- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00315380
Longitudinal Study for Eosinophilic Granulomatosis With Polyangiitis (Churg-Strauss)
Longitudinal Protocol for Eosinophilic Granulomatosis With Polyangiitis (Churg-Strauss)
Study Overview
Status
Detailed Description
EGPA, also known as allergic granulomatosis angiitis, is a systemic vasculitis. EGPA is marked by three distinct symptoms: asthma; eosinophilia, evidenced by an excessive number of eosinophils in the blood and tissues; and vasculitis involving the skin, lungs, nerves, kidneys, and other organs. Nerve involvement may also occur in EGPA, causing pain, tingling, numbness, and muscle wasting in the hands and feet. Because EGPA patients may not show any visible signs of active disease, current methods of monitoring disease progression usually represent a period of extended inflammation and disease activity. Thus, patients may go untreated during a period of undetectable disease when damage might be preventable. This study will use novel scientific methods to identify new biomarkers that can be used to monitor disease activity in EGPA patients. These biomarkers may be used to help direct clinical care for EGPA patients and assist in future drug development.
Study visits will occur every 6 months, or annually. Blood and urine collection will occur at every visit. A physical exam and medical and medication history will at every visit; also, participants will be asked to complete several questionnaires to assess disease activity, health status, and tobacco, alcohol, and drug use.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
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Ontario
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Hamilton, Ontario, Canada
- Recruiting
- St. Joseph's Healthcare
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Contact:
- Sandra Messier
- Phone Number: 35873 905-522-1155
- Email: smessier@stjoes.ca
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Principal Investigator:
- Nader A. Khalidi, MD
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Toronto, Ontario, Canada
- Recruiting
- Mount Sinai Hospital
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Principal Investigator:
- Christian Pagnoux, MD, MS
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Contact:
- Nazrana Haq
- Email: Nazrana.Haq@sinaihealth.ca
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California
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San Diego, California, United States, 92122
- Recruiting
- University of California San Diego
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Contact:
- Damaris Diaz
- Email: dad003@health.ucsd.edu
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Principal Investigator:
- Praveen Akuthota, MD
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Colorado
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Denver, Colorado, United States, 80206
- Recruiting
- National Jewish Health
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Contact:
- Genna Frappaolo
- Email: frappaolog@njhealth.org
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Principal Investigator:
- Michael Wechsler, MD
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Massachusetts
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Boston, Massachusetts, United States, 02215
- Completed
- Brigham and Women's Hospital
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Minnesota
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Rochester, Minnesota, United States, 55905
- Recruiting
- Mayo Clinic
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Contact:
- Michael Stachowitz
- Email: stachowitz.michael@mayo.edu
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Principal Investigator:
- Ulrich Specks, MD
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Principal Investigator:
- Kenneth Warrington, MD
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Ohio
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Cleveland, Ohio, United States, 44195
- Recruiting
- Cleveland Clinic Foundation
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Principal Investigator:
- Carol A. Langford, MD, MHS
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Contact:
- Sonya Crook
- Email: crooks@ccf.org
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- Recruiting
- University of Pennsylvania
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Contact:
- Sarah Hopkins
- Email: Sarah.Hopkins@Pennmedicine.upenn.edu
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Principal Investigator:
- Peter Merkel, MD, MPH
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Pittsburgh, Pennsylvania, United States, 15260
- Completed
- University of Pittsburgh
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Utah
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Salt Lake City, Utah, United States, 84112
- Completed
- University of Utah
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
Patients with a diagnosis of eosinophilic granulomatosis with polyangiitis are eligible for the study.
Parent or guardian willing to provide informed consent, if applicable
Exclusion Criteria:
- Inability to give informed consent and to sign the consent form
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Discover biomarkers in EGPA capable of measuring disease activity and response to treatment
Time Frame: Study completion
|
Study completion
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Measure the predictive value of biomarkers for clinical outcome in EGPA
Time Frame: Study completion.
|
Study completion.
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Peter A. Merkel, MD, MPH, University of Pennsylvania
Publications and helpful links
General Publications
- Said G, Lacroix C. Primary and secondary vasculitic neuropathy. J Neurol. 2005 Jun;252(6):633-41. doi: 10.1007/s00415-005-0833-9. Epub 2005 Apr 5.
- Doubelt I, Springer JM, Kermani TA, Sreih AG, Burroughs C, Cuthbertson D, Carette S, Khalidi NA, Koening CL, Langford C, McAlear CA, Moreland LW, Monach PA, Shaw DG, Seo P, Specks U, Warrington KJ, Young K, Merkel PA, Pagnoux C. Self-Reported Data and Physician-Reported Data in Patients With Eosinophilic Granulomatosis With Polyangiitis: Comparative Analysis. Interact J Med Res. 2022 May 25;11(1):e27273. doi: 10.2196/27273.
- Radice A, Sinico RA. Antineutrophil cytoplasmic antibodies (ANCA). Autoimmunity. 2005 Feb;38(1):93-103. doi: 10.1080/08916930400022673.
- Heeringa P, Schreiber A, Falk RJ, Jennette JC. Pathogenesis of pulmonary vasculitis. Semin Respir Crit Care Med. 2004 Oct;25(5):465-74. doi: 10.1055/s-2004-836140.
Study record dates
Study Major Dates
Study Start
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Skin Diseases
- Respiratory Tract Diseases
- Immune System Diseases
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Autoimmune Diseases
- Lung Diseases
- Vasculitis
- Skin Diseases, Vascular
- Lung Diseases, Interstitial
- Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
- Granuloma
- Granulomatosis with Polyangiitis
- Churg-Strauss Syndrome
- Systemic Vasculitis
Other Study ID Numbers
- VCRC5506
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Churg-Strauss Syndrome
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Brigham and Women's HospitalGlaxoSmithKlineCompletedChurg Strauss SyndromeUnited States
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University Hospital Schleswig-HolsteinGlaxoSmithKlineCompletedChurg Strauss SyndromeGermany
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University of PennsylvaniaUniversity of South Florida; University of OxfordCompletedVasculitis | Churg-Strauss Syndrome (CSS) | Microscopic Polyangiitis (MPA) | Eosinophilic Granulomatosis With Polyangiitis (Churg-Strauss) (EGPA) | Granulomatosis With Polyangiitis (Wegener's) (GPA) | Wegener Granulomatosis (WG) | ANCA-Associated Vasculitis (AAV)United States
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GlaxoSmithKlineActive, not recruiting
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Hospices Civils de LyonUnknownChurg-Strauss SyndromeSwitzerland
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Mounzer AghaTerminated
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Fernando FervenzaGenentech, Inc.; Biogen; National Center for Research Resources (NCRR)Terminated
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University of OxfordAmerican College of Rheumatology; The European League Against Rheumatism (EULAR) and other collaboratorsUnknownGiant Cell Arteritis | Wegener's Granulomatosis | Microscopic Polyangiitis | Polyarteritis Nodosa | Takayasu Arteritis | Churg Strauss SyndromeKorea, Republic of, United States, Germany, Australia, Japan, Ireland, Belgium, Italy, Denmark, Slovenia, Switzerland, Canada, Argentina, Austria, China, Czech Republic, Egypt, Finland, France, Hungary, India, Mexico, Netherlands, New... and more
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Children's Hospital Medical Center, CincinnatiCompletedEosinophilic Gastroenteritis | Eosinophilic Esophagitis | Churg-Strauss Syndrome | Hypereosinophilic SyndromesUnited States
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AstraZenecaActive, not recruitingEosinophilic Granulomatous VasculitisUnited States, Canada, France, Italy, Israel, United Kingdom, Japan, Germany, Belgium