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

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ClinicalTrials.gov Identifier: NCT01772069
Recruitment Status : Completed
First Posted : January 21, 2013
Last Update Posted : February 2, 2017
Sponsor:
Information provided by (Responsible Party):
Jun-Ki Min, The Catholic University of Korea

Brief 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.


Condition or disease
Quality of Life

Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Case-Control
Time Perspective: Prospective
Study Start Date : January 2013
Actual Primary Completion Date : May 2015
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia Lupus
U.S. FDA Resources




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


Information from the National Library of Medicine

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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
Criteria

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

Responsible Party: Jun-Ki Min, Professor, The Catholic University of Korea
ClinicalTrials.gov Identifier: NCT01772069     History of Changes
Other Study ID Numbers: HC12QIMI0020
First Posted: January 21, 2013    Key Record Dates
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