Clinical trial NCT02176070: Reproductive Health in Men and Women With Vasculitis
Official title: Reproductive Health in Men and Women With Vasculitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Giant Cell Arteritis
Takayasu's Arteritis
Polyarteritis Nodosa
Wegener's Granulomatosis
Microscopic Polyangiitis
Churg-Strauss Syndrome
Behcet's Disease
Kawasaki Disease
Henoch-schoenlein Purpura
Vasculitis, Central Nervous System
Drug-induced Necrotizing Vasculitis
Lead sponsor: University of South Florida
Sponsor class: OTHER
Collaborators: name: Duke University
name: Boston University
name: Data Management and Coordinating Center (DMCC)
First posted: 2014-06-26
Enrollment: 467
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Inability to provide informed consent and complete survey

Primary outcomes:
measure: The rate of infertility with and without prior cyc.
timeFrame: 1 year after the study is closed to enrollment
Secondary outcomes:
measure: The rate of pregnancy complications in pregnancies delivered before and after vasculitis diagnosis.
timeFrame: 1 year after the study is closed to enrollment
Other outcomes:
Locations:
city: Tampa
country: United States
facility: University of South Florida Data Management Coordinating Center
state: Florida
Study officials:
affiliation: Duke University
name: Megan Clowse, MD, MPH
role: STUDY_CHAIR
affiliation: USF College of Medicine
name: Amanda M. Terry, MA
role: STUDY_CHAIR
References: