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

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

This is a long-term continuation study to provide continuing treatment to subjects with SLE.

Study Overview

• Status: Completed
• Conditions: Systemic Lupus Erythematosus
• Intervention / Treatment: Drug: belimumab

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 738
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1280AEB
    • GSK Investigational Site
  • Ciudad Autonoma Buenos Aires, Argentina, C1426AAL
    • GSK Investigational Site
  • Ciudad Autónoma de Buenos Aires, Argentina, C1417EYG
    • GSK Investigational Site
  • Buenos Aires
    • Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1419AHN
      • GSK Investigational Site
    • Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, 1015
      • GSK Investigational Site
    • La Plata, Buenos Aires, Argentina, B1904CFH,
      • GSK Investigational Site
  • Santa Fe
    • Rosario, Santa Fe, Argentina, 2000
      • GSK Investigational Site
  • Tucumán
    • San Miguel de Tucuman, Tucumán, Argentina, T4000AXL
      • GSK Investigational Site
• Austria
  • Vienna, Austria, A-1100
    • GSK Investigational Site
• Belgium
  • Liège, Belgium, 4000
    • GSK Investigational Site
• Brazil
  • Campinas, Brazil, 13083-888
    • GSK Investigational Site
  • Rio de Janeiro, Brazil, 22411-001
    • GSK Investigational Site
  • São Paulo, Brazil, 04266-010
    • GSK Investigational Site
  • São Paulo, Brazil, 04032-060
    • GSK Investigational Site
  • Bahía
    • Salvador, Bahía, Brazil, 40.150-410
      • GSK Investigational Site
  • Goiás
    • Goiania, Goiás, Brazil, 74110-120
      • GSK Investigational Site
  • Minas Gerais
    • Juiz de Fora, Minas Gerais, Brazil, 36010-570
      • GSK Investigational Site
  • Pernambuco
    • Recife, Pernambuco, Brazil, 50670-420
      • GSK Investigational Site
  • Rio Grande Do Sul
    • Porto Alegre, Rio Grande Do Sul, Brazil, 90610000
      • GSK Investigational Site
  • São Paulo
    • Sao Paulo, São Paulo, Brazil, 04039-901
      • GSK Investigational Site
• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5T 2S8
      • GSK Investigational Site
  • Quebec
    • Montreal, Quebec, Canada, H3G 1A4
      • GSK Investigational Site
• Chile
  • Santiago, Chile, 8431657
    • GSK Investigational Site
  • Valparaíso
    • Viña del Mar, Valparaíso, Chile, 2570017
      • GSK Investigational Site
• Colombia
  • Barranquilla, Colombia
    • GSK Investigational Site
  • Bogota, Colombia
    • GSK Investigational Site
  • Bucaramanga, Colombia
    • GSK Investigational Site
  • Medellin, Colombia
    • GSK Investigational Site
• Czechia
  • Brno - Bohunice, Czechia, 625 00
    • GSK Investigational Site
  • Hradec Králové, Czechia, 500 05
    • GSK Investigational Site
  • Olomouc, Czechia, 775 20
    • GSK Investigational Site
  • Praha 2, Czechia, 128 50
    • GSK Investigational Site
• France
  • Suresnes, France, 92150
    • GSK Investigational Site
• Germany
  • Berlin, Germany, 14059
    • GSK Investigational Site
  • Berlin, Germany, 10117
    • GSK Investigational Site
  • Kiel, Germany, 24105
    • GSK Investigational Site
  • Baden-Wuerttemberg
    • Freiburg, Baden-Wuerttemberg, Germany, 79106
      • GSK Investigational Site
  • Bayern
    • Erlangen, Bayern, Germany, 91054
      • GSK Investigational Site
  • Hessen
    • Frankfurt, Hessen, Germany, 60590
      • GSK Investigational Site
  • Niedersachsen
    • Hannover, Niedersachsen, Germany, 30625
      • GSK Investigational Site
  • Rheinland-Pfalz
    • Mainz, Rheinland-Pfalz, Germany, 55131
      • GSK Investigational Site
  • Sachsen
    • Leipzig, Sachsen, Germany, 04103
      • GSK Investigational Site
  • Thueringen
    • Jena, Thueringen, Germany, 07743
      • GSK Investigational Site
• Hong Kong
  • Chai Wan, Hong Kong
    • GSK Investigational Site
  • New Territories, Hong Kong
    • GSK Investigational Site
• India
  • Bangalore, India, 560034
    • GSK Investigational Site
  • Hyderabad, Andhra Pradesh, India, 500482
    • GSK Investigational Site
  • Lucknow, India, 226003
    • GSK Investigational Site
  • Secunderabad, India, 500003
    • GSK Investigational Site
  • Trivandrum, India, 695029
    • GSK Investigational Site
• Israel
  • Beer Sheva, Israel, 84101
    • GSK Investigational Site
  • Haifa, Israel, 31096
    • GSK Investigational Site
  • Haifa, Israel, 31048
    • GSK Investigational Site
  • Haifa, Israel, 34362
    • GSK Investigational Site
  • Petach Tikva, Israel, 49100
    • GSK Investigational Site
  • Ramat-Gan, Israel, 52621
    • GSK Investigational Site
  • Rehovot, Israel, 76100
    • GSK Investigational Site
• Italy
  • Roma, Italy, 00152
    • GSK Investigational Site
• Korea, Republic of
  • Busan, Korea, Republic of, 602-715
    • GSK Investigational Site
  • Daejeon, Korea, Republic of, 302-799
    • GSK Investigational Site
  • Incheon, Korea, Republic of, 400-711
    • GSK Investigational Site
  • Pusan, Korea, Republic of, 602-739
    • GSK Investigational Site
  • Seoul, Korea, Republic of, 137-701
    • GSK Investigational Site
  • Seoul, Korea, Republic of
    • GSK Investigational Site
  • Suwon, Kyonggi-do, Korea, Republic of, 443-721
    • GSK Investigational Site
• Mexico
  • Mexico, Mexico, 7760
    • GSK Investigational Site
  • San Luis Potosí, Mexico, 78240
    • GSK Investigational Site
  • Jalisco
    • Guadalajara, Jalisco, Mexico, 44280
      • GSK Investigational Site
    • Guadalajara, Jalisco, Mexico, 44160
      • GSK Investigational Site
• Netherlands
  • Maastricht, Netherlands, 6229 HX
    • GSK Investigational Site
  • Rotterdam, Netherlands, 3015 CE
    • GSK Investigational Site
  • Rotterdam, Netherlands, 3083 AN
    • GSK Investigational Site
• Peru
  • Callao, Peru, Callao 2
    • GSK Investigational Site
  • Lima 27, Peru, Lima 27
    • GSK Investigational Site
  • Lima
    • Surco, Lima, Peru
      • GSK Investigational Site
• Philippines
  • Cebu City, Philippines, 6000
    • GSK Investigational Site
  • Davao City, Philippines, 8000
    • GSK Investigational Site
  • Las Pinas, Philippines, 1740
    • GSK Investigational Site
  • Manila, Philippines, 1000
    • GSK Investigational Site
  • Quezon City, Philippines, 1102
    • GSK Investigational Site
  • Sampaloc Manila, Philippines, 1008
    • GSK Investigational Site
• Poland
  • Konskie, Poland, 26-200
    • GSK Investigational Site
• Puerto Rico
  • Ponce, Puerto Rico, 00716
    • GSK Investigational Site
  • San Juan, Puerto Rico, 00936-5067
    • GSK Investigational Site
• Romania
  • Bucharest, Romania, 020125
    • GSK Investigational Site
  • Bucuresti, Romania, 020475
    • GSK Investigational Site
  • Bucuresti, Romania, 021392
    • GSK Investigational Site
  • Cluj Napoca, Romania, 400006
    • GSK Investigational Site
• Russian Federation
  • Moscow, Russian Federation, 115522
    • GSK Investigational Site
  • Saint Petersburg, Russian Federation, 194291
    • GSK Investigational Site
  • Saint-Petersburg, Russian Federation, 190068
    • GSK Investigational Site
  • St. Petersburg, Russian Federation, 191015
    • GSK Investigational Site
  • Yaroslavl, Russian Federation, 150003
    • GSK Investigational Site
  • Yaroslavl, Russian Federation, 150023
    • GSK Investigational Site
• Slovakia
  • Piestany, Slovakia, 921 12
    • GSK Investigational Site
• Spain
  • Barcelona, Spain, 08036
    • GSK Investigational Site
  • Madrid, Spain, 28046
    • GSK Investigational Site
• Sweden
  • Stockholm, Sweden, SE-171 76
    • GSK Investigational Site
• Taiwan
  • Dalin Township, Chiayi County, Taiwan, 662
    • GSK Investigational Site
  • Gueishan Township,Taoyuan County, Taiwan, 333
    • GSK Investigational Site
  • Hualien, Taiwan, 970
    • GSK Investigational Site
  • Kaohsiung, Taiwan, 833
    • GSK Investigational Site
  • Kaohsiung, Taiwan, 813
    • GSK Investigational Site
  • Kaohsiung, Taiwan, 807
    • GSK Investigational Site
  • Taichung, Taiwan, 404
    • GSK Investigational Site
  • Taichung, Taiwan, 40705
    • GSK Investigational Site
  • Taichung, Taiwan, 402
    • GSK Investigational Site
  • Taipei, Taiwan, 100
    • GSK Investigational Site
• United Kingdom
  • London, United Kingdom, SE1 7EH
    • GSK Investigational Site
  • Newcastle Upon Tyne, United Kingdom, NE7 7DN
    • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Adverse Events (AE)	An adverse event 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: increase in frequency or severity) of preexisting conditions. Participants with incidences of any event at any time post-baseline are presented by yearly interval. Only treatment-emergent AEs are summarized.	Up to 9 years
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 AEs are summarized. The event rate of an AE was calculated as the number of events per 100 participant years. Participant years were calculated as sum across all participants ([last visit of interval day - first visit of interval day + 1] divided by365). Participant years excluded between study gaps if participant had not started extension study on date of last visit of parent study.	Up to 9 years
Number of Participants With Serious Adverse Events (SAE)	An adverse event resulting in death, is life threatening (ie, an immediate threat to life), inpatient hospitalization, prolongation of existing hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect or any other situation which is medically important is categorized as SAE. Only treatment-emergent AEs are summarized.	Up to 9 years
SAE Rates by 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 event rate of an SAE was calculated as the number of events per 100 participant years. Participants years were calculated as = sum across all participants ([last visit of interval day - first visit of interval day + 1] divided by 365). Participants years excluded between study gaps if participant had not started extension study on date of last visit of parent study.	Up to 9 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 4,12,24,36, and 48 during Year 1. From Year 2-9 hematology parameters were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks post infusion). Change from Baseline in APTT and PT is summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were 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. NA indicates standard deviation was not calculable for a single data point	Baseline and up to 9 years
Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points	Hematology parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 hematology parameters were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks post infusion). Change from Baseline in Plt, Lymp, Leu, Eos, Baso, Mono, Neu, NeuBF, and NueS are summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were 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. NA indicates standard deviation was not calculable for a single data point.	Baseline and up to 9 years
Change From Baseline in Hemoglobin (Hg) at the Indicated Time Points	Hematology parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 hematology parameters were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks post infusion). Change from Baseline in Hg is summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were 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. NA indicates standard deviation was not calculable for a single data point.	Baseline and up to 9 years
Change From Baseline in Hematocrit at the Indicated Time Points	Hematology parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 hematology parameters were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks). Change from Baseline in Hematocrit is summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were 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. NA indicates standard deviation was not calculable for a single data point.	Baseline and up to 9 years
Change From Baseline in Erythrocytes (Eryth) at the Indicated Time Points	Hematology parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 hematology parameters were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks post infusion). Change from Baseline in Erythrocytes is summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were 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. NA indicates standard deviation was not calculable for a single data point.	Baseline and up to 9 years
Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points	Electrolytes parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 electrolytes parameters were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks post infusion). Change from Baseline in Ca,CO2, Chloride, Mg, Phos, K and Na were summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were 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. NA indicates standard deviation was not calculable for a single data point.	Baseline and up to 9 years
Change From Baseline in Blood Urea Nitrogen/Creatinine (BUN/Cr) at the Indicated Time Points	Other chemistries parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 other chemistries parameters were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks post infusion). Change from Baseline in BUN/Cr is summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were 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.	Baseline and up to 9 years
Change From Baseline in Albumin (Alb) and Protein (Pro) at the Indicated Time Points	Other chemistries parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 other chemistries parameters were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks post infusion). Change from Baseline in Alb and Protein were summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were 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. NA indicates standard deviation was not calculable for a single data point.	Baseline and up to 9 years
Change From Baseline in BUN and Glucose at the Indicated Time Points	Other chemistries parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 other chemistries were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks post infusion). Change from Baseline in BUN and Glucose were summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were 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. NA indicates standard deviation was not calculable for a single data point.	Baseline and up to 9 years
Change From Baseline in Creatinine (Cr) and Urate at the Indicated Time Points	Other chemistries parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 other chemistries were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks post infusion). Change from Baseline in Cr and Urate were summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were 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. NA indicates standard deviation was not calculable for a single data point.	Baseline and up to 9 years
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels	Liver function parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 liver function parameters were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks post infusion). Change from Baseline in ALT, ALP, AST, GGT and LDH were summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were 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.NA indicates standard deviation was not calculable for a single data point.	Baseline and up to 9 years
Change From Baseline in Bilirubin (Bili) Levels	Liver function parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 liver function parameters were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks post infusion). Change from Baseline in Bili were summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were 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. NA indicates standard deviation was not calculable for a single data point.	Baseline and up to 9 years
Change From Baseline in Immunoglobulin G (IgG) Levels	Immunoglobulin (Ig) parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 Ig parameters were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks post infusion). Change from Baseline in Ig G were summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were 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. NA indicates standard deviation was not calculable for a single data point.	Baseline and up to 9 years
Number of Participants With Immunogenic Response by Year	Immunogenic response was analyzed using serum samples for anti-belimumab antibody measurements in MITT population. Categories of response are Negative, Transient Positive (+) means single + response that does not occur at the final assessment, and Persistent + means + response that occurs at least 2 consecutive assessments or a single result 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 9 years
Number of Participants With IgG Values Below the Lower Limit of Normal by Year	Blood samples were collected to evaluate IgG levels at Baseline and at Weeks 12, 24 and 48 during Year 1. From Year 2-9, IgG was evaluated at Week 24 and 48 ; Exit visit and at follow-up visit (up to 8 weeks post last infusion). Number of participants with IgG immunoglobulin values below the LLN at each one year interval are presented. Baseline includes Extension Year 1 Day 0 values for MITT participants treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants treated with Belimumab in the parent study. If a participant had more than one response within a year, then the last response within the year interval (usually the Week 48 assessment) was summarized. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.	Up to 9 years
Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit	Participants who had improving SLE disease activity for at least 8 weeks, at the investigator's discretion, the steroid dose was reduced by reduction to 7.5 mg/day. If the participant continued to have stable or improving disease activity after 4 weeks on a reduced dose, then the investigator considered reducing the dose again. Baseline includes extension Year 1 Day 0 values for MITT participants treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants treated with Belimumab in the parent study. Number of participants with shifts from Baseline total daily dose category by visit is summarized.	Up to 9 years
Number of Participants With Any SLICC/ ACR Damage Index Worsening (Change > 0) From Baseline by Visit	The SLICC/ACR Damage Index was assessed every 48 weeks and at the exit visit as a measure of disease activity. It was developed to assess the accumulated damage since the onset of the disease. The number of participants with worsening in their SLICC/ACR Damage Index score compared with Baseline have been presented. Worsening was defined as a change in score (post-Baseline visit score - Baseline score) > 0. Baseline includes extension Year 1 Day 0 values for MITT participants treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants treated with Belimumab in the parent study. For years in which a participant was withdrawn from the study, the exit visit assessment was used in place of the Week 48 assessment for the year. This value was not carried forward through later years. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.	Up to 9 years

Collaborators and Investigators

• Sponsor: Human Genome Sciences Inc., a GSK Company
• Collaborators: GlaxoSmithKline

Publications and helpful links

General Publications

• Bruce IN, Urowitz M, van Vollenhoven R, Aranow C, Fettiplace J, Oldham M, Wilson B, Molta C, Roth D, Gordon D. Long-term organ damage accrual and safety in patients with SLE treated with belimumab plus standard of care. Lupus. 2016 Jun;25(7):699-709. doi: 10.1177/0961203315625119. Epub 2016 Mar 1.
• van Vollenhoven RF, Navarra SV, Levy RA, Thomas M, Heath A, Lustine T, Adamkovic A, Fettiplace J, Wang ML, Ji B, Roth D. Long-term safety and limited organ damage in patients with systemic lupus erythematosus treated with belimumab: a Phase III study extension. Rheumatology (Oxford). 2020 Feb 1;59(2):281-291. doi: 10.1093/rheumatology/kez279.
• Urowitz MB, Ohsfeldt RL, Wielage RC, Dever JJ, Zakerifar M, Asukai Y, Ramachandran S, Joshi AV. Comparative analysis of long-term organ damage in patients with systemic lupus erythematosus using belimumab versus standard therapy: a post hoc longitudinal study. Lupus Sci Med. 2020 Oct;7(1):e000412. doi: 10.1136/lupus-2020-000412.

Study record dates

Study Major Dates

• Study Start (Actual): May 30, 2008
• Primary Completion (Actual): December 9, 2016
• Study Completion (Actual): December 9, 2016

Study Registration Dates

• First Submitted: July 8, 2008
• First Submitted That Met QC Criteria: July 9, 2008
• First Posted (Estimate): July 10, 2008

Study Record Updates

• Last Update Posted (Actual): December 5, 2019
• Last Update Submitted That Met QC Criteria: November 19, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: Lupus; SLE; Systemic Lupus Erythematosus; Autoimmune Diseases; Antibodies; Belimumab
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Connective Tissue Diseases; Lupus Erythematosus, Systemic; Physiological Effects of Drugs; Immunosuppressive Agents; Immunologic Factors; Belimumab
• Other Study ID Numbers: 112234; 2007-007648-85 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: IPD for this study will be made available via the Clinical Study Data Request site.
• IPD Sharing Time Frame: IPD is available via the Clinical Study Data Request site (click on the link provided below)
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR