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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified January 2013 by The Catholic University of Korea
Sponsor:
Information provided by (Responsible Party):
Jun-Ki Min, The Catholic University of Korea
ClinicalTrials.gov Identifier:
NCT01772069
First received: January 17, 2013
Last updated: NA
Last verified: January 2013
History: No changes posted
  Purpose

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
Quality of Life

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months

Resource links provided by NLM:


Further study details as provided by The Catholic University of Korea:

Primary Outcome Measures:
  • EuroQoL (EQ-5D) [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: January 2013
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   30 Years to 60 Years
Genders 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01772069

Contacts
Contact: Jun-Ki Min, MD, PhD 82-32-340-7016 min6403@catholic.ac.kr

Sponsors and Collaborators
The Catholic University of Korea
  More Information

No publications provided

Responsible Party: Jun-Ki Min, Professor, The Catholic University of Korea
ClinicalTrials.gov Identifier: NCT01772069     History of Changes
Other Study ID Numbers: HC12QIMI0020
Study First Received: January 17, 2013
Last Updated: January 17, 2013
Health Authority: Korea: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on October 23, 2014