Last updated: 07/21/2020 17:20:15
HO-16-16611 - SLICC/SDI Indirect Cohort Comparison
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
Official title: HO-16-16611 - SLICC/SDI Indirect Cohort Comparison
Trial description: Two Phase 3 randomized controlled trials of intravenously (IV) administered belimumab have established the clinical effectiveness of belimumab plus standard of care (SoC) versus SoC alone at 52 (BLISS 52) and 76 (BLISS 76) weeks. The purpose of this study is to provide a long-term comparative analysis between belimumab plus SoC versus SoC alone in the treatment of systemic lupus erythematosus (SLE). It plans to do so by comparing BLISS long term extension (LTE) subjects to propensity score-matched SLE subjects with similar Baseline characteristics taken from an external SLE cohort. Based on the literature review, Toronto Lupus Cohort (TLC) is identified as the preferred source of SoC data for this study. A subset of the TLC with subject Baseline characteristics similar to the BLISS trials has previously been used in a GlaxoSmithKline (GSK) study of mortality and damage progression in SLE. The use of a similar subset of the TLC is envisioned in this study.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
The difference in change in Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index (SDI) from Baseline to year 5 interval
Timeframe: Baseline and up to 5 years
Secondary outcomes:
The difference in time to first SDI worsening between subjects treated with belimumab or SoC.
Timeframe: Up to 6.5 years
The change from Baseline SDI score by year interval for subjects treated with belimumab or SoC.
Timeframe: Baseline and up to 6.5 years
The difference in change from Baseline SDI score by year interval between subjects treated with belimumab or SoC.
Timeframe: Baseline and up to 6.5 years
Transition analysis of SDI from Baseline over a 5-year period for subjects treated with belimumab or SoC
Timeframe: Baseline and up to 5 years
Change from Baseline in SDI organ damage system
Timeframe: Baseline and up to 5 years
The frequency of increase from Baseline in SDI organ damage system subscores between subjects treated with belimumab or SoC
Timeframe: Baseline and up to 6.5 years
The difference in mean Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) from Baseline over the 5-year period
Timeframe: Baseline and up to 5 years
The difference in cumulative corticosteroid usage from Baseline over the 5-year period
Timeframe: Baseline and up to 5 years
Interventions:
Other: Standard of care
Vaccine: Belimumab
Enrollment:
1
Observational study model:
Case-Control
Primary completion date:
2017-10-07
Time perspective:
Retrospective
Clinical publications:
Murray B. Urowitz, Robert L. Ohsfeldt, Ronald C. Wielage, Kari A. Kelton, Yumi Asukai, Sulabha Ramachandran. Organ damage in patients treated with belimumab versus standard of care: a propensity score-matched comparative analysis. Ann Rheum Dis. 2019;78(3):372-379
DOI: 10.1136/annrheumdis-2018-214043
PMID: 30610066
Medical condition
Systemic Lupus Erythematosus
Product
belimumab
Collaborators
University of Toronto Lupus Clinic, Medical Decision Modeling Inc.
Study date(s)
August 2016 to July 2017
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
none
- Diagnosis of systemic lupus erythematosus (International Classification of Diseases-9 710.0) using >= 4 of 11 American College of Rheumatology (ACR) criteria (710.0)
- >=18 years of age
- Active severe lupus nephritis or central nervous system lupus
- Receipt of Beta cell target therapy at any time
Inclusion and exclusion criteria
Inclusion criteria:
- Diagnosis of systemic lupus erythematosus (International Classification of Diseases-9 710.0) using >= 4 of 11 American College of Rheumatology (ACR) criteria (710.0)
- >=18 years of age
- SELENA SLEDAI/SLEDAI-Version 2K score >= 6 at Baseline
- Auto-antibody positive (anti-nuclear antibody >= 1:80 and/or anti-double stranded DNA [dsDNA] >=30 International unit per milliliter)
Exclusion criteria:
- Active severe lupus nephritis or central nervous system lupus
- Receipt of Beta cell target therapy at any time
- For TLC patients, previous use of belimumab
Trial location(s)
No location data available.
Study documents
Clinical study report
Available language(s): English
Protocol
Available language(s): English
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
2017-10-07
Actual study completion date
2017-10-07
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
Participate in clinical trial
Access to clinical trial data by researchers
Visit website