Last updated: 07/21/2020 17:20:15

HO-16-16611 - SLICC/SDI Indirect Cohort Comparison

GSK study ID
206347
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: 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
    Primary completion date:
    2017-10-07
    Observational study model:
    Case-Control
    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)

    This study does not involve prospective enrollment of participants.

    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    Protocol
    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
    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