A Continuation Trial for Subjects With Lupus That Completed Protocol HGS1006-C1056 or HGS1006-C1057 - Full Text View

Sponsors and Collaborators:	Human Genome Sciences GlaxoSmithKline
Information provided by:	Human Genome Sciences
ClinicalTrials.gov Identifier:	NCT00712933

Purpose

This is a long-term continuation study to provide continuing treatment to subjects with SLE.

Condition	Intervention	Phase
Systemic Lupus Erythematosus	Drug: belimumab	Phase III

MedlinePlus related topics: Lupus

Drug Information available for: Immunoglobulins Globulin, Immune Belimumab

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
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 or HGS1006-C1057

Further study details as provided by Human Genome Sciences:

Primary Outcome Measures:

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

Secondary Outcome Measures:

At Wk52, the percent of subjects with ≥ 4 point reduction from baseline in SELENA SLEDAI score and no worsening in PGA and no new BILAG A organ domain score or 2 new BILAG B organ domain scores compared with baseline at the time of assessment. [ Time Frame: every 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	1620
Study Start Date:	June 2008
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 1 mg/kg dose of belimumab given IV every 28 days.	Drug: belimumab Recombinant, fully human, monoclonal antibody Comparison of the 1 mg/kg and 10 mg/kg dose of belimumab given IV every 28 days.
2.: Experimental 10 mg/kg dose of belimumab given IV every 28 days.	Drug: belimumab Recombinant, fully human, monoclonal antibody Comparison of the 1 mg/kg and 10 mg/kg dose of belimumab given IV every 28 days.

Detailed Description:

This trial is a long-term continuation study to provide continuing treatment to subjects with System Lupus Erythematosus (SLE).

Eligibility

Criteria

Inclusion Criteria:

Have completed the HGS 1006-C1056 or HGS 1006-C1057 protocol through the Week 72 or Week 48 visits, respectively.

Exclusion Criteria:

Have developed any other medical disease or condition that has made the patient unsuitable for this study in the opinion of their physician.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00712933

Sponsors and Collaborators

Human Genome Sciences

GlaxoSmithKline

Investigators

Study Director:

William Freimuth, MD, PhD

Human Genome Sciences, Inc.

More Information

www.bliss-study.com This link exits the ClinicalTrials.gov site

Responsible Party:	Human Genome Sciences, Inc. ( William Freimuth, MD, PhD/Vice President, Clinical Research Immunology, Rheumatology & Infectious Diseases )
Study ID Numbers:	HGS1006-C1074
Study First Received:	July 8, 2008
Last Updated:	December 12, 2008
ClinicalTrials.gov Identifier:	NCT00712933
Health Authority:	United States: Food and Drug Administration; Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica; Brazil: Ministry of Health; Chile: Instituto de Salud Publica de Chile; India: Ministry of Health; Romania: National Medicines Agency; Korea: Food and Drug Administration; Taiwan: Department of Health; Philippines: Department of Health; Australia: National Health and Medical Research Council; Hong Kong: Department of Health; Russia: Ministry of Health and Social Development of the Russian Federation; Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos; Peru: General Directorate of Pharmaceuticals, Devices, and Drugs; Canada: Health Canada; Mexico: Ministry of Health; Germany: Paul-Ehrlich-Institut; Belgium: Ministry of Social Affairs, Public Health and the Environment; Netherlands: Independent Ethics Committee; Czech Republic: State Institute for Drug Control; Slovakia: State Institute for Drug Control; United Kingdom: Department of Health; Spain: Ministry of Health; Poland: Ministry of Health; Italy: Ministry of Health; Austria: Agency for Health and Food Safety; Israel: Ministry of Health; Sweden: Medical Products Agency

Keywords provided by Human Genome Sciences:

SLE
Lupus
Systemic Lupus Erythematosus

Antibodies
Autoimmune Diseases
Belimumab

Study placed in the following topic categories:

Antibodies, Monoclonal
Antibodies
Autoimmune Diseases

Lupus Erythematosus, Systemic
Connective Tissue Diseases
Immunoglobulins

Additional relevant MeSH terms:

Immune System Diseases

ClinicalTrials.gov processed this record on January 14, 2009