Health-Related Quality of Life in Patients With Systemic Lupus Erythematosus:Focusing on Fibromyalgia

Systemic lupus erythematosus (SLE) patients show a high prevalence of fibromyalgia though rates vary considerably from one study to another (from 8.2% to 45%). Although fibromyalgia can bring out the disability in daily life, the majority of previous reports only ascertained no significant association between the presence of fibromyalgia and the severity of SLE.

It is necessary to make unremitting effort to reduce the mortality and life-threatening disease flare-up due to SLE disease itself. Additionally, we think that physicians need to pay more attention to improve health-related quality of life (HRQoL) in the patients with SLE. HRQoL could be influenced by various factors such as depression, fibromyalgia, disease duration, disease activity and etc. To improve the HRQoL in SLE patients, it might be the clinically important and constructive theme to investigate that which is the most important factor among the fibromyalgia, depression, sleep quality, SLE activity and SLE duration.

The objective of this study is to evaluate the degree of contribution of fibromyalgia for reduced HRQoL and to identify the status of managing fibromyalgia in Korean patients with SLE.

Study Overview

• Status: Completed
• Conditions: Quality of Life

• Study Type: Observational
• Enrollment (Anticipated): 300

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 60 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

• Patients : 150 women age 30 to 60 years with SLE
• Control subjects : age, sex matched control subject (150 subjects)
• Patients : First visit and second visit after an interval of six months
• Control subjects : baseline only

Description

Inclusion Criteria:

1. Woman between 30 and 60 years of age, inclusive
2. Have a diagnosis of Systemic lupus erythematosus according to the 1997 updated American college of Rheumatology criteria for classification of systemic lupus erythematosus

Exclusion Criteria:

1. Patients were excluded if they had had a history of head injury that led to unconsciousness
2. Have unstable disease necessitating an increase in prednisone dose or the addition of another immunosuppressive medication
3. Have a current malignancy
4. Have a history of or current evidence of substance abuse (drug or alcohol) problem within the previous 2 years

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
EuroQoL (EQ-5D)	1 year

Collaborators and Investigators

• Sponsor: The Catholic University of Korea

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (ACTUAL): May 1, 2015
• Study Completion (ACTUAL): November 1, 2015

Study Registration Dates

• First Submitted: January 17, 2013
• First Submitted That Met QC Criteria: January 17, 2013
• First Posted (ESTIMATE): January 21, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): February 2, 2017
• Last Update Submitted That Met QC Criteria: January 31, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: systemic lupus erythematosus, disease activity, sleep, quality of life
• Other Study ID Numbers: HC12QIMI0020