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

Quality of Life Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01772069
• Other study ID #: HC12QIMI0020
• Status: Completed
• Phase: N/A
• First received: January 17, 2013
• Last updated: January 31, 2017
• Start date: January 2013
• Est. completion date: November 2015

Study information

• Verified date: January 2017
• Source: The Catholic University of Korea
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: November 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 30 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Quality of Life

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The Catholic University of Korea

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	EuroQoL (EQ-5D)		1 year