NCT00342095

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

Completed Last updated 2 July 2017

What this trial tests

trial in Systemic Lupus Erythematosus in 640 participants. Completed in 7 March 2007.

Timeline

17 December 1996

7 March 2007

Quick facts

Lead sponsor	National Institute of Environmental Health Sciences (NIEHS)
Status	Completed
Study type	OBSERVATIONAL
Enrollment	640
Start date	17 December 1996
Estimated completion	7 March 2007
Sites	6 locations across United States

Conditions studied

• Systemic Lupus Erythematosus — all drugs for Systemic Lupus Erythematosus →

Sponsor

National Institute of Environmental Health Sciences (NIEHS)

Who can join

18 and older, any sex, with Systemic Lupus Erythematosus. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own 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.

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.