Duke Lupus Registry

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Duke University
Sponsor:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00512694
First received: August 6, 2007
Last updated: July 11, 2014
Last verified: May 2014
  Purpose

Lupus is a systemic autoimmune disease that can present with many varied symptoms, including joint pain, fevers, kidney disease, and rashes. Lupus can affect anyone, but it is most common in younger women.

The Duke Lupus Registry will collect information and blood samples from patients with lupus (systemic lupus erythematosus or cutaneous lupus) seen in the Duke Rheumatology clinics. The goal of this Registry is to understand how lupus changes over time so that we can improve the treatment of patients with lupus.


Condition
Systemic Lupus Erythematosus
Cutaneous Lupus

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Duke Lupus Registry

Resource links provided by NLM:


Further study details as provided by Duke University:

Biospecimen Retention:   Samples Without DNA

Blood samples will be collected for future research.


Estimated Enrollment: 1000
Study Start Date: July 2007
Detailed Description:

The Duke Lupus Registry is a prospective cohort comprised of patients with lupus seen in the Duke Rheumatology clinic.

The Duke Lupus Registry has two main purposes:

  1. Improved patient care. By following disease activity scores and medication usage, we expect to improve our care of the patients seen in clinic.
  2. Future research on lupus outcomes. This may encompass a broad array of areas, including but not limited to cardiovascular health, pregnancy and fertility, infections, medication use, quality of life, and depression.

At each office visit, patients will complete a questionnaire, physicians will measure lupus activity, and patients may be asked to provide a small blood sample. Patients will not be required to make extra visits to Duke in order to participate -- all paperwork and blood draws will occur during a regularly scheduled office visit with the physician.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Any patients with lupus.

Criteria

Inclusion Criteria:

  • Diagnosis of Systemic Lupus Erythematosus or Cutaneous Lupus
  • Patient of a rheumatologist at Duke University Medical Center

Exclusion Criteria:

  • Inability to travel to Duke for follow-up visits
  • Inability to speak English
  • Not able to provide informed consent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00512694

Contacts
Contact: Martin Tochacek, PhD (919) 684-5586 martin.tochacek@duke.edu

Locations
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Martin Tochacek, PhD         
Sub-Investigator: Stacy Ardoin, MD         
Sub-Investigator: Lisa G. Criscione-Schreiber, MD         
Principal Investigator: Megan E. B. Clowse, MD, MPH         
Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: Megan E. B. Clowse, MD, MPH Duke University
  More Information

Additional Information:
No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00512694     History of Changes
Other Study ID Numbers: Pro00008875, 8652-07-6R1
Study First Received: August 6, 2007
Last Updated: July 11, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Duke University:
Lupus
Systemic Lupus Erythematosus
Cutaneous Lupus

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on August 19, 2014