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

November 19, 2019 updated by: Human Genome Sciences Inc., a GSK Company

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
738

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants With Adverse Events (AE)
Time Frame: Up to 9 years
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
Time Frame: Up to 9 years
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)
Time Frame: Up to 9 years
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
Time Frame: Up to 9 years
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
Time Frame: Baseline and up to 9 years
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
Time Frame: Baseline and up to 9 years
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
Time Frame: Baseline and up to 9 years
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
Time Frame: Baseline and up to 9 years
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
Time Frame: Baseline and up to 9 years
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
Time Frame: Baseline and up to 9 years
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
Time Frame: Baseline and up to 9 years
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
Time Frame: Baseline and up to 9 years
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
Time Frame: Baseline and up to 9 years
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
Time Frame: Baseline and up to 9 years
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
Time Frame: Baseline and up to 9 years
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
Time Frame: Baseline and up to 9 years
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
Time Frame: Baseline and up to 9 years
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
Time Frame: Up to 9 years
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
Time Frame: Up to 9 years
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
Time Frame: Up to 9 years
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
Time Frame: Up to 9 years
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Human Genome Sciences Inc., a GSK Company

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
GlaxoSmithKline

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 30, 2008

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 9, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 9, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 8, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 9, 2008

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 10, 2008

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 5, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 19, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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