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

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

GlaxoSmithKline

ClinicalTrials.gov Identifier:

NCT00712933

First received: July 8, 2008

Last updated: December 19, 2012

Last verified: November 2012

History of Changes

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 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 or HGS1006-C1057

Resource links provided by NLM:

MedlinePlus related topics: Autoimmune Diseases Lupus

Drug Information available for: Belimumab

U.S. FDA Resources

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 ]

Enrollment:	733
Study Start Date:	June 2008
Estimated Study Completion Date:	March 2015
Estimated Primary Completion Date:	March 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 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. Other Names: LymphoStat-B™ HGS1006
Experimental: 2. 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. Other Names: LymphoStat-B™ HGS1006

Detailed Description:

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

Eligibility

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

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

Show 116 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00712933 History of Changes
Other Study ID Numbers:	112234, HGS1006-C1074
Study First Received:	July 8, 2008
Last Updated:	December 19, 2012
Health Authority:	United Kingdom: Department of Health Slovakia: State Institute for Drug Control Germany: Paul-Ehrlich-Institut United States: Food and Drug Administration Austria: Agency for Health and Food Safety Korea: Food and Drug Administration Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos Chile: Instituto de Salud Publica de Chile Spain: Ministry of Health Netherlands: Independent Ethics Committee Taiwan: Department of Health Italy: Ministry of Health Poland: Ministry of Health Philippines: Department of Health Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica Hong Kong: Department of Health India: Ministry of Health Brazil: Ministry of Health Canada: Health Canada Romania: National Medicines Agency Mexico: Ministry of Health Russia: Ministry of Health of the Russian Federation Israel: Ministry of Health Sweden: Medical Products Agency Belgium: Ministry of Social Affairs, Public Health and the Environment Peru: General Directorate of Pharmaceuticals, Devices, and Drugs Czech Republic: State Institute for Drug Control

Keywords provided by GlaxoSmithKline:

SLE
Belimumab
Antibodies

Systemic Lupus Erythematosus
Lupus
Autoimmune Diseases

Additional relevant MeSH terms:

Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

Antibodies
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013

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