Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00712933
Recruitment Status : Completed
First Posted : July 10, 2008
Results First Posted : January 16, 2018
Last Update Posted : January 16, 2018
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline ( Human Genome Sciences Inc., a GSK Company )

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

Condition or disease Intervention/treatment Phase
Systemic Lupus Erythematosus Drug: belimumab Phase 3

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 738 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multi-Center, Continuation Trial of Belimumab (HGS1006, LymphoStat-B™)a Fully Human Monoclonal Anti-BLyS Antibody in Subjects With Systemic Lupus Erythematosus (SLE) Who Completed the Phase 3 Protocol HGS1006-C1056 or HGS1006-C1057
Study Start Date : May 1, 2008
Actual Primary Completion Date : December 1, 2016
Actual Study Completion Date : December 9, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus
Drug Information available for: Belimumab

Arm Intervention/treatment
Experimental: 1
1 mg/kg dose of belimumab given IV every 28 days.
Drug: belimumab

Recombinant, fully human, monoclonal antibody

Comparison of the 1 mg/kg and 10 mg/kg dose of belimumab given IV every 28 days.

Other Names:
  • LymphoStat-B™
  • HGS1006

Experimental: 2.
10 mg/kg dose of belimumab given IV every 28 days.
Drug: belimumab

Recombinant, fully human, monoclonal antibody

Comparison of the 1 mg/kg and 10 mg/kg dose of belimumab given IV every 28 days.

Other Names:
  • LymphoStat-B™
  • HGS1006




Primary Outcome Measures :
  1. Number of Participants With Adverse Events (AE) [ Time Frame: Up to 9 years ]
    An adverse event is defined as any unfavorable or unintended sign, symptom, or disease that is temporally associated with the use of a study agent but is not necessarily caused by the study agent. This includes worsening (example: increase in frequency or severity) of preexisting conditions. Participants with incidences of any event at any time post-baseline are presented by yearly interval. Only treatment-emergent AEs are summarized.

  2. AE Rates by System Organ Class (SOC) During the Study [ Time Frame: Up to 9 years ]
    AE rates by SOC adjusting for participant-years on study drug anytime post Baseline are summarized, which included the follow up visits. Only treatment-emergent AEs are summarized. The event rate of an AE was calculated as the number of events per 100 participant years. Participant years were calculated as sum across all participants ([last visit of interval day - first visit of interval day + 1] divided by365). Participant years excluded between study gaps if participant had not started extension study on date of last visit of parent study.

  3. Number of Participants With Serious Adverse Events (SAE) [ Time Frame: Up to 9 years ]
    An adverse event resulting in death, is life threatening (ie, an immediate threat to life), inpatient hospitalization, prolongation of existing hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect or any other situation which is medically important is categorized as SAE. Only treatment-emergent AEs are summarized.

  4. SAE Rates by SOC During the Study [ Time Frame: Up to 9 years ]
    SAE rates by SOC adjusting for participants-years on study drug anytime post Baseline are summarized, which included the follow up visits. Only treatment-emergent SAEs are summarized. The event rate of an SAE was calculated as the number of events per 100 participant years. Participants years were calculated as = sum across all participants ([last visit of interval day - first visit of interval day + 1] divided by 365). Participants years excluded between study gaps if participant had not started extension study on date of last visit of parent study.

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

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

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

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

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

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

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

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

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

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

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

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

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

  18. Number of Participants With Immunogenic Response by Year [ Time Frame: Up to 9 years ]
    Immunogenic response was analyzed using serum samples for anti-belimumab antibody measurements in MITT population. Categories of response are Negative, Transient Positive (+) means single + response that does not occur at the final assessment, and Persistent + means + response that occurs at least 2 consecutive assessments or a single result at the final assessment. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.

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

  20. Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit [ Time Frame: Up to 9 years ]
    Participants who had improving SLE disease activity for at least 8 weeks, at the investigator's discretion, the steroid dose was reduced by reduction to 7.5 mg/day. If the participant continued to have stable or improving disease activity after 4 weeks on a reduced dose, then the investigator considered reducing the dose again. Baseline includes extension Year 1 Day 0 values for MITT participants treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants treated with Belimumab in the parent study. Number of participants with shifts from Baseline total daily dose category by visit is summarized.

  21. Number of Participants With Any SLICC/ ACR Damage Index Worsening (Change > 0) From Baseline by Visit [ Time Frame: Up to 9 years ]
    The SLICC/ACR Damage Index was assessed every 48 weeks and at the exit visit as a measure of disease activity. It was developed to assess the accumulated damage since the onset of the disease. The number of participants with worsening in their SLICC/ACR Damage Index score compared with Baseline have been presented. Worsening was defined as a change in score (post-Baseline visit score - Baseline score) > 0. Baseline includes extension Year 1 Day 0 values for MITT participants treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants treated with Belimumab in the parent study. For years in which a participant was withdrawn from the study, the exit visit assessment was used in place of the Week 48 assessment for the year. This value was not carried forward through later years. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00712933


  Hide Study Locations
Locations
Layout table for location information
Argentina
GSK Investigational Site
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, 1015
GSK Investigational Site
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1419AHN
GSK Investigational Site
La Plata, Buenos Aires, Argentina, B1904CFH,
GSK Investigational Site
Rosario, Santa Fe, Argentina, 2000
GSK Investigational Site
Buenos Aires, Argentina, C1280AEB
GSK Investigational Site
Ciudad Autonoma Buenos Aires, Argentina, C1426AAL
GSK Investigational Site
Ciudad Autónoma de Buenos Aires, Argentina, C1417EYG
GSK Investigational Site
San Miguel de Tucuman, Argentina, T4000AXL
Austria
GSK Investigational Site
Vienna, Austria, A-1100
Belgium
GSK Investigational Site
Liège, Belgium, 4000
Brazil
GSK Investigational Site
Salvador, Bahía, Brazil, 40.150-410
GSK Investigational Site
Goiania, Goiás, Brazil, 74110-120
GSK Investigational Site
Juiz de Fora, Minas Gerais, Brazil, 36010-570
GSK Investigational Site
Recife, Pernambuco, Brazil, 50670-420
GSK Investigational Site
Porto Alegre, Rio Grande Do Sul, Brazil, 90610000
GSK Investigational Site
Sao Paulo, São Paulo, Brazil, 04039-901
GSK Investigational Site
Campinas, Brazil, 13083-888
GSK Investigational Site
Rio de Janeiro, Brazil, 22411-001
GSK Investigational Site
São Paulo, Brazil, 04032-060
GSK Investigational Site
São Paulo, Brazil, 04266-010
Canada, Ontario
GSK Investigational Site
Toronto, Ontario, Canada, M5T 2S8
Canada, Quebec
GSK Investigational Site
Montreal, Quebec, Canada, H3G 1A4
Chile
GSK Investigational Site
Viña del Mar, Valparaíso, Chile, 2570017
GSK Investigational Site
Santiago, Chile, 8431657
Colombia
GSK Investigational Site
Barranquilla, Colombia
GSK Investigational Site
Bogota, Colombia
GSK Investigational Site
Bucaramanga, Colombia
GSK Investigational Site
Medellin, Colombia
Czechia
GSK Investigational Site
Brno - Bohunice, Czechia, 625 00
GSK Investigational Site
Hradec Králové, Czechia, 500 05
GSK Investigational Site
Olomouc, Czechia, 775 20
GSK Investigational Site
Praha 2, Czechia, 128 50
France
GSK Investigational Site
Suresnes, France, 92150
Germany
GSK Investigational Site
Freiburg, Baden-Wuerttemberg, Germany, 79106
GSK Investigational Site
Erlangen, Bayern, Germany, 91054
GSK Investigational Site
Frankfurt, Hessen, Germany, 60590
GSK Investigational Site
Hannover, Niedersachsen, Germany, 30625
GSK Investigational Site
Mainz, Rheinland-Pfalz, Germany, 55131
GSK Investigational Site
Leipzig, Sachsen, Germany, 04103
GSK Investigational Site
Jena, Thueringen, Germany, 07743
GSK Investigational Site
Berlin, Germany, 10117
GSK Investigational Site
Berlin, Germany, 14059
GSK Investigational Site
Kiel, Germany, 24105
Hong Kong
GSK Investigational Site
Chai Wan, Hong Kong
GSK Investigational Site
New Territories, Hong Kong
India
GSK Investigational Site
Bangalore, India, 560034
GSK Investigational Site
Hyderabad, Andhra Pradesh, India, 500482
GSK Investigational Site
Lucknow, India, 226003
GSK Investigational Site
Secunderabad, India, 500003
GSK Investigational Site
Trivandrum, India, 695029
Israel
GSK Investigational Site
Beer Sheva, Israel, 84101
GSK Investigational Site
Haifa, Israel, 31048
GSK Investigational Site
Haifa, Israel, 31096
GSK Investigational Site
Haifa, Israel, 34362
GSK Investigational Site
Petach Tikva, Israel, 49100
GSK Investigational Site
Ramat-Gan, Israel, 52621
GSK Investigational Site
Rehovot, Israel, 76100
Italy
GSK Investigational Site
Roma, Italy, 00152
Korea, Republic of
GSK Investigational Site
Busan, Korea, Republic of, 602-715
GSK Investigational Site
Daejeon, Korea, Republic of, 302-799
GSK Investigational Site
Incheon, Korea, Republic of, 400-711
GSK Investigational Site
Pusan, Korea, Republic of, 602-739
GSK Investigational Site
Seoul, Korea, Republic of, 137-701
GSK Investigational Site
Seoul, Korea, Republic of
GSK Investigational Site
Suwon, Kyonggi-do, Korea, Republic of, 443-721
Mexico
GSK Investigational Site
Guadalajara, Jalisco, Mexico, 44160
GSK Investigational Site
Guadalajara, Jalisco, Mexico, 44280
GSK Investigational Site
Mexico, Mexico, 7760
GSK Investigational Site
San Luis Potosí, Mexico, 78240
Netherlands
GSK Investigational Site
Maastricht, Netherlands, 6229 HX
GSK Investigational Site
Rotterdam, Netherlands, 3015 CE
GSK Investigational Site
Rotterdam, Netherlands, 3083 AN
Peru
GSK Investigational Site
Surco, Lima, Peru
GSK Investigational Site
Callao, Peru, Callao 2
GSK Investigational Site
Lima 27, Peru, Lima 27
Philippines
GSK Investigational Site
Cebu City, Philippines, 6000
GSK Investigational Site
Davao City, Philippines, 8000
GSK Investigational Site
Las Pinas, Philippines, 1740
GSK Investigational Site
Manila, Philippines, 1000
GSK Investigational Site
Quezon City, Philippines, 1102
GSK Investigational Site
Sampaloc Manila, Philippines, 1008
Poland
GSK Investigational Site
Konskie, Poland, 26-200
Puerto Rico
GSK Investigational Site
Ponce, Puerto Rico, 00716
GSK Investigational Site
San Juan, Puerto Rico, 00936-5067
Romania
GSK Investigational Site
Bucharest, Romania, 020125
GSK Investigational Site
Bucuresti, Romania, 020475
GSK Investigational Site
Bucuresti, Romania, 021392
GSK Investigational Site
Cluj Napoca, Romania, 400006
Russian Federation
GSK Investigational Site
Moscow, Russian Federation, 115522
GSK Investigational Site
Saint Petersburg, Russian Federation, 194291
GSK Investigational Site
Saint-Petersburg, Russian Federation, 190068
GSK Investigational Site
St. Petersburg, Russian Federation, 191015
GSK Investigational Site
Yaroslavl, Russian Federation, 150003
GSK Investigational Site
Yaroslavl, Russian Federation, 150023
Slovakia
GSK Investigational Site
Piestany, Slovakia, 921 12
Spain
GSK Investigational Site
Barcelona, Spain, 08036
GSK Investigational Site
Madrid, Spain, 28046
Sweden
GSK Investigational Site
Stockholm, Sweden, SE-171 76
Taiwan
GSK Investigational Site
Dalin Township, Chiayi County, Taiwan, 662
GSK Investigational Site
Gueishan Township,Taoyuan County, Taiwan, 333
GSK Investigational Site
Hualien, Taiwan, 970
GSK Investigational Site
Kaohsiung, Taiwan, 807
GSK Investigational Site
Kaohsiung, Taiwan, 813
GSK Investigational Site
Kaohsiung, Taiwan, 833
GSK Investigational Site
Taichung, Taiwan, 402
GSK Investigational Site
Taichung, Taiwan, 404
GSK Investigational Site
Taichung, Taiwan, 40705
GSK Investigational Site
Taipei, Taiwan, 100
United Kingdom
GSK Investigational Site
London, United Kingdom, SE1 7EH
GSK Investigational Site
Newcastle Upon Tyne, United Kingdom, NE7 7DN
Sponsors and Collaborators
Human Genome Sciences Inc., a GSK Company
GlaxoSmithKline
Investigators
Layout table for investigator information
Study Director: GSK Clinical Trials GlaxoSmithKline

Layout table for additonal information
Responsible Party: Human Genome Sciences Inc., a GSK Company
ClinicalTrials.gov Identifier: NCT00712933     History of Changes
Other Study ID Numbers: 112234
First Posted: July 10, 2008    Key Record Dates
Results First Posted: January 16, 2018
Last Update Posted: January 16, 2018
Last Verified: November 2017

Keywords provided by GlaxoSmithKline ( Human Genome Sciences Inc., a GSK Company ):
SLE
Belimumab
Antibodies
Systemic Lupus Erythematosus
Lupus
Autoimmune Diseases

Additional relevant MeSH terms:
Layout table for MeSH terms
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Antibodies
Belimumab
Immunologic Factors
Physiological Effects of Drugs
Immunosuppressive Agents