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

Primary Purpose

Systemic Lupus Erythematosus

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Belimumab

About this trial

This is an interventional treatment trial for Systemic Lupus Erythematosus focused on measuring SLE, Lupus

Eligibility Criteria

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

Primary Inclusion Criteria

1. Have completed the LBSL02 trial and achieved a satisfactory response.

Primary Exclusion Criteria

Required more than 2 courses of corticosteroids for treatment of severe SLE flares in the last 5 months of LBSL02.
Had an SLE flare during the last 30 days of LBSL02 and through the 1st dose in LBSL99.
Used any of the following prohibited medications during their participation in LBSL02:
- Other investigational agents.
- Biologic therapeutic agents: adalimumab (Humira™), etanercept (Enbrel™), infliximab (Remicade™), and rituximab (Rituxan™).
- Intravenous cyclophosphamide.
- Corticosteroids >100 mg/day prednisone equivalent for reasons other than severe SLE flare.

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Belimumab 10 mg/kg

Arm Description

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

Outcomes

Primary Outcome Measures

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

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

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

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

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

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

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

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

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

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

Change From Baseline in Erythrocytes at the Indicated Time Points

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

Change From Baseline in Hematocrit at the Indicated Time Points

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

Change From Baseline in Hemoglobin at the Indicated Time Points

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

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

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

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

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

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

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

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

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

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

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

Secondary Outcome Measures

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

SRI response was assessed at Week 16, 32, and 48 during Year 1 to 12 and Week 16 and 32 during Year 13. Baseline is defined as the last available value prior to belimumab start date, for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. SRI response is defined as:>=4 point reduction from the Baseline in safety of estrogen in lupus national assessment (SELENA) SLE disease activity index (SLEDAI) score and no worsening (increase of <0.30 points from the Baseline) in Physician's Global Assessment (PGA), and no new British Isles Lupus Assessment Group (BILAG) A organ domain score or 2 new BILAG B organ domain scores compared with the Baseline at the time of assessment.

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

Anti-double stranded DNA levels in participants positive at Baseline were assessed at Baseline, Week 16, 32, and 48 during Year 1 to 11, Week 16 and 32 during Year 13, Exit visit and at follow-up (up to 8 weeks and 24 weeks post last infusion). The Baseline is defined as the last available value prior to belimumab start date, for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. For Year 1, Baseline included 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.

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

Anti-double stranded DNA levels for participants positive at Baseline were assessed at Baseline, Week 16, 32, and 48 during Year 1 to 11, Week 16 and 32 during Year 13, Exit visit and at follow-up (up to 8 weeks and 24 weeks post last infusion). The Baseline is defined as the last available value prior to belimumab start date, for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. For Year 1, Baseline included 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. Percent change from Baseline is defined as the percentage of the difference between the post-dose post-Baseline visit value and the Baseline value.

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

Complement C3 and C4 levels were assessed in participants low at Baseline at Baseline, Week 16, 32, and 48 during Year 1 to 12, Week 16 and 32 during Year 13, and Exit visit. The Baseline is defined as the last available value prior to belimumab start date, for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. For Year 1, Baseline included 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.

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

Percentage of Participants With Daily Prednisone Dose Reduction at Indicated Time Points

Daily prednisone dose reduction was assessed at Baseline, Week 8, 16, 24, 32, 40, and 48 during Year 1 to 12 and Week 8, 16, 24, 32, and 40 during Year 13. Percentage of participants with daily prednisone dose reduced to <=7.5 mg/day from >7.5 mg/kg at the Baseline are summarized. Baseline is defined as the last available value prior to belimumab start date, for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study.

Absolute Serum Immunoglobulin G Values at Indicated Time Points

Serum immunoglobulin G values were assessed at Baseline, Week 8, 16, 24, 32, 40, and 48 during Year 1 to 12 and Week 8, 16, 24, 32, and 40 during Year 13, Exit visit and at follow-up (up to 8 weeks and 24 weeks post last infusion). Baseline is defined as the last available value prior to belimumab start date, for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. For Year 1, Baseline included 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.

Median Percent Change From Baseline in Immunoglobulin G at Indicated Time Points

Full Information

NCT ID

NCT00583362

First Posted

December 20, 2007

Last Updated

July 10, 2019

Sponsor

Human Genome Sciences Inc., a GSK Company

Collaborators

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT00583362

Brief Title

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

Official Title

A Multi-Center, Open-Label, Continuation Trial LymphoStat-B™ Antibody (Monoclonal Anti-BLyS Antibody) in Subjects With Systemic Lupus Erythematosus (SLE) Who Completed the Phase 2 Protocol LBSL02

Study Type

Interventional

2. Study Status

Record Verification Date

June 2019

Overall Recruitment Status

Completed

Study Start Date

May 4, 2005 (Actual)

Primary Completion Date

February 23, 2016 (Actual)

Study Completion Date

February 23, 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 continuation study to evaluate the long-term safety and efficacy of LymphoStat-B™ in subjects with SLE disease, that completed study LBSL02 and benefitted from treatment.

Detailed Description

The purpose of this continuation study to evaluate the long-term safety and efficacy of LymphoStat-B™ in subjects with Systemic Lupus Erythematosus (SLE), that completed study LBSL02 and benefitted from treatment.

6. Conditions and Keywords

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

Systemic Lupus Erythematosus

Keywords

SLE, Lupus

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

298 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Belimumab 10 mg/kg

Arm Type

Experimental

Arm Description

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

Intervention Type

Biological

Intervention Name(s)

Belimumab

Other Intervention Name(s)

LymphoStat-B™, HGS1006, BENLYSTA

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

Time Frame

Approximately up to 13 years

Title

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

Description

Time Frame

Approximately up to 13 years

Title

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

Description

Time Frame

Approximately up to 13 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 approximately up to 13 years

Title

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

Description

Time Frame

Baseline and approximately up to 13 years

Title

Change From Baseline in Erythrocytes at the Indicated Time Points

Description

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

Time Frame

Baseline and approximately up to 13 years

Title

Change From Baseline in Hematocrit at the Indicated Time Points

Description

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

Time Frame

Baseline and approximately up to 13 years

Title

Change From Baseline in Hemoglobin at the Indicated Time Points

Description

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

Time Frame

Baseline and approximately up to 13 years

Title

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

Description

Time Frame

Baseline and approximately up to 13 years

Title

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

Description

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

Time Frame

Baseline and approximately up to 13 years

Title

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

Description

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

Time Frame

Baseline and approximately up to 13 years

Title

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

Description

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

Time Frame

Baseline and approximately up to 13 years

Title

Description

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

Time Frame

Baseline and approximately up to 13 years

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

Approximately up to 13 years

Title

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

Description

Time Frame

Approximately up to 13 years

Title

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

Description

Time Frame

Baseline and approximately up to 13 years

Title

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

Description

Time Frame

Approximately up to 13 years

Title

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

Description

Time Frame

Baseline and approximately up to 13 years

Title

Percentage of Participants With Daily Prednisone Dose Reduction at Indicated Time Points

Description

Time Frame

Approximately up to 13 years

Title

Absolute Serum Immunoglobulin G Values at Indicated Time Points

Description

Time Frame

Approximately up to 13 years

Title

Median Percent Change From Baseline in Immunoglobulin G at Indicated Time Points

Description

Time Frame

Baseline and approximately up to 13 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Primary Inclusion Criteria 1. Have completed the LBSL02 trial and achieved a satisfactory response. Primary Exclusion Criteria Required more than 2 courses of corticosteroids for treatment of severe SLE flares in the last 5 months of LBSL02. Had an SLE flare during the last 30 days of LBSL02 and through the 1st dose in LBSL99. Used any of the following prohibited medications during their participation in LBSL02: Other investigational agents. Biologic therapeutic agents: adalimumab (Humira™), etanercept (Enbrel™), infliximab (Remicade™), and rituximab (Rituxan™). Intravenous cyclophosphamide. Corticosteroids >100 mg/day prednisone equivalent for reasons other than severe SLE flare.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

GSK Clinical Trials

Organizational Affiliation

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

Official's Role

Study Director

Facility Information:

Facility Name

GSK Investigational Site

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35294

Country

United States

Facility Name

GSK Investigational Site

City

Scottsdale

State/Province

Arizona

ZIP/Postal Code

85260

Country

United States

Facility Name

GSK Investigational Site

City

Tucson

State/Province

Arizona

ZIP/Postal Code

85724

Country

United States

Facility Name

GSK Investigational Site

City

La Jolla

State/Province

California

ZIP/Postal Code

92037

Country

United States

Facility Name

GSK Investigational Site

City

Los Angeles

State/Province

California

ZIP/Postal Code

90033

Country

United States

Facility Name

GSK Investigational Site

City

Los Angeles

State/Province

California

ZIP/Postal Code

90048

Country

United States

Facility Name

GSK Investigational Site

City

Sacramento

State/Province

California

ZIP/Postal Code

95817

Country

United States

Facility Name

GSK Investigational Site

City

San Jose

State/Province

California

ZIP/Postal Code

95124

Country

United States

Facility Name

GSK Investigational Site

City

Upland

State/Province

California

ZIP/Postal Code

91786

Country

United States

Facility Name

GSK Investigational Site

City

Colorado Springs

State/Province

Colorado

ZIP/Postal Code

80920

Country

United States

Facility Name

GSK Investigational Site

City

Washington

State/Province

District of Columbia

ZIP/Postal Code

20010

Country

United States

Facility Name

GSK Investigational Site

City

Aventura

State/Province

Florida

ZIP/Postal Code

33180

Country

United States

Facility Name

GSK Investigational Site

City

Orlando

State/Province

Florida

ZIP/Postal Code

32806-6264

Country

United States

Facility Name

GSK Investigational Site

City

Tampa

State/Province

Florida

ZIP/Postal Code

33614

Country

United States

Facility Name

GSK Investigational Site

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30303

Country

United States

Facility Name

GSK Investigational Site

City

Boise

State/Province

Idaho

ZIP/Postal Code

83704

Country

United States

Facility Name

GSK Investigational Site

City

Idaho Falls

State/Province

Idaho

ZIP/Postal Code

83401

Country

United States

Facility Name

GSK Investigational Site

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60611

Country

United States

Facility Name

GSK Investigational Site

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60612

Country

United States

Facility Name

GSK Investigational Site

City

Munster

State/Province

Indiana

ZIP/Postal Code

46321

Country

United States

Facility Name

GSK Investigational Site

City

Kansas City

State/Province

Kansas

ZIP/Postal Code

66160

Country

United States

Facility Name

GSK Investigational Site

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40202

Country

United States

Facility Name

GSK Investigational Site

City

Baton Rouge

State/Province

Louisiana

ZIP/Postal Code

70809

Country

United States

Facility Name

GSK Investigational Site

City

New Orleans

State/Province

Louisiana

ZIP/Postal Code

70121

Country

United States

Facility Name

GSK Investigational Site

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21201

Country

United States

Facility Name

GSK Investigational Site

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21287

Country

United States

Facility Name

GSK Investigational Site

City

Cumberland

State/Province

Maryland

ZIP/Postal Code

21502

Country

United States

Facility Name

GSK Investigational Site

City

Wheaton

State/Province

Maryland

ZIP/Postal Code

20902

Country

United States

Facility Name

GSK Investigational Site

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02111

Country

United States

Facility Name

GSK Investigational Site

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48109-5542

Country

United States

Facility Name

GSK Investigational Site

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63110

Country

United States

Facility Name

GSK Investigational Site

City

Lincoln

State/Province

Nebraska

ZIP/Postal Code

68516

Country

United States

Facility Name

GSK Investigational Site

City

Concord

State/Province

New Hampshire

ZIP/Postal Code

03301

Country

United States

Facility Name

GSK Investigational Site

City

Dover

State/Province

New Hampshire

ZIP/Postal Code

03820

Country

United States

Facility Name

GSK Investigational Site

City

Albany

State/Province

New York

ZIP/Postal Code

12206

Country

United States

Facility Name

GSK Investigational Site

City

Brooklyn

State/Province

New York

ZIP/Postal Code

11203

Country

United States

Facility Name

GSK Investigational Site

City

Great Neck

State/Province

New York

ZIP/Postal Code

11021

Country

United States

Facility Name

GSK Investigational Site

City

Manhasset

State/Province

New York

ZIP/Postal Code

11030

Country

United States

Facility Name

GSK Investigational Site

City

Rochester

State/Province

New York

ZIP/Postal Code

14618

Country

United States

Facility Name

GSK Investigational Site

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28210

Country

United States

Facility Name

GSK Investigational Site

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27157

Country

United States

Facility Name

GSK Investigational Site

City

Dayton

State/Province

Ohio

ZIP/Postal Code

45417

Country

United States

Facility Name

GSK Investigational Site

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73103

Country

United States

Facility Name

GSK Investigational Site

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73104

Country

United States

Facility Name

GSK Investigational Site

City

Tulsa

State/Province

Oklahoma

ZIP/Postal Code

74104

Country

United States

Facility Name

GSK Investigational Site

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15217

Country

United States

Facility Name

GSK Investigational Site

City

Willow Grove

State/Province

Pennsylvania

ZIP/Postal Code

19090

Country

United States

Facility Name

GSK Investigational Site

City

Dallas

State/Province

Texas

ZIP/Postal Code

75246

Country

United States

Facility Name

GSK Investigational Site

City

Dallas

State/Province

Texas

ZIP/Postal Code

75390-8550

Country

United States

Facility Name

GSK Investigational Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77074

Country

United States

Facility Name

GSK Investigational Site

City

Sugar Land

State/Province

Texas

ZIP/Postal Code

77479

Country

United States

Facility Name

GSK Investigational Site

City

Arlington

State/Province

Virginia

ZIP/Postal Code

22205-3606

Country

United States

Facility Name

GSK Investigational Site

City

Seattle

State/Province

Washington

ZIP/Postal Code

98133

Country

United States

Facility Name

GSK Investigational Site

City

Spokane

State/Province

Washington

ZIP/Postal Code

99204

Country

United States

Facility Name

GSK Investigational Site

City

Milwaukee

State/Province

Wisconsin

ZIP/Postal Code

53226

Country

United States

Facility Name

GSK Investigational Site

City

Onalaska

State/Province

Wisconsin

ZIP/Postal Code

54650

Country

United States

Facility Name

GSK Investigational Site

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H3G 1A4

Country

Canada

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://www.clinicalstudydatarequest.com/SearchAllPostings.aspx?searchparam=bel112626

Citations:

PubMed Identifier

24187095

Citation

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

Results Reference

derived

PubMed Identifier

22674457

Citation

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

Results Reference

derived

Learn more about this trial

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

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

Systemic Lupus Erythematosus

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

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