AzTrials
AzTrials

Systemic Lupus ErythematosusPhase 3BLISS-SCNCT01484496

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

A Phase 3 study testing Belimumab 200 mg SC and Standard therapy in people with Systemic Lupus Erythematosus, run by Human Genome Sciences Inc., a GSK Company at 207 sites in 31 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Systemic Lupus Erythematosus
What is being tested?
Belimumab 200 mg SC and Standard therapy
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
839 participants
Where
207 sitesin 31 countries
Study dates
16 Nov 2011to 1 Oct 2015
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • At least 18 years of age.
  • Clinical diagnosis of Systemic Lupus Erythematosus (SLE) by ACR criteria.
  • Active SLE disease.
  • Autoantibody-positive.
  • 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.)

Who cannot join

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

Trial locations and contacts

207 sites in 31 countries.

207 sites in 31 countries

United States82 sites

  • GSK Investigational Site

    Arlington, Virginia, 22205-3606

  • GSK Investigational Site

    Atlanta, Georgia, 30303

  • GSK Investigational Site

    Atlanta, Georgia, 30342

  • GSK Investigational Site

    Austin, Texas, 78705

  • GSK Investigational Site

    Austin, Texas, 78758

  • GSK Investigational Site

    Aventura, Florida, 33180

  • GSK Investigational Site

    Baltimore, Maryland, 21205

  • GSK Investigational Site

    Baton Rouge, Louisiana, 70809

  • GSK Investigational Site

    Bethlehem, Pennsylvania, 18015

  • GSK Investigational Site

    Birmingham, Alabama, 35294

  • GSK Investigational Site

    Boca Raton, Florida, 33432

  • GSK Investigational Site

    Boca Raton, Florida, 33486

  • GSK Investigational Site

    Boise, Idaho, 83704

  • GSK Investigational Site

    Boston, Massachusetts, 02115

  • GSK Investigational Site

    Boston, Massachusetts, 02118

  • GSK Investigational Site

    Bridgeport, Connecticut, 06606

  • GSK Investigational Site

    Brooklyn, New York, 11203

  • GSK Investigational Site

    Chapel Hill, North Carolina, 27599-7280

  • GSK Investigational Site

    Charleston, South Carolina, 29406

  • GSK Investigational Site

    Charleston, South Carolina, 29425

  • GSK Investigational Site

    Charlotte, North Carolina, 28207

  • GSK Investigational Site

    Charlotte, North Carolina, 28210

  • GSK Investigational Site

    Cleveland, Ohio, 44109

  • GSK Investigational Site

    Columbus, Ohio, 43203

  • GSK Investigational Site

    Coral Gables, Florida, 33134

  • GSK Investigational Site

    Cumberland, Maryland, 21502

  • GSK Investigational Site

    Dallas, Texas, 75231

  • GSK Investigational Site

    Dayton, Ohio, 45417

  • GSK Investigational Site

    Detroit, Michigan, 48202

  • GSK Investigational Site

    Duluth, Georgia, 30096

  • GSK Investigational Site

    Duncansville, Pennsylvania, 16635

  • GSK Investigational Site

    Durham, North Carolina, 27710

  • GSK Investigational Site

    Fort Lauderdale, Florida, 33334

  • GSK Investigational Site

    Greenville, North Carolina, 27834

  • GSK Investigational Site

    Greenville, South Carolina, 29601

  • GSK Investigational Site

    Hagerstown, Maryland, 21740

  • GSK Investigational Site

    Houston, Texas, 77004

  • GSK Investigational Site

    Houston, Texas, 77008

  • GSK Investigational Site

    Houston, Texas, 77034

  • GSK Investigational Site

    Houston, Texas, 77074

  • GSK Investigational Site

    Jackson, Mississippi, 39202

  • GSK Investigational Site

    Jackson, Tennessee, 38305

  • GSK Investigational Site

    Jonesboro, Arkansas, 72401

  • GSK Investigational Site

    La Jolla, California, 92037-0943

  • GSK Investigational Site

    Lake Success, New York, 11042

  • GSK Investigational Site

    Las Cruces, New Mexico, 88011

  • GSK Investigational Site

    Lawrenceville, Georgia, 30045

  • GSK Investigational Site

    Long Beach, California, 90806

  • GSK Investigational Site

    Los Angeles, California, 90033

  • GSK Investigational Site

    Manhasset, New York, 11030

  • GSK Investigational Site

    Marietta, Georgia, 30060

  • GSK Investigational Site

    Memphis, Tennessee, 38119

  • GSK Investigational Site

    Miami, Florida, 33136

  • GSK Investigational Site

    Milwaukee, Wisconsin, 53226

  • GSK Investigational Site

    Nassau Bay, Texas, 77058

  • GSK Investigational Site

    New Orleans, Louisiana, 70121

  • GSK Investigational Site

    New York, New York, 10016

  • GSK Investigational Site

    Oklahoma City, Oklahoma, 73103

  • GSK Investigational Site

    Orangeburg, South Carolina, 29118

  • GSK Investigational Site

    Orlando, Florida, 32804

  • GSK Investigational Site

    Orlando, Florida, 32806-6264

  • GSK Investigational Site

    Pennsylvania, Wyoming, 19610

  • GSK Investigational Site

    Peoria, Arizona, 85381

  • GSK Investigational Site

    Plantation, Florida, 33324

  • GSK Investigational Site

    Royalty, Texas, 75013

  • GSK Investigational Site

    Saint Clair Shores, Michigan, 48081

  • GSK Investigational Site

    San Diego, California, 92120

  • GSK Investigational Site

    San Francisco, California, 94118

  • GSK Investigational Site

    San Jose, California, 95126-1650

  • GSK Investigational Site

    San Leandro, California, 94578

  • GSK Investigational Site

    Seattle, Washington, 98133

  • GSK Investigational Site

    Smithtown, New York, 11787

  • GSK Investigational Site

    Springfield, Illinois, 62704

  • GSK Investigational Site

    St Louis, Missouri, 63110

  • GSK Investigational Site

    Tampa, Florida, 33614

  • GSK Investigational Site

    Toledo, Ohio, 43614

  • GSK Investigational Site

    Tucson, Arizona, 85712

  • GSK Investigational Site

    Tucson, Arizona, 85724

  • GSK Investigational Site

    Tulsa, Oklahoma, 74104

  • GSK Investigational Site

    Tustin, California, 92780

  • GSK Investigational Site

    Upland, California, 91786

  • GSK Investigational Site

    Wyomissing, Pennsylvania, 19610

Other trials in United States

Japan11 sites

  • GSK Investigational Site

    Fukuoka, 807-8555

  • GSK Investigational Site

    Fukuoka, 810-8563

  • GSK Investigational Site

    Hokkaido, 060-8604

  • GSK Investigational Site

    Hokkaido, 060-8648

  • GSK Investigational Site

    Miyagi, 980-8574

  • GSK Investigational Site

    Nagasaki, 857-1195

  • GSK Investigational Site

    Okinawa, 901-0243

  • GSK Investigational Site

    Shizuoka, 430-8558

  • GSK Investigational Site

    Tokyo, 104-8560

  • GSK Investigational Site

    Tokyo, 160-8582

  • GSK Investigational Site

    Tokyo, 162-8655

Other trials in Japan

Brazil8 sites

  • GSK Investigational Site

    Cuiabá, Mato Grosso, 78005-000

  • GSK Investigational Site

    Curitiba, Paraná, 80440-080

  • GSK Investigational Site

    Juiz de Fora, Minas Gerais, 36038-330

  • GSK Investigational Site

    Porto Alegre, Rio Grande do Sul, 90035-903

  • GSK Investigational Site

    Porto Alegre, Rio Grande do Sul, 90110-270

  • GSK Investigational Site

    Rio de Janeiro, 21941-913

  • GSK Investigational Site

    Salvador, 40050-410

  • GSK Investigational Site

    São Paulo, 04032-060

Other trials in Brazil

Philippines8 sites

  • GSK Investigational Site

    Cebu City, 6000

  • GSK Investigational Site

    Davao City, 8000

  • GSK Investigational Site

    Iloilo City, 5000

  • GSK Investigational Site

    Las Piñas, 1740

  • GSK Investigational Site

    Manila, 1000

  • GSK Investigational Site

    Manila, 1015

  • GSK Investigational Site

    Quezon City, 1102

  • GSK Investigational Site

    Quezon City, 1118

Other trials in Philippines

Germany7 sites

  • GSK Investigational Site

    Bad Nauheim, Hesse, 61231

  • GSK Investigational Site

    Düsseldorf, North Rhine-Westphalia, 40225

  • GSK Investigational Site

    Frankfurt, 60590

  • GSK Investigational Site

    Hamburg, 22081

  • GSK Investigational Site

    Hanover, Lower Saxony, 30625

  • GSK Investigational Site

    Mainz, Rhineland-Palatinate, 55131

  • GSK Investigational Site

    Würzburg, Bavaria, 97080

Other trials in Germany

Mexico7 sites

  • GSK Investigational Site

    Cuernavaca, Morelos, 62270

  • GSK Investigational Site

    Guadalajara, Jalisco, 44158

  • GSK Investigational Site

    Guadalajara, Jalisco, 44690

  • GSK Investigational Site

    Mérida, Yucatán, 97130

  • GSK Investigational Site

    México, 06700

  • GSK Investigational Site

    México, 3100

  • GSK Investigational Site

    San Luis Potosí City, 78240

Other trials in Mexico

France6 sites

  • GSK Investigational Site

    Paris, 75651

  • GSK Investigational Site

    Paris, 75679

  • GSK Investigational Site

    Pessac, 33604

  • GSK Investigational Site

    Strasbourg, 67091

  • GSK Investigational Site

    Suresnes, 92150

  • GSK Investigational Site

    Vandœuvre-lès-Nancy, 54511

Other trials in France

Taiwan6 sites

  • GSK Investigational Site

    Gueishan Township,Taoyuan County, 333

  • GSK Investigational Site

    Kaohsiung City, 807

  • GSK Investigational Site

    Kaohsiung City, 813

  • GSK Investigational Site

    Kaohsiung City, 833

  • GSK Investigational Site

    Taichung, 404

  • GSK Investigational Site

    Taipei, 100

Other trials in Taiwan

Thailand6 sites

  • GSK Investigational Site

    Bangkok, 10400

  • GSK Investigational Site

    Bangkok, 10700

  • GSK Investigational Site

    Chiang Mai, 50200

  • GSK Investigational Site

    Rajathevee, 10400

  • GSK Investigational Site

    Ratchatewi, 10400

  • GSK Investigational Site

    Songkhla, 90110

Other trials in Thailand

Ukraine6 sites

  • GSK Investigational Site

    Kharkiv, 61039

  • GSK Investigational Site

    Kyiv, 01601

  • GSK Investigational Site

    Odesa, 65026

  • GSK Investigational Site

    Poltava, 36011

  • GSK Investigational Site

    Vinnytsia, 21018

  • GSK Investigational Site

    Zaporizhzhya, 69600

Other trials in Ukraine

Argentina5 sites

  • GSK Investigational Site

    Ciudad Autonoma Buenos Aires, C1015ABO

  • GSK Investigational Site

    Ciudad Autonoma Buenos Aires, C1426AAL

  • GSK Investigational Site

    Ciudad Autonoma de Buenos Aires, Buenos Aires, C1181ACI

  • GSK Investigational Site

    Ciudad Autonoma de Buenos Aires, Buenos Aires, C1419AHN

  • GSK Investigational Site

    La Plata, Buenos Aires, B1902COS

Other trials in Argentina

Portugal5 sites

  • GSK Investigational Site

    Almada, 2801-915

  • GSK Investigational Site

    Amadora, 2720-276

  • GSK Investigational Site

    Coimbra, 3000-075

  • GSK Investigational Site

    Lisbon, 1649-035

  • GSK Investigational Site

    Porto, 4099-001

Other trials in Portugal

Colombia4 sites

  • GSK Investigational Site

    Barranquilla

  • GSK Investigational Site

    Bogotá

  • GSK Investigational Site

    Bucaramanga

  • GSK Investigational Site

    Medellín

Other trials in Colombia

Poland4 sites

  • GSK Investigational Site

    Bydgoszcz, 85-168

  • GSK Investigational Site

    Katowice, 40-635

  • GSK Investigational Site

    Krakow, 31-066

  • GSK Investigational Site

    Wroclaw, 50-556

Other trials in Poland

Belgium3 sites

  • GSK Investigational Site

    Brussels, 1090

  • GSK Investigational Site

    Brussels, 1200

  • GSK Investigational Site

    Liège, 4000

Other trials in Belgium

Bulgaria3 sites

  • GSK Investigational Site

    Plovdiv, 4002

  • GSK Investigational Site

    Rousse, 7002

  • GSK Investigational Site

    Sofia, 1784

Other trials in Bulgaria

Chile3 sites

  • GSK Investigational Site

    Santiago, Región Metro de Santiago, 7501126

  • GSK Investigational Site

    Santiago, 7500000

  • GSK Investigational Site

    Viña del Mar, 2570017

Other trials in Chile

Croatia3 sites

  • GSK Investigational Site

    Osijek, 31000

  • GSK Investigational Site

    Rijeka, 51000

  • GSK Investigational Site

    Zagreb, 10000

Other trials in Croatia

Italy3 sites

  • GSK Investigational Site

    Genova, 16132

  • GSK Investigational Site

    Padova, Veneto, 35128

  • GSK Investigational Site

    Pisa, Tuscany, 56126

Other trials in Italy

Romania3 sites

  • GSK Investigational Site

    Bucharest, 020125

  • GSK Investigational Site

    Bucharest, 020475

  • GSK Investigational Site

    Bucharest, 11172

Other trials in Romania

Russia3 sites

  • GSK Investigational Site

    Moscow, 115522

  • GSK Investigational Site

    Saint Petersburg, 190068

  • GSK Investigational Site

    Yaroslavl, 150030

Other trials in Russia

Spain3 sites

  • GSK Investigational Site

    Barcelona, 08036

  • GSK Investigational Site

    Barcelona, 8035

  • GSK Investigational Site

    Granada, 18012

Other trials in Spain

Sweden3 sites

  • GSK Investigational Site

    Gothenburg, SE-413 45

  • GSK Investigational Site

    Lund, SE-221 85

  • GSK Investigational Site

    Stockholm, SE-171 76

Other trials in Sweden

United Kingdom3 sites

  • GSK Investigational Site

    Birmingham, B15 2TH

  • GSK Investigational Site

    Coventry, Warwickshire, CV2 2DX

  • GSK Investigational Site

    London, SE1 7EH

Other trials in United Kingdom

Czechia2 sites

  • GSK Investigational Site

    Prague, 128 50

  • GSK Investigational Site

    Zlín, 760 01

Other trials in Czechia

Denmark2 sites

  • GSK Investigational Site

    Copenhagen, 2100

  • GSK Investigational Site

    Odense C, 5000

Other trials in Denmark

Hungary2 sites

  • GSK Investigational Site

    Debrecen, 4032

  • GSK Investigational Site

    Zalaegerszeg, 8900

Other trials in Hungary

Malaysia2 sites

  • GSK Investigational Site

    Kuala Lumpur, 59100

  • GSK Investigational Site

    Seremban, Negeri Sembilan, 70300

Other trials in Malaysia

Serbia2 sites

  • GSK Investigational Site

    Belgrade, 11000

  • GSK Investigational Site

    Belgrade, 11080

Other trials in Serbia

Austria1 site

  • GSK Investigational Site

    Vienna, A-1100

Other trials in Austria

Singapore1 site

  • GSK Investigational Site

    Singapore, 529889

Other trials in Singapore

About this study

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)

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).

Read the 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.

Being tested
Placebo, Belimumab 200 mg SC, Standard therapy
Keywords
Subcutaneous, Lupus, Systemic Lupus Erythematosus, SLE, Belimumab, Autoimmune Disease, Antibodies
Medical subject headings
Lupus Erythematosus, Systemic, Autoimmune Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboBiological

    Placebo

  • Belimumab 200 mg SCBiological

    Also called BENLYSTA™

    Belimumab 200 mg SC

  • Standard therapyDrug

    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.

Study groups in NCT01484496
Study groupRoleWhat they receive
Placebo plus standard therapyPlacebo comparatorPlacebo 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.
Receives: Biological: Placebo; Drug: Standard therapy
Belimumab 200 mg SC plus standard therapyExperimentalBelimumab 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.
Receives: Biological: Belimumab 200 mg SC; Drug: Standard therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: Week 52

Secondary outcomes (2)

  1. 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.

    Measured: Baseline (Day 0, prior to dosing) to Week 52

  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

    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).

    Measured: Baseline (Day 0, prior to dosing), Weeks 40 through Week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Dec 2011 (estimated)
  2. Study start16 Nov 2011
  3. Primary completion13 Feb 2015
  4. Study completion1 Oct 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
839 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01484496
Sponsor's protocol ID
112341
Other IDs
2011-003814-18, HGS1006-C1115
Acronym
BLISS-SC
Status last verified
May 2018
First submitted
28 Nov 2011
Last updated
6 Jun 2018
Data monitoring committee
Yes
Individual data sharing
Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Publications

  • Depascale R, Da Mutten R, Lindblom J, Cetrez N, Palazzo L, Iaccarino L, Doria A, Nikolopoulos D, Gatto M, Parodis I. Unsupervised machine learning identifies distinct SLE patient endotypes with differential response to belimumab. Rheumatology (Oxford). 2025 Aug 1;64(8):4650-4658. doi: 10.1093/rheumatology/keaf215.

    PubMed 40244828

  • Parodis I, Lindblom J, Levy RA, Zen M, Cetrez N, Gomez A, Oon S, Henning C, Khamashta M, Quasny HA, Chauhan D, Askanase A, van Vollenhoven R, Nikpour M. Attainment of remission and low disease activity after treatment with belimumab in patients with systemic lupus erythematosus: a post-hoc analysis of pooled data from five randomised clinical trials. Lancet Rheumatol. 2024 Nov;6(11):e751-e761. doi: 10.1016/S2665-9913(24)00162-0. Epub 2024 Aug 26.

    PubMed 39208825

  • Nikolopoulos D, Cetrez N, Lindblom J, Parodis I. Neuropsychiatric involvement in systemic lupus erythematosus contributes to organ damage beyond the nervous system: a post-hoc analysis of 5 phase III randomized clinical trials. Rheumatol Int. 2024 Sep;44(9):1679-1689. doi: 10.1007/s00296-024-05667-5. Epub 2024 Aug 8.

    PubMed 39115551

  • Rendas-Baum R, Chen WH, Gairy K, Anderson S, Henning C, Hammer A, Kosinski M. SF-36v2 and FACIT-Fatigue quality of life improvements with organ-specific SELENA-SLEDAI response and belimumab treatment in patients with systemic lupus erythematosus. Lupus Sci Med. 2024 May 8;11(1):e001118. doi: 10.1136/lupus-2023-001118.

    PubMed 38724182

  • Jagerback S, Gomez A, Parodis I. Predictors of renal flares in systemic lupus erythematosus: a post-hoc analysis of four phase III clinical trials of belimumab. Rheumatology (Oxford). 2025 Feb 1;64(2):623-631. doi: 10.1093/rheumatology/keae023.

    PubMed 38216728

  • Gomez A, Jagerback S, Sjowall C, Parodis I. Belimumab and antimalarials combined against renal flares in patients treated for extra-renal systemic lupus erythematosus: results from 4 phase III clinical trials. Rheumatology (Oxford). 2024 Feb 1;63(2):338-348. doi: 10.1093/rheumatology/kead253.

    PubMed 37228028

  • 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.

    PubMed 34531304

  • 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.

    PubMed 33687069

  • 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.

    PubMed 33568389

  • 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.

    PubMed 33558436

  • 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.

    PubMed 29807477

  • 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.

    PubMed 29671280

  • 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.

    PubMed 28118533

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Belimumab 200 mg SC and Standard therapy in people with Systemic Lupus Erythematosus, run by Human Genome Sciences Inc., a GSK Company at 207 sites in 31 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 207 sites in United States, Japan, Brazil, Philippines, Germany and 26 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Jul 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Par. Achieving a SLE Responder Index (SRI) Response Rate at Week 52 (time frame: Week 52). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01484496, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2018.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in