Eosinophilic Granulomatosis With PolyangiitisNCT00315380
Longitudinal Study for Eosinophilic Granulomatosis With Polyangiitis
An observational study of Eosinophilic Granulomatosis With Polyangiitis and Churg-Strauss Syndrome, run by University of Pennsylvania at 15 sites in 5 countries.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Eosinophilic Granulomatosis With Polyangiitis, Churg-Strauss Syndrome
- How many people
- 700 participants
- Where
- 15 sitesin 5 countries
- Study dates
- Apr 2006to Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- Patients with a diagnosis of eosinophilic granulomatosis with polyangiitis are eligible for the study.
- Parent or guardian willing to provide informed consent, if applicable
Who cannot join
- Inability to give informed consent and to sign the consent form
Trial locations and contacts
15 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
15 sites in 5 countries
United States8 sites
- Completed
Brigham and Women's Hospital
Boston, Massachusetts, 02215
- Completed
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
- Completed
National Jewish Health
Denver, Colorado, 80206
- Completed
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
- Completed
University of Pittsburgh
Pittsburgh, Pennsylvania, 15260
- Completed
Mayo Clinic
Rochester, Minnesota, 55905
- Completed
University of Utah
Salt Lake City, Utah, 84112
- Completed
University of California San Diego
San Diego, California, 92122
United Kingdom3 sites, 3 recruiting
- Recruiting
Cambridge University Hospitals Nhs Foundation Trust
Cambridge
Kim Mynard, kim.mynard@nhs.net
- Recruiting
Imperial College Healthcare NHS Trust/ Imperial College London
London, W12 0NN
Beverly Kowlessar, b.kowlessar@nhs.net
Salman Siddiqui
- Recruiting
Guy'S and St Thomas' Nhs Foundation Trust
London
Alicia PEREZ VALLES, alicia.perezvalles@nhs.net
Canada2 sites, 1 recruiting
- Recruiting
St. Joseph's Healthcare
Hamilton, Ontario
Sandra Messier, 905-522-1155 ext. 35873, smessier@stjoes.ca
Nader A. Khalidi, MD
- Completed
Mount Sinai Hospital
Toronto, Ontario
Germany1 site, 1 recruiting
- Recruiting
medius KLINIK KIRCHHEIM
Kirchheim unter Teck, 73230
Nicole Hollinger, n.hollinger@medius-kliniken.de
Bernhard Hellmich, MD
Italy1 site, 1 recruiting
- Recruiting
AOU Meyer IRCCS
Florence
Ilaria Fibbi, ilaria.fibbi@meyer.it
Augusto Vaglio, MD
About this study
Official title: Longitudinal Protocol for Eosinophilic Granulomatosis With Polyangiitis
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.
Read the 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.
- Keywords
- EGPA, CSS
- Medical subject headings
- Churg-Strauss Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Discover biomarkers in EGPA capable of measuring disease activity and response to treatment
Measured: Study completion
Secondary outcomes (1)
Measure the predictive value of biomarkers for clinical outcome in EGPA
Measured: Study completion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2006 (estimated)
- Study startApr 2006
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Eosinophilic Granulomatosis With PolyangiitisStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline, AstraZeneca
- Responsible party
- Principal investigator, Peter Merkel, University of Pennsylvania
- Investigators
- Peter A. Merkel, MD, MPH, Study chair, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00315380
- Sponsor's protocol ID
- VCRC5506
- Status last verified
- Aug 2026
- First submitted
- 14 Apr 2006
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 16088492Radice A, Sinico RA. Antineutrophil cytoplasmic antibodies (ANCA). Autoimmunity. 2005 Feb;38(1):93-103. doi: 10.1080/08916930400022673.
PubMed 15804710Said 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.
PubMed 15806339Doubelt 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.
PubMed 36874269Doubelt 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.
PubMed 35612893
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Protocol for Eosinophilic Granulomatosis With Polyangiitis
- ClinicalTrials.gov ID
- NCT00315380
- Acronym / sponsor ID
- VCRC5506
- Keywords
- EGPA, CSS
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- GlaxoSmithKline, AstraZeneca
- Study start
- Apr 2006
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 18 Apr 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Patients with a diagnosis of eosinophilic granulomatosis with polyangiitis are eligible for the study.
- Parent or guardian willing to provide informed consent, if applicable
Key exclusion criteria (1 listed)
- Inability to give informed consent and to sign the consent form
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Discover biomarkers in EGPA capable of measuring disease activity and response to treatment
Time frame: Study completion
1 secondary outcome
Measure the predictive value of biomarkers for clinical outcome in EGPA
Time frame: Study completion.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
- Background: PubMed 16088492Heeringa 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.
- Background: PubMed 15804710Radice A, Sinico RA. Antineutrophil cytoplasmic antibodies (ANCA). Autoimmunity. 2005 Feb;38(1):93-103. doi: 10.1080/08916930400022673.
- Background: PubMed 15806339Said 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.
- Derived from this study: PubMed 36874269Doubelt 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.
- Derived from this study: PubMed 35612893Doubelt 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.
- Vasculitis Clinical Research ConsortiumLink provided by the sponsor.
- Rare Diseases Clinical Research ConsortiumLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Peter A. Merkel, MD, MPH study chair
University of Pennsylvania
15 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Eosinophilic Granulomatosis With Polyangiitis and Churg-Strauss Syndrome, run by University of Pennsylvania at 15 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States, United Kingdom, Canada, Germany, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Discover biomarkers in EGPA capable of measuring disease activity and response to treatment (time frame: Study completion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00315380, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2026.