Duke Lupus Registry

January 6, 2026 updated by: Duke University

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.

Study Overview

Status

Recruiting

Conditions

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

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Any patients with lupus.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Investigators

  • Principal Investigator: Megan E. B. Clowse, MD, MPH, Duke University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2007

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

June 1, 2028

Study Registration Dates

First Submitted

August 6, 2007

First Submitted That Met QC Criteria

August 6, 2007

First Posted (Estimated)

August 8, 2007

Study Record Updates

Last Update Posted (Estimated)

January 8, 2026

Last Update Submitted That Met QC Criteria

January 6, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00008875
  • 8652-07-6R1 (Other Identifier: Duke legacy protocol number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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