A Continuation Trial for Subjects With Systemic Lupus Erythematosus That Have Completed Protocol LBSL02

NCT00583362 | Completed Phase 2 Results DMC

• 1 other identifier: 112626
• Study Type: interventional
• Target: 298
• Locations: 2 countries
• Sites: 57

Brief Summary

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.

Conditions

Systemic Lupus Erythematosus

Keywords

SLE; Lupus

Outcome Measures

Primary Outcomes (13)

• Number of Participants With the Indicated Type of Adverse Event (AEs) and Serious Adverse Event (SAEs)

  An AE is defined as any unfavorable or unintended sign, symptom, or disease that is temporally associated with the use of a study agent but is not necessarily caused by the study agent. This includes worsening (example \[eg\], increase in frequency or severity) of pre-existing conditions. An SAE is defined as an AE resulting in any of the following outcomes: death, is life threatening (that is, an immediate threat to life), inpatient hospitalization, prolongation of an existing hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, and is medically important.

  Approximately up to 13 years

• Adverse Event (AE) Rates by System Organ Class (SOC) During the Study

  AE rates by SOC adjusting for participant-years on study drug anytime post Baseline are summarized, which included the follow up visits. Only treatmentemergent AEs are summarized. The Baseline is defined as the last available value prior to belimumab start date, for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. The event rate of an AE was calculated as the number of events per 100 participant years: Event Rate=100\* number of events divided by participant years. Participant years were calculated as sum across all participants (\[last visit of interval day minus first visit of interval day plus 1\] divided by 365).

  Approximately up to 13 years

• SAE Rates by System Organ Class (SOC) During the Study

  SAE rates by SOC adjusting for participant-years on study drug anytime post Baseline are summarized, which included the follow up visits. Only treatmentemergent SAEs are summarized. The Baseline is defined as the last available value prior to belimumab start date, for participants treated with placebo in the parent study and last pretreatment value in the parent study for participants treated with belimumab in the parent study. The event rate of an SAE was calculated as the number of events per 100 participant years: Event Rate=100\* number of events divided by participant years. Participant years were calculated as sum across all participants (\[last visit of interval day minus first visit of interval day plus 1\] divided by 365).

  Approximately up to 13 years

• Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points

  Hematology parameters were assessed at Baseline, Week 8, 16, 24, 40, and 48 during Year 1 to 8; Week 8, 16, 24, and 40 during Year 9; Week 24 and 40 during Year 10; Week 48 during Year 11; Week 32 during Year 13; Exit visit and at follow-up (up to 8 weeks and 24 weeks post last infusion). Change from Baseline in APTT and PT is summarized. The Baseline is defined as the Extension Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value.

  Baseline and approximately up to 13 years

• Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points

  Hematology parameters were assessed at Baseline, Week 8, 16, 24, 32, 40 and 48 during Year 1 to 12; Week 8, 16, 24, 32, and 40 during Year 13; Exit visit and at follow-up (up to 8 weeks and 24 weeks post last infusion). Change from Baseline in basophils, eosinophils, lymphocytes, monocytes, neutrophils segmented and platelets is summarized. The Baseline is defined as the Extension Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value.

  Baseline and approximately up to 13 years

• Change From Baseline in Erythrocytes at the Indicated Time Points

  Hematology parameters were assessed at Baseline, Week 8, 16, 24, 32, 40 and 48 during Year 1 to 12; Week 8, 16, 24, 32, and 40 during Year 13; Exit visit and at follow-up (up to 8 weeks and 24 weeks post last infusion). Change from Baseline in erythrocytes is summarized. The Baseline is defined as the Extension Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value.

  Baseline and approximately up to 13 years

• Change From Baseline in Hematocrit at the Indicated Time Points

  Hematology parameters were assessed at Baseline, Week 8, 16, 24, 32, 40 and 48 during Year 1 to 12; Week 8, 16, 24, 32, and 40 during Year 13; Exit visit and at follow-up (up to 8 weeks and 24 weeks post last infusion). Change from Baseline in hematocrit is summarized. The Baseline is defined as the Extension Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value.

  Baseline and approximately up to 13 years

• Change From Baseline in Hemoglobin at the Indicated Time Points

  Hematology parameters were assessed at Baseline, Week 8, 16, 24, 32, 40 and 48 during Year 1 to 12; Week 8, 16, 24, 32, and 40 during Year 13; Exit visit and at follow-up (up to 8 weeks and 24 weeks post last infusion). Change from Baseline in hemoglobin is summarized. The Baseline is defined as the Extension Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value.

  Baseline and approximately up to 13 years

• Change From Baseline in Albumin and Protein at the Indicated Time Points

  Clinical chemistry parameters were assessed at Baseline, Week 8, 16, 24, 32, 40 and 48 during Year 1 to 12; Week 8, 16, 24, 32, and 40 during Year 13; Exit visit and at follow-up (up to 8 weeks and 24 weeks post last infusion). Change from Baseline in albumin and protein is summarized. The Baseline is defined as the Extension Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value.

  Baseline and approximately up to 13 years

• Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points

  Clinical chemistry parameters were assessed at Baseline, Week 8, 16, 24, 32, 40 and 48 during Year 1 to 12; Week 8, 16, 24, 32, and 40 during Year 13; Exit visit and at follow-up (up to 8 weeks and 24 weeks post last infusion). Change from Baseline in BUN, glucose, calcium, carbon dioxide, chloride, magnesium, phosphate, potassium and sodium is summarized. The Baseline is defined as the Extension Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value.

  Baseline and approximately up to 13 years

• Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points

  Clinical chemistry parameters were assessed at Baseline, Week 8, 16, 24, 32, 40 and 48 during Year 1 to 12; Week 8, 16, 24, 32, and 40 during Year 13; Exit visit and at follow-up (up to 8 weeks and 24 weeks post last infusion). Change from Baseline in creatinine, urate, and bilirubin is summarized. The Baseline is defined as the Extension Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post- Baseline visit value and the Baseline value.

  Baseline and approximately up to 13 years

• Change From Baseline in BUN/Creatinine at the Indicated Time Points

  Clinical chemistry parameters were assessed at Baseline, Week 8, 16, 24, 32, 40 and 48 during Year 1 to 12; Week 8, 16, 24, 32, and 40 during Year 13; Exit visit and at follow-up (up to 8 weeks and 24 weeks post last infusion). Change from Baseline in BUN/creatinine is summarized. The Baseline is defined as the Extension Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value.

  Baseline and approximately up to 13 years

• Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points

  Clinical chemistry parameters were assessed at Baseline, Week 8, 16, 24, 32, 40 and 48 during Year 1 to 12; Week 8, 16, 24, 32, and 40 during Year 13; Exit visit and at follow-up (up to 8 weeks and 24 weeks post last infusion). Change from Baseline in ALT, AP, AST, GGT and LD are summarized. Baseline is defined as the Extension Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value.

  Baseline and approximately up to 13 years

Secondary Outcomes (8)

• Percentage of Participants Achieving SLE Responder Index (SRI) Response at Indicated Time Points

  Approximately up to 13 years

• Observed Anti-double Stranded DNA Levels in Participants Positive at Baseline at Indicated Time Points

  Approximately up to 13 years

• Median Percent Change From Baseline in Anti-double Stranded DNA in Participants Positive at Baseline at Indicated Time Points

  Baseline and approximately up to 13 years

• Observed Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points

  Approximately up to 13 years

• Median Percent Change From Baseline in Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points

  Baseline and approximately up to 13 years

Study Arms (1)

Belimumab 10 mg/kg

EXPERIMENTAL

Belimumab 10 mg/kg IV over one hour every 28 days.

Biological: Belimumab

Interventions

Belimumab BIOLOGICAL

Belimumab 10mg/kg IV over one hour every 28 days

Also known as: LymphoStat-B™, HGS1006, BENLYSTA

Belimumab 10 mg/kg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Have completed the LBSL02 trial and achieved a satisfactory response.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Human Genome Sciences Inc., a GSK Company: lead
• GlaxoSmithKline: collaborator

Study Sites (57)

GSK Investigational Site

Birmingham, Alabama, 35294, United States

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GSK Investigational Site

Scottsdale, Arizona, 85260, United States

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GSK Investigational Site

Tucson, Arizona, 85724, United States

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GSK Investigational Site

La Jolla, California, 92037, United States

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GSK Investigational Site

Los Angeles, California, 90033, United States

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GSK Investigational Site

Los Angeles, California, 90048, United States

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GSK Investigational Site

Sacramento, California, 95817, United States

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GSK Investigational Site

San Jose, California, 95124, United States

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GSK Investigational Site

Upland, California, 91786, United States

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GSK Investigational Site

Colorado Springs, Colorado, 80920, United States

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GSK Investigational Site

Washington D.C., District of Columbia, 20010, United States

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GSK Investigational Site

Aventura, Florida, 33180, United States

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GSK Investigational Site

Orlando, Florida, 32806-6264, United States

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GSK Investigational Site

Tampa, Florida, 33614, United States

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GSK Investigational Site

Atlanta, Georgia, 30303, United States

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GSK Investigational Site

Boise, Idaho, 83704, United States

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GSK Investigational Site

Idaho Falls, Idaho, 83401, United States

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GSK Investigational Site

Chicago, Illinois, 60611, United States

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GSK Investigational Site

Chicago, Illinois, 60612, United States

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GSK Investigational Site

Munster, Indiana, 46321, United States

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GSK Investigational Site

Kansas City, Kansas, 66160, United States

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GSK Investigational Site

Louisville, Kentucky, 40202, United States

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GSK Investigational Site

Baton Rouge, Louisiana, 70809, United States

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GSK Investigational Site

New Orleans, Louisiana, 70121, United States

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GSK Investigational Site

Baltimore, Maryland, 21201, United States

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GSK Investigational Site

Baltimore, Maryland, 21287, United States

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GSK Investigational Site

Cumberland, Maryland, 21502, United States

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GSK Investigational Site

Wheaton, Maryland, 20902, United States

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GSK Investigational Site

Boston, Massachusetts, 02111, United States

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GSK Investigational Site

Ann Arbor, Michigan, 48109-5542, United States

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GSK Investigational Site

St Louis, Missouri, 63110, United States

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GSK Investigational Site

Lincoln, Nebraska, 68516, United States

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GSK Investigational Site

Concord, New Hampshire, 03301, United States

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GSK Investigational Site

Dover, New Hampshire, 03820, United States

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GSK Investigational Site

Albany, New York, 12206, United States

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GSK Investigational Site

Brooklyn, New York, 11203, United States

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GSK Investigational Site

Great Neck, New York, 11021, United States

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GSK Investigational Site

Manhasset, New York, 11030, United States

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GSK Investigational Site

Rochester, New York, 14618, United States

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GSK Investigational Site

Charlotte, North Carolina, 28210, United States

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GSK Investigational Site

Winston-Salem, North Carolina, 27157, United States

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GSK Investigational Site

Dayton, Ohio, 45417, United States

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GSK Investigational Site

Oklahoma City, Oklahoma, 73103, United States

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GSK Investigational Site

Oklahoma City, Oklahoma, 73104, United States

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GSK Investigational Site

Tulsa, Oklahoma, 74104, United States

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GSK Investigational Site

Pittsburgh, Pennsylvania, 15217, United States

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GSK Investigational Site

Willow Grove, Pennsylvania, 19090, United States

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GSK Investigational Site

Dallas, Texas, 75246, United States

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GSK Investigational Site

Dallas, Texas, 75390-8550, United States

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GSK Investigational Site

Houston, Texas, 77074, United States

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GSK Investigational Site

Sugar Land, Texas, 77479, United States

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GSK Investigational Site

Arlington, Virginia, 22205-3606, United States

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GSK Investigational Site

Seattle, Washington, 98133, United States

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GSK Investigational Site

Spokane, Washington, 99204, United States

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GSK Investigational Site

Milwaukee, Wisconsin, 53226, United States

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GSK Investigational Site

Onalaska, Wisconsin, 54650, United States

Location

GSK Investigational Site

Montreal, Quebec, H3G 1A4, Canada

Location

Related Publications (2)

• Ginzler EM, Wallace DJ, Merrill JT, Furie RA, Stohl W, Chatham WW, Weinstein A, McKay JD, McCune WJ, Zhong ZJ, Freimuth WW, Petri MA; LBSL02/99 Study Group. Disease control and safety of belimumab plus standard therapy over 7 years in patients with systemic lupus erythematosus. J Rheumatol. 2014 Feb;41(2):300-9. doi: 10.3899/jrheum.121368. Epub 2013 Nov 1.

  PMID: 24187095 DERIVED

• Merrill JT, Ginzler EM, Wallace DJ, McKay JD, Lisse JR, Aranow C, Wellborne FR, Burnette M, Condemi J, Zhong ZJ, Pineda L, Klein J, Freimuth WW; LBSL02/99 Study Group. Long-term safety profile of belimumab plus standard therapy in patients with systemic lupus erythematosus. Arthritis Rheum. 2012 Oct;64(10):3364-73. doi: 10.1002/art.34564.

  PMID: 22674457 DERIVED

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Interventions

belimumab

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline (for GlaxoSmithKline; Human Genome Sciences Inc., a GSK Company; Sirtris, a GSK Company; Stiefel, a GSK Company; ViiV Healthcare)

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2007
• First Posted: December 31, 2007
• Study Start: May 4, 2005
• Primary Completion: February 23, 2016
• Study Completion: February 23, 2016
• Last Updated: July 23, 2019
• Results First Posted: April 28, 2017

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: IPD is available via the Clinical Study Data Request site (click on the link provided below)
• Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.

Locations

US (56); CA (1)