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A Study of Belimumab Administered Subcutaneously in Subjects With Systemic Lupus Erythematosus (SLE) (BLISS-SC)

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: NCT01484496
Recruitment Status : Completed
First Posted : December 2, 2011
Results First Posted : July 25, 2017
Last Update Posted : June 5, 2018
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline ( Human Genome Sciences Inc., a GSK Company )

Brief Summary:
The purpose of this study is to evaluate the efficacy, safety and tolerability of belimumab administered subcutaneously (SC) to adult subjects with Systemic Lupus Erythematosus (SLE).

Condition or disease Intervention/treatment Phase
Systemic Lupus Erythematosus Biological: Placebo Biological: Belimumab 200 mg SC Drug: Standard therapy Phase 3

Detailed Description:
This is a Phase 3, multi-center, international, randomized, double-blind, placebo-controlled, 52-week study to evaluate the efficacy, safety and tolerability of belimumab administered subcutaneously (SC) (200 mg weekly) in adult subjects with active Systemic Lupus Erythematosus (SLE). Approximately 816 SLE subjects will be randomized, with a target of about 544 subjects receiving belimumab and 272 subjects receiving placebo. Subjects completing the 52-week double-blind period can enter a 6-month open-label extension in which all subjects receive belimumab 200 mg SC weekly.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 839 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) Administered Subcutaneously (SC) to Subjects With Systemic Lupus Erythematosus (SLE)
Study Start Date : November 16, 2011
Actual Primary Completion Date : February 13, 2015
Actual Study Completion Date : October 1, 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus
Drug Information available for: Belimumab

Arm Intervention/treatment
Placebo Comparator: Placebo plus standard therapy
Placebo SC plus standard therapy; placebo administered on Day 0 and then weekly (ie, every 7 days) through Week 51, with final evaluation at Week 52 in the double-blind period. In the open-label extension period, placebo subjects who opt to participate will receive belimumab 200 mg SC weekly for an additional 6-months.
Biological: Placebo
Placebo

Drug: Standard therapy
Standard therapy comprises any of the following (alone or in combination): corticosteroids, antimalarials, non-steroidal anti-inflammatory drugs (NSAIDs), and immunosuppressives; biologics and intravenous cyclophosphamide are not permitted.

Experimental: Belimumab 200 mg SC plus standard therapy
Belimumab 200 mg SC plus standard therapy; belimumab administered on Day 0 and then weekly (ie, every 7 days) through Week 51, with a final evaluation at Week 52 in the double-blind period. In the open-label extension period, subjects who opt to participate will continue on the same dose of belimumab for an additional 6-months.
Biological: Belimumab 200 mg SC
Belimumab 200 mg SC
Other Name: BENLYSTA™

Drug: Standard therapy
Standard therapy comprises any of the following (alone or in combination): corticosteroids, antimalarials, non-steroidal anti-inflammatory drugs (NSAIDs), and immunosuppressives; biologics and intravenous cyclophosphamide are not permitted.




Primary Outcome Measures :
  1. Percentage of Par. Achieving a SLE Responder Index (SRI) Response Rate at Week 52 [ Time Frame: Week 52 ]
    SRI response is defined as >=4 point reduction, from Baseline in safety of estrogen in lupus national assessment (SELENA) systemic lupus erythematosus disease activity index (SLEDAI) score, no worsening (increase of <0.30 points from Baseline) in physician's global assessment (PGA) and no new British Isles Lupus Assessment Group of SLE clinics (BILAG) A organ domain score or 2 new BILAG B organ domain scores compared with Baseline. Analysis was performed using a logistic regression model for the comparison between belimumab and placebo with covariates treatment group, Baseline SELENA SLEDAI score (<=9 vs. >=10), Baseline complement levels (low C3 and/or C4 vs. no low C3 or C4) and race (black vs. other).


Secondary Outcome Measures :
  1. Time to First Severe Flare (as Measured by the Modified SLE Flare Index) [ Time Frame: Baseline (Day 0, prior to dosing) to Week 52 ]
    Time to first severe SLE flare is defined as the number of days from treatment start date until the participant met an event (event date - treatment start date +1). Analyses of severe SLE flare was performed on modified SELENA SLEDAI SLE flare index that excludes severe flares that were triggered only by an increase in SELENA SLEDAI score to >12 (since this may only represent a modest increase in disease activity). Only post-baseline severe flares were considered.

  2. Percentage of Par. Whose Average Prednisone Dose Had Been Reduced by >=25% From Baseline to <=7.5 mg/Day During Weeks 40 Through 52 in Par. Receiving Greater Than 7.5 mg/Day at Baseline [ Time Frame: Baseline (Day 0, prior to dosing), Weeks 40 through Week 52 ]
    For the analysis of steroid use, all steroid dosages were converted to a prednisone equivalent in mg. The average daily prednisone dose was calculated taking into account all steroids taken intravenously, intramuscularly, SC, intradermally and orally for both SLE and non-SLE reasons. A responder was defined as having a prednisone reduction by >=25% from Baseline to <=7.5 mg/day during Weeks 40 through 52. At Baseline, the average daily prednisone dose was the sum of all prednisone doses over 7 consecutive days up to, but not including Day 0, divided by 7. For this analysis, the average prednisone dose was the total prednisone dose during weeks 40 through 52 divided by the number of days during Weeks 40 through 52. Analysis was performed using a logistic regression model with covariates treatment group, Baseline prednisone dose, Baseline SELENA SLEDAI score, (<=9 vs >=10), Baseline complement levels (low C3 and/or C4 vs. no low C3 or C4) and race (black vs. other).



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

Inclusion Criteria:

  1. At least 18 years of age.
  2. Clinical diagnosis of Systemic Lupus Erythematosus (SLE) by ACR criteria.
  3. Active SLE disease.
  4. Autoantibody-positive.
  5. On stable SLE treatment regimen which may include corticosteroids (for example, prednisone), antimalarial (for example, hydroxychloroquine) and/or immunosuppressants (for example, azathioprine, methotrexate, mycophenolate, etc.)

Exclusion Criteria:

  1. Pregnant or nursing.
  2. Have received treatment with any B cell targeted therapy (for example, rituximab or belimumab).
  3. Have received treatment an investigational biological agent in the past year.
  4. Have received intravenous (IV) cyclophosphamide within 90 days of Day 0.
  5. Have severe active lupus kidney disease.
  6. Have severe active central nervous system (CNS) lupus.
  7. Have required management of acute or chronic infections within the past 60 days.
  8. Have current drug or alcohol abuse or dependence.
  9. Have a positive test for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C.
  10. Have a history of hypersensitivity reactions to contrast agents or biological medicines.

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): NCT01484496


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Locations
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United States, Alabama
GSK Investigational Site
Birmingham, Alabama, United States, 35294
United States, Arizona
GSK Investigational Site
Peoria, Arizona, United States, 85381
GSK Investigational Site
Tucson, Arizona, United States, 85712
GSK Investigational Site
Tucson, Arizona, United States, 85724
United States, Arkansas
GSK Investigational Site
Jonesboro, Arkansas, United States, 72401
United States, California
GSK Investigational Site
La Jolla, California, United States, 92037-0943
GSK Investigational Site
Long Beach, California, United States, 90806
GSK Investigational Site
Los Angeles, California, United States, 90033
GSK Investigational Site
San Diego, California, United States, 92120
GSK Investigational Site
San Francisco, California, United States, 94118
GSK Investigational Site
San Jose, California, United States, 95126-1650
GSK Investigational Site
San Leandro, California, United States, 94578
GSK Investigational Site
Tustin, California, United States, 92780
GSK Investigational Site
Upland, California, United States, 91786
United States, Connecticut
GSK Investigational Site
Bridgeport, Connecticut, United States, 06606
United States, Florida
GSK Investigational Site
Aventura, Florida, United States, 33180
GSK Investigational Site
Boca Raton, Florida, United States, 33432
GSK Investigational Site
Boca Raton, Florida, United States, 33486
GSK Investigational Site
Coral Gables, Florida, United States, 33134
GSK Investigational Site
Fort Lauderdale, Florida, United States, 33334
GSK Investigational Site
Miami, Florida, United States, 33136
GSK Investigational Site
Orlando, Florida, United States, 32804
GSK Investigational Site
Orlando, Florida, United States, 32806-6264
GSK Investigational Site
Plantation, Florida, United States, 33324
GSK Investigational Site
Tampa, Florida, United States, 33614
United States, Georgia
GSK Investigational Site
Atlanta, Georgia, United States, 30303
GSK Investigational Site
Atlanta, Georgia, United States, 30342
GSK Investigational Site
Duluth, Georgia, United States, 30096
GSK Investigational Site
Lawrenceville, Georgia, United States, 30045
GSK Investigational Site
Marietta, Georgia, United States, 30060
United States, Idaho
GSK Investigational Site
Boise, Idaho, United States, 83704
United States, Illinois
GSK Investigational Site
Springfield, Illinois, United States, 62704
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, 21205
GSK Investigational Site
Cumberland, Maryland, United States, 21502
GSK Investigational Site
Hagerstown, Maryland, United States, 21740
United States, Massachusetts
GSK Investigational Site
Boston, Massachusetts, United States, 02115
GSK Investigational Site
Boston, Massachusetts, United States, 02118
United States, Michigan
GSK Investigational Site
Detroit, Michigan, United States, 48202
GSK Investigational Site
Saint Clair Shores, Michigan, United States, 48081
United States, Mississippi
GSK Investigational Site
Jackson, Mississippi, United States, 39202
United States, Missouri
GSK Investigational Site
Saint Louis, Missouri, United States, 63110
United States, New Mexico
GSK Investigational Site
Las Cruces, New Mexico, United States, 88011
United States, New York
GSK Investigational Site
Brooklyn, New York, United States, 11203
GSK Investigational Site
Lake Success, New York, United States, 11042
GSK Investigational Site
Manhasset, New York, United States, 11030
GSK Investigational Site
New York, New York, United States, 10016
GSK Investigational Site
Smithtown, New York, United States, 11787
United States, North Carolina
GSK Investigational Site
Chapel Hill, North Carolina, United States, 27599-7280
GSK Investigational Site
Charlotte, North Carolina, United States, 28207
GSK Investigational Site
Charlotte, North Carolina, United States, 28210
GSK Investigational Site
Durham, North Carolina, United States, 27710
GSK Investigational Site
Greenville, North Carolina, United States, 27834
United States, Ohio
GSK Investigational Site
Cleveland, Ohio, United States, 44109
GSK Investigational Site
Columbus, Ohio, United States, 43203
GSK Investigational Site
Dayton, Ohio, United States, 45417
GSK Investigational Site
Toledo, Ohio, United States, 43614
United States, Oklahoma
GSK Investigational Site
Oklahoma City, Oklahoma, United States, 73103
GSK Investigational Site
Tulsa, Oklahoma, United States, 74104
United States, Pennsylvania
GSK Investigational Site
Bethlehem, Pennsylvania, United States, 18015
GSK Investigational Site
Duncansville, Pennsylvania, United States, 16635
GSK Investigational Site
Wyomissing, Pennsylvania, United States, 19610
United States, South Carolina
GSK Investigational Site
Charleston, South Carolina, United States, 29406
GSK Investigational Site
Charleston, South Carolina, United States, 29425
GSK Investigational Site
Greenville, South Carolina, United States, 29601
GSK Investigational Site
Orangeburg, South Carolina, United States, 29118
United States, Tennessee
GSK Investigational Site
Jackson, Tennessee, United States, 38305
GSK Investigational Site
Memphis, Tennessee, United States, 38119
United States, Texas
GSK Investigational Site
Allentown, Texas, United States, 75013
GSK Investigational Site
Austin, Texas, United States, 78705
GSK Investigational Site
Austin, Texas, United States, 78758
GSK Investigational Site
Dallas, Texas, United States, 75231
GSK Investigational Site
Houston, Texas, United States, 77004
GSK Investigational Site
Houston, Texas, United States, 77008
GSK Investigational Site
Houston, Texas, United States, 77034
GSK Investigational Site
Houston, Texas, United States, 77074
GSK Investigational Site
Nassau Bay, Texas, United States, 77058
United States, Virginia
GSK Investigational Site
Arlington, Virginia, United States, 22205-3606
United States, Washington
GSK Investigational Site
Seattle, Washington, United States, 98133
United States, Wisconsin
GSK Investigational Site
Milwaukee, Wisconsin, United States, 53226
United States, Wyoming
GSK Investigational Site
Pennsylvania, Wyoming, United States, 19610
Argentina
GSK Investigational Site
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1181ACI
GSK Investigational Site
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1419AHN
GSK Investigational Site
La Plata, Buenos Aires, Argentina, B1902COS
GSK Investigational Site
Ciudad Autonoma Buenos Aires, Argentina, C1015ABO
GSK Investigational Site
Ciudad Autonoma Buenos Aires, Argentina, C1426AAL
Austria
GSK Investigational Site
Vienna, Austria, A-1100
Belgium
GSK Investigational Site
Brussels, Belgium, 1090
GSK Investigational Site
Bruxelles, Belgium, 1200
GSK Investigational Site
Liège, Belgium, 4000
Brazil
GSK Investigational Site
Cuiaba, Mato Grosso, Brazil, 78005-000
GSK Investigational Site
Juiz de Fora, Minas Gerais, Brazil, 36038-330
GSK Investigational Site
Curitiba, Paraná, Brazil, 80440-080
GSK Investigational Site
Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903
GSK Investigational Site
Porto Alegre, Rio Grande Do Sul, Brazil, 90110-270
GSK Investigational Site
Rio de Janeiro, Brazil, 21941-913
GSK Investigational Site
Salvador, Brazil, 40050-410
GSK Investigational Site
São Paulo, Brazil, 04032-060
Bulgaria
GSK Investigational Site
Plovdiv, Bulgaria, 4002
GSK Investigational Site
Ruse, Bulgaria, 7002
GSK Investigational Site
Sofia, Bulgaria, 1784
Chile
GSK Investigational Site
Santiago, Región Metro De Santiago, Chile, 7501126
GSK Investigational Site
Santiago, Chile, 7500000
GSK Investigational Site
Viña del Mar, Chile, 2570017
Colombia
GSK Investigational Site
Barranquilla, Colombia
GSK Investigational Site
Bogota, Colombia
GSK Investigational Site
Bucaramanga, Colombia
GSK Investigational Site
Medellin, Colombia
Croatia
GSK Investigational Site
Osijek, Croatia, 31000
GSK Investigational Site
Rijeka, Croatia, 51000
GSK Investigational Site
Zagreb, Croatia, 10000
Czechia
GSK Investigational Site
Praha 2, Czechia, 128 50
GSK Investigational Site
Zlin, Czechia, 760 01
Denmark
GSK Investigational Site
Koebenhavn, Denmark, 2100
GSK Investigational Site
Odense C, Denmark, 5000
France
GSK Investigational Site
Paris cedex 13, France, 75651
GSK Investigational Site
Paris, France, 75679
GSK Investigational Site
Pessac Cedex, France, 33604
GSK Investigational Site
Strasbourg cedex, France, 67091
GSK Investigational Site
Suresnes, France, 92150
GSK Investigational Site
Vandoeuvre les Nancy, France, 54511
Germany
GSK Investigational Site
Wuerzburg, Bayern, Germany, 97080
GSK Investigational Site
Bad Nauheim, Hessen, Germany, 61231
GSK Investigational Site
Hannover, Niedersachsen, Germany, 30625
GSK Investigational Site
Duesseldorf, Nordrhein-Westfalen, Germany, 40225
GSK Investigational Site
Mainz, Rheinland-Pfalz, Germany, 55131
GSK Investigational Site
Frankfurt, Germany, 60590
GSK Investigational Site
Hamburg, Germany, 22081
Hungary
GSK Investigational Site
Debrecen, Hungary, 4032
GSK Investigational Site
Zalaegerszeg, Hungary, 8900
Italy
GSK Investigational Site
Pisa, Toscana, Italy, 56126
GSK Investigational Site
Padova, Veneto, Italy, 35128
GSK Investigational Site
Genova, Italy, 16132
Japan
GSK Investigational Site
Fukuoka, Japan, 807-8555
GSK Investigational Site
Fukuoka, Japan, 810-8563
GSK Investigational Site
Hokkaido, Japan, 060-8604
GSK Investigational Site
Hokkaido, Japan, 060-8648
GSK Investigational Site
Miyagi, Japan, 980-8574
GSK Investigational Site
Nagasaki, Japan, 857-1195
GSK Investigational Site
Okinawa, Japan, 901-0243
GSK Investigational Site
Shizuoka, Japan, 430-8558
GSK Investigational Site
Tokyo, Japan, 104-8560
GSK Investigational Site
Tokyo, Japan, 160-8582
GSK Investigational Site
Tokyo, Japan, 162-8655
Malaysia
GSK Investigational Site
Kuala Lumpur, Malaysia, 59100
GSK Investigational Site
Seremban, Negeri Sembilan, Malaysia, 70300
Mexico
GSK Investigational Site
Guadalajara, Jalisco, Mexico, 44158
GSK Investigational Site
Guadalajara, Jalisco, Mexico, 44690
GSK Investigational Site
Cuernavaca, Morelos, Mexico, 62270
GSK Investigational Site
Merida, Yucatán, Mexico, 97130
GSK Investigational Site
Mexico, Mexico, 06700
GSK Investigational Site
Mexico, Mexico, 3100
GSK Investigational Site
San Luis Potosi, Mexico, 78240
Philippines
GSK Investigational Site
Cebu City, Philippines, 6000
GSK Investigational Site
Davao City, Philippines, 8000
GSK Investigational Site
Iloilo City, Philippines, 5000
GSK Investigational Site
Las Pinas, Philippines, 1740
GSK Investigational Site
Manila, Philippines, 1000
GSK Investigational Site
Manila, Philippines, 1015
GSK Investigational Site
Quezon City, Philippines, 1102
GSK Investigational Site
Quezon City, Philippines, 1118
Poland
GSK Investigational Site
Bydgoszcz, Poland, 85-168
GSK Investigational Site
Katowice, Poland, 40-635
GSK Investigational Site
Krakow, Poland, 31-066
GSK Investigational Site
Wroclaw, Poland, 50-556
Portugal
GSK Investigational Site
Almada, Portugal, 2801-915
GSK Investigational Site
Amadora, Portugal, 2720-276
GSK Investigational Site
Coimbra, Portugal, 3000-075
GSK Investigational Site
Lisboa, Portugal, 1649-035
GSK Investigational Site
Porto, Portugal, 4099-001
Romania
GSK Investigational Site
Bucharest, Romania, 020125
GSK Investigational Site
Bucharest, Romania, 11172
GSK Investigational Site
Bucuresti, Romania, 020475
Russian Federation
GSK Investigational Site
Moscow, Russian Federation, 115522
GSK Investigational Site
Saint-Petersburg, Russian Federation, 190068
GSK Investigational Site
Yaroslavl, Russian Federation, 150030
Serbia
GSK Investigational Site
Belgrade, Serbia, 11000
GSK Investigational Site
Belgrade, Serbia, 11080
Singapore
GSK Investigational Site
Singapore, Singapore, 529889
Spain
GSK Investigational Site
Barcelona, Spain, 08036
GSK Investigational Site
Barcelona, Spain, 8035
GSK Investigational Site
Granada, Spain, 18012
Sweden
GSK Investigational Site
Göteborg, Sweden, SE-413 45
GSK Investigational Site
Lund, Sweden, SE-221 85
GSK Investigational Site
Stockholm, Sweden, SE-171 76
Taiwan
GSK Investigational Site
Gueishan Township,Taoyuan County, Taiwan, 333
GSK Investigational Site
Kaohsiung, Taiwan, 807
GSK Investigational Site
Kaohsiung, Taiwan, 813
GSK Investigational Site
Kaohsiung, Taiwan, 833
GSK Investigational Site
Taichung, Taiwan, 404
GSK Investigational Site
Taipei, Taiwan, 100
Thailand
GSK Investigational Site
Bangkok, Thailand, 10400
GSK Investigational Site
Bangkok, Thailand, 10700
GSK Investigational Site
Chiangmai, Thailand, 50200
GSK Investigational Site
Rajathevee, Thailand, 10400
GSK Investigational Site
Ratchatewi, Thailand, 10400
GSK Investigational Site
Songkla, Thailand, 90110
Ukraine
GSK Investigational Site
Kharkiv, Ukraine, 61039
GSK Investigational Site
Kyiv, Ukraine, 01601
GSK Investigational Site
Odesa, Ukraine, 65026
GSK Investigational Site
Poltava, Ukraine, 36011
GSK Investigational Site
Vinnytsia, Ukraine, 21018
GSK Investigational Site
Zaporizhzhia, Ukraine, 69600
United Kingdom
GSK Investigational Site
Coventry, Warwickshire, United Kingdom, CV2 2DX
GSK Investigational Site
Birmingham, United Kingdom, B15 2TH
GSK Investigational Site
London, United Kingdom, SE1 7EH
Sponsors and Collaborators
Human Genome Sciences Inc., a GSK Company
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline

Additional Information:
Study Data/Documents: Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: 112341
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: 112341
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: 112341
For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: 112341
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: 112341
For additional information about this study please refer to the GSK Clinical Study Register
Annotated Case Report Form  This link exits the ClinicalTrials.gov site
Identifier: 112341
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 112341
For additional information about this study please refer to the GSK Clinical Study Register

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Human Genome Sciences Inc., a GSK Company
ClinicalTrials.gov Identifier: NCT01484496     History of Changes
Other Study ID Numbers: 112341
2011-003814-18
HGS1006-C1115
First Posted: December 2, 2011    Key Record Dates
Results First Posted: July 25, 2017
Last Update Posted: June 5, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

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

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