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.

Completed

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Key information

Conditions

Quality of Life Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Lupus Erythematosus, Systemic Skin and Connective Tissue Diseases

Age range

30 year–60 year

Sex eligibility

Female

Study type

Observational

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Woman between 30 and 60 years of age, inclusive
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

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

Treatment and study plan

Primary outcomes

EuroQoL (EQ-5D)

Time frame: 1 year

Sponsors and collaborators

Lead sponsor

The Catholic University of Korea

Other

Registry information

Important dates

Study start: 2013
Primary completion: 2015
Study completion: 2015
First posted: Jan 21, 2013
Registry last updated: Feb 2, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed