A Continuation Trial for Subjects With Lupus Who Completed Protocol HGS1006-C1056 in the United States

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline ( Human Genome Sciences Inc., a GSK Company )
ClinicalTrials.gov Identifier:
NCT00724867
First received: July 28, 2008
Last updated: November 7, 2013
Last verified: November 2013
  Purpose

This is a continuation study to provide continuing treatment to subjects who completed study HGS1006-C1056 in the United States, to evaluate the long-term safety and efficacy of belimumab(LymphoStat-B™) in subjects with SLE disease.


Condition Intervention Phase
Systemic Lupus Erythematosus
Biological: Belimumab 1 mg/kg
Biological: Belimumab 10 mg/kg
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multi-Center, Continuation Trial of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects With Systemic Lupus Erythematosus (SLE) Who Completed the Phase 3 Protocol HGS1006-C1056 in the United States

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

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

Secondary Outcome Measures:
  • Assessment of efficacy and biomarkers including: disease activity, anti-dsDNA and serum complement levels, prednisone use, proteinuria level, serum immunoglobulin G, and B-cell subsets. [ Time Frame: Until study completion ] [ Designated as safety issue: No ]
  • Assessment of quality of life according to the following scales: SF-36 Health Survey, and FACIT-Fatigue scale. [ Time Frame: Until study completion ] [ Designated as safety issue: No ]
  • Assessment of efficacy according to the SLICC/ACR Damage Index. [ Time Frame: Until study completion ] [ Designated as safety issue: No ]

Enrollment: 268
Study Start Date: August 2008
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Belimumab 1 mg/kg
Belimumab 1 mg/kg IV every 28 days
Biological: Belimumab 1 mg/kg
Belimumab 1 mg/kg IV over one hour every 28 days
Other Names:
  • BENLYSTA
  • HGS1006
  • LymphoStat-B™
Experimental: Belimumab 10 mg/kg
Belimumab 10 mg/kg IV every 28 days
Biological: Belimumab 10 mg/kg
Belimumab 10 mg/kg IV over one hour every 28 days
Other Names:
  • LymphoStat-B™
  • BENLYSTA
  • HGS1006

Detailed Description:

This is a long-term continuation study to provide continuing treatment to subjects who completed study HGS1006-C1056 in the United States. This study is to evaluate the long-term safety and efficacy of belimumab (LymphoStat-B™) in subjects with SLE disease.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have completed the HGS1006-C1056 protocol in the United States through Week 72 visit.
  • Be able to receive 1st dose of belimumab for HGS 1006-c1066 four weeks after last dose in HGS1006-c1056.

Exclusion Criteria:

  • Have developed any other medical disease or condition that has made the subject unsuitable for this study in the opinion of their physician.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00724867

  Show 50 Study Locations
Sponsors and Collaborators
Human Genome Sciences Inc., a GSK Company
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline ( Human Genome Sciences Inc., a GSK Company )
ClinicalTrials.gov Identifier: NCT00724867     History of Changes
Other Study ID Numbers: 112233, HGS1006-C1066
Study First Received: July 28, 2008
Last Updated: November 7, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
Systemic Lupus Erythematosus
Belimumab
SLE
Antibodies
Lupus
Autoimmune Diseases

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Belimumab
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 31, 2014