Last updated: 07/17/2024 15:22:48

A Continuation Trial for Subjects with Systemic Lupus Erythematosus that have completed Protocol LBSL02

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GSK study ID
112626
See study documents
Clinicaltrials.gov ID
NCT00583362
See results summary
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: A Multi-Center, Open-Label, Continuation Trial LymphoStat-B™ Antibody (Monoclonal Anti-BLyS Antibody) in Subjects With Systemic Lupus Erythematosus (SLE) who Completed the Phase 2 Protocol LBSL02
Trial description: This is a continuation study to evaluate the long-term safety and efficacy of LymphoStat-B™ in subjects with SLE disease, that completed study LBSL02 and benefitted from treatment.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Not applicable
Primary outcomes:

Number of participants with the indicated type of adverse event (AEs) and serious adverse event (SAEs)

Timeframe: Approximately up to 13 years

Adverse event (AE) rates by system organ class (SOC) during the study

Timeframe: Approximately up to 13 years

SAE rates by system organ class (SOC) during the study

Timeframe: Approximately up to 13 years

Change from Baseline in activated partial thromboplastin time (APTT) and prothrombin time (PT) at the indicated time points

Timeframe: Baseline and approximately up to 13 years

Change from Baseline in basophils, eosinophils, lymphocytes, monocytes, neutrophils segmented and platelets at the indicated time points

Timeframe: Baseline and approximately up to 13 years

Change from Baseline in erythrocytes at the indicated time points

Timeframe: Baseline and approximately up to 13 years

Change from Baseline in hematocrit at the indicated time points

Timeframe: Baseline and approximately up to 13 years

Change from Baseline in hemoglobin at the indicated time points

Timeframe: Baseline and approximately up to 13 years

Change from Baseline in albumin and protein at the indicated time points

Timeframe: Baseline and approximately up to 13 years

Change from Baseline in blood urea nitrogen (BUN), glucose, calcium, carbon dioxide, chloride, magnesium, phosphate, potassium and sodium at the indicated time points

Timeframe: Baseline and approximately up to 13 years

Change from Baseline in creatinine, urate and bilirubin at the indicated time points

Timeframe: Baseline and approximately up to 13 years

Change from Baseline in BUN/creatinine at the indicated time points

Timeframe: Baseline and approximately up to 13 years

Change from Baseline in alanine aminotransferase (ALT), alkaline phosphatase (AP), aspartate aminotransferase (AST), gamma glutamyl transferase (GGT) and lactate dehydrogenase (LD) at the indicated time points

Timeframe: Baseline and approximately up to 13 years

Secondary outcomes:

Percentage of participants achieving SLE Responder Index (SRI) Response at indicated time points

Timeframe: Approximately up to 13 years

Observed anti-double stranded DNA levels in participants positive at Baseline at indicated time points

Timeframe: Approximately up to 13 years

Median percent change from Baseline in anti-double stranded DNA in participants positive at Baseline at indicated time points

Timeframe: Baseline and approximately up to 13 years

Observed complement C3 and C4 levels in participants low at Baseline at indicated time points

Timeframe: Approximately up to 13 years

Median percent change from Baseline in complement C3 and C4 levels in participants low at Baseline at indicated time points

Timeframe: Baseline and approximately up to 13 years

Percentage of participants with daily prednisone dose reduction at indicated time points

Timeframe: Approximately up to 13 years

Absolute serum immunoglobulin G values at indicated time points

Timeframe: Approximately up to 13 years

Median percent change from Baseline in Immunoglobulin G at indicated time points

Timeframe: Baseline and approximately up to 13 years

Interventions:
  • Biological/vaccine: Belimumab
    • Enrollment:
    298
    Primary completion date:
    2016-23-02
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Daniel J Wallace, Ellen M Ginzler, Joan T Merrill, Richard A Furie, William Stohl, W Winn Chatham, Arthur Weinstein, James McKay, W Joseph McCune, Michelle Petri, James Fettiplace, David Roth, Beulah Ji, Amy Heath. SAFETY AND EFFICACY OF BELIMUMAB PLUS STANDARD THERAPY FOR UP TO 13 YEARS IN PATIENTS WITH SYSTEMIC LUPUS ERYTHEMATOSUS. Arthritis Rheumatol. 2019;71(7):1125-1134 DOI: 10.1002/art.40861 PMID: 30771238
    Medical condition
    Systemic Lupus Erythematosus
    Product
    belimumab
    Collaborators
    GSK
    Study date(s)
    May 2005 to February 2016
    Type
    Interventional
    Phase
    2

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    Accepts healthy volunteers
    No
    • Primary Inclusion Criteria
    • 1. Have completed the LBSL02 trial and achieved a satisfactory response.
    Inclusion and exclusion criteria
    Inclusion criteria:

      Primary Inclusion Criteria 1. Have completed the LBSL02 trial and achieved a satisfactory response. Primary Exclusion Criteria 1. Required more than 2 courses of corticosteroids for treatment of severe SLE flares in the last 5 months of LBSL02. 2. Had an SLE flare during the last 30 days of LBSL02 and through the 1st dose in LBSL99. 3. Used any of the following prohibited medications during their participation in LBSL02:

      • Other investigational agents.
      • Biologic therapeutic agents: adalimumab (Humira™), etanercept (Enbrel™), infliximab (Remicade™), and rituximab (Rituxan™).
      • Intravenous cyclophosphamide.
      • Corticosteroids >100 mg/day prednisone equivalent for reasons other than severe SLE flare.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Albany, New York, United States, 12206
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Ann Arbor, Michigan, United States, 48109-5542
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Arlington, Virginia, United States, 22205-3606
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Atlanta, Georgia, United States, 30303
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Aventura, Florida, United States, 33180
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Baltimore, Maryland, United States, 21201
    Status
    Study Complete
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    Showing 1 - 6 of 57 Results

    Study documents

    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

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    Actual primary completion date
    2016-23-02
    Actual study completion date
    2016-23-02

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

    Additional information
    Not applicable
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