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

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)

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).

Study Overview

• Status: Completed
• Conditions: Systemic Lupus Erythematosus
• Intervention / Treatment: Biological: Placebo; Drug: Standard therapy; Biological: Belimumab 200 mg SC

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.

• Study Type: Interventional
• Enrollment (Actual): 839
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Ciudad Autonoma Buenos Aires, Argentina, C1015ABO
    • GSK Investigational Site
  • Ciudad Autonoma Buenos Aires, Argentina, C1426AAL
    • GSK Investigational Site
  • Buenos Aires
    • Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1419AHN
      • GSK Investigational Site
    • Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1181ACI
      • GSK Investigational Site
    • La Plata, Buenos Aires, Argentina, B1902COS
      • GSK Investigational Site
• Austria
  • Vienna, Austria, A-1100
    • GSK Investigational Site
• Belgium
  • Brussels, Belgium, 1090
    • GSK Investigational Site
  • Bruxelles, Belgium, 1200
    • GSK Investigational Site
  • Liège, Belgium, 4000
    • GSK Investigational Site
• Brazil
  • Rio de Janeiro, Brazil, 21941-913
    • GSK Investigational Site
  • Salvador, Brazil, 40050-410
    • GSK Investigational Site
  • São Paulo, Brazil, 04032-060
    • GSK Investigational Site
  • Mato Grosso
    • Cuiaba, Mato Grosso, Brazil, 78005-000
      • GSK Investigational Site
  • Minas Gerais
    • Juiz de Fora, Minas Gerais, Brazil, 36038-330
      • GSK Investigational Site
  • Paraná
    • Curitiba, Paraná, Brazil, 80440-080
      • GSK Investigational Site
  • Rio Grande Do Sul
    • Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903
      • GSK Investigational Site
    • Porto Alegre, Rio Grande Do Sul, Brazil, 90110-270
      • GSK Investigational Site
• Bulgaria
  • Plovdiv, Bulgaria, 4002
    • GSK Investigational Site
  • Ruse, Bulgaria, 7002
    • GSK Investigational Site
  • Sofia, Bulgaria, 1784
    • GSK Investigational Site
• Chile
  • Santiago, Chile, 7500000
    • GSK Investigational Site
  • Viña del Mar, Chile, 2570017
    • GSK Investigational Site
  • Región Metro De Santiago
    • Santiago, Región Metro De Santiago, Chile, 7501126
      • GSK Investigational Site
• Colombia
  • Barranquilla, Colombia
    • GSK Investigational Site
  • Bogota, Colombia
    • GSK Investigational Site
  • Bucaramanga, Colombia
    • GSK Investigational Site
  • Medellin, Colombia
    • GSK Investigational Site
• Croatia
  • Osijek, Croatia, 31000
    • GSK Investigational Site
  • Rijeka, Croatia, 51000
    • GSK Investigational Site
  • Zagreb, Croatia, 10000
    • GSK Investigational Site
• Czechia
  • Praha 2, Czechia, 128 50
    • GSK Investigational Site
  • Zlin, Czechia, 760 01
    • GSK Investigational Site
• Denmark
  • Koebenhavn, Denmark, 2100
    • GSK Investigational Site
  • Odense C, Denmark, 5000
    • GSK Investigational Site
• France
  • Paris, France, 75679
    • GSK Investigational Site
  • Paris cedex 13, France, 75651
    • 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
    • GSK Investigational Site
• Germany
  • Frankfurt, Germany, 60590
    • GSK Investigational Site
  • Hamburg, Germany, 22081
    • GSK Investigational Site
  • Bayern
    • Wuerzburg, Bayern, Germany, 97080
      • GSK Investigational Site
  • Hessen
    • Bad Nauheim, Hessen, Germany, 61231
      • GSK Investigational Site
  • Niedersachsen
    • Hannover, Niedersachsen, Germany, 30625
      • GSK Investigational Site
  • Nordrhein-Westfalen
    • Duesseldorf, Nordrhein-Westfalen, Germany, 40225
      • GSK Investigational Site
  • Rheinland-Pfalz
    • Mainz, Rheinland-Pfalz, Germany, 55131
      • GSK Investigational Site
• Hungary
  • Debrecen, Hungary, 4032
    • GSK Investigational Site
  • Zalaegerszeg, Hungary, 8900
    • GSK Investigational Site
• Italy
  • Genova, Italy, 16132
    • GSK Investigational Site
  • Toscana
    • Pisa, Toscana, Italy, 56126
      • GSK Investigational Site
  • Veneto
    • Padova, Veneto, Italy, 35128
      • GSK Investigational Site
• Japan
  • Fukuoka, Japan, 807-8555
    • GSK Investigational Site
  • Fukuoka, Japan, 810-8563
    • GSK Investigational Site
  • Hokkaido, Japan, 060-8648
    • GSK Investigational Site
  • Hokkaido, Japan, 060-8604
    • 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, 160-8582
    • GSK Investigational Site
  • Tokyo, Japan, 162-8655
    • GSK Investigational Site
  • Tokyo, Japan, 104-8560
    • GSK Investigational Site
• Malaysia
  • Kuala Lumpur, Malaysia, 59100
    • GSK Investigational Site
  • Seremban, Negeri Sembilan, Malaysia, 70300
    • GSK Investigational Site
• Mexico
  • Mexico, Mexico, 06700
    • GSK Investigational Site
  • Mexico, Mexico, 3100
    • GSK Investigational Site
  • San Luis Potosi, Mexico, 78240
    • GSK Investigational Site
  • Jalisco
    • Guadalajara, Jalisco, Mexico, 44158
      • GSK Investigational Site
    • Guadalajara, Jalisco, Mexico, 44690
      • GSK Investigational Site
  • Morelos
    • Cuernavaca, Morelos, Mexico, 62270
      • GSK Investigational Site
  • Yucatán
    • Merida, Yucatán, Mexico, 97130
      • GSK Investigational Site
• Philippines
  • 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
    • GSK Investigational Site
• Poland
  • 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
    • GSK Investigational Site
• Portugal
  • 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
    • GSK Investigational Site
• Romania
  • Bucharest, Romania, 020125
    • GSK Investigational Site
  • Bucharest, Romania, 11172
    • GSK Investigational Site
  • Bucuresti, Romania, 020475
    • GSK Investigational Site
• Russian Federation
  • Moscow, Russian Federation, 115522
    • GSK Investigational Site
  • Saint-Petersburg, Russian Federation, 190068
    • GSK Investigational Site
  • Yaroslavl, Russian Federation, 150030
    • GSK Investigational Site
• Serbia
  • Belgrade, Serbia, 11000
    • GSK Investigational Site
  • Belgrade, Serbia, 11080
    • GSK Investigational Site
• Singapore
  • Singapore, Singapore, 529889
    • GSK Investigational Site
• Spain
  • Barcelona, Spain, 08036
    • GSK Investigational Site
  • Barcelona, Spain, 8035
    • GSK Investigational Site
  • Granada, Spain, 18012
    • GSK Investigational Site
• Sweden
  • Göteborg, Sweden, SE-413 45
    • GSK Investigational Site
  • Lund, Sweden, SE-221 85
    • GSK Investigational Site
  • Stockholm, Sweden, SE-171 76
    • GSK Investigational Site
• Taiwan
  • Gueishan Township,Taoyuan County, Taiwan, 333
    • GSK Investigational Site
  • Kaohsiung, Taiwan, 833
    • GSK Investigational Site
  • Kaohsiung, Taiwan, 813
    • GSK Investigational Site
  • Kaohsiung, Taiwan, 807
    • GSK Investigational Site
  • Taichung, Taiwan, 404
    • GSK Investigational Site
  • Taipei, Taiwan, 100
    • GSK Investigational Site
• Thailand
  • 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
    • GSK Investigational Site
• Ukraine
  • 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
    • GSK Investigational Site
• United Kingdom
  • Birmingham, United Kingdom, B15 2TH
    • GSK Investigational Site
  • London, United Kingdom, SE1 7EH
    • GSK Investigational Site
  • Warwickshire
    • Coventry, Warwickshire, United Kingdom, CV2 2DX
      • GSK Investigational Site
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • GSK Investigational Site
  • Arizona
    • Peoria, Arizona, United States, 85381
      • GSK Investigational Site
    • Tucson, Arizona, United States, 85712
      • GSK Investigational Site
    • Tucson, Arizona, United States, 85724
      • GSK Investigational Site
  • Arkansas
    • Jonesboro, Arkansas, United States, 72401
      • GSK Investigational Site
  • California
    • 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
      • GSK Investigational Site
  • Connecticut
    • Bridgeport, Connecticut, United States, 06606
      • GSK Investigational Site
  • Florida
    • Aventura, Florida, United States, 33180
      • GSK Investigational Site
    • Boca Raton, Florida, United States, 33486
      • GSK Investigational Site
    • Boca Raton, Florida, United States, 33432
      • 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
      • GSK Investigational Site
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • GSK Investigational Site
    • Atlanta, Georgia, United States, 30303
      • GSK Investigational Site
    • Duluth, Georgia, United States, 30096
      • GSK Investigational Site
    • Lawrenceville, Georgia, United States, 30045
      • GSK Investigational Site
    • Marietta, Georgia, United States, 30060
      • GSK Investigational Site
  • Idaho
    • Boise, Idaho, United States, 83704
      • GSK Investigational Site
  • Illinois
    • Springfield, Illinois, United States, 62704
      • GSK Investigational Site
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70809
      • GSK Investigational Site
    • New Orleans, Louisiana, United States, 70121
      • GSK Investigational Site
  • Maryland
    • Baltimore, Maryland, United States, 21205
      • GSK Investigational Site
    • Cumberland, Maryland, United States, 21502
      • GSK Investigational Site
    • Hagerstown, Maryland, United States, 21740
      • GSK Investigational Site
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • GSK Investigational Site
    • Boston, Massachusetts, United States, 02115
      • GSK Investigational Site
  • Michigan
    • Detroit, Michigan, United States, 48202
      • GSK Investigational Site
    • Saint Clair Shores, Michigan, United States, 48081
      • GSK Investigational Site
  • Mississippi
    • Jackson, Mississippi, United States, 39202
      • GSK Investigational Site
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • GSK Investigational Site
  • New Mexico
    • Las Cruces, New Mexico, United States, 88011
      • GSK Investigational Site
  • New York
    • 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
      • GSK Investigational Site
  • North Carolina
    • 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
      • GSK Investigational Site
  • Ohio
    • 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
      • GSK Investigational Site
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73103
      • GSK Investigational Site
    • Tulsa, Oklahoma, United States, 74104
      • GSK Investigational Site
  • Pennsylvania
    • Bethlehem, Pennsylvania, United States, 18015
      • GSK Investigational Site
    • Duncansville, Pennsylvania, United States, 16635
      • GSK Investigational Site
    • Wyomissing, Pennsylvania, United States, 19610
      • GSK Investigational Site
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • GSK Investigational Site
    • Charleston, South Carolina, United States, 29406
      • GSK Investigational Site
    • Greenville, South Carolina, United States, 29601
      • GSK Investigational Site
    • Orangeburg, South Carolina, United States, 29118
      • GSK Investigational Site
  • Tennessee
    • Jackson, Tennessee, United States, 38305
      • GSK Investigational Site
    • Memphis, Tennessee, United States, 38119
      • GSK Investigational Site
  • Texas
    • 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, 77074
      • 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
    • Nassau Bay, Texas, United States, 77058
      • GSK Investigational Site
  • Virginia
    • Arlington, Virginia, United States, 22205-3606
      • GSK Investigational Site
  • Washington
    • Seattle, Washington, United States, 98133
      • GSK Investigational Site
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • GSK Investigational Site
  • Wyoming
    • Pennsylvania, Wyoming, United States, 19610
      • GSK Investigational Site

Participation Criteria

Eligibility Criteria

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

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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.	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.; Biological: Belimumab 200 mg SC; Belimumab 200 mg SC; Other Names: BENLYSTA™

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Par. Achieving a SLE Responder Index (SRI) Response Rate at 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).	Week 52

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to First Severe Flare (as Measured by the Modified SLE Flare Index)	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.	Baseline (Day 0, prior to dosing) to Week 52
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	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).	Baseline (Day 0, prior to dosing), Weeks 40 through Week 52

Collaborators and Investigators

• Sponsor: Human Genome Sciences Inc., a GSK Company
• Collaborators: GlaxoSmithKline

Publications and helpful links

General Publications

• Hannon CW, McCourt C, Lima HC, Chen S, Bennett C. Interventions for cutaneous disease in systemic lupus erythematosus. Cochrane Database Syst Rev. 2021 Mar 9;3(3):CD007478. doi: 10.1002/14651858.CD007478.pub2.
• Brunner HI, Abud-Mendoza C, Mori M, Pilkington CA, Syed R, Takei S, Viola DO, Furie RA, Navarra S, Zhang F, Bass DL, Eriksson G, Hammer AE, Ji BN, Okily M, Roth DA, Quasny H, Ruperto N. Efficacy and safety of belimumab in paediatric and adult patients with systemic lupus erythematosus: an across-study comparison. RMD Open. 2021 Sep;7(3):e001747. doi: 10.1136/rmdopen-2021-001747.
• Maslen T, Bruce IN, D'Cruz D, Ianosev M, Bass DL, Wilkinson C, Roth DA. Efficacy of belimumab in two serologically distinct high disease activity subgroups of patients with systemic lupus erythematosus: post-hoc analysis of data from the phase III programme. Lupus Sci Med. 2021 Feb;8(1):e000459. doi: 10.1136/lupus-2020-000459.
• Lokhandwala T, Yue B, Coutinho AD, Bell CF. Within-trial economic analysis of flare data from the BLISS-SC trial of subcutaneous belimumab in systemic lupus erythematosus. Lupus Sci Med. 2021 Feb;8(1):e000438. doi: 10.1136/lupus-2020-000438.
• Doria A, Bass D, Schwarting A, Hammer A, Gordon D, Scheinberg M, Fox NL, Groark J, Stohl W, Kleoudis C, Roth D. A 6-month open-label extension study of the safety and efficacy of subcutaneous belimumab in patients with systemic lupus erythematosus. Lupus. 2018 Aug;27(9):1489-1498. doi: 10.1177/0961203318777634. Epub 2018 May 28.
• Doria A, Stohl W, Schwarting A, Okada M, Scheinberg M, van Vollenhoven R, Hammer AE, Groark J, Bass D, Fox NL, Roth D, Gordon D. Efficacy and Safety of Subcutaneous Belimumab in Anti-Double-Stranded DNA-Positive, Hypocomplementemic Patients With Systemic Lupus Erythematosus. Arthritis Rheumatol. 2018 Aug;70(8):1256-1264. doi: 10.1002/art.40511. Epub 2018 Jun 15.
• Stohl W, Schwarting A, Okada M, Scheinberg M, Doria A, Hammer AE, Kleoudis C, Groark J, Bass D, Fox NL, Roth D, Gordon D. Efficacy and Safety of Subcutaneous Belimumab in Systemic Lupus Erythematosus: A Fifty-Two-Week Randomized, Double-Blind, Placebo-Controlled Study. Arthritis Rheumatol. 2017 May;69(5):1016-1027. doi: 10.1002/art.40049. Epub 2017 Apr 7.

Helpful Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Study record dates

Study Major Dates

• Study Start: November 16, 2011
• Primary Completion (Actual): February 13, 2015
• Study Completion (Actual): October 1, 2015

Study Registration Dates

• First Submitted: November 28, 2011
• First Submitted That Met QC Criteria: November 30, 2011
• First Posted (Estimate): December 2, 2011

Study Record Updates

• Last Update Posted (Actual): June 6, 2018
• Last Update Submitted That Met QC Criteria: May 31, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: Lupus; SLE; Subcutaneous; Systemic Lupus Erythematosus; Antibodies; Autoimmune Disease; Belimumab
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Connective Tissue Diseases; Lupus Erythematosus, Systemic; Physiological Effects of Drugs; Immunosuppressive Agents; Immunologic Factors; Belimumab
• Other Study ID Numbers: 112341; 2011-003814-18; HGS1006-C1115

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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.

Study Data/Documents

1. Informed Consent Form
   Information identifier: 112341
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
2. Dataset Specification
   Information identifier: 112341
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
3. Clinical Study Report
   Information identifier: 112341
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
4. Individual Participant Data Set
   Information identifier: 112341
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
5. Statistical Analysis Plan
   Information identifier: 112341
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
6. Annotated Case Report Form
   Information identifier: 112341
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
7. Study Protocol
   Information identifier: 112341
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register