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A Continuation Trial for Subjects With Systemic Lupus Erythematosus That Have Completed Protocol LBSL02

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00583362
First received: December 20, 2007
Last updated: December 13, 2012
Last verified: December 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Systemic Lupus Erythematosus
 Biological: Belimumab
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Lupus
Drug Information available for: Belimumab
U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • To evaluate the long-term safety of LymphoStat-B™ in subjects with SLE. [ Time Frame: Until study completion ] [ Designated as safety issue: Yes ]

Enrollment: 298
Study Start Date: November 2004
Estimated Study Completion Date: May 2016
Primary Completion Date: September 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Belimumab 10 mg/kg
Belimumab 10 mg/kg IV over one hour every 28 days.
 Biological: Belimumab
Belimumab 10mg/kg IV over one hour every 28 days
Other Names:
  • HGS1006
  • BENLYSTA
  • LymphoStat-B™

Detailed Description:

The purpose of this continuation study to evaluate the long-term safety and efficacy of LymphoStat-B™ in subjects with Systemic Lupus Erythematosus (SLE), that completed study LBSL02 and benefitted from treatment.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00583362

  Show 69 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided by GlaxoSmithKline

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00583362     History of Changes
Other Study ID Numbers: 112626, LBSL99
Study First Received: December 20, 2007
Last Updated: December 13, 2012
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by GlaxoSmithKline:
SLE
Lupus

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on May 19, 2013