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A Continuation Trial for Subjects With Systemic Lupus Erythematosus That Have Completed Protocol LBSL02

NCT ID: NCT00583362

Last Updated: 2019-07-23

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

298 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-05-04

Study Completion Date

2016-02-23

Brief Summary

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This is a continuation study to evaluate the long-term safety and efficacy of LymphoStat-B™ in subjects with SLE disease, that completed study LBSL02 and benefitted from treatment.

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Detailed Description

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The purpose of this continuation study to evaluate the long-term safety and efficacy of LymphoStat-B™ in subjects with Systemic Lupus Erythematosus (SLE), that completed study LBSL02 and benefitted from treatment.

Conditions

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Systemic Lupus Erythematosus

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Belimumab 10 mg/kg

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

Group Type EXPERIMENTAL

Belimumab

Intervention Type BIOLOGICAL

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

Interventions

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Belimumab

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

Intervention Type BIOLOGICAL

Other Intervention Names

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LymphoStat-B™ HGS1006 BENLYSTA

Eligibility Criteria

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Inclusion Criteria

1\. Have completed the LBSL02 trial and achieved a satisfactory response.

Exclusion Criteria

1. Required more than 2 courses of corticosteroids for treatment of severe SLE flares in the last 5 months of LBSL02.
2. Had an SLE flare during the last 30 days of LBSL02 and through the 1st dose in LBSL99.
3. Used any of the following prohibited medications during their participation in LBSL02:

* Other investigational agents.
* Biologic therapeutic agents: adalimumab (Humira™), etanercept (Enbrel™), infliximab (Remicade™), and rituximab (Rituxan™).
* Intravenous cyclophosphamide.
* Corticosteroids \>100 mg/day prednisone equivalent for reasons other than severe SLE flare.
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 (for GlaxoSmithKline; Human Genome Sciences Inc., a GSK Company; Sirtris, a GSK Company; Stiefel, a GSK Company; ViiV Healthcare)

Locations

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GSK Investigational Site

Birmingham, Alabama, United States

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Scottsdale, Arizona, United States

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Tucson, Arizona, United States

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La Jolla, California, United States

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Los Angeles, California, United States

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Los Angeles, California, United States

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Sacramento, California, United States

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San Jose, California, United States

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Upland, California, United States

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Colorado Springs, Colorado, United States

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

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Aventura, Florida, United States

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Orlando, Florida, United States

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Tampa, Florida, United States

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Atlanta, Georgia, United States

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Boise, Idaho, United States

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Idaho Falls, Idaho, United States

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Chicago, Illinois, United States

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Chicago, Illinois, United States

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Munster, Indiana, United States

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Kansas City, Kansas, United States

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Louisville, Kentucky, United States

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Baton Rouge, Louisiana, United States

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New Orleans, Louisiana, United States

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Baltimore, Maryland, United States

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Baltimore, Maryland, United States

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Cumberland, Maryland, United States

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Wheaton, Maryland, United States

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Boston, Massachusetts, United States

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Ann Arbor, Michigan, United States

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St Louis, Missouri, United States

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Lincoln, Nebraska, United States

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Concord, New Hampshire, United States

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Dover, New Hampshire, United States

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Albany, New York, United States

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Brooklyn, New York, United States

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Great Neck, New York, United States

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Manhasset, New York, United States

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Rochester, New York, United States

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Charlotte, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Dayton, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Oklahoma City, Oklahoma, United States

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Tulsa, Oklahoma, United States

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Pittsburgh, Pennsylvania, United States

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Willow Grove, Pennsylvania, United States

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Dallas, Texas, United States

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Dallas, Texas, United States

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Houston, Texas, United States

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Sugar Land, Texas, United States

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Arlington, Virginia, United States

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Seattle, Washington, United States

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Spokane, Washington, United States

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Milwaukee, Wisconsin, United States

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GSK Investigational Site

Onalaska, Wisconsin, United States

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GSK Investigational Site

Montreal, Quebec, Canada

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Countries

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United States Canada

References

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Ginzler EM, Wallace DJ, Merrill JT, Furie RA, Stohl W, Chatham WW, Weinstein A, McKay JD, McCune WJ, Zhong ZJ, Freimuth WW, Petri MA; LBSL02/99 Study Group. Disease control and safety of belimumab plus standard therapy over 7 years in patients with systemic lupus erythematosus. J Rheumatol. 2014 Feb;41(2):300-9. doi: 10.3899/jrheum.121368. Epub 2013 Nov 1.

Reference Type DERIVED
PMID: 24187095 (View on PubMed)

Merrill JT, Ginzler EM, Wallace DJ, McKay JD, Lisse JR, Aranow C, Wellborne FR, Burnette M, Condemi J, Zhong ZJ, Pineda L, Klein J, Freimuth WW; LBSL02/99 Study Group. Long-term safety profile of belimumab plus standard therapy in patients with systemic lupus erythematosus. Arthritis Rheum. 2012 Oct;64(10):3364-73. doi: 10.1002/art.34564.

Reference Type DERIVED
PMID: 22674457 (View on PubMed)

Other Identifiers

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112626

Identifier Type: -

Identifier Source: org_study_id

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