Reproductive Health in Men and Women With Vasculitis

NCT ID: NCT02176070

Last Updated: 2014-06-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

467 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-02-28

Study Completion Date

2012-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Duke University

OTHER

Sponsor Role collaborator

Boston University

OTHER

Sponsor Role collaborator

Data Management and Coordinating Center (DMCC)

OTHER

Sponsor Role collaborator

University of South Florida

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Megan Clowse, MD, MPH

Role: STUDY_CHAIR

Duke University

Amanda M. Terry, MA

Role: STUDY_CHAIR

USF College of Medicine

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of South Florida Data Management Coordinating Center

Tampa, Florida, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

5531

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

VCRC Tissue Repository
NCT02967068 RECRUITING
Pediatric Vasculitis Initiative
NCT02006134 RECRUITING
Belimumab in Remission of VASculitis
NCT01663623 COMPLETED PHASE3