Longitudinal Study for Eosinophilic Granulomatosis With Polyangiitis

NCT ID: NCT00315380

Last Updated: 2026-01-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

700 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-04-30

Study Completion Date

2028-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Eosinophilic granulomatosis with polyangiitis (EGPA) is a rare immune system disorder that causes asthma, an excessive number of eosinophils (a type of white blood cell) in the blood, and the inflammation of blood vessels, or vasculitis. In order to properly treat EGPA, 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 this disease in people with EGPA.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Eosinophilic Granulomatosis With Polyangiitis Churg-Strauss Syndrome

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

GlaxoSmithKline

INDUSTRY

Sponsor Role collaborator

AstraZeneca

INDUSTRY

Sponsor Role collaborator

University of Pennsylvania

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Peter Merkel

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Peter A. Merkel, MD, MPH

Role: STUDY_CHAIR

University of Pennsylvania

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of California San Diego

San Diego, California, United States

Site Status COMPLETED

National Jewish Health

Denver, Colorado, United States

Site Status COMPLETED

Brigham and Women's Hospital

Boston, Massachusetts, United States

Site Status COMPLETED

Mayo Clinic

Rochester, Minnesota, United States

Site Status COMPLETED

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Site Status COMPLETED

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status COMPLETED

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Site Status COMPLETED

University of Utah

Salt Lake City, Utah, United States

Site Status COMPLETED

St. Joseph's Healthcare

Hamilton, Ontario, Canada

Site Status RECRUITING

Mount Sinai Hospital

Toronto, Ontario, Canada

Site Status COMPLETED

medius KLINIK KIRCHHEIM

Kirchheim unter Teck, , Germany

Site Status RECRUITING

AOU Meyer IRCCS

Florence, , Italy

Site Status RECRUITING

Imperial College Healthcare NHS Trust/ Imperial College London

London, , United Kingdom

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States Canada Germany Italy United Kingdom

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Sandra Messier

Role: primary

905-522-1155 ext. 35873

Nicole Hollinger

Role: primary

Ilaria Fibbi

Role: primary

Beverly Kowlessar

Role: primary

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 16088492 (View on PubMed)

Radice A, Sinico RA. Antineutrophil cytoplasmic antibodies (ANCA). Autoimmunity. 2005 Feb;38(1):93-103. doi: 10.1080/08916930400022673.

Reference Type BACKGROUND
PMID: 15804710 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15806339 (View on PubMed)

Doubelt I, Cuthbertson D, Carette S, Khalidi NA, Koening CL, Langford C, McAlear CA, Moreland LW, Monach P, Seo P, Specks U, Warrington KJ, Merkel PA, Pagnoux C. Vitamin D status in ANCA-associated vasculitis. Rheumatol Adv Pract. 2023 Feb 10;7(1):rkad021. doi: 10.1093/rap/rkad021. eCollection 2023.

Reference Type DERIVED
PMID: 36874269 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35612893 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

http://rarediseasesnetwork.org/cms/vcrc/

Vasculitis Clinical Research Consortium

http://rarediseasesnetwork.org/

Rare Diseases Clinical Research Consortium

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

VCRC5506

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.