Reproductive Health in Men and Women With Vasculitis

Giant Cell Arteritis Clinical Trial

Official title:

Reproductive Health in Men and Women With Vasculitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02176070
• Other study ID #: 5531
• Status: Completed
• Phase: N/A
• First received: May 30, 2014
• Last updated: June 25, 2014
• Start date: February 2011
• Est. completion date: March 2012

Study information

• Verified date: June 2014
• Source: University of South Florida
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The purpose of this study is to learn about reproductive health, including fertility and pregnancies, in people with vasculitis.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 467
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Arteritis
• Behcet Syndrome
• Behcet's Disease
• Churg-Strauss Syndrome
• Drug-induced Necrotizing Vasculitis
• Giant Cell Arteritis
• Henoch-schoenlein Purpura
• Kawasaki Disease
• Microscopic Polyangiitis
• Mucocutaneous Lymph Node Syndrome
• Polyarteritis Nodosa
• Polymyalgia Rheumatica
• Purpura, Schoenlein-Henoch
• Systemic Vasculitis
• Takayasu Arteritis
• Takayasu's Arteritis
• Vasculitis
• Vasculitis, Central Nervous System
• Wegener Granulomatosis
• Wegener's Granulomatosis

Locations

Country	Name	City	State
United States	University of South Florida Data Management Coordinating Center	Tampa	Florida

Sponsors (4)

Lead Sponsor	Collaborator
University of South Florida	Boston University, Data Management and Coordinating Center (DMCC), Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The rate of infertility with and without prior cyc.		1 year after the study is closed to enrollment	No
Secondary	The rate of pregnancy complications in pregnancies delivered before and after vasculitis diagnosis.		1 year after the study is closed to enrollment	No

External Links

•   Vasculitis Clinical Research Consortium