Last updated: 01/09/2019 20:10:29
Description of QoL data (SF-36 and FACIT) from the BLISS long-term extension study
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
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
Observational study model:
Cohort
Primary completion date:
2016-08-06
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)
No location data available.
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Finalized
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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