Eosinophilic Granulomatosis With Polyangiitis (Churg-Strauss) (EGPA)AAV-PRONCT02507024
The ANCA Vasculitis Questionnaire (AAV-PRO©)
An observational study of Eosinophilic Granulomatosis With Polyangiitis (Churg-Strauss) (EGPA) and Churg-Strauss Syndrome (CSS), run by University of Pennsylvania at 2 sites in United States.
Trial summary
The aim of this project is to develop a disease specific patient reported outcome measure (PROM) for patients with AAV (the AAV-PRO). Investigators are developing and validating a questionnaire to assess quality of life in patients with ANCA-associated vasculitis (AAV). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Eosinophilic Granulomatosis With Polyangiitis (Churg-Strauss) (EGPA), Churg-Strauss Syndrome (CSS), Granulomatosis With Polyangiitis (Wegener's) (GPA)
- What is being tested?
- Online questionnaire
- How many people
- 280 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2015to Dec 2016
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients with AAV participating in the V-PPRN.
Who may be able to join
- Registered in the Vasculitis Patient-Powered Research Network (V-PPRN)
- Patients greater than 18 years of age
- Diagnosis of ANCA-associated vasculitis including: Eosinophilic Granulomatosis with Polyangiitis (also called Churg-Strauss Syndrome), Granulomatosis with Polyangiitis (also called Wegener's granulomatosis or GPA), Microscopic Polyangiitis (MPA)
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
University of South Florida
Tampa, Florida, 33612
About this study
The aim of this project is to develop a disease specific patient reported outcome measure (PROM) for patients with AAV (the AAV-PRO). Investigators are developing and validating a questionnaire to assess quality of life in patients with ANCA-associated vasculitis (AAV). Patients with AAV have inflammation in the small blood vessels leading to involvement of a range of organs and can suffer from ongoing disease activity or treatment side effects. Quality of life can be measured by patient reported outcome measures (PROMs).
Read the detailed description
Patients with ANCA-associated vasculitis have inflammation in the small vessels that impact a range of organs and Investigators understand that patients may suffer ongoing disease activity, as well as side effects from the treatments. Assessing patients quality of life can be an important tool for conducting clinical trials for new treatments and medications.
Quality of life can be measured by questionnaires called "patient reported outcome measures" (PROM). What is a patient-reported outcome? Patient-reported outcomes, or PROs, are patients' feedback on what they are feeling or what they are able to do as participants are dealing with a chronic disease . Patient-reported outcomes are important because they provide doctors and researchers information about patients' quality of life. Questionnaires can be designed to measure specific PROs that are of specific importance to a disease and can provide much needed information on evaluating the effectiveness of health care. The aim of this survey is to develop a disease specific patient reported outcome measure, or PROM, for patients with AAV.
A small group of Investigators and Patient-Partners developed this survey for people with ANCA-associated vasculitis (the AAV-PRO). Investigators will invite patients with AAV to complete the questionnaire they have designed, called the AAV-PRO. By analysing how people fill in the questionnaire, Investigators will be able to find out how well the questions work, and whether they need to ask all of them.
- Conditions
- Eosinophilic Granulomatosis With Polyangiitis (Churg-Strauss) (EGPA), Churg-Strauss Syndrome (CSS), Granulomatosis With Polyangiitis (Wegener's) (GPA), Wegener Granulomatosis (WG), Microscopic Polyangiitis (MPA), ANCA-Associated Vasculitis (AAV)
- Being tested
- Online questionnaire
- Medical subject headings
- Churg-Strauss Syndrome, Granulomatosis with Polyangiitis, Microscopic Polyangiitis, Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis, Vasculitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online questionnaireOther
| Study group | Role | What they receive |
|---|---|---|
| Intervention | The online questionnaire includes questions about how ANCA-associated vasculitis effects patients quality of life. Receives: Other: Online questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Completion of AAV-PRO questionnaire.
Analysis of how people fill in the questionnaire to determine if these specific questions work, and whether we need to ask all of them.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2015 (estimated)
- Study startJul 2015
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eosinophilic Granulomatosis With Polyangiitis (Churg-Strauss) (EGPA)Studies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 280 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oxford, University of South Florida
- Responsible party
- Sponsor
- Investigators
- Joanna Robson, MD, Principal investigator, University of OxfordPeter A Merkel, MD, MPH, Study director, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02507024
- Sponsor's protocol ID
- VCRC 5537
- Acronym
- AAV-PRO
- Status last verified
- May 2017
- First submitted
- 15 Jul 2015
- Last updated
- 4 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The ANCA Vasculitis Questionnaire (AAV-PRO©)
- ClinicalTrials.gov ID
- NCT02507024
- Acronym / sponsor ID
- AAV-PRO / VCRC 5537
- Conditions
- Eosinophilic Granulomatosis With Polyangiitis (Churg-Strauss) (EGPA), Churg-Strauss Syndrome (CSS), Granulomatosis With Polyangiitis (Wegener's) (GPA), Wegener Granulomatosis (WG), Microscopic Polyangiitis (MPA), ANCA-Associated Vasculitis (AAV)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 280 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- University of Oxford, University of South Florida
- Study start
- Jul 2015 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 23 Jul 2015 (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.
The aim of this project is to develop a disease specific patient reported outcome measure (PROM) for patients with AAV (the AAV-PRO). Investigators are developing and validating a questionnaire to assess quality of life in patients with ANCA-associated vasculitis (AAV). Patients with AAV have inflammation in the small blood vessels leading to involvement of a range of organs and can suffer from ongoing disease activity or treatment side effects. Quality of life can be measured by patient reported outcome measures (PROMs).
Detailed description
Patients with ANCA-associated vasculitis have inflammation in the small vessels that impact a range of organs and Investigators understand that patients may suffer ongoing disease activity, as well as side effects from the treatments. Assessing patients quality of life can be an important tool for conducting clinical trials for new treatments and medications.
Quality of life can be measured by questionnaires called "patient reported outcome measures" (PROM). What is a patient-reported outcome? Patient-reported outcomes, or PROs, are patients' feedback on what they are feeling or what they are able to do as participants are dealing with a chronic disease . Patient-reported outcomes are important because they provide doctors and researchers information about patients' quality of life. Questionnaires can be designed to measure specific PROs that are of specific importance to a disease and can provide much needed information on evaluating the effectiveness of health care. The aim of this survey is to develop a disease specific patient reported outcome measure, or PROM, for patients with AAV.
A small group of Investigators and Patient-Partners developed this survey for people with ANCA-associated vasculitis (the AAV-PRO). Investigators will invite patients with AAV to complete the questionnaire they have designed, called the AAV-PRO. By analysing how people fill in the questionnaire, Investigators will be able to find out how well the questions work, and whether they need to ask all of them.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | – | Other: Online questionnaireThe online questionnaire includes questions about how ANCA-associated vasculitis effects patients quality of life. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with AAV participating in the V-PPRN.
Key inclusion criteria (3 listed)
- Registered in the Vasculitis Patient-Powered Research Network (V-PPRN)
- Patients greater than 18 years of age
- Diagnosis of ANCA-associated vasculitis including: Eosinophilic Granulomatosis with Polyangiitis (also called Churg-Strauss Syndrome), Granulomatosis with Polyangiitis (also called Wegener's granulomatosis or GPA), Microscopic Polyangiitis (MPA)
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Online questionnaire | Other | Intervention |
Primary outcome
Completion of AAV-PRO questionnaire.
Time frame: 6 months
Analysis of how people fill in the questionnaire to determine if these specific questions work, and whether we need to ask all of them.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2017.
- V-PPRN Study OverviewLink 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. This study is not recruiting at the moment.
Joanna Robson, MD principal investigator
University of Oxford
Peter A Merkel, MD, MPH study director
University of Pennsylvania
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Eosinophilic Granulomatosis With Polyangiitis (Churg-Strauss) (EGPA) and Churg-Strauss Syndrome (CSS), run by University of Pennsylvania at 2 sites in United States.
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 3 inclusion and 0 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: finished, as of the sponsor's last update on 4 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Completion of AAV-PRO questionnaire. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 May 2017; AzTrials last refreshed its copy on 29 Oct 2026.