Duke Lupus Registry

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT00512694
Recruitment Status : Recruiting
First Posted : August 8, 2007
Last Update Posted : July 28, 2017
Information provided by (Responsible Party):
Duke University

Brief Summary:

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 or disease
Systemic Lupus Erythematosus Cutaneous Lupus

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.

Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Duke Lupus Registry
Study Start Date : July 2007
Estimated Primary Completion Date : June 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus
U.S. FDA Resources

Biospecimen Retention:   Samples Without DNA
Blood samples will be collected for future research.

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Any patients with lupus.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00512694

Contact: Laura Neil (919) 684-8936

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

Additional Information:
Responsible Party: Duke University Identifier: NCT00512694     History of Changes
Other Study ID Numbers: Pro00008875
8652-07-6R1 ( Other Identifier: Duke legacy protocol number )
First Posted: August 8, 2007    Key Record Dates
Last Update Posted: July 28, 2017
Last Verified: July 2017

Keywords provided by Duke University:
Systemic Lupus Erythematosus
Cutaneous Lupus

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