Last updated: 01/09/2019 20:10:29

Description of QoL data (SF-36 and FACIT) from the BLISS long-term extension study

GSK study ID
206350
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: Description of QoL data (SF-36 and FACIT) from the BLISS long-term extension study
Trial description: The objective of this post-hoc analysis is to describe the change in, and maintenance of, QoL over long-term (up to six years) in SLE patients treated with belimumab and standard of care therapy. Currently, only descriptive summary of aggregated data is available for the 36-Item Short Form Health Survey (SF-36) and Functional Assessment of Chronic Illness Therapy (FACIT) from the BLISS long-term extension study. Subjects will be from the modified intention-to-treat (MITT) population, defined as those who completed the 72-week BLISS parent study and received either belimumab 1 or 10 milligrams per kilogram (mg/kg) or placebo, followed by enrollment in the long-term extension study and received at least one dose of the study treatment. In this study, subjects’ QoL will be assessed based on the self-administered questionnaire, completed annually up to 6 years after completing the study treatment.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Change from Baseline in SF-36 Physical Component Summary (PCS) and Mental Component summary (MCS) scores to Year 6

Timeframe: Baseline and at Week 48 of each study year up to year 6

Change from Baseline in FACIT-Fatigue scores to Year 6

Timeframe: Baseline and at Week 48 of each study year up to year 6

Secondary outcomes:

SF-36 PCS, MCS and domain scores at annual time points from Year 0 to Year 6

Timeframe: Up to Year 6

FACIT-Fatigue scores at annual time points from Year 0 to Year 6

Timeframe: Up to Year 6

Interventions:
  • Other: SF-36
  • Drug: Belimumab
  • Other: FACIT
    • Enrollment:
    1
    Primary completion date:
    2016-08-06
    Observational study model:
    Cohort
    Time perspective:
    Cross-Sectional
    Clinical publications:
    Strand V, Berry P, Lin X, Asukai Y, Punwaney R, Ramachandran S. Long-Term Impact of Belimumab on Health-Related Quality of Life and Fatigue in Patients with Systemic Lupus Erythematosus: 6 Years of Treatment. Arthritis Care Res. 2018;71(6):829-838 DOI: 10.1002/acr.23788 PMID: 30320964
    Medical condition
    Systemic Lupus Erythematosus
    Product
    belimumab
    Collaborators
    Not applicable
    Study date(s)
    May 2016 to June 2016
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    Accepts healthy volunteers
    none
    • Population: The primary population is the modified intention-to-treat (MITT) population defined as all subjects who completed BEL110751, enrolled in BEL112233 and was treated with at least one dose of study treatment.
    • Subgroups: The primary subgroup are- All subjects who had a response. Responders will be defined as those who have a minimum SLE Responder Index (SRI) improvement of 4 points at one year from the start of the long-term extension (LTE) study.
    • None
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Population: The primary population is the modified intention-to-treat (MITT) population defined as all subjects who completed BEL110751, enrolled in BEL112233 and was treated with at least one dose of study treatment.
    • Subgroups: The primary subgroup are- All subjects who had a response. Responders will be defined as those who have a minimum SLE Responder Index (SRI) improvement of 4 points at one year from the start of the long-term extension (LTE) study.
    • All subjects who experienced a flare according to SLE Flare Index (SFI) at Baseline.
    • All subjects who experienced a flare according to British Isles Lupus Assessment Group (BILAG) at Baseline.
    • All subjects with high disease activity at Baseline defined as Patients with elevated anti–double-stranded DNA (anti-dsDNA) and/or complement (C3/C4)
    • The secondary subgroups are: Stratified by parent study treatment. The patient population will be stratified in two ways: 1. Belimumab parent study vs placebo parent study 2. Belimumab 10mg parent study, belimumab 1 mg parent study, placebo parent study
    • Stratified by glucocorticoid dose (prednisone equivalent) at baseline (0, <7.5 or ≥7.5 mg/day)
    • By Systemic lupus international collaborating clinics (SLICC)/American college of rheumatology (ACR) damage index (SDI) organ damage: three sub-groups: SDI score 0, 1 and 2+ (removing Baseline SDI as covariate).
    Exclusion criteria:
    • None

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    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
    2016-08-06
    Actual study completion date
    2016-08-06

    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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