A Continuation Trial for Subjects With Lupus Who Completed Protocol HGS1006-C1056 in the United States

Systemic Lupus Erythematosus Clinical Trial

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 in the United States

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00724867
• Other study ID #: 112233
• Secondary ID: HGS1006-C1066
• Status: Completed
• Phase: Phase 3
• First received: July 28, 2008
• Last updated: May 11, 2015
• Start date: August 2008
• Est. completion date: March 2015

Study information

• Verified date: May 2015
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This is a continuation study to provide continuing treatment to subjects who completed study HGS1006-C1056 in the United States, to evaluate the long-term safety and efficacy of belimumab(LymphoStat-B™) in subjects with SLE disease.

Description:

This is a long-term continuation study to provide continuing treatment to subjects who completed study HGS1006-C1056 in the United States. This study is to evaluate the long-term safety and efficacy of belimumab (LymphoStat-B™) in subjects with SLE disease.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 268
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Have completed the HGS1006-C1056 protocol in the United States through Week 72 visit.

• Be able to receive 1st dose of belimumab for HGS 1006-c1066 four weeks after last dose in HGS1006-c1056.

Exclusion Criteria:

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus

Intervention

Biological:
• Belimumab 1 mg/kg
Belimumab 1 mg/kg IV over one hour every 28 days
• Belimumab 10 mg/kg
Belimumab 10 mg/kg IV over one hour every 28 days

Locations

Country	Name	City	State
Canada	MUHC - The Montreal General Hospital	Montreal	Quebec
United States	The Center for Rheumatology	Albany	New York
United States	University of Michigan Medical Center - Regents of the University of Michigan	Ann Arbor	Michigan
United States	Arthritis Clinic of N. Virginia	Arlington	Virginia
United States	Emory University	Atlanta	Georgia
United States	Arthritis & Rheumatic Disease Specialites	Aventure	Florida
United States	Johns Hopkins University	Baltimore	Maryland
United States	University of Maryland School of Medicine	Baltimore	Maryland
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Radiant Resarch Boise	Boise	Idaho
United States	Tufts-New England Medical Center	Boston	Massachusetts
United States	SUNY Downstate Medical Center	Brooklyn	New York
United States	Arthritis Clinic and Carolina Bone and Joint	Charlotte	North Carolina
United States	Northwestern Center for Clinical Research	Chicago	Illinois
United States	Rheumatology Associates, SC	Chicago	Illinois
United States	Arthritis Associates & Osteoporosis Center of Colorado Springs	Colorado Springs	Colorado
United States	Arthritis Centers of Texas	Dallas	Texas
United States	UT Southwestern Medical Center at Dallas	Dallas	Texas
United States	STAT Research, Inc.	Dayton	Ohio
United States	Houston Institute for Clinical Research	Houston	Texas
United States	Kansas University Medical Center	Kansas City	Kansas
United States	University of Kansas Medical Center	Kansas City	Kansas
United States	North Shore-LIJ Health System/ Rheumatology and Allergy Clinical Immunology	Lake Success	New York
United States	Arthritis Center of Nebraska	Lincoln	Nebraska
United States	Cedar-Sinai Medical Center	Los Angeles	California
United States	University of Southern California	Los Angeles	California
United States	Kentuckiana Center for Better Bone & Joint Health	Louisville	Kentucky
United States	Feinstein Institute	Manhasset	New York
United States	Medical Specialists	Munster	Indiana
United States	Arthritis and Rheumatic Diseases Clinic	Ogden	Utah
United States	Bone & Joint Hospital	Oklahoma City	Oklahoma
United States	Oklahoma Center for Arthritis Therapy & Research	Oklahoma City	Oklahoma
United States	Oklahoma Medical Research Center	Oklahoma City	Oklahoma
United States	Gunderson Clinical,LTD	Onalaska	Wisconsin
United States	Rheumatology Association of Central Florida	Orlando	Florida
United States	University of Pittsburgh	Pittsburgh	Pennsylvania
United States	AAIR Research Center	Rochester	New York
United States	University of California, Davis Medical Center	Sacramento	California
United States	Arthritis Care Center, Inc.	San Jose	California
United States	The Seattle Arthritis Clinic	Seattle	Washington
United States	Arthritis Northwest Rheumatology, PLLC	Spokane	Washington
United States	Washington University Center for Clinical Studies	St. Louis	Missouri
United States	Texas Research Center	Sugar Land	Texas
United States	Tampa Medical Group	Tampa	Florida
United States	University of Arizona Arthritis Center	Tucson	Arizona
United States	Inland Rheumatology Clinical Trials, Inc.	Upland	California
United States	Washington Hospital Center	Washington	District of Columbia
United States	Center for Rheumatology and Bone Research	Wheaton	Maryland
United States	Rheumatic Disease Associates	Willow Grove	Pennsylvania
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Human Genome Sciences Inc., a GSK Company	GlaxoSmithKline

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the long term safety of belimumab (LymphoStat-B™) in subjects with SLE		Until study completion	Yes
Secondary	Assessment of efficacy and biomarkers including: disease activity, anti-dsDNA and serum complement levels, prednisone use, proteinuria level, serum immunoglobulin G, and B-cell subsets.		Until study completion	No
Secondary	Assessment of quality of life according to the following scales: SF-36 Health Survey, and FACIT-Fatigue scale.		Until study completion	No
Secondary	Assessment of efficacy according to the SLICC/ACR Damage Index.		Until study completion	No

External Links

•   www.bliss-study.com