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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline ( Human Genome Sciences Inc., a GSK Company )
ClinicalTrials.gov Identifier:
NCT00712933
First received: July 8, 2008
Last updated: October 9, 2014
Last verified: October 2014
  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:


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: September 2015
Estimated Primary Completion Date: September 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Show 116 Study Locations
Sponsors and Collaborators
Human Genome Sciences Inc., a GSK Company
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline ( Human Genome Sciences Inc., a GSK Company )
ClinicalTrials.gov Identifier: NCT00712933     History of Changes
Other Study ID Numbers: 112234, HGS1006-C1074
Study First Received: July 8, 2008
Last Updated: October 9, 2014
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 Pública 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:
Antibodies
SLE
Belimumab
Systemic Lupus Erythematosus
Lupus
Autoimmune Diseases

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Belimumab
Immunologic Factors
Immunosuppressive Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 20, 2014