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Hormonal and Environmental Risk Factors for Developing Systemic Lupus Erythematosus: The Carolina Lupus (CLU) Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00342095
First Posted: June 21, 2006
Last Update Posted: July 2, 2017
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. Read our disclaimer for details.
Information provided by:
National Institutes of Health Clinical Center (CC)
  Purpose

Systemic lupus erythematosus (SLE) is severe, chronic, disabling autoimmune disease that significantly affects health status and quality of life. Since the disease occurs most often in young to middle-aged adults, SLE can also affect work and disability. However, there is currently little information on work-related disability from longitudinal, population-based studies of SLE.

Participants were enrolled into the Carolina Lupus Study between February, 1997 and July 1999. We plan to conduct two telephone contacts with patients and one telephone contact with controls in a follow-up study to be conducted in 2001. The first patient contact will follow an introductory letter that describes the follow-up study. This letter provides participants the opportunity (via a toll-free phone number) to decline further contact about this study. The first patient contact will be a short (5 minute) interview in which we determine their current source of lupus-related medical care, timing of next expected visit, and update contact information. The second contact will involve a 60-minute telephone interview covering medical care utilization, current health status (including a patient-administered measure of lupus activity), work and disability issues, psychosocial attributes (e.g. helplessness, social support, daily stressors including race-related issues), and changes in exposures since the initial interview. We will attempt to schedule the patients' interviews within 3 months before or after the patient sees his or her own physician for SLE-related evaluation or treatment. A short (15 minutes or less) telephone interview will be conducted with controls focusing on current health, work status, and daily stresso.

Ddisease damage will be assessed using the System Lupus international Collaborating Clinics (SLICC)/American College of Rheumatology (ACR) Damage Index, a standardized and validated instrument that is completed by the patient's physician.

We will seek death certificates for patients and controls who have died in order to obtain cause of death information. Next-of-kin information from death certificates will not be used.

This study will allow up to determine the feasibility of obtaining reliable data on disease damage from more than 50 physicians involved in the treatment of patients in the Carolina Lupus Study. This developmental work is a necessary foundation for any additional follow-up studies of the Carolina Lupus Study cohort. We will also be able to examine associations with disability in patients and in controls and to examine the contribution of various factors to the increased disease severity experience by African-American SLE patients.


Condition
Systemic Lupus Erythematosus

Study Type: Observational
Official Title: Hormonal and Environmental Risk Factors for Developing Systemic Lupus Erythematosus: The Carolina Lupus Study (CLU) and Disease Progression and Activity in the Carolina Lupus Study

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 640
Study Start Date: December 17, 1996
Estimated Study Completion Date: March 7, 2007
Detailed Description:

Systemic lupus erythematosus (SLE) is severe, chronic, disabling autoimmune disease that significantly affects health status and quality of life. Since the disease occurs most often in young to middle-aged adults, SLE can also affect work and disability. However, there is currently little information on work-related disability from longitudinal, population-based studies of SLE.

Disease damage will be assessed using the System Lupus international Collaborating Clinics (SLICC)/American College of Rheumatology (ACR) Damage Index, a standardized and validated instrument that is completed by the patient's physician.

This study will allow us to determine the feasibility of obtaining reliable data on disease damage from more than 50 physicians involved in the treatment of patients in the Carolina Lupus Study. This developmental work is a necessary foundation for any additional follow-up studies of the Carolina Lupus Study cohort. We will also be able to examine associations with disability in patients and in controls and to examine the contribution of various factors to the increased disease severity experience by African-American SLE patients.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria
  • INCLUSION CRITERIA:

Patients were eligible for the study if they met the 1997 revised American College of Rheumatology classification criteria for SLE (32, 33), were diagnosed between January 1, 1995 and July 31, 1999, were 18 years or older at study enrollment, had lived within the study area during at least 6 months of the year prior to diagnosis, and could speak and understand English.

  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00342095


Locations
United States, North Carolina
University of North Carolina
Chapel Hill, North Carolina, United States, 27599-7030
Duke University Medical Center
Durham, North Carolina, United States, 27710
East Carolina University
Greenville, North Carolina, United States, 27858-4354
Wake Medical Center
Raleigh, North Carolina, United States
NIEHS, Research Triangle Park
Research Triangle Park, North Carolina, United States, 27709
United States, South Carolina
Medical University of South Carolina
Columbia, South Carolina, United States, 29208
Sponsors and Collaborators
National Institute of Environmental Health Sciences (NIEHS)
  More Information

ClinicalTrials.gov Identifier: NCT00342095     History of Changes
Other Study ID Numbers: 999997002
OH97-E-N002
First Submitted: June 19, 2006
First Posted: June 21, 2006
Last Update Posted: July 2, 2017
Last Verified: March 7, 2007

Keywords provided by National Institutes of Health Clinical Center (CC):
Autoimmune Diseases
Estrogen
Silica
Pesticides
Major Histocompatibility Complex
Genetic Susceptibility

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