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

  Hide Study Locations
Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35249
United States, Arizona
University of Arizona Arthritis Center
Tucson, Arizona, United States, 85724
United States, California
Cedar-Sinai Medical Center
Los Angeles, California, United States, 90048
University of Southern California
Los Angeles, California, United States, 90033
University of California, Davis Medical Center
Sacramento, California, United States, 95817
Arthritis Care Center, Inc.
San Jose, California, United States, 95126
Inland Rheumatology Clinical Trials, Inc.
Upland, California, United States, 91786
United States, Colorado
Arthritis Associates & Osteoporosis Center of Colorado Springs
Colorado Springs, Colorado, United States, 80910
United States, District of Columbia
Washington Hospital Center
Washington, District of Columbia, United States, 20010
United States, Florida
Arthritis & Rheumatic Disease Specialites
Aventure, Florida, United States, 33180
Rheumatology Association of Central Florida
Orlando, Florida, United States, 32806
Tampa Medical Group
Tampa, Florida, United States, 33614
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30303
United States, Idaho
Radiant Resarch Boise
Boise, Idaho, United States, 83704
United States, Illinois
Rheumatology Associates, SC
Chicago, Illinois, United States, 60612
Northwestern Center for Clinical Research
Chicago, Illinois, United States, 60611
United States, Indiana
Medical Specialists
Munster, Indiana, United States, 46321
United States, Kansas
Kansas University Medical Center
Kansas City, Kansas, United States, 66160
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
United States, Kentucky
Kentuckiana Center for Better Bone & Joint Health
Louisville, Kentucky, United States, 40202
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21205
University of Maryland School of Medicine
Baltimore, Maryland, United States, 21201
Center for Rheumatology and Bone Research
Wheaton, Maryland, United States, 20902
United States, Massachusetts
Tufts-New England Medical Center
Boston, Massachusetts, United States, 02111
United States, Michigan
University of Michigan Medical Center - Regents of the University of Michigan
Ann Arbor, Michigan, United States, 48109
United States, Missouri
Washington University Center for Clinical Studies
St. Louis, Missouri, United States, 63110
United States, Nebraska
Arthritis Center of Nebraska
Lincoln, Nebraska, United States, 68516
United States, New York
The Center for Rheumatology
Albany, New York, United States, 12206
SUNY Downstate Medical Center
Brooklyn, New York, United States, 11203
North Shore-LIJ Health System/ Rheumatology and Allergy Clinical Immunology
Lake Success, New York, United States, 11042
Feinstein Institute
Manhasset, New York, United States, 11030
AAIR Research Center
Rochester, New York, United States, 14618
United States, North Carolina
Arthritis Clinic and Carolina Bone and Joint
Charlotte, North Carolina, United States, 28210
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
STAT Research, Inc.
Dayton, Ohio, United States, 45417
United States, Oklahoma
Bone & Joint Hospital
Oklahoma City, Oklahoma, United States, 73103
Oklahoma Medical Research Center
Oklahoma City, Oklahoma, United States, 74104
Oklahoma Center for Arthritis Therapy & Research
Oklahoma City, Oklahoma, United States, 74104
United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
Rheumatic Disease Associates
Willow Grove, Pennsylvania, United States, 19090
United States, Texas
Arthritis Centers of Texas
Dallas, Texas, United States, 75246
UT Southwestern Medical Center at Dallas
Dallas, Texas, United States, 75390
Houston Institute for Clinical Research
Houston, Texas, United States, 77074
Texas Research Center
Sugar Land, Texas, United States, 77479
United States, Utah
Arthritis and Rheumatic Diseases Clinic
Ogden, Utah, United States, 84403
United States, Virginia
Arthritis Clinic of N. Virginia
Arlington, Virginia, United States, 22205
United States, Washington
The Seattle Arthritis Clinic
Seattle, Washington, United States, 98133
Arthritis Northwest Rheumatology, PLLC
Spokane, Washington, United States, 99204
United States, Wisconsin
Gunderson Clinical,LTD
Onalaska, Wisconsin, United States, 54650
Canada, Quebec
MUHC - The Montreal General Hospital
Montreal, Quebec, Canada, H3G 1A4
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

ClinicalTrials.gov processed this record on July 20, 2014