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

NCT ID: NCT00724867

Last Updated: 2016-03-28

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

268 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2015-03-31

Brief Summary

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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.

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Phase 2 Study of Belimumab Administered Subcutaneously to Subjects With Systemic Lupus Erythematosus (SLE)

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Detailed Description

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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.

Conditions

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Systemic Lupus Erythematosus

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Belimumab 1 mg/kg

Belimumab 1 mg/kg IV every 28 days

Group Type EXPERIMENTAL

Belimumab 1 mg/kg

Intervention Type BIOLOGICAL

Belimumab 1 mg/kg IV over one hour every 28 days

Belimumab 10 mg/kg

Belimumab 10 mg/kg IV every 28 days

Group Type EXPERIMENTAL

Belimumab 10 mg/kg

Intervention Type BIOLOGICAL

Belimumab 10 mg/kg IV over one hour every 28 days

Interventions

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Belimumab 1 mg/kg

Belimumab 1 mg/kg IV over one hour every 28 days

Intervention Type BIOLOGICAL

Belimumab 10 mg/kg

Belimumab 10 mg/kg IV over one hour every 28 days

Intervention Type BIOLOGICAL

Other Intervention Names

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BENLYSTA HGS1006 LymphoStat-B™ LymphoStat-B™ BENLYSTA HGS1006

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role collaborator

Human Genome Sciences Inc., a GSK Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Birmingham, Alabama, United States

Site Status

GSK Investigational Site

Phoenix, Arizona, United States

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GSK Investigational Site

Tucson, Arizona, United States

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GSK Investigational Site

Long Beach, California, United States

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GSK Investigational Site

Los Angeles, California, United States

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GSK Investigational Site

Los Angeles, California, United States

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GSK Investigational Site

Upland, California, United States

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GSK Investigational Site

Washington D.C., District of Columbia, United States

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GSK Investigational Site

Aventura, Florida, United States

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GSK Investigational Site

Orlando, Florida, United States

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GSK Investigational Site

Tampa, Florida, United States

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GSK Investigational Site

Atlanta, Georgia, United States

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GSK Investigational Site

Chicago, Illinois, United States

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GSK Investigational Site

Chicago, Illinois, United States

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GSK Investigational Site

Munster, Indiana, United States

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GSK Investigational Site

Kansas City, Kansas, United States

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GSK Investigational Site

Louisville, Kentucky, United States

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GSK Investigational Site

Baton Rouge, Louisiana, United States

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Baltimore, Maryland, United States

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GSK Investigational Site

Cumberland, Maryland, United States

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GSK Investigational Site

Hagerstown, Maryland, United States

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Ann Arbor, Michigan, United States

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GSK Investigational Site

Lansing, Michigan, United States

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GSK Investigational Site

Brooklyn, New York, United States

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GSK Investigational Site

Great Neck, New York, United States

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GSK Investigational Site

Manhasset, New York, United States

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GSK Investigational Site

New York, New York, United States

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GSK Investigational Site

Rochester, New York, United States

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GSK Investigational Site

Smithtown, New York, United States

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GSK Investigational Site

The Bronx, New York, United States

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GSK Investigational Site

Chapel Hill, North Carolina, United States

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GSK Investigational Site

Greenville, North Carolina, United States

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GSK Investigational Site

Winston-Salem, North Carolina, United States

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GSK Investigational Site

Columbus, Ohio, United States

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GSK Investigational Site

Dayton, Ohio, United States

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GSK Investigational Site

Oklahoma City, Oklahoma, United States

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GSK Investigational Site

Tulsa, Oklahoma, United States

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GSK Investigational Site

Bethlehem, Pennsylvania, United States

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GSK Investigational Site

Pittsburgh, Pennsylvania, United States

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GSK Investigational Site

Charleston, South Carolina, United States

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GSK Investigational Site

Charleston, South Carolina, United States

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GSK Investigational Site

Greenville, South Carolina, United States

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GSK Investigational Site

Austin, Texas, United States

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GSK Investigational Site

Houston, Texas, United States

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GSK Investigational Site

Houston, Texas, United States

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GSK Investigational Site

Houston, Texas, United States

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GSK Investigational Site

San Antonio, Texas, United States

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GSK Investigational Site

Sugar Land, Texas, United States

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GSK Investigational Site

Arlington, Virginia, United States

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GSK Investigational Site

Seattle, Washington, United States

Site Status

GSK Investigational Site

Onalaska, Wisconsin, United States

Site Status

Countries

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United States

References

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Strand V, Berry P, Lin X, Asukai Y, Punwaney R, Ramachandran S. Long-Term Impact of Belimumab on Health-Related Quality of Life and Fatigue in Patients With Systemic Lupus Erythematosus: Six Years of Treatment. Arthritis Care Res (Hoboken). 2019 Jun;71(6):829-838. doi: 10.1002/acr.23788. Epub 2019 Apr 29.

Reference Type DERIVED
PMID: 30320964 (View on PubMed)

Furie RA, Wallace DJ, Aranow C, Fettiplace J, Wilson B, Mistry P, Roth DA, Gordon D. Long-Term Safety and Efficacy of Belimumab in Patients With Systemic Lupus Erythematosus: A Continuation of a Seventy-Six-Week Phase III Parent Study in the United States. Arthritis Rheumatol. 2018 Jun;70(6):868-877. doi: 10.1002/art.40439. Epub 2018 Apr 25.

Reference Type DERIVED
PMID: 29409143 (View on PubMed)

Other Identifiers

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HGS1006-C1066

Identifier Type: OTHER

Identifier Source: secondary_id

112233

Identifier Type: -

Identifier Source: org_study_id

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