Last updated: 07/21/2020 17:00:06

Indirect treatment comparison of IV formulation and SC formulation of belimumab for the treatment of adult patients with active, autoantibody-positive systemic lupus erythematosus (SLE) who are receiving standard therapy

GSK study ID
207255
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: Indirect treatment comparison of IV formulation and SC formulation of belimumab for the treatment of adult patients with active, autoantibody-positive systemic lupus erythematosus (SLE) who are receiving standard therapy
Trial description: This study will evaluate four, published, randomized controlled clinical trials (RCTs) of belimumab in subjects with active, autoantibody-positive SLE who are receiving standard therapy and have high disease status. Both formulations of belimumab, IV and SC have not been compared directly in any trial. SC administration is believed to be more convenient than IV infusion as it may offer an alternative to subjects with poor venous access. The flexibility of administration will also reduce the time of infusion. The SLE population is comprised predominately of females of reproductive age who need a more flexible method of receiving belimumab that has less impact on time for work, family duties, and travel. Therefore meta-analysis will be performed to evaluate the relative efficacy and safety between IV formulation and SC formulation of Belimumab.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

SLE Response Index (SRI) at Week 52

Timeframe: Week 52

Secondary outcomes:

Number of subjects with >= 4 point reduction in SELENA SLEDAI score at Week 52

Timeframe: Week 52

Rate of severe flare occurrence over 52 Weeks

Timeframe: 52 weeks

Interventions:
  • Drug: Belimumab IV
  • Drug: Belimumab SC
    • Enrollment:
    0
    Primary completion date:
    2017-23-01
    Observational study model:
    Cohort
    Time perspective:
    Retrospective
    Clinical publications:
    Sulabha Ramachandran, Daniel Parks, Milena Kurtinecz, David Roth, Rafael Alfonso Cristancho. An indirect comparison of intravenous and subcutaneous belimumab efficacy in patients with SLE and high disease activity. J Compar Effect Res. 2018;7(6):581-593. DOI: 10.2217/cer-2017-0085 PMID: 29692179
    Medical condition
    Systemic Lupus Erythematosus
    Product
    belimumab
    Collaborators
    Not applicable
    Study date(s)
    November 2016 to January 2017
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    Accepts healthy volunteers
    none
    • Inclusion Criteria
    • Subjects who were at least 18 years of age at screening visit.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Inclusion Criteria
    • Subjects who were at least 18 years of age at screening visit.
    • Diagnosis of SLE according to American College of Rheumatology (ACR) Criteria
    • Active SLE defined by SELENA SLEDAI score at screening of >=6
    • Positive antinuclear antibody test (titer >=1:80) or anti-double stranded deoxyribonucleic acid (DNA) (>=30 international unit /milliliter) from 2 independent time points, 1 within the screening period
    • Stable SLE treatment regimen for a period of 30 days or more (depending on agent/study) prior to Day 0 Exclusion Criteria
    • Any prior B cell targeted therapy
    • Investigational biologic (including abatacept): within past year
    • IV cyclophosphamide within past 180 days
    • Anti-tumor necrosis factor, anakinra, intravenous immunoglobulin, high dose prednisone, plasmapheresis within past 90 days
    • New immunosuppressive, anti-malarial, non-steroidal anti-inflammatory drugs within past 60 days
    • Severe lupus kidney disease/active nephritis within past 90 days
    • Severe central nervous system lupus requiring intervention within past 60 days
    • History of renal transplant
    • Grade 3 or 4 laboratory abnormality (some lupus-related exceptions permitted)
    • History of anaphylactic reaction to parenterally administered contrast agents/proteins

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    Protocol
    Available language(s): English
    Download document(s)
    Clinical study report
    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
    2017-23-01
    Actual study completion date
    2017-23-01

    Plain language summaries

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

    Additional information about the trial

    Not applicable
    Participate in clinical trial
    Access to clinical trial data by researchers
    Visit website