An observational study in Giant Cell Arteritis, Takayasu's Arteritis and Polyarteritis Nodosa, sponsored by University of South Florida. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-06-26.
Sponsored by University of South Florida · Observational
The purpose of this study is to learn about reproductive health, including fertility and pregnancies, in people with vasculitis.
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.
147 studies on the registry are indexed under Giant Cell Arteritis; 49 are open to participants now.
This study's enrollment of 467 is above the median of 128 across 78 observational studies indexed under Giant Cell Arteritis.
Browse Giant Cell Arteritis studies →University of South Florida is the lead sponsor of 340 studies on the registry; 65 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 4 (24%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The rate of infertility with and without prior cyc.
Time frame: 1 year after the study is closed to enrollment
The rate of pregnancy complications in pregnancies delivered before and after vasculitis diagnosis.
Time frame: 1 year after the study is closed to enrollment
This study is completed, as verified in Jun 2014. You cannot join it, but the record below documents what was studied.
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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.