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

• ClinicalTrials.gov Identifier: NCT00583362
• Recruitment Status: Completed
• First Posted: December 31, 2007
• Results First Posted: April 28, 2017
• Last Update Posted: July 23, 2019
• Sponsor: Human Genome Sciences Inc., a GSK Company
• Collaborator: GlaxoSmithKline
• Information provided by (Responsible Party): GlaxoSmithKline ( Human Genome Sciences Inc., a GSK Company )

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.

Condition or disease	Intervention/treatment	Phase
Systemic Lupus Erythematosus	Biological: Belimumab	Phase 2

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 298 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: May 4, 2005
• Actual Primary Completion Date: February 23, 2016
• Actual Study Completion Date: February 23, 2016

Arms and Interventions

Arm	Intervention/treatment
Experimental: Belimumab 10 mg/kg; Belimumab 10 mg/kg IV over one hour every 28 days.	Biological: Belimumab; Belimumab 10mg/kg IV over one hour every 28 days; Other Names: LymphoStat-B™; HGS1006; BENLYSTA

Outcome Measures

Primary Outcome Measures :

1. Number of Participants With the Indicated Type of Adverse Event (AEs) and Serious Adverse Event (SAEs) [ Time Frame: Approximately up to 13 years ]
   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.
2. Adverse Event (AE) Rates by System Organ Class (SOC) During the Study [ Time Frame: Approximately up to 13 years ]
   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).
3. SAE Rates by System Organ Class (SOC) During the Study [ Time Frame: Approximately up to 13 years ]
   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).
4. Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points [ Time Frame: Baseline and approximately up to 13 years ]
   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.
5. Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points [ Time Frame: Baseline and approximately up to 13 years ]
   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.
6. Change From Baseline in Erythrocytes at the Indicated Time Points [ Time Frame: Baseline and approximately up to 13 years ]
   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.
7. Change From Baseline in Hematocrit at the Indicated Time Points [ Time Frame: Baseline and approximately up to 13 years ]
   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.
8. Change From Baseline in Hemoglobin at the Indicated Time Points [ Time Frame: Baseline and approximately up to 13 years ]
   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.
9. Change From Baseline in Albumin and Protein at the Indicated Time Points [ Time Frame: Baseline and approximately up to 13 years ]
   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.
10. Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points [ Time Frame: Baseline and approximately up to 13 years ]
    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.
11. Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points [ Time Frame: Baseline and approximately up to 13 years ]
    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.
12. Change From Baseline in BUN/Creatinine at the Indicated Time Points [ Time Frame: Baseline and approximately up to 13 years ]
    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.
13. 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 [ Time Frame: Baseline and approximately up to 13 years ]
    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 :

1. Percentage of Participants Achieving SLE Responder Index (SRI) Response at Indicated Time Points [ Time Frame: Approximately up to 13 years ]
   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.
2. Observed Anti-double Stranded DNA Levels in Participants Positive at Baseline at Indicated Time Points [ Time Frame: Approximately up to 13 years ]
   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.
3. Median Percent Change From Baseline in Anti-double Stranded DNA in Participants Positive at Baseline at Indicated Time Points [ Time Frame: Baseline and approximately up to 13 years ]
   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.
4. Observed Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points [ Time Frame: Approximately up to 13 years ]
   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.
5. Median Percent Change From Baseline in Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points [ Time Frame: Baseline and approximately up to 13 years ]
   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. Percent change from Baseline is defined as the percentage of the difference between the post-dose post-Baseline visit value and the Baseline value.
6. Percentage of Participants With Daily Prednisone Dose Reduction at Indicated Time Points [ Time Frame: Approximately up to 13 years ]
   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.
7. Absolute Serum Immunoglobulin G Values at Indicated Time Points [ Time Frame: Approximately up to 13 years ]
   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.
8. Median Percent Change From Baseline in Immunoglobulin G at Indicated Time Points [ Time Frame: Baseline and approximately up to 13 years ]
   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. Percent change from Baseline is defined as the percentage of the difference between the post-dose post-Baseline visit value and the Baseline value.

Eligibility Criteria

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

Criteria

Primary Inclusion Criteria

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

Primary Exclusion Criteria

1. Required more than 2 courses of corticosteroids for treatment of severe SLE flares in the last 5 months of LBSL02.
2. Had an SLE flare during the last 30 days of LBSL02 and through the 1st dose in LBSL99.

3. 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.

Contacts and Locations

Locations

United States, Alabama

GSK Investigational Site

Birmingham, Alabama, United States, 35294

United States, Arizona

GSK Investigational Site

Scottsdale, Arizona, United States, 85260

GSK Investigational Site

Tucson, Arizona, United States, 85724

United States, California

GSK Investigational Site

La Jolla, California, United States, 92037

GSK Investigational Site

Los Angeles, California, United States, 90033

GSK Investigational Site

Los Angeles, California, United States, 90048

GSK Investigational Site

Sacramento, California, United States, 95817

GSK Investigational Site

San Jose, California, United States, 95124

GSK Investigational Site

Upland, California, United States, 91786

United States, Colorado

GSK Investigational Site

Colorado Springs, Colorado, United States, 80920

United States, District of Columbia

GSK Investigational Site

Washington, District of Columbia, United States, 20010

United States, Florida

GSK Investigational Site

Aventura, Florida, United States, 33180

GSK Investigational Site

Orlando, Florida, United States, 32806-6264

GSK Investigational Site

Tampa, Florida, United States, 33614

United States, Georgia

GSK Investigational Site

Atlanta, Georgia, United States, 30303

United States, Idaho

GSK Investigational Site

Boise, Idaho, United States, 83704

GSK Investigational Site

Idaho Falls, Idaho, United States, 83401

United States, Illinois

GSK Investigational Site

Chicago, Illinois, United States, 60611

GSK Investigational Site

Chicago, Illinois, United States, 60612

United States, Indiana

GSK Investigational Site

Munster, Indiana, United States, 46321

United States, Kansas

GSK Investigational Site

Kansas City, Kansas, United States, 66160

United States, Kentucky

GSK Investigational Site

Louisville, Kentucky, United States, 40202

United States, Louisiana

GSK Investigational Site

Baton Rouge, Louisiana, United States, 70809

GSK Investigational Site

New Orleans, Louisiana, United States, 70121

United States, Maryland

GSK Investigational Site

Baltimore, Maryland, United States, 21201

GSK Investigational Site

Baltimore, Maryland, United States, 21287

GSK Investigational Site

Cumberland, Maryland, United States, 21502

GSK Investigational Site

Wheaton, Maryland, United States, 20902

United States, Massachusetts

GSK Investigational Site

Boston, Massachusetts, United States, 02111

United States, Michigan

GSK Investigational Site

Ann Arbor, Michigan, United States, 48109-5542

United States, Missouri

GSK Investigational Site

Saint Louis, Missouri, United States, 63110

United States, Nebraska

GSK Investigational Site

Lincoln, Nebraska, United States, 68516

United States, New Hampshire

GSK Investigational Site

Concord, New Hampshire, United States, 03301

GSK Investigational Site

Dover, New Hampshire, United States, 03820

United States, New York

GSK Investigational Site

Albany, New York, United States, 12206

GSK Investigational Site

Brooklyn, New York, United States, 11203

GSK Investigational Site

Great Neck, New York, United States, 11021

GSK Investigational Site

Manhasset, New York, United States, 11030

GSK Investigational Site

Rochester, New York, United States, 14618

United States, North Carolina

GSK Investigational Site

Charlotte, North Carolina, United States, 28210

GSK Investigational Site

Winston-Salem, North Carolina, United States, 27157

United States, Ohio

GSK Investigational Site

Dayton, Ohio, United States, 45417

United States, Oklahoma

GSK Investigational Site

Oklahoma City, Oklahoma, United States, 73103

GSK Investigational Site

Oklahoma City, Oklahoma, United States, 73104

GSK Investigational Site

Tulsa, Oklahoma, United States, 74104

United States, Pennsylvania

GSK Investigational Site

Pittsburgh, Pennsylvania, United States, 15217

GSK Investigational Site

Willow Grove, Pennsylvania, United States, 19090

United States, Texas

GSK Investigational Site

Dallas, Texas, United States, 75246

GSK Investigational Site

Dallas, Texas, United States, 75390-8550

GSK Investigational Site

Houston, Texas, United States, 77074

GSK Investigational Site

Sugar Land, Texas, United States, 77479

United States, Virginia

GSK Investigational Site

Arlington, Virginia, United States, 22205-3606

United States, Washington

GSK Investigational Site

Seattle, Washington, United States, 98133

GSK Investigational Site

Spokane, Washington, United States, 99204

United States, Wisconsin

GSK Investigational Site

Milwaukee, Wisconsin, United States, 53226

GSK Investigational Site

Onalaska, Wisconsin, United States, 54650

Canada, Quebec

GSK Investigational Site

Montreal, Quebec, Canada, H3G 1A4

Sponsors and Collaborators

Human Genome Sciences Inc., a GSK Company

GlaxoSmithKline

Investigators

• Study Director: GSK Clinical Trials; GlaxoSmithKline (for GlaxoSmithKline; Human Genome Sciences Inc., a GSK Company; Sirtris, a GSK Company; Stiefel, a GSK Company; ViiV Healthcare)

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.

• Responsible Party: Human Genome Sciences Inc., a GSK Company
• ClinicalTrials.gov Identifier: NCT00583362
• Other Study ID Numbers: 112626
• First Posted: December 31, 2007
• Results First Posted: April 28, 2017
• Last Update Posted: July 23, 2019
• Last Verified: June 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: IPD for this study will be made available via the Clinical Study Data Request site.
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR)
• Time Frame: IPD is available via the Clinical Study Data Request site (click on the link provided below)
• 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.
• URL: https://www.clinicalstudydatarequest.com/SearchAllPostings.aspx?searchparam=bel112626

Keywords provided by GlaxoSmithKline ( Human Genome Sciences Inc., a GSK Company ):

SLE; Lupus

Additional relevant MeSH terms:

Lupus Erythematosus, Systemic; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Belimumab; Immunosuppressive Agents; Immunologic Factors; Physiological Effects of Drugs