VasculitisV-PREGNCT02593565
Vasculitis Pregnancy Registry
An observational study of Vasculitis and Behcet's Disease, run by University of Pennsylvania at 1 site in United States.
Trial summary
The purpose of this study is to learn about the experience of women with vasculitis who become pregnant. In particular, the study will consist of several online surveys to assess 1. each woman's vasculitis severity and pregnancy-related experiences, and 2. pregnancy outcomes. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Vasculitis, Behcet's Disease, CNS Vasculitis
- What is being tested?
- Online questionnaires
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2015to Dec 2027
- How long will I take part?
- 12 Months
- 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 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Study population: Women with vasculitis who are currently pregnant.
Who may be able to join
- Women 18 years of age or older with one of the following diseases may take part in the study:
- Behçet's disease;
- Central nervous system (CNS) vasculitis;
- Cryoglobulinemic vasculitis (Cryoglobulinemia);
- Eosinophilic granulomatosis with polyangiitis (also called Churg-Strauss Syndrome);
- Giant Cell (Temporal) Arteritis (GCA);
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- Granulomatosis with polyangiitis (also called Wegener's);
- IgA vasculitis (Henoch-Schoenlein purpura);
- Microscopic polyangiitis (MPA);
- Polyarteritis nodosa (PAN);
- Takayasu's arteritis (TAK);
- Urticarial vasculitis;
- Other/Suspected Diagnosis.
- Women must be pregnant (self-report) at the time of enrollment into the registry.
Who cannot join
- Non-English speaking, with the exception of people who speak Spanish, Portuguese, Italian, or Turkish.
- Unable to provide consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Christine Yeung contact
Carol McAlear, MA contact
United States1 site, 1 recruiting
- Recruiting
University of South Florida Data Management and Coordinating Center
Tampa, Florida, 33612
Cristina Burroughs, networkmanager@vpprn.org
About this study
Official title: The Vasculitis Pregnancy Registry (V-PREG)
The purpose of this study is to learn about the experience of women with vasculitis who become pregnant. In particular, the study will consist of several online surveys to assess
- each woman's vasculitis severity and pregnancy-related experiences, and
- pregnancy outcomes.
Read the detailed description
The study will consist of several on-line surveys to assess each woman's vasculitis severity, pregnancy-related experiences, and pregnancy outcomes. Participants will be asked to complete questionnaires at study entry, during the second trimester, during the third trimester, and postpartum. Investigators estimate that it will take approximately 20 minutes to complete each survey. The survey is available in Spanish, Portuguese, Italian, and Turkish.
All women enrolled in the Vasculitis Patient-Powered Research Network (VPPRN) (with specified disease, sex, and age inclusion criteria described below) will be invited via email to participate in this on-line study. The survey data will be stored by the Data Management and Coordinating Center (DMCC) at the University of South Florida. Upon conclusion of the study period, the data will be sent to the Study Chairs.
- Conditions
- Vasculitis, Behcet's Disease, CNS Vasculitis, Cryoglobulinemic Vasculitis, Eosinophilic Granulomatosis With Polyangiitis (EGPA), Churg-Strauss Syndrome (CSS)
- Being tested
- Online questionnaires
- Medical subject headings
- Vasculitis, Behcet Syndrome, Vasculitis, Central Nervous System, Cryoglobulinemia, Familial Mixed, Churg-Strauss Syndrome, Granulomatosis with Polyangiitis, IgA Vasculitis, Microscopic Polyangiitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online questionnairesOther
Women will be asked to complete questionnaires during their pregnancy and a postpartum questionnaire.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Woman, 18 years of age or older, currently pregnant, and have a diagnosis of vasculitis. Receives: Other: Online questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Unique pregnancy characteristics among women with vasculitis.
To understand pregnancy characteristics and outcomes among women with vasculitis using patient-reported questionnaires in each trimester.
Measured: Four years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2015 (estimated)
- Study startNov 2015
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for VasculitisStudies 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
- 100 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Duke University, University of South Florida
- Responsible party
- Sponsor
- Investigators
- Megan Clowse, MD, MPH, Study chair, Duke UniversityPeter A Merkel, MD, MPH, Study chair, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02593565
- Sponsor's protocol ID
- VCRC 5532
- Acronym
- V-PREG
- Status last verified
- Jan 2026
- First submitted
- 26 Oct 2015
- Last updated
- 23 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Sims CA, Eudy AM, Larson K, Yeung C, Tam H, Kullman J, Borchin RL, Burroughs C, Merkel PA, Clowse MEB; VPREG Collaborative Group. Reproductive Outcomes for Women With Vasculitis. J Rheumatol. 2024 Oct 1;51(10):1003-1008. doi: 10.3899/jrheum.2023-1246.
PubMed 38825354Sims CA, Perry B, Yeung C, Tam H, Kullman J, Borchin RL, Burroughs C, Merkel PA, Clowse MEB. Exploring Reproductive Experiences With Women Enrolled in the International Vasculitis Pregnancy Registry. J Rheumatol. 2024 Oct 1;51(10):997-1002. doi: 10.3899/jrheum.2023-1055.
PubMed 38825350
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Vasculitis Pregnancy Registry (V-PREG)
- ClinicalTrials.gov ID
- NCT02593565
- Acronym / sponsor ID
- V-PREG / VCRC 5532
- Conditions
- Vasculitis, Behcet's Disease, CNS Vasculitis, Cryoglobulinemic Vasculitis, Eosinophilic Granulomatosis With Polyangiitis (EGPA), Churg-Strauss Syndrome (CSS)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- Duke University, University of South Florida
- Study start
- Nov 2015
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 2 Nov 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 purpose of this study is to learn about the experience of women with vasculitis who become pregnant. In particular, the study will consist of several online surveys to assess
- each woman's vasculitis severity and pregnancy-related experiences, and
- pregnancy outcomes.
Detailed description
The study will consist of several on-line surveys to assess each woman's vasculitis severity, pregnancy-related experiences, and pregnancy outcomes. Participants will be asked to complete questionnaires at study entry, during the second trimester, during the third trimester, and postpartum. Investigators estimate that it will take approximately 20 minutes to complete each survey. The survey is available in Spanish, Portuguese, Italian, and Turkish.
All women enrolled in the Vasculitis Patient-Powered Research Network (VPPRN) (with specified disease, sex, and age inclusion criteria described below) will be invited via email to participate in this on-line study. The survey data will be stored by the Data Management and Coordinating Center (DMCC) at the University of South Florida. Upon conclusion of the study period, the data will be sent to the Study Chairs.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | – | Other: Online questionnairesWoman, 18 years of age or older, currently pregnant, and have a diagnosis of vasculitis. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Women with vasculitis who are currently pregnant.
Key inclusion criteria (14 listed)
- Women 18 years of age or older with one of the following diseases may take part in the study:
- Women must be pregnant (self-report) at the time of enrollment into the registry.
Key exclusion criteria (2 listed)
- Non-English speaking, with the exception of people who speak Spanish, Portuguese, Italian, or Turkish.
- Unable to provide consent.
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 questionnairesWomen will be asked to complete questionnaires during their pregnancy and a postpartum questionnaire. | Other | Intervention |
Primary outcome
Unique pregnancy characteristics among women with vasculitis.
Time frame: Four years
To understand pregnancy characteristics and outcomes among women with vasculitis using patient-reported questionnaires in each trimester.
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 23 Jan 2026.
- Results publication: PubMed 38825354Sims CA, Eudy AM, Larson K, Yeung C, Tam H, Kullman J, Borchin RL, Burroughs C, Merkel PA, Clowse MEB; VPREG Collaborative Group. Reproductive Outcomes for Women With Vasculitis. J Rheumatol. 2024 Oct 1;51(10):1003-1008. doi: 10.3899/jrheum.2023-1246.
- Results publication: PubMed 38825350Sims CA, Perry B, Yeung C, Tam H, Kullman J, Borchin RL, Burroughs C, Merkel PA, Clowse MEB. Exploring Reproductive Experiences With Women Enrolled in the International Vasculitis Pregnancy Registry. J Rheumatol. 2024 Oct 1;51(10):997-1002. doi: 10.3899/jrheum.2023-1055.
- The Vasculitis Patient-Powered Research NetworkLink provided by the sponsor.
- Vasculitis Pregnancy Registry (VPREG) InformationLink provided by the sponsor.
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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.
Christine Yeung contact
Carol McAlear, MA contact
Megan Clowse, MD, MPH study chair
Duke University
Peter A Merkel, MD, MPH study chair
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vasculitis and Behcet's Disease, run by University of Pennsylvania at 1 site 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 14 inclusion and 2 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 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
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?
Contact Christine Yeung (christine.yeung@pennmedicine.upenn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Unique pregnancy characteristics among women with vasculitis. (time frame: Four years). 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 NCT02593565, which also lists 2 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 23 Jan 2026.