Longitudinal Study for Eosinophilic Granulomatosis With Polyangiitis

NCT00315380 | Recruiting DMC

• 1 other identifier: VCRC5506
• Study Type: observational
• Target: 700
• Locations: 5 countries
• Sites: 13

Brief Summary

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.

Conditions

Eosinophilic Granulomatosis With Polyangiitis; Churg-Strauss Syndrome

Keywords

EGPA; CSS

Outcome Measures

Primary Outcomes (1)

• Discover biomarkers in EGPA capable of measuring disease activity and response to treatment

  Study completion

Secondary Outcomes (1)

• Measure the predictive value of biomarkers for clinical outcome in EGPA

  Study completion.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Individuals with eosinophilic granulomatosis with polyangiitis (Churg-Strauss). Enrollment will be sequential and participants will have disease in various stages and of different duration.

You may qualify if:

• Patients with a diagnosis of eosinophilic granulomatosis with polyangiitis are eligible for the study.
• Parent or guardian willing to provide informed consent, if applicable

You may not qualify if:

• \- Inability to give informed consent and to sign the consent form

Sponsors & Collaborators

• University of Pennsylvania: lead
• GlaxoSmithKline: collaborator
• AstraZeneca: collaborator

Study Sites (13)

University of California San Diego

San Diego, California, 92122, United States

COMPLETED

National Jewish Health

Denver, Colorado, 80206, United States

COMPLETED

Brigham and Women's Hospital

Boston, Massachusetts, 02215, United States

COMPLETED

Mayo Clinic

Rochester, Minnesota, 55905, United States

COMPLETED

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

COMPLETED

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

COMPLETED

University of Pittsburgh

Pittsburgh, Pennsylvania, 15260, United States

COMPLETED

University of Utah

Salt Lake City, Utah, 84112, United States

COMPLETED

St. Joseph's Healthcare

Hamilton, Ontario, Canada

RECRUITING

Mount Sinai Hospital

Toronto, Ontario, Canada

COMPLETED

medius KLINIK KIRCHHEIM

Kirchheim unter Teck, 73230, Germany

RECRUITING

AOU Meyer IRCCS

Florence, Italy

RECRUITING

Imperial College Healthcare NHS Trust/ Imperial College London

London, W12 0NN, United Kingdom

RECRUITING

Related Publications (5)

• 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.

  PMID: 16088492 BACKGROUND

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

  PMID: 15804710 BACKGROUND

• 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.

  PMID: 15806339 BACKGROUND

• 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.

  PMID: 36874269 DERIVED

• 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.

  PMID: 35612893 DERIVED

Related Links

• Vasculitis Clinical Research Consortium
• Rare Diseases Clinical Research Consortium

Biospecimen

Retention: SAMPLES WITH DNA

Blood (serum and plasma), urine, and DNA

MeSH Terms

Conditions

Churg-Strauss Syndrome

Condition Hierarchy (Ancestors)

Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis; Systemic Vasculitis; Vasculitis; Vascular Diseases; Cardiovascular Diseases; Granuloma; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Peter A. Merkel, MD, MPH

  University of Pennsylvania

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 14, 2006
• First Posted: April 18, 2006
• Study Start: April 1, 2006
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: January 23, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1); GB (1); DE (1); CA (2); US (8)