Last updated: 10/09/2024 06:30:09

A study to evaluate Health-related quality of life in participants with lupus nephritis

GSK study ID
212981
See study documents
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: The Health-related Quality of Life, Fatigue and Health Utility of Patients with Lupus Nephritis
Trial description: This is a non-interventional, multicenter, prospective cross-sectional survey study with a retrospective chart review component, and a sub-study including a
Sub-group of participants in the United States (US) undergoing a face-to-face qualitative interview (or by telephone if needed). The purpose of this non-interventional study is to characterize the participant’s perspective of Lupus nephritis (LN), including its impact on health-related quality of life (HRQoL), fatigue, and health utility in the US and Germany. The participant’s overall treatment and disease experience will also be explored. The content validity of selected patient report outcomes (PROs) in an LN population will be explored in a subset of US participants.
Primary purpose:
Other
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Short Form-36 (SF-36) score

Timeframe: Up to 10 minutes

Secondary outcomes:

LupusQoL score

Timeframe: Up to 10 minutes

FACIT-Fatigue score

Timeframe: Up to 10 minutes

Patient Global Assessment (PtGA) score

Timeframe: Up to 1 minute

Work Productivity and Activity Impairment (WPAI)-Lupus score

Timeframe: Up to 5 minutes

Euro Quality-5 dimension-3 level (EQ-5D-3L) score

Timeframe: Up to 10 minutes

Number of participants assessed for content validity of selected PROs

Timeframe: Up to 90 minutes

Interventions:
  • Other: Participant Survey
  • Other: Qualitative interviews
    • Enrollment:
    44
    Primary completion date:
    2021-23-11
    Observational study model:
    Cohort
    Time perspective:
    Prospective
    Clinical publications:
    Not applicable
    Medical condition
    Lupus Nephritis
    Product
    belimumab
    Collaborators
    Evidera
    Study date(s)
    December 2020 to January 2022
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    Accepts healthy volunteers
    No
    • Inclusion criteria:
    • Biopsy-proven diagnosis of LN class III, IV or VI (with or without class V) or pure class V.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Inclusion criteria:
    • Biopsy-proven diagnosis of LN class III, IV or VI (with or without class V) or pure class V.
    • Males or females of age 18 years or older.
    • Ability to understand the requirements of the study, provide informed consent (including consent for the use and disclosure of research-related health information), ability to use a computer or hand-held device with internet access, to speak and read English or German and to complete a one-time electronic survey.
    • Consent to medical record access. Exclusion Criteria:
    • Absence of any of the following from the medical record within the last six months: renal laboratory results (urinary protein to creatinine ratio [UPCR] or 24-hour proteinuria or urine sediment [activity], serum creatinine or estimated glomerular filtration rate [eGFR] or GFR, if eGFR is not available).
    • Current enrolment in an interventional clinical trial.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Boston, Massachusetts, United States, 02115
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Chapel Hill, North Carolina, United States, 27517
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Duesseldorf, Nordrhein-Westfalen, Germany, 40225
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Graz, Austria, 8036
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Mainz, Rheinland-Pfalz, Germany, 55131
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Manhasset, New York, United States, 11030
    Status
    Study Complete
    Contact us
    Showing 1 - 6 of 11 Results

    Study documents

    Protocol
    Available language(s): English
    Download document(s)
    Statistical analysis plan
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    2021-23-11
    Actual study completion date
    2022-05-01

    Plain language summaries

    Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

    Additional information about the trial

    Not applicable
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