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NCT00315380 Clinical Trial

Longitudinal Study for Eosinophilic Granulomatosis With Polyangiitis

Churg-Strauss Syndrome Clinical Trial

Official title:
Longitudinal Protocol for Eosinophilic Granulomatosis With Polyangiitis

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00315380
Other study ID # VCRC5506
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 2006
Est. completion date December 2028

Study information
Verified date April 2024
Source University of Pennsylvania
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 700
Est. completion date December 2028
Est. primary completion date December 2028
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
Canada St. Joseph's Healthcare Hamilton Ontario
Canada Mount Sinai Hospital Toronto Ontario
United States Brigham and Women's Hospital Boston Massachusetts
United States Cleveland Clinic Foundation Cleveland Ohio
United States National Jewish Health Denver Colorado
United States University of Pennsylvania Philadelphia Pennsylvania
United States University of Pittsburgh Pittsburgh Pennsylvania
United States Mayo Clinic Rochester Minnesota
United States University of Utah Salt Lake City Utah
United States University of California San Diego San Diego California

Sponsors (3)
Lead Sponsor Collaborator
University of Pennsylvania AstraZeneca, GlaxoSmithKline

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (3)

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. — View Citation

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

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Discover biomarkers in EGPA capable of measuring disease activity and response to treatment Study completion
Secondary Measure the predictive value of biomarkers for clinical outcome in EGPA Study completion.
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Completed NCT02020889 - A Study to Investigate Mepolizumab in the Treatment of Eosinophilic Granulomatosis With Polyangiitis Phase 3
Completed NCT02176070 - Reproductive Health in Men and Women With Vasculitis N/A
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Recruiting NCT06046222 - Trial of Efficacy and Safety of NS-229 Versus Placebo in Patients With Eosinophilic Granulomatosis With Polyangiitis Phase 2
Recruiting NCT04316494 - Hydroxychloroquine in ANCA Vasculitis Evaluation Phase 4
Active, not recruiting NCT04551989 - Mepolizumab Long-term Study to Assess Real World Safety and Effectiveness of Eosinophilic Granulomatosis With Polyangiitis (EGPA) in Japan
Recruiting NCT04671446 - Identification of Autoantigens in EGPA and Severe Eosinophilic Asthma
Completed NCT03036670 - Eosinophilic Granulomatosis With Polyangiitis Cohort
Terminated NCT02728271 - Immuno-ablation With Chemoimmunoradiation and Autologous Stem Cell Transplant for Churg-Strauss Syndrome Early Phase 1

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