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A Continuation Trial for Subjects With Lupus That Completed Protocol HGS1006-C1056 or HGS1006-C1057

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline ( Human Genome Sciences Inc., a GSK Company )
ClinicalTrials.gov Identifier:
NCT00712933
First received: July 8, 2008
Last updated: March 21, 2017
Last verified: March 2017
  Purpose
This is a long-term continuation study to provide continuing treatment to subjects with SLE.

Condition Intervention Phase
Systemic Lupus Erythematosus Drug: belimumab Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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 or HGS1006-C1057

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline ( Human Genome Sciences Inc., a GSK Company ):

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

Enrollment: 738
Study Start Date: May 2008
Study Completion Date: December 2016
Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
1 mg/kg dose of belimumab given IV every 28 days.
Drug: belimumab

Recombinant, fully human, monoclonal antibody

Comparison of the 1 mg/kg and 10 mg/kg dose of belimumab given IV every 28 days.

Other Names:
  • LymphoStat-B™
  • HGS1006
Experimental: 2.
10 mg/kg dose of belimumab given IV every 28 days.
Drug: belimumab

Recombinant, fully human, monoclonal antibody

Comparison of the 1 mg/kg and 10 mg/kg dose of belimumab given IV every 28 days.

Other Names:
  • LymphoStat-B™
  • HGS1006

Detailed Description:
This trial is a long-term continuation study to provide continuing treatment to subjects with System Lupus Erythematosus (SLE).
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have completed the HGS 1006-C1056 or HGS 1006-C1057 protocol through the Week 72 or Week 48 visits, respectively.

Exclusion Criteria:

  • Have developed any other medical disease or condition that has made the patient 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: NCT00712933

  Show 110 Study Locations
Sponsors and Collaborators
Human Genome Sciences Inc., a GSK Company
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Responsible Party: Human Genome Sciences Inc., a GSK Company
ClinicalTrials.gov Identifier: NCT00712933     History of Changes
Other Study ID Numbers: 112234
Study First Received: July 8, 2008
Last Updated: March 21, 2017

Keywords provided by GlaxoSmithKline ( Human Genome Sciences Inc., a GSK Company ):
SLE
Belimumab
Antibodies
Systemic Lupus Erythematosus
Lupus
Autoimmune Diseases

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

ClinicalTrials.gov processed this record on August 22, 2017