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

NCT00724867 | Completed Phase 3 Results DMC

• 2 other identifiers: 112233HGS1006-C1066
• Study Type: interventional
• Target: 268
• Locations: 1 country
• Sites: 51

Brief 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.

Conditions

Systemic Lupus Erythematosus

Keywords

Systemic Lupus Erythematosus; Belimumab; SLE; Antibodies; Lupus; Autoimmune Diseases

Outcome Measures

Primary Outcomes (18)

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

  An AE is defined as any untoward medical occurrence in a participant (par.) temporally associated with the use of a investigational product (IP), whether or not considered related to the IP. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of an IP. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, is an important medical event that jeopardizes the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition, or is associated with liver injury and impaired liver function. Only those participants available at the specified time points (represented by n=X, in the category titles) were analyzed.

  Up to Week 440

• 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 treatment-emergent adverse events (AEs) are summarized. The Baseline is defined as the 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. The event rate of an AE was calculated as the number of events per 100 participant years: Event Rate = 100\* Number of Events / Participant Years. Participant years were calculated as sum across all participants (\[last visit of interval day - first visit of interval day + 1\]/365). Participant years excluded between study gaps if participant had not started extension study on date of last visit of parent study.

  Up Week 440

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

  SAE rates by SOC adjusting for participants-years on study drug anytime post Baseline are summarized, which included the follow up visits. Only treatment-emergent SAEs are summarized. The Baseline is defined as the 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. The event rate of an SAE was calculated as the number of events per 100 participant years: Event Rate = 100\* Number of Events / participants Years. participants years were calculated as = sum across all participants (\[last visit of interval day - first visit of interval day + 1\]/365). participants years excluded between study gaps if participant had not started extension study on date of last visit of parent study.

  Up to Week 440

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

  Hematology parameters were assessed at Baseline (BL) (Day 0), Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at follow-up (up to 8 weeks post last infusion). Change from Baseline in APTT and PT is summarized. The Baseline is defined as the 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. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.

  Up to Week 440

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

  Hematology parameters were assessed at Baseline (BL) (Day 0), Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to440 weeks and at follow-up (up to 8 weeks post last infusion). Change from Baseline in basophils, eosinophils, lymphocytes, monocytes, neutrophils, neutrophils segmented and platelets is summarized. The Baseline is defined as the 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. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.

  Up to Week 440

• Change From Baseline in Erythrocytes at the Indicated Time Points

  Hematology parameters were assessed at Baseline (BL) (Day 0), at Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at follow-up (up to 8 weeks post last infusion). Change from Baseline in erythrocytes is summarized. The Baseline is defined as the 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. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.

  Up to Week 440

• Change From Baseline in Hematocrit at the Indicated Time Points

  Hematology parameters were assessed at Baseline (BL) (Day 0), Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at follow-up (up to 8 weeks post last infusion). Change from Baseline in hematocrit is summarized. The Baseline is defined as the 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. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.

  Up to Week 440

• Change From Baseline in Hemoglobin at the Indicated Time Points

  Hematology parameters were assessed at Baseline (BL) (Day 0), Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at follow-up (up to 8 weeks post last infusion). Change from Baseline in hemoglobin is summarized. The Baseline is defined as the 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. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.

  Up to Week 440

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

  Clinical chemistry parameters were assessed at Baseline (BL) (Day 0), at Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at follow-up (up to 8 weeks post last infusion). Change from Baseline in albumin and protein is summarized. The Baseline is defined as the 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. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.

  Up to Week 440

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

  Clinical chemistry parameters were assessed at Baseline (BL) (Day 0), at Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at follow-up (up to 8 weeks post last infusion). Change from Baseline in blood urea nitrogen, glucose, calcium, carbon dioxide, chloride, magnesium, phosphate, potassium and sodium is summarized. The Baseline is defined as the 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. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.

  Up to Week 440

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

  Clinical chemistry parameters were assessed at Baseline (BL) (Day 0), at Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at follow-up (up to 8 weeks post last infusion). Change from Baseline in urate, creatinine and bilirubin is summarized. The Baseline is defined as the 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. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.

  Up to Week 440

• Change From Baseline in Creatinine Clearance at the Indicated Time Points

  Clinical chemistry parameters were assessed at Baseline (BL) (Day 0), at Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at follow-up (up to 8 weeks post last infusion). Change from Baseline in creatinine clearance is summarized. The Baseline is defined as the 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. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.

  Up to Week 440

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

  Clinical chemistry parameters were assessed at Baseline (BL) (Day 0), at Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at follow-up (up to 8 weeks post last infusion). Change from Baseline in BUN/creatinine is summarized. The Baseline is defined as the 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. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.

  Up to Week 440

• Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points

  Clinical chemistry parameters were assessed at Baseline (BL) (Day 0), at Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to 432 weeks and at exit visit. Change from Baseline in alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, gamma glutamyl transferase and lactate dehydrogenase is summarized. The Baseline is defined as the 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. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.

  Up to Week 432

• Number of Participants With the Indicated Immunogenic Response

  Immunogenic response was assessed by binding confirmatory assay at Baseline (BL) (Day 0), at Week 24 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at follow-up (up to 8 weeks post last infusion). Number of participants with the indicated immunogenic response are summarized. The Baseline is defined as the 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. Results of binding confirmatory assay were categorized as negative, persistent positive (defined as a positive immunogenic response that occurs at least 2 consecutive assessments or a single result at the final assessment) or transient positive (defined as a single positive immunogenic response that does not occur at the final assessment). Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.

  Up to Week 440

• Systolic Blood Pressure and Diastolic Blood Pressure at Indicated Time Points.

  Systolic blood pressure (SBP) and diastolic blood pressure (DBP) was measured at Baseline (BL) (Day 0), at Week 24 and 48 in first year, at Week 24 and 48 in subsequent years up to 432 weeks and at exit visit. The Baseline is defined as the 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. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.

  Up to Week 432

• Percentage of Participants With at Least 25% Increase From Baseline in Creatinine at Indicated Time Points.

  Serum creatinine was assessed at Baseline (BL) (Day 0), at Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at follow-up (up to 8 weeks post last infusion). Percentage of participants with at least 25% increase from baseline in creatinine are summarized. The Baseline is defined as the 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. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.

  Up to Week 440

• Percentage of Participants With at Least 25% Reduction From Baseline in Creatinine at Indicated Time Points. Amongst Subjects With Abnormal (>124 Umol/L) Creatinine at Baseline by Year Interval.

  Serum creatinine was assessed at Baseline (BL) (Day 0), at Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at follow-up (up to 8 weeks post last infusion). Percentage of participants with at least 25% reduction from baseline in creatinine are summarized. The Baseline is defined as the 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. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.

  Up to Week 440

Secondary Outcomes (15)

• Number of Participants With Serum Immunoglobulins Below the Lower Limit of Normal at Indicated Time Points.

  Up to Week 392

• Percentage of Participants Achieving SRI Response at Indicated Time Points

  Up to Week 440

• Observed Anti-double Stranded DNA Levels at Indicated Time Points.

  Up to Week 432

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

  Up to Week 432

• Observed Complement C3 and C4 Levels at Indicated Time Points

  Up to Week 440

Study Arms (2)

Belimumab 1 mg/kg

EXPERIMENTAL

Belimumab 1 mg/kg IV every 28 days

Biological: Belimumab 1 mg/kg

Belimumab 10 mg/kg

EXPERIMENTAL

Belimumab 10 mg/kg IV every 28 days

Biological: Belimumab 10 mg/kg

Interventions

Belimumab 1 mg/kg BIOLOGICAL

Belimumab 1 mg/kg IV over one hour every 28 days

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

Belimumab 1 mg/kg

Belimumab 10 mg/kg BIOLOGICAL

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

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

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 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.

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (51)

GSK Investigational Site

Birmingham, Alabama, 35249, United States

Location

GSK Investigational Site

Phoenix, Arizona, 85032, United States

Location

GSK Investigational Site

Tucson, Arizona, 85724, United States

Location

GSK Investigational Site

Long Beach, California, 90806, United States

Location

GSK Investigational Site

Los Angeles, California, 90033, United States

Location

GSK Investigational Site

Los Angeles, California, 90048, United States

Location

GSK Investigational Site

Upland, California, 91786, United States

Location

GSK Investigational Site

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

Location

GSK Investigational Site

Aventura, Florida, 33180, United States

Location

GSK Investigational Site

Orlando, Florida, 32806, United States

Location

GSK Investigational Site

Tampa, Florida, 33614, United States

Location

GSK Investigational Site

Atlanta, Georgia, 30303, United States

Location

GSK Investigational Site

Chicago, Illinois, 60612, United States

Location

GSK Investigational Site

Chicago, Illinois, 60637, United States

Location

GSK Investigational Site

Munster, Indiana, 46321, United States

Location

GSK Investigational Site

Kansas City, Kansas, 66160, United States

Location

GSK Investigational Site

Louisville, Kentucky, 40202, United States

Location

GSK Investigational Site

Baton Rouge, Louisiana, 70809, United States

Location

GSK Investigational Site

Baltimore, Maryland, 21205, United States

Location

GSK Investigational Site

Cumberland, Maryland, 21502, United States

Location

GSK Investigational Site

Hagerstown, Maryland, 21740, United States

Location

GSK Investigational Site

Ann Arbor, Michigan, 48109-5542, United States

Location

GSK Investigational Site

Lansing, Michigan, 48910, United States

Location

GSK Investigational Site

Brooklyn, New York, 11203, United States

Location

GSK Investigational Site

Great Neck, New York, 11021, United States

Location

GSK Investigational Site

Manhasset, New York, 11030, United States

Location

GSK Investigational Site

New York, New York, 10016, United States

Location

GSK Investigational Site

Rochester, New York, 14618, United States

Location

GSK Investigational Site

Smithtown, New York, 11787, United States

Location

GSK Investigational Site

The Bronx, New York, 10461, United States

Location

GSK Investigational Site

Chapel Hill, North Carolina, 27599, United States

Location

GSK Investigational Site

Greenville, North Carolina, 27834, United States

Location

GSK Investigational Site

Winston-Salem, North Carolina, 27157, United States

Location

GSK Investigational Site

Columbus, Ohio, 43203, United States

Location

GSK Investigational Site

Dayton, Ohio, 45417, United States

Location

GSK Investigational Site

Oklahoma City, Oklahoma, 74104, United States

Location

GSK Investigational Site

Tulsa, Oklahoma, 74104, United States

Location

GSK Investigational Site

Bethlehem, Pennsylvania, 18015, United States

Location

GSK Investigational Site

Pittsburgh, Pennsylvania, 15217, United States

Location

GSK Investigational Site

Charleston, South Carolina, 29406, United States

Location

GSK Investigational Site

Charleston, South Carolina, 29425, United States

Location

GSK Investigational Site

Greenville, South Carolina, 29601, United States

Location

GSK Investigational Site

Austin, Texas, 78705, United States

Location

GSK Investigational Site

Houston, Texas, 77004, United States

Location

GSK Investigational Site

Houston, Texas, 77034, United States

Location

GSK Investigational Site

Houston, Texas, 77074, United States

Location

GSK Investigational Site

San Antonio, Texas, 78232, United States

Location

GSK Investigational Site

Sugar Land, Texas, 77479, United States

Location

GSK Investigational Site

Arlington, Virginia, 22205-3606, United States

Location

GSK Investigational Site

Seattle, Washington, 98133, United States

Location

GSK Investigational Site

Onalaska, Wisconsin, 54650, United States

Location

Related Publications (2)

• Strand V, Berry P, Lin X, Asukai Y, Punwaney R, Ramachandran S. Long-Term Impact of Belimumab on Health-Related Quality of Life and Fatigue in Patients With Systemic Lupus Erythematosus: Six Years of Treatment. Arthritis Care Res (Hoboken). 2019 Jun;71(6):829-838. doi: 10.1002/acr.23788. Epub 2019 Apr 29.

  PMID: 30320964 DERIVED

• Furie RA, Wallace DJ, Aranow C, Fettiplace J, Wilson B, Mistry P, Roth DA, Gordon D. Long-Term Safety and Efficacy of Belimumab in Patients With Systemic Lupus Erythematosus: A Continuation of a Seventy-Six-Week Phase III Parent Study in the United States. Arthritis Rheumatol. 2018 Jun;70(6):868-877. doi: 10.1002/art.40439. Epub 2018 Apr 25.

  PMID: 29409143 DERIVED

MeSH Terms

Conditions

Lupus Erythematosus, Systemic; Autoimmune Diseases

Interventions

belimumab

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2008
• First Posted: July 30, 2008
• Study Start: August 1, 2008
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: March 28, 2016
• Results First Posted: March 28, 2016

Record last verified: 2016-03

Locations

US (51)