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:
Human Genome Sciences Inc., a GSK Company
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: March 22, 2013
Last verified: March 2013
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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 |
| 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:
|
|
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:
|
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00724867
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Hide Study LocationsLocations
| 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: | March 22, 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 May 21, 2013