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

NCT00712933 | Completed Phase 3 Results DMC

• 2 other identifiers: 1122342007-007648-85
• Study Type: interventional
• Target: 738
• Locations: 28 countries
• Sites: 110

Brief Summary

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

Conditions

Systemic Lupus Erythematosus

Keywords

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

Outcome Measures

Primary Outcomes (21)

• Number of Participants With Adverse Events (AE)

  An adverse event is defined as any unfavorable or unintended sign, symptom, or disease that is temporally associated with the use of a study agent but is not necessarily caused by the study agent. This includes worsening (example: increase in frequency or severity) of preexisting conditions. Participants with incidences of any event at any time post-baseline are presented by yearly interval. Only treatment-emergent AEs are summarized.

  Up to 9 years

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

  AE rates by SOC adjusting for participant-years on study drug anytime post Baseline are summarized, which included the follow up visits. Only treatment-emergent AEs are summarized. The event rate of an AE was calculated as the number of events per 100 participant years. Participant years were calculated as sum across all participants (\[last visit of interval day - first visit of interval day + 1\] divided by365). Participant years excluded between study gaps if participant had not started extension study on date of last visit of parent study.

  Up to 9 years

• Number of Participants With Serious Adverse Events (SAE)

  An adverse event resulting in death, is life threatening (ie, an immediate threat to life), inpatient hospitalization, prolongation of existing hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect or any other situation which is medically important is categorized as SAE. Only treatment-emergent AEs are summarized.

  Up to 9 years

• SAE Rates by SOC During the Study

  SAE rates by SOC adjusting for participants-years on study drug anytime post Baseline are summarized, which included the follow up visits. Only treatment-emergent SAEs are summarized. The event rate of an SAE was calculated as the number of events per 100 participant years. Participants years were calculated as = sum across all participants (\[last visit of interval day - first visit of interval day + 1\] divided by 365). Participants years excluded between study gaps if participant had not started extension study on date of last visit of parent study.

  Up to 9 years

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

  Hematology parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 hematology parameters were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks post infusion). Change from Baseline in APTT and PT is summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. NA indicates standard deviation was not calculable for a single data point

  Baseline and up to 9 years

• Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points

  Hematology parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 hematology parameters were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks post infusion). Change from Baseline in Plt, Lymp, Leu, Eos, Baso, Mono, Neu, NeuBF, and NueS are summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. NA indicates standard deviation was not calculable for a single data point.

  Baseline and up to 9 years

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

  Hematology parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 hematology parameters were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks post infusion). Change from Baseline in Hg is summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. NA indicates standard deviation was not calculable for a single data point.

  Baseline and up to 9 years

• Change From Baseline in Hematocrit at the Indicated Time Points

  Hematology parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 hematology parameters were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks). Change from Baseline in Hematocrit is summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. NA indicates standard deviation was not calculable for a single data point.

  Baseline and up to 9 years

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

  Hematology parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 hematology parameters were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks post infusion). Change from Baseline in Erythrocytes is summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. NA indicates standard deviation was not calculable for a single data point.

  Baseline and up to 9 years

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

  Electrolytes parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 electrolytes parameters were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks post infusion). Change from Baseline in Ca,CO2, Chloride, Mg, Phos, K and Na were summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. NA indicates standard deviation was not calculable for a single data point.

  Baseline and up to 9 years

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

  Other chemistries parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 other chemistries parameters were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks post infusion). Change from Baseline in BUN/Cr is summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.

  Baseline and up to 9 years

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

  Other chemistries parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 other chemistries parameters were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks post infusion). Change from Baseline in Alb and Protein were summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. NA indicates standard deviation was not calculable for a single data point.

  Baseline and up to 9 years

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

  Other chemistries parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 other chemistries were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks post infusion). Change from Baseline in BUN and Glucose were summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. NA indicates standard deviation was not calculable for a single data point.

  Baseline and up to 9 years

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

  Other chemistries parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 other chemistries were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks post infusion). Change from Baseline in Cr and Urate were summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. NA indicates standard deviation was not calculable for a single data point.

  Baseline and up to 9 years

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

  Liver function parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 liver function parameters were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks post infusion). Change from Baseline in ALT, ALP, AST, GGT and LDH were summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.NA indicates standard deviation was not calculable for a single data point.

  Baseline and up to 9 years

• Change From Baseline in Bilirubin (Bili) Levels

  Liver function parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 liver function parameters were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks post infusion). Change from Baseline in Bili were summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. NA indicates standard deviation was not calculable for a single data point.

  Baseline and up to 9 years

• Change From Baseline in Immunoglobulin G (IgG) Levels

  Immunoglobulin (Ig) parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 Ig parameters were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks post infusion). Change from Baseline in Ig G were summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. NA indicates standard deviation was not calculable for a single data point.

  Baseline and up to 9 years

• Number of Participants With Immunogenic Response by Year

  Immunogenic response was analyzed using serum samples for anti-belimumab antibody measurements in MITT population. Categories of response are Negative, Transient Positive (+) means single + response that does not occur at the final assessment, and Persistent + means + response that occurs at least 2 consecutive assessments or a single result at the final assessment. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.

  Up to 9 years

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

  Blood samples were collected to evaluate IgG levels at Baseline and at Weeks 12, 24 and 48 during Year 1. From Year 2-9, IgG was evaluated at Week 24 and 48 ; Exit visit and at follow-up visit (up to 8 weeks post last infusion). Number of participants with IgG immunoglobulin values below the LLN at each one year interval are presented. Baseline includes Extension Year 1 Day 0 values for MITT participants treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants treated with Belimumab in the parent study. If a participant had more than one response within a year, then the last response within the year interval (usually the Week 48 assessment) was summarized. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.

  Up to 9 years

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

  Participants who had improving SLE disease activity for at least 8 weeks, at the investigator's discretion, the steroid dose was reduced by reduction to 7.5 mg/day. If the participant continued to have stable or improving disease activity after 4 weeks on a reduced dose, then the investigator considered reducing the dose again. Baseline includes extension Year 1 Day 0 values for MITT participants treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants treated with Belimumab in the parent study. Number of participants with shifts from Baseline total daily dose category by visit is summarized.

  Up to 9 years

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

  The SLICC/ACR Damage Index was assessed every 48 weeks and at the exit visit as a measure of disease activity. It was developed to assess the accumulated damage since the onset of the disease. The number of participants with worsening in their SLICC/ACR Damage Index score compared with Baseline have been presented. Worsening was defined as a change in score (post-Baseline visit score - Baseline score) \> 0. Baseline includes extension Year 1 Day 0 values for MITT participants treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants treated with Belimumab in the parent study. For years in which a participant was withdrawn from the study, the exit visit assessment was used in place of the Week 48 assessment for the year. This value was not carried forward through later years. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.

  Up to 9 years

Study Arms (2)

1

EXPERIMENTAL

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

Drug: belimumab

2.

EXPERIMENTAL

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

Drug: belimumab

Interventions

belimumab DRUG

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

Also known as: LymphoStat-B™, HGS1006

1; 2.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have completed the HGS 1006-C1056 or HGS 1006-C1057 protocol through the Week 72 or Week 48 visits, respectively.

You may not qualify if:

• Have developed any other medical disease or condition that has made the patient unsuitable for this study in the opinion of their physician.

Sponsors & Collaborators

• Human Genome Sciences Inc., a GSK Company: lead
• GlaxoSmithKline: collaborator

Study Sites (110)

GSK Investigational Site

Ciudad Autonoma de Buenos Aires, Buenos Aires, 1015, Argentina

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GSK Investigational Site

Ciudad Autonoma de Buenos Aires, Buenos Aires, C1419AHN, Argentina

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GSK Investigational Site

La Plata, Buenos Aires, B1904CFH,, Argentina

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GSK Investigational Site

Rosario, Santa Fe Province, 2000, Argentina

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GSK Investigational Site

San Miguel de Tucumán, Tucumán Province, T4000AXL, Argentina

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GSK Investigational Site

Buenos Aires, C1280AEB, Argentina

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GSK Investigational Site

Buenos Aires, C1417EYG, Argentina

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GSK Investigational Site

Ciudad Autonoma Buenos Aires, C1426AAL, Argentina

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GSK Investigational Site

Vienna, A-1100, Austria

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GSK Investigational Site

Liège, 4000, Belgium

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GSK Investigational Site

Salvador, Estado de Bahia, 40.150-410, Brazil

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GSK Investigational Site

Goiânia, Goiás, 74110-120, Brazil

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GSK Investigational Site

Juiz de Fora, Minas Gerais, 36010-570, Brazil

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GSK Investigational Site

Recife, Pernambuco, 50670-420, Brazil

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GSK Investigational Site

Porto Alegre, Rio Grande do Sul, 90610000, Brazil

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GSK Investigational Site

São Paulo, São Paulo, 04039-901, Brazil

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GSK Investigational Site

Campinas, 13083-888, Brazil

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GSK Investigational Site

Rio de Janeiro, 22411-001, Brazil

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GSK Investigational Site

São Paulo, 04032-060, Brazil

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GSK Investigational Site

São Paulo, 04266-010, Brazil

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GSK Investigational Site

Toronto, Ontario, M5T 2S8, Canada

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GSK Investigational Site

Montreal, Quebec, H3G 1A4, Canada

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GSK Investigational Site

Viña del Mar, Región de Valparaíso, 2570017, Chile

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GSK Investigational Site

Santiago, 8431657, Chile

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GSK Investigational Site

Barranquilla, Colombia

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GSK Investigational Site

Bogotá, Colombia

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GSK Investigational Site

Bucaramanga, Colombia

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GSK Investigational Site

Medellín, Colombia

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GSK Investigational Site

Brno-Bohunice, 625 00, Czechia

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GSK Investigational Site

Hradec Králové, 500 05, Czechia

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GSK Investigational Site

Olomouc, 775 20, Czechia

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GSK Investigational Site

Prague, 128 50, Czechia

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GSK Investigational Site

Suresnes, 92150, France

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GSK Investigational Site

Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

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GSK Investigational Site

Erlangen, Bavaria, 91054, Germany

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GSK Investigational Site

Frankfurt am Main, Hesse, 60590, Germany

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GSK Investigational Site

Hanover, Lower Saxony, 30625, Germany

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GSK Investigational Site

Mainz, Rhineland-Palatinate, 55131, Germany

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GSK Investigational Site

Leipzig, Saxony, 04103, Germany

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GSK Investigational Site

Jena, Thuringia, 07743, Germany

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GSK Investigational Site

Berlin, 10117, Germany

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GSK Investigational Site

Berlin, 14059, Germany

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GSK Investigational Site

Kiel, 24105, Germany

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GSK Investigational Site

Chai Wan, Hong Kong

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GSK Investigational Site

New Territories, Hong Kong

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GSK Investigational Site

Bangalore, 560034, India

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GSK Investigational Site

Hyderabad, Andhra Pradesh, 500482, India

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GSK Investigational Site

Lucknow, 226003, India

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GSK Investigational Site

Secunderabad, 500003, India

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GSK Investigational Site

Trivandrum, 695029, India

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GSK Investigational Site

Beersheba, 84101, Israel

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GSK Investigational Site

Haifa, 31048, Israel

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GSK Investigational Site

Haifa, 31096, Israel

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GSK Investigational Site

Haifa, 34362, Israel

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GSK Investigational Site

Petah Tikva, 49100, Israel

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GSK Investigational Site

Ramat Gan, 52621, Israel

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GSK Investigational Site

Rehovot, 76100, Israel

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GSK Investigational Site

Roma, 00152, Italy

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GSK Investigational Site

Guadalajara, Jalisco, 44160, Mexico

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GSK Investigational Site

Guadalajara, Jalisco, 44280, Mexico

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GSK Investigational Site

México, 7760, Mexico

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GSK Investigational Site

San Luis Potosí City, 78240, Mexico

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GSK Investigational Site

Maastricht, 6229 HX, Netherlands

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GSK Investigational Site

Rotterdam, 3015 CE, Netherlands

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GSK Investigational Site

Rotterdam, 3083 AN, Netherlands

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GSK Investigational Site

Surco, Lima region, Peru

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GSK Investigational Site

Callao, Callao 2, Peru

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GSK Investigational Site

Lima, Lima 27, Peru

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GSK Investigational Site

Cebu City, 6000, Philippines

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GSK Investigational Site

Davao City, 8000, Philippines

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GSK Investigational Site

Las Piñas, 1740, Philippines

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GSK Investigational Site

Manila, 1000, Philippines

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GSK Investigational Site

Quezon City, 1102, Philippines

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GSK Investigational Site

Sampaloc Manila, 1008, Philippines

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GSK Investigational Site

Gmina Końskie, 26-200, Poland

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GSK Investigational Site

Ponce, 00716, Puerto Rico

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GSK Investigational Site

San Juan, 00936-5067, Puerto Rico

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GSK Investigational Site

Bucharest, 020125, Romania

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GSK Investigational Site

Bucharest, 020475, Romania

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GSK Investigational Site

Bucharest, 021392, Romania

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GSK Investigational Site

Cluj-Napoca, 400006, Romania

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GSK Investigational Site

Moscow, 115522, Russia

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GSK Investigational Site

Saint Petersburg, 190068, Russia

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GSK Investigational Site

Saint Petersburg, 191015, Russia

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GSK Investigational Site

Saint Petersburg, 194291, Russia

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GSK Investigational Site

Yaroslavl, 150003, Russia

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GSK Investigational Site

Yaroslavl, 150023, Russia

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GSK Investigational Site

Piešťany, 921 12, Slovakia

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GSK Investigational Site

Busan, 602-715, South Korea

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GSK Investigational Site

Daejeon, 302-799, South Korea

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GSK Investigational Site

Incheon, 400-711, South Korea

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GSK Investigational Site

Pusan, 602-739, South Korea

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GSK Investigational Site

Seoul, 137-701, South Korea

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GSK Investigational Site

Seoul, South Korea

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GSK Investigational Site

Suwon, Kyonggi-do, 443-721, South Korea

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GSK Investigational Site

Barcelona, 08036, Spain

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GSK Investigational Site

Madrid, 28046, Spain

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GSK Investigational Site

Stockholm, SE-171 76, Sweden

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GSK Investigational Site

Dalin Township, Chiayi County, 662, Taiwan

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GSK Investigational Site

Gueishan Township,Taoyuan County, 333, Taiwan

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GSK Investigational Site

Hualien City, 970, Taiwan

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GSK Investigational Site

Kaohsiung City, 807, Taiwan

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GSK Investigational Site

Kaohsiung City, 813, Taiwan

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GSK Investigational Site

Kaohsiung City, 833, Taiwan

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GSK Investigational Site

Taichung, 402, Taiwan

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GSK Investigational Site

Taichung, 404, Taiwan

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GSK Investigational Site

Taichung, 40705, Taiwan

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GSK Investigational Site

Taipei, 100, Taiwan

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GSK Investigational Site

London, SE1 7EH, United Kingdom

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GSK Investigational Site

Newcastle upon Tyne, NE7 7DN, United Kingdom

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Related Publications (3)

• 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.

  PMID: 26936891 BACKGROUND

• 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.

  PMID: 31302695 BACKGROUND

• 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.

  PMID: 33051264 DERIVED

MeSH Terms

Conditions

Lupus Erythematosus, Systemic; Autoimmune Diseases

Interventions

belimumab

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Immune System Diseases

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2008
• First Posted: July 10, 2008
• Study Start: May 30, 2008
• Primary Completion: December 9, 2016
• Study Completion: December 9, 2016
• Last Updated: December 5, 2019
• Results First Posted: January 16, 2018

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, 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.

Locations

RO (4); NL (3); GB (2); TW (10); CO (4); IN (5); IT (1); RU (6); ES (2); BR (10); PH (6); SL (1); CZ (4); DE (10); CA (2); ME (4); CL (2); BE (1); AR (8); AU (1); HK (2); FR (1); IL (7); PE (3); PR (2); SE (1); PL (1); KR (7)