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

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: January 21, 2013
Last Update Posted: February 2, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Jun-Ki Min, The Catholic University of Korea

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.

Quality of Life

Study Type: Observational
Study Design: Observational Model: Case-Control
Time Perspective: Prospective

Resource links provided by NLM:

Further study details as provided by Jun-Ki Min, The Catholic University of Korea:

Primary Outcome Measures:
  • EuroQoL (EQ-5D) [ Time Frame: 1 year ]

Estimated Enrollment: 300
Study Start Date: January 2013
Study Completion Date: November 2015
Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)

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Ages Eligible for Study:   30 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: Jun-Ki Min, Professor, The Catholic University of Korea
ClinicalTrials.gov Identifier: NCT01772069     History of Changes
Other Study ID Numbers: HC12QIMI0020
First Submitted: January 17, 2013
First Posted: January 21, 2013
Last Update Posted: February 2, 2017
Last Verified: January 2017

Keywords provided by Jun-Ki Min, The Catholic University of Korea:
systemic lupus erythematosus, disease activity, sleep, quality of life

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases