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

• ClinicalTrials.gov Identifier: NCT00342095
• Recruitment Status: Completed
• First Posted: June 21, 2006
• Last Update Posted: July 2, 2017
• Sponsor: National Institute of Environmental Health Sciences (NIEHS)
• Information provided by: National Institutes of Health Clinical Center (CC)

Study Description

Brief Summary:

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 or disease
Systemic Lupus Erythematosus

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.

Study Design

• Study Type: Observational
• Enrollment: 640 participants
• 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
• Study Start Date: December 17, 1996
• Study Completion Date: March 7, 2007

Groups and Cohorts

Outcome Measures

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• 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

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
• Other Study ID Numbers: 999997002; OH97-E-N002
• 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