Last updated: 11/07/2018 04:45:25
A Study of Belimumab Administered Subcutaneously in Subjects with Systemic Lupus Erythematosus (SLE)BLISS-SC
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
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)
Trial description: 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).
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
Percentage of par. achieving a SLE Responder Index (SRI) response rate at Week 52
Timeframe: Week 52
Secondary outcomes:
Time to first severe flare (as measured by the modified SLE Flare Index)
Timeframe: 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
Timeframe: Baseline (Day 0, prior to dosing), Weeks 40 through Week 52
Interventions:
Biological/vaccine: Placebo
Biological/vaccine: Belimumab 200 mg SC
Drug: Standard therapy
Enrollment:
839
Observational study model:
Not applicable
Primary completion date:
2015-13-02
Time perspective:
Not applicable
Clinical publications:
Stohl W, Schwarting A, Okada M, Scheinberg MA, Doria A, Hammer A, Kleoudis C, Groark J,Bass D, Fox NL, Roth D, Gordon D. Efficacy and safety of subcutaneous belimumab in systemic lupus erythematosus: A randomized, double-blind, placebo-controlled, 52-week study. Arthritis Rheum. 2017;69(5):1016-1027.
Medical condition
Systemic Lupus Erythematosus
Product
belimumab
Collaborators
GlaxoSmithKline, GSK
Study date(s)
November 2011 to October 2015
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- 1. At least 18 years of age.
- 2. Clinical diagnosis of Systemic Lupus Erythematosus (SLE) by ACR criteria.
- 1. Pregnant or nursing.
- 2. Have received treatment with any B cell targeted therapy (for example, rituximab or belimumab).
Inclusion and exclusion 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.
Trial location(s)
Location
GSK Investigational Site
Boston, Massachusetts, United States, 02115
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Ft. Lauderdale, Florida, United States, 33334
Status
Study Complete
Location
GSK Investigational Site
Ciudad Autonoma Buenos Aires, Argentina, C1426AAL
Status
Study Complete
Location
GSK Investigational Site
St. Clair Shores, Michigan, United States, 48081
Status
Study Complete
Location
GSK Investigational Site
San Leandro, California, United States, 94578
Status
Study Complete
Location
GSK Investigational Site
Santiago, Región Metro De Santiago, Chile, 7501126
Status
Study Complete
Location
GSK Investigational Site
Las Cruces, New Mexico, United States, 88011
Status
Study Complete
Location
GSK Investigational Site
Charlotte, North Carolina, United States, 28207
Status
Study Complete
Location
GSK Investigational Site
Durham, North Carolina, United States, 27710
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Pennsylvania, Wyoming, United States, 19610
Status
Study Complete
Location
GSK Investigational Site
Lawrenceville, Georgia, United States, 30045
Status
Study Complete
Location
GSK Investigational Site
Bethlehem, Pennsylvania, United States, 18015
Status
Study Complete
Location
GSK Investigational Site
Boston, Massachusetts, United States, 02118
Status
Study Complete
Location
GSK Investigational Site
Wyomissing, Pennsylvania, United States, 19610
Status
Study Complete
Location
GSK Investigational Site
Duesseldorf, Nordrhein-Westfalen, Germany, 40225
Status
Study Complete
Location
GSK Investigational Site
La Jolla, California, United States, 92037-0943
Status
Study Complete
Location
GSK Investigational Site
Greenville, North Carolina, United States, 27834
Status
Study Complete
Location
GSK Investigational Site
Baltimore, Maryland, United States, 21205
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Orangeburg, South Carolina, United States, 29118
Status
Study Complete
Location
GSK Investigational Site
Atlanta, Georgia, United States, 30342
Status
Study Complete
Location
GSK Investigational Site
Vandoeuvre les Nancy, France, 54511
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Upland, California, United States, 91786
Status
Study Complete
Location
GSK Investigational Site
Bridgeport, Connecticut, United States, 06606
Status
Study Complete
Location
GSK Investigational Site
Smithtown, New York, United States, 11787
Status
Study Complete
Location
GSK Investigational Site
Atlanta, Georgia, United States, 30303
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Orlando, Florida, United States, 32804
Status
Study Complete
Location
GSK Investigational Site
Jonesboro, Arkansas, United States, 72401
Status
Study Complete
Location
GSK Investigational Site
Gueishan Township,Taoyuan County, Taiwan, 333
Status
Study Complete
Location
GSK Investigational Site
Tustin, California, United States, 92780
Status
Study Complete
Location
GSK Investigational Site
Hagerstown, Maryland, United States, 21740
Status
Study Complete
Location
GSK Investigational Site
Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903
Status
Study Complete
Location
GSK Investigational Site
Greenville, South Carolina, United States, 29601
Status
Study Complete
Location
GSK Investigational Site
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1419AHN
Status
Study Complete
Location
GSK Investigational Site
Cuiaba, Mato Grosso, Brazil, 78005-000
Status
Study Complete
Location
GSK Investigational Site
Charleston, South Carolina, United States, 29425
Status
Study Complete
Location
GSK Investigational Site
Duncansville, Pennsylvania, United States, 16635
Status
Study Complete
Location
GSK Investigational Site
New York, New York, United States, 10016
Status
Study Complete
Location
GSK Investigational Site
Oklahoma City, Oklahoma, United States, 73103
Status
Study Complete
Location
GSK Investigational Site
Juiz de Fora, Minas Gerais, Brazil, 36038-330
Status
Study Complete
Location
GSK Investigational Site
Bad Nauheim, Hessen, Germany, 61231
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Coventry, Warwickshire, United Kingdom, CV2 2DX
Status
Study Complete
Location
GSK Investigational Site
São Paulo, São Paulo, Brazil, 04032-060
Status
Study Complete
Location
GSK Investigational Site
Seremban, Negeri Sembilan, Malaysia, 70300
Status
Study Complete
Location
GSK Investigational Site
La Plata, Buenos Aires, Argentina, B1902COS
Status
Study Complete
Location
GSK Investigational Site
Lake Success, New York, United States, 11042
Status
Study Complete
Location
GSK Investigational Site
Cumberland, Maryland, United States, 21502
Status
Study Complete
Location
GSK Investigational Site
Manhasset, New York, United States, 11030
Status
Study Complete
Location
GSK Investigational Site
Porto Alegre, Rio Grande Do Sul, Brazil, 90110-270
Status
Study Complete
Location
GSK Investigational Site
Birmingham, Alabama, United States, 35294
Status
Study Complete
Location
GSK Investigational Site
Boca Raton, Florida, United States, 33432
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Charleston, South Carolina, United States, 29406
Status
Study Complete
Location
GSK Investigational Site
Mainz, Rheinland-Pfalz, Germany, 55131
Status
Study Complete
Location
GSK Investigational Site
Seattle, Washington, United States, 98133
Status
Study Complete
Location
GSK Investigational Site
San Jose, California, United States, 95126-1650
Status
Study Complete
Location
GSK Investigational Site
Baton Rouge, Louisiana, United States, 70809
Status
Study Complete
Location
GSK Investigational Site
NEW ORLEANS, Louisiana, United States, 70121
Status
Study Complete
Location
GSK Investigational Site
Plantation, Florida, United States, 33324
Status
Study Complete
Location
GSK Investigational Site
Detroit, Michigan, United States, 48202
Status
Study Complete
Location
GSK Investigational Site
Arlington, Virginia, United States, 22205-3606
Status
Study Complete
Location
GSK Investigational Site
San Francisco, California, United States, 94118
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Orlando, Florida, United States, 32806-6264
Status
Study Complete
Location
GSK Investigational Site
Memphis, Tennessee, United States, 38119
Status
Study Complete
Location
GSK Investigational Site
Charlotte, North Carolina, United States, 28210
Status
Study Complete
Location
GSK Investigational Site
Aventura, Florida, United States, 33180
Status
Study Complete
Location
GSK Investigational Site
Boca Raton, Florida, United States, 33486
Status
Study Complete
Location
GSK Investigational Site
San Diego, California, United States, 92120
Status
Study Complete
Location
GSK Investigational Site
Los Angeles, California, United States, 90033
Status
Study Complete
Location
GSK Investigational Site
Milwaukee, Wisconsin, United States, 53226
Status
Study Complete
Location
GSK Investigational Site
Marietta, Georgia, United States, 30060
Status
Study Complete
Location
GSK Investigational Site
Springfield, Illinois, United States, 62704
Status
Study Complete
Location
GSK Investigational Site
Jackson, Mississippi, United States, 39202
Status
Study Complete
Location
GSK Investigational Site
Brooklyn, New York, United States, 11203
Status
Study Complete
Location
GSK Investigational Site
Long Beach, California, United States, 90806
Status
Study Complete
Location
GSK Investigational Site
Nassau Bay, Texas, United States, 77058
Status
Study Complete
Location
GSK Investigational Site
Coral Gables, Florida, United States, 33134
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Chapel Hill, North Carolina, United States, 27599-7280
Status
Study Complete
Location
GSK Investigational Site
Jackson, Tennessee, United States, 38305
Status
Study Complete
Location
GSK Investigational Site
Allentown, Texas, United States, 75013
Status
Study Complete
Location
GSK Investigational Site
Hannover, Niedersachsen, Germany, 30625
Status
Study Complete
Location
GSK Investigational Site
St. Louis, Missouri, United States, 63110
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2015-13-02
Actual study completion date
2015-01-10
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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