A Continuation Trial for Subjects With Systemic Lupus Erythematosus That Have Completed Protocol LBSL02 - Full Text View

Purpose

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.

Condition	Intervention	Phase
Systemic Lupus Erythematosus	Drug: belimumab	Phase II

MedlinePlus related topics:

Lupus

Drug Information available for:

Belimumab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study

Official Title:	A Multi-Center, Open-Label, Continuation Trial LymphoStat-B™ Antibody (Monoclonal Anti-BLyS Antibody) in Subjects With Systemic Lupus Erythematosus (SLE) Who Completed the Phase 2 Protocol LBSL02

Further study details as provided by Human Genome Sciences:

Primary Outcome Measures:

To evaluate the long-term safety of LymphoStat-B™ in subjects with SLE. [ Time Frame: Until the drug is approved ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

The efficacy endpoints will include time-to-flare SELENA SLEDAI, PGA, BILAG, reduction in steroid use, biological markers and autoantibodies. [ Time Frame: Until the drug is approved. ] [ Designated as safety issue: No ]

Enrollment:	298
Study Start Date:	May 2005
Estimated Study Completion Date:	September 2010
Estimated Primary Completion Date:	September 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: belimumab IV 10mg/kg Q28 days

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Primary Inclusion Criteria

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

Primary Exclusion Criteria

Required more than 2 courses of corticosteroids for treatment of severe SLE flares in the last 5 months of LBSL02.
Had an SLE flare during the last 30 days of LBSL02 and through the 1st dose in LBSL99.
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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00583362

Show 61 Study Locations

Sponsors and Collaborators

Human Genome Sciences

Investigators


Study Director:	William Freimuth, MD, PhD	Human Genome Sciences, Inc.

More Information

Responsible Party:	Human Genome Sciences, Inc. ( William Freimuth, MD, PhD/Vice President of Clinical Research, Immunology, Rheumatology and Infectious Diseases )
Study ID Numbers:	LBSL99
First Received:	December 20, 2007
Last Updated:	April 9, 2008
ClinicalTrials.gov Identifier:	NCT00583362
Health Authority:	United States: Food and Drug Administration; Canada: Health Canada

Keywords provided by Human Genome Sciences:

SLE

Lupus

Study placed in the following topic categories:

Antibodies

Autoimmune Diseases

Lupus Erythematosus, Systemic

Connective Tissue Diseases

Additional relevant MeSH terms:

Immune System Diseases

ClinicalTrials.gov processed this record on October 31, 2008

Sponsored by:	Human Genome Sciences
Information provided by:	Human Genome Sciences
ClinicalTrials.gov Identifier:	NCT00583362