Reproductive Health in Men and Women With Vasculitis

NCT02176070 | Completed DMC

• 1 other identifier: 5531
• Study Type: observational
• Target: 467
• Locations: 1 country
• Sites: 1

Brief Summary

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

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

Outcome Measures

Primary Outcomes (1)

• The rate of infertility with and without prior cyc.

  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.

  1 year after the study is closed to enrollment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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
• years of age or older
• English speaking

You may not qualify if:

• Inability to provide informed consent and complete survey

Sponsors & Collaborators

• University of South Florida: lead
• Duke University: collaborator
• Boston University: collaborator
• Data Management and Coordinating Center (DMCC): collaborator

Study Sites (1)

University of South Florida Data Management Coordinating Center

Tampa, Florida, 33612, United States

Location

MeSH Terms

Conditions

Giant Cell Arteritis; Takayasu Arteritis; Polyarteritis Nodosa; Granulomatosis with Polyangiitis; Microscopic Polyangiitis; Churg-Strauss Syndrome; Behcet Syndrome; Mucocutaneous Lymph Node Syndrome; IgA Vasculitis; Vasculitis, Central Nervous System

Condition Hierarchy (Ancestors)

Autoimmune Diseases of the Nervous System; Nervous System Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Arteritis; Vasculitis; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Aortic Arch Syndromes; Aortic Diseases; Systemic Vasculitis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis; Cerebral Small Vessel Diseases; Granuloma; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Mouth Diseases; Stomatognathic Diseases; Uveitis, Anterior; Panuveitis; Uveitis; Uveal Diseases; Eye Diseases; Hereditary Autoinflammatory Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases, Genetic; Purpura; Blood Coagulation Disorders; Hematologic Diseases; Hemostatic Disorders; Hemorrhagic Disorders; Immune Complex Diseases; Hypersensitivity; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms

Study Officials

• Megan Clowse, MD, MPH

  Duke University

  STUDY CHAIR

• Amanda M. Terry, MA

  USF College of Medicine

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2014
• First Posted: June 26, 2014
• Study Start: February 1, 2011
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: June 26, 2014

Record last verified: 2014-06

Locations

US (1)