular area on biopsy
- 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:
- Necrotizing vasculitis, with few or no immune deposits, that affects small vessels (i.e., capillaries, venules, arterioles)
- Necrotizing arteritis involving small- and medium-sized arteries may be present
- Necrotizing glomerulonephritis is very common
- Pulmonary capillaritis often occurs
- Parent or guardian willing to provide informed consent, if applicable
Exclusion Criteria:
- Simultaneous diagnoses of both GPA and MPA
- Granulomatosis with polyangiitis (Churg-Strauss)
- Takayasu's arteritis
- Giant cell arteritis
- Polyarteritis nodosa
- Cogan's syndrome
- Behcet's disease
- Sarcoidosis
- Kawasaki 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
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: NCT00315393
Please refer to this study by its ClinicalTrials.gov identifier: NCT00315393
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: Sue Donlinger 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: Marina Fanous marina.fanous@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, M5T 3L9 | |
| 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:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Peter Merkel, Professor, University of Pennsylvania |
| ClinicalTrials.gov Identifier: | NCT00315393 History of Changes |
| Other Study ID Numbers: |
VCRC5505 U54AR057319 ( US NIH Grant/Contract Award Number ) |
| Study First Received: | April 14, 2006 |
| Last Updated: | February 21, 2017 |
Keywords provided by Peter Merkel, University of Pennsylvania:
|
GPA MPA WG |
Additional relevant MeSH terms:
|
Granulomatosis with Polyangiitis Systemic Vasculitis Microscopic Polyangiitis Vasculitis Vascular Diseases Cardiovascular Diseases Lung Diseases, Interstitial Lung Diseases Respiratory Tract Diseases |
Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis Autoimmune Diseases Immune System Diseases Cerebral Small Vessel Diseases Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases |
ClinicalTrials.gov processed this record on June 23, 2017