Quality of LifeNCT01772069
Health-Related Quality of Life in Patients With Systemic Lupus Erythematosus:Focusing on Fibromyalgia
An observational study of Quality of Life, run by The Catholic University of Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages 30 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Quality of Life
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- Jan 2013to Nov 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
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
Who may be able to join
- 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
Who cannot join
- 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
About this study
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.
- Conditions
- Quality of Life
- Keywords
- systemic lupus erythematosus, disease activity, sleep, quality of life
- Medical subject headings
- Lupus Erythematosus, Systemic
What is being measured
The primary outcome is the main question the study is designed to answer.
EuroQoL (EQ-5D)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2013 (estimated)
- Study startJan 2013
- Primary completionMay 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Catholic University of Korea
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jun-Ki Min, The Catholic University of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01772069
- Sponsor's protocol ID
- HC12QIMI0020
- Status last verified
- Jan 2017
- First submitted
- 17 Jan 2013
- Last updated
- 2 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health-Related Quality of Life in Patients With Systemic Lupus Erythematosus:Focusing on Fibromyalgia
- ClinicalTrials.gov ID
- NCT01772069
- Acronym / sponsor ID
- HC12QIMI0020
- Conditions
- Quality of Life
- Keywords
- systemic lupus erythematosus, disease activity, sleep, quality of life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- The Catholic University of KoreaUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- May 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 21 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 30 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
EuroQoL (EQ-5D)
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Quality of Life, run by The Catholic University of Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EuroQoL (EQ-5D) (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2017.