Giant Cell ArteritisNCT02176070
Reproductive Health in Men and Women With Vasculitis
An observational study of Giant Cell Arteritis and Takayasu's Arteritis, run by University of South Florida at 1 site in United States.
Trial summary
The purpose of this study is to learn about reproductive health, including fertility and pregnancies, in people with vasculitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Giant Cell Arteritis, Takayasu's Arteritis, Polyarteritis Nodosa
- How many people
- 467 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2011to Mar 2012
- How long will I take part?
- 1 Year
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients with vasculitis included in the VCRC Contact Registry were invited to participate. Data was included for all patients who provided a vasculitis diagnosis, estimated date of diagnosis, confirmed that the diagnosis was made by a rheumatologist, and reported having taken at least one appropriate anti-rheumatic medication. Other participants were excluded as the likelihood that they have a true vasculitis condition is low.
Who may be able to join
- Enrolled in VCRC Contact Registry
- Patient reported diagnosis of Wegener's Granulomatosis, Microscopic Polyangiitis, Churg-Strauss Syndrome, Polyarteritis Nodosa, Takayasu's Arteritis, Giant Cell Arteritis, Behcet's Disease, Kawasaki Disease, Henoch-Schoenlein Purpura, CNS or Drug-induced Vasculitis
- 18 years of age or older
- English speaking
Who cannot join
- Inability to provide informed consent and complete survey
Trial locations and contacts
1 site in 1 country.
United States1 site
University of South Florida Data Management Coordinating Center
Tampa, Florida, 33612
About this study
The purpose of this study is to learn about reproductive health, including fertility and pregnancies, in people with vasculitis.
Read the detailed description
All patients enrolled in the Vasculitis Clinical Research Consortium's Contact Registry were invited via email to participate in this study. The Contract Registry includes people who self-identify as having one of 6 vasculitities: Wegener's Granulomatosis, Microscopic Polyangiitis, Churg-Strauss Syndrome, Polyarteritis Nodosum, Takayasu's Arteritis, and Giant Cell Arteritis. People voluntarily enroll in this Registry with the understanding that they will receive information about clinical studies for which they might be eligible. The introductory email included basic information about the study and all of the required elements for informed consent in a brief format. By clicking the link to the reproductive health questionnaire, participants gave their consent to be included in the study.
- Conditions
- Giant Cell Arteritis, Takayasu's Arteritis, Polyarteritis Nodosa, Wegener's Granulomatosis, Microscopic Polyangiitis, Churg-Strauss Syndrome
- Medical subject headings
- Giant Cell Arteritis, Takayasu Arteritis, Polyarteritis Nodosa, Granulomatosis with Polyangiitis, Microscopic Polyangiitis, Churg-Strauss Syndrome, Behcet Syndrome, Mucocutaneous Lymph Node Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of infertility with and without prior cyc.
Measured: 1 year after the study is closed to enrollment
Secondary outcomes (1)
The rate of pregnancy complications in pregnancies delivered before and after vasculitis diagnosis.
Measured: 1 year after the study is closed to enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2014 (estimated)
- Study startFeb 2011
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Giant Cell ArteritisStudies of the same condition, open and under way.
- More trials run by University of South FloridaThe 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
- Cross-sectional
- Enrolment
- 467 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- University of South Florida
- Sponsor type
- University, hospital or other
- Collaborators
- Duke University, Boston University, Data Management and Coordinating Center (DMCC)
- Responsible party
- Sponsor
- Investigators
- Megan Clowse, MD, MPH, Study chair, Duke UniversityAmanda M. Terry, MA, Study chair, USF College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02176070
- Sponsor's protocol ID
- 5531
- Status last verified
- Jun 2014
- First submitted
- 30 May 2014
- Last updated
- 26 Jun 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reproductive Health in Men and Women With Vasculitis
- ClinicalTrials.gov ID
- NCT02176070
- Acronym / sponsor ID
- 5531
- Conditions
- Giant Cell Arteritis, Takayasu's Arteritis, Polyarteritis Nodosa, Wegener's Granulomatosis, Microscopic Polyangiitis, Churg-Strauss Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 467 participants (actual)
- Lead sponsor
- University of South FloridaUniversity, hospital or other
- Collaborators
- Duke University, Boston University, Data Management and Coordinating Center (DMCC)
- Study start
- Feb 2011
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 26 Jun 2014 (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 reproductive health, including fertility and pregnancies, in people with vasculitis.
Detailed description
All patients enrolled in the Vasculitis Clinical Research Consortium's Contact Registry were invited via email to participate in this study. The Contract Registry includes people who self-identify as having one of 6 vasculitities: Wegener's Granulomatosis, Microscopic Polyangiitis, Churg-Strauss Syndrome, Polyarteritis Nodosum, Takayasu's Arteritis, and Giant Cell Arteritis. People voluntarily enroll in this Registry with the understanding that they will receive information about clinical studies for which they might be eligible. The introductory email included basic information about the study and all of the required elements for informed consent in a brief format. By clicking the link to the reproductive health questionnaire, participants gave their consent to be included in the study.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with vasculitis included in the VCRC Contact Registry were invited to participate. Data was included for all patients who provided a vasculitis diagnosis, estimated date of diagnosis, confirmed that the diagnosis was made by a rheumatologist, and reported having taken at least one appropriate anti-rheumatic medication. Other participants were excluded as the likelihood that they have a true vasculitis condition is low.
Key inclusion criteria (4 listed)
- Enrolled in VCRC Contact Registry
- Patient reported diagnosis of Wegener's Granulomatosis, Microscopic Polyangiitis, Churg-Strauss Syndrome, Polyarteritis Nodosa, Takayasu's Arteritis, Giant Cell Arteritis, Behcet's Disease, Kawasaki Disease, Henoch-Schoenlein Purpura, CNS or Drug-induced Vasculitis
- 18 years of age or older
- English speaking
Key exclusion criteria (1 listed)
- Inability to provide informed consent and complete survey
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
The rate of infertility with and without prior cyc.
Time frame: 1 year after the study is closed to enrollment
1 secondary outcome
The rate of pregnancy complications in pregnancies delivered before and after vasculitis diagnosis.
Time frame: 1 year after the study is closed to enrollment
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 26 Jun 2014.
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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.
Megan Clowse, MD, MPH study chair
Duke University
Amanda M. Terry, MA study chair
USF College of Medicine
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 Giant Cell Arteritis and Takayasu's Arteritis, run by University of South Florida 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 4 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: finished, as of the sponsor's last update on 26 Jun 2014. 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?
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?
The rate of infertility with and without prior cyc. (time frame: 1 year after the study is closed to enrollment). 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 26 Jun 2014.