Ignite Creation Date:
2025-12-24 @ 10:55 PM
Ignite Modification Date:
2026-02-20 @ 6:58 AM
Study NCT ID:
NCT01772069
Status:
COMPLETED
Last Update Posted:
2017-02-02
First Post:
2013-01-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Health-Related Quality of Life in Patients With Systemic Lupus Erythematosus:Focusing on Fibromyalgia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008180', 'term': 'Lupus Erythematosus, Systemic'}], 'ancestors': [{'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-31', 'studyFirstSubmitDate': '2013-01-17', 'studyFirstSubmitQcDate': '2013-01-17', 'lastUpdatePostDateStruct': {'date': '2017-02-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-01-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'EuroQoL (EQ-5D)', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['systemic lupus erythematosus, disease activity, sleep, quality of life'], 'conditions': ['Quality of Life']}, 'descriptionModule': {'briefSummary': '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.\n\nIt 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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '30 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '* Patients : 150 women age 30 to 60 years with SLE\n* Control subjects : age, sex matched control subject (150 subjects)\n* Patients : First visit and second visit after an interval of six months\n* Control subjects : baseline only', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Woman between 30 and 60 years of age, inclusive\n2. Have a diagnosis of Systemic lupus erythematosus according to the 1997 updated American college of Rheumatology criteria for classification of systemic lupus erythematosus\n\nExclusion Criteria:\n\n1. Patients were excluded if they had had a history of head injury that led to unconsciousness\n2. Have unstable disease necessitating an increase in prednisone dose or the addition of another immunosuppressive medication\n3. Have a current malignancy\n4. Have a history of or current evidence of substance abuse (drug or alcohol) problem within the previous 2 years'}, 'identificationModule': {'nctId': 'NCT01772069', 'briefTitle': 'Health-Related Quality of Life in Patients With Systemic Lupus Erythematosus:Focusing on Fibromyalgia', 'organization': {'class': 'OTHER', 'fullName': 'The Catholic University of Korea'}, 'orgStudyIdInfo': {'id': 'HC12QIMI0020'}}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Catholic University of Korea', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Jun-Ki Min', 'investigatorAffiliation': 'The Catholic University of Korea'}}}}