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

Primary Purpose

Systemic Lupus Erythematosus

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

belimumab

About this trial

This is an interventional treatment trial for Systemic Lupus Erythematosus focused on measuring SLE, Belimumab, Antibodies, Systemic Lupus Erythematosus, Lupus, Autoimmune Diseases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Arm Description

1 mg/kg dose of belimumab given IV every 28 days.

10 mg/kg dose of belimumab given IV every 28 days.

Outcomes

Primary Outcome Measures

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.

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.

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.

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.

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

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT00712933

First Posted

July 8, 2008

Last Updated

November 19, 2019

Sponsor

Human Genome Sciences Inc., a GSK Company

Collaborators

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT00712933

Brief Title

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

Official Title

A Multi-Center, Continuation Trial of Belimumab (HGS1006, LymphoStat-B™)a Fully Human Monoclonal Anti-BLyS Antibody in Subjects With Systemic Lupus Erythematosus (SLE) Who Completed the Phase 3 Protocol HGS1006-C1056 or HGS1006-C1057

Study Type

Interventional

2. Study Status

Record Verification Date

November 2019

Overall Recruitment Status

Completed

Study Start Date

May 30, 2008 (Actual)

Primary Completion Date

December 9, 2016 (Actual)

Study Completion Date

December 9, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Human Genome Sciences Inc., a GSK Company

Collaborators

GlaxoSmithKline

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

Detailed Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Systemic Lupus Erythematosus

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

738 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

1 mg/kg dose of belimumab given IV every 28 days.

Arm Title

Arm Type

Experimental

Arm Description

10 mg/kg dose of belimumab given IV every 28 days.

Intervention Type

Drug

Intervention Name(s)

belimumab

Other Intervention Name(s)

LymphoStat-B™, HGS1006

Intervention Description

Recombinant, fully human, monoclonal antibody Comparison of the 1 mg/kg and 10 mg/kg dose of belimumab given IV every 28 days.

Primary Outcome Measure Information:

Title

Number of Participants With Adverse Events (AE)

Description

Time Frame

Up to 9 years

Title

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

Description

Time Frame

Up to 9 years

Title

Number of Participants With Serious Adverse Events (SAE)

Description

Time Frame

Up to 9 years

Title

SAE Rates by SOC During the Study

Description

Time Frame

Up to 9 years

Title

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

Description

Time Frame

Baseline and up to 9 years

Title

Description

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.

Time Frame

Baseline and up to 9 years

Title

Change From Baseline in Hemoglobin (Hg) at the Indicated Time Points

Description

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.

Time Frame

Baseline and up to 9 years

Title

Change From Baseline in Hematocrit at the Indicated Time Points

Description

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.

Time Frame

Baseline and up to 9 years

Title

Change From Baseline in Erythrocytes (Eryth) at the Indicated Time Points

Description

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.

Time Frame

Baseline and up to 9 years

Title

Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points

Description

Time Frame

Baseline and up to 9 years

Title

Change From Baseline in Blood Urea Nitrogen/Creatinine (BUN/Cr) at the Indicated Time Points

Description

Time Frame

Baseline and up to 9 years

Title

Change From Baseline in Albumin (Alb) and Protein (Pro) at the Indicated Time Points

Description

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.

Time Frame

Baseline and up to 9 years

Title

Change From Baseline in BUN and Glucose at the Indicated Time Points

Description

Time Frame

Baseline and up to 9 years

Title

Change From Baseline in Creatinine (Cr) and Urate at the Indicated Time Points

Description

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.

Time Frame

Baseline and up to 9 years

Title

Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels

Description

Time Frame

Baseline and up to 9 years

Title

Change From Baseline in Bilirubin (Bili) Levels

Description

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.

Time Frame

Baseline and up to 9 years

Title

Change From Baseline in Immunoglobulin G (IgG) Levels

Description

Time Frame

Baseline and up to 9 years

Title

Number of Participants With Immunogenic Response by Year

Description

Time Frame

Up to 9 years

Title

Number of Participants With IgG Values Below the Lower Limit of Normal by Year

Description

Time Frame

Up to 9 years

Title

Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit

Description

Time Frame

Up to 9 years

Title

Number of Participants With Any SLICC/ ACR Damage Index Worsening (Change > 0) From Baseline by Visit

Description

Time Frame

Up to 9 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

GSK Clinical Trials

Organizational Affiliation

GlaxoSmithKline

Official's Role

Study Director

Facility Information:

Facility Name

GSK Investigational Site

City

Ciudad Autonoma de Buenos Aires

State/Province

Buenos Aires

ZIP/Postal Code

1015

Country

Argentina

Facility Name

GSK Investigational Site

City

Ciudad Autonoma de Buenos Aires

State/Province

Buenos Aires

ZIP/Postal Code

C1419AHN

Country

Argentina

Facility Name

GSK Investigational Site

City

La Plata

State/Province

Buenos Aires

ZIP/Postal Code

B1904CFH,

Country

Argentina

Facility Name

GSK Investigational Site

City

Rosario

State/Province

Santa Fe

ZIP/Postal Code

2000

Country

Argentina

Facility Name

GSK Investigational Site

City

San Miguel de Tucuman

State/Province

Tucumán

ZIP/Postal Code

T4000AXL

Country

Argentina

Facility Name

GSK Investigational Site

City

Buenos Aires

ZIP/Postal Code

C1280AEB

Country

Argentina

Facility Name

GSK Investigational Site

City

Ciudad Autonoma Buenos Aires

ZIP/Postal Code

C1426AAL

Country

Argentina

Facility Name

GSK Investigational Site

City

Ciudad Autónoma de Buenos Aires

ZIP/Postal Code

C1417EYG

Country

Argentina

Facility Name

GSK Investigational Site

City

Vienna

ZIP/Postal Code

A-1100

Country

Austria

Facility Name

GSK Investigational Site

City

Liège

ZIP/Postal Code

4000

Country

Belgium

Facility Name

GSK Investigational Site

City

Salvador

State/Province

Bahía

ZIP/Postal Code

40.150-410

Country

Brazil

Facility Name

GSK Investigational Site

City

Goiania

State/Province

Goiás

ZIP/Postal Code

74110-120

Country

Brazil

Facility Name

GSK Investigational Site

City

Juiz de Fora

State/Province

Minas Gerais

ZIP/Postal Code

36010-570

Country

Brazil

Facility Name

GSK Investigational Site

City

Recife

State/Province

Pernambuco

ZIP/Postal Code

50670-420

Country

Brazil

Facility Name

GSK Investigational Site

City

Porto Alegre

State/Province

Rio Grande Do Sul

ZIP/Postal Code

90610000

Country

Brazil

Facility Name

GSK Investigational Site

City

Sao Paulo

State/Province

São Paulo

ZIP/Postal Code

04039-901

Country

Brazil

Facility Name

GSK Investigational Site

City

Campinas

ZIP/Postal Code

13083-888

Country

Brazil

Facility Name

GSK Investigational Site

City

Rio de Janeiro

ZIP/Postal Code

22411-001

Country

Brazil

Facility Name

GSK Investigational Site

City

São Paulo

ZIP/Postal Code

04032-060

Country

Brazil

Facility Name

GSK Investigational Site

City

São Paulo

ZIP/Postal Code

04266-010

Country

Brazil

Facility Name

GSK Investigational Site

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5T 2S8

Country

Canada

Facility Name

GSK Investigational Site

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H3G 1A4

Country

Canada

Facility Name

GSK Investigational Site

City

Viña del Mar

State/Province

Valparaíso

ZIP/Postal Code

2570017

Country

Chile

Facility Name

GSK Investigational Site

City

Santiago

ZIP/Postal Code

8431657

Country

Chile

Facility Name

GSK Investigational Site

City

Barranquilla

Country

Colombia

Facility Name

GSK Investigational Site

City

Bogota

Country

Colombia

Facility Name

GSK Investigational Site

City

Bucaramanga

Country

Colombia

Facility Name

GSK Investigational Site

City

Medellin

Country

Colombia

Facility Name

GSK Investigational Site

City

Brno - Bohunice

ZIP/Postal Code

625 00

Country

Czechia

Facility Name

GSK Investigational Site

City

Hradec Králové

ZIP/Postal Code

500 05

Country

Czechia

Facility Name

GSK Investigational Site

City

Olomouc

ZIP/Postal Code

775 20

Country

Czechia

Facility Name

GSK Investigational Site

City

Praha 2

ZIP/Postal Code

128 50

Country

Czechia

Facility Name

GSK Investigational Site

City

Suresnes

ZIP/Postal Code

92150

Country

France

Facility Name

GSK Investigational Site

City

Freiburg

State/Province

Baden-Wuerttemberg

ZIP/Postal Code

79106

Country

Germany

Facility Name

GSK Investigational Site

City

Erlangen

State/Province

Bayern

ZIP/Postal Code

91054

Country

Germany

Facility Name

GSK Investigational Site

City

Frankfurt

State/Province

Hessen

ZIP/Postal Code

60590

Country

Germany

Facility Name

GSK Investigational Site

City

Hannover

State/Province

Niedersachsen

ZIP/Postal Code

30625

Country

Germany

Facility Name

GSK Investigational Site

City

Mainz

State/Province

Rheinland-Pfalz

ZIP/Postal Code

55131

Country

Germany

Facility Name

GSK Investigational Site

City

Leipzig

State/Province

Sachsen

ZIP/Postal Code

04103

Country

Germany

Facility Name

GSK Investigational Site

City

Jena

State/Province

Thueringen

ZIP/Postal Code

07743

Country

Germany

Facility Name

GSK Investigational Site

City

Berlin

ZIP/Postal Code

10117

Country

Germany

Facility Name

GSK Investigational Site

City

Berlin

ZIP/Postal Code

14059

Country

Germany

Facility Name

GSK Investigational Site

City

Kiel

ZIP/Postal Code

24105

Country

Germany

Facility Name

GSK Investigational Site

City

Chai Wan

Country

Hong Kong

Facility Name

GSK Investigational Site

City

New Territories

Country

Hong Kong

Facility Name

GSK Investigational Site

City

Bangalore

ZIP/Postal Code

560034

Country

India

Facility Name

GSK Investigational Site

City

Hyderabad, Andhra Pradesh

ZIP/Postal Code

500482

Country

India

Facility Name

GSK Investigational Site

City

Lucknow

ZIP/Postal Code

226003

Country

India

Facility Name

GSK Investigational Site

City

Secunderabad

ZIP/Postal Code

500003

Country

India

Facility Name

GSK Investigational Site

City

Trivandrum

ZIP/Postal Code

695029

Country

India

Facility Name

GSK Investigational Site

City

Beer Sheva

ZIP/Postal Code

84101

Country

Israel

Facility Name

GSK Investigational Site

City

Haifa

ZIP/Postal Code

31048

Country

Israel

Facility Name

GSK Investigational Site

City

Haifa

ZIP/Postal Code

31096

Country

Israel

Facility Name

GSK Investigational Site

City

Haifa

ZIP/Postal Code

34362

Country

Israel

Facility Name

GSK Investigational Site

City

Petach Tikva

ZIP/Postal Code

49100

Country

Israel

Facility Name

GSK Investigational Site

City

Ramat-Gan

ZIP/Postal Code

52621

Country

Israel

Facility Name

GSK Investigational Site

City

Rehovot

ZIP/Postal Code

76100

Country

Israel

Facility Name

GSK Investigational Site

City

Roma

ZIP/Postal Code

00152

Country

Italy

Facility Name

GSK Investigational Site

City

Busan

ZIP/Postal Code

602-715

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Daejeon

ZIP/Postal Code

302-799

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Incheon

ZIP/Postal Code

400-711

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Pusan

ZIP/Postal Code

602-739

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Seoul

ZIP/Postal Code

137-701

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Seoul

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Suwon, Kyonggi-do

ZIP/Postal Code

443-721

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Guadalajara

State/Province

Jalisco

ZIP/Postal Code

44160

Country

Mexico

Facility Name

GSK Investigational Site

City

Guadalajara

State/Province

Jalisco

ZIP/Postal Code

44280

Country

Mexico

Facility Name

GSK Investigational Site

City

Mexico

ZIP/Postal Code

7760

Country

Mexico

Facility Name

GSK Investigational Site

City

San Luis Potosí

ZIP/Postal Code

78240

Country

Mexico

Facility Name

GSK Investigational Site

City

Maastricht

ZIP/Postal Code

6229 HX

Country

Netherlands

Facility Name

GSK Investigational Site

City

Rotterdam

ZIP/Postal Code

3015 CE

Country

Netherlands

Facility Name

GSK Investigational Site

City

Rotterdam

ZIP/Postal Code

3083 AN

Country

Netherlands

Facility Name

GSK Investigational Site

City

Surco

State/Province

Lima

Country

Peru

Facility Name

GSK Investigational Site

City

Callao

ZIP/Postal Code

Callao 2

Country

Peru

Facility Name

GSK Investigational Site

City

Lima 27

ZIP/Postal Code

Lima 27

Country

Peru

Facility Name

GSK Investigational Site

City

Cebu City

ZIP/Postal Code

6000

Country

Philippines

Facility Name

GSK Investigational Site

City

Davao City

ZIP/Postal Code

8000

Country

Philippines

Facility Name

GSK Investigational Site

City

Las Pinas

ZIP/Postal Code

1740

Country

Philippines

Facility Name

GSK Investigational Site

City

Manila

ZIP/Postal Code

1000

Country

Philippines

Facility Name

GSK Investigational Site

City

Quezon City

ZIP/Postal Code

1102

Country

Philippines

Facility Name

GSK Investigational Site

City

Sampaloc Manila

ZIP/Postal Code

1008

Country

Philippines

Facility Name

GSK Investigational Site

City

Konskie

ZIP/Postal Code

26-200

Country

Poland

Facility Name

GSK Investigational Site

City

Ponce

ZIP/Postal Code

00716

Country

Puerto Rico

Facility Name

GSK Investigational Site

City

San Juan

ZIP/Postal Code

00936-5067

Country

Puerto Rico

Facility Name

GSK Investigational Site

City

Bucharest

ZIP/Postal Code

020125

Country

Romania

Facility Name

GSK Investigational Site

City

Bucuresti

ZIP/Postal Code

020475

Country

Romania

Facility Name

GSK Investigational Site

City

Bucuresti

ZIP/Postal Code

021392

Country

Romania

Facility Name

GSK Investigational Site

City

Cluj Napoca

ZIP/Postal Code

400006

Country

Romania

Facility Name

GSK Investigational Site

City

Moscow

ZIP/Postal Code

115522

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Saint Petersburg

ZIP/Postal Code

194291

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Saint-Petersburg

ZIP/Postal Code

190068

Country

Russian Federation

Facility Name

GSK Investigational Site

City

St. Petersburg

ZIP/Postal Code

191015

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Yaroslavl

ZIP/Postal Code

150003

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Yaroslavl

ZIP/Postal Code

150023

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Piestany

ZIP/Postal Code

921 12

Country

Slovakia

Facility Name

GSK Investigational Site

City

Barcelona

ZIP/Postal Code

08036

Country

Spain

Facility Name

GSK Investigational Site

City

Madrid

ZIP/Postal Code

28046

Country

Spain

Facility Name

GSK Investigational Site

City

Stockholm

ZIP/Postal Code

SE-171 76

Country

Sweden

Facility Name

GSK Investigational Site

City

Dalin Township, Chiayi County

ZIP/Postal Code

662

Country

Taiwan

Facility Name

GSK Investigational Site

City

Gueishan Township,Taoyuan County

ZIP/Postal Code

333

Country

Taiwan

Facility Name

GSK Investigational Site

City

Hualien

ZIP/Postal Code

970

Country

Taiwan

Facility Name

GSK Investigational Site

City

Kaohsiung

ZIP/Postal Code

807

Country

Taiwan

Facility Name

GSK Investigational Site

City

Kaohsiung

ZIP/Postal Code

813

Country

Taiwan

Facility Name

GSK Investigational Site

City

Kaohsiung

ZIP/Postal Code

833

Country

Taiwan

Facility Name

GSK Investigational Site

City

Taichung

ZIP/Postal Code

402

Country

Taiwan

Facility Name

GSK Investigational Site

City

Taichung

ZIP/Postal Code

404

Country

Taiwan

Facility Name

GSK Investigational Site

City

Taichung

ZIP/Postal Code

40705

Country

Taiwan

Facility Name

GSK Investigational Site

City

Taipei

ZIP/Postal Code

100

Country

Taiwan

Facility Name

GSK Investigational Site

City

London

ZIP/Postal Code

SE1 7EH

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Newcastle Upon Tyne

ZIP/Postal Code

NE7 7DN

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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 URL

https://clinicalstudydatarequest.com/Posting.aspx?ID=20055

Citations:

PubMed Identifier

26936891

Citation

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.

Results Reference

background

PubMed Identifier

31302695

Citation

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.

Results Reference

background

PubMed Identifier

33051264

Citation

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.

Results Reference

derived

Learn more about this trial

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

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

Systemic Lupus Erythematosus

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial