Longitudinal Protocol for Granulomatosis With Polyangiitis (Wegener's) and Microscopic Polyangiitis
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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 |
- Discover biomarkers in GPA/MPA capable of measuring disease activity and response to treatment. [ Time Frame: Study completion ] [ Designated as safety issue: No ]
- Measure the predictive value of biomarkers for clinical outcome in GPA/MPA [ Time Frame: Study completion. ] [ Designated as safety issue: No ]
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) |
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 |
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.
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 LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00315393
| 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: Cindy Beinhorn 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: Brian Rice 215-614-4407 Brian.Rice@uphs.upenn.edu | |
| Principal Investigator: Peter Merkel, MD, MPH | |
| University of Pittsburgh | Recruiting |
| Pittsburgh, Pennsylvania, United States, 15260 | |
| Contact: Dawn McBride, RN 412-586-3545 dlmc@pitt.edu | |
| Principal Investigator: Larry Moreland, MD | |
| 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: Samyukta Jagadeesh 416-586-8616 sjagadeesh@mtsinai.on.ca | |
| Principal Investigator: Simon Carette, MD | |
| Study Chair: | Peter A. Merkel, MD, MPH | University of Pennsylvania |
More Information
Additional Information:
Publications:
Additional 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: | RDCRN 5505, U54AR057319 |
| Study First Received: | April 14, 2006 |
| Last Updated: | February 13, 2015 |
| Health Authority: | United States: Federal Government |
Keywords provided by University of Pennsylvania:
|
GPA MPA WG |
Additional relevant MeSH terms:
|
Wegener Granulomatosis Microscopic Polyangiitis Systemic Vasculitis Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis Autoimmune Diseases Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebral Small Vessel Diseases |
Cerebrovascular Disorders Immune System Diseases Lung Diseases Lung Diseases, Interstitial Nervous System Diseases Respiratory Tract Diseases Vascular Diseases Vasculitis |
ClinicalTrials.gov processed this record on March 03, 2015