AzTrials
AzTrials

Systemic Lupus ErythematosusPhase 4BASENCT01705977

Belimumab Assessment of Safety in SLE

A Phase 4 study testing Belimumab 10 mg/kg plus standard therapy and Standard therapy in people with Systemic Lupus Erythematosus, run by GlaxoSmithKline at 250 sites in 33 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 further enhance the existing knowledge regarding the side effects of belimumab when given with other lupus medicines to adults with active 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 10 mg/kg plus standard therapy and Standard therapy
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
4,019 participants
Where
250 sitesin 33 countries
Study dates
27 Nov 2012to 10 Aug 2022
Phase
Phase 4
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

  • Clinical diagnosis of SLE by American College of Rheumatology (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).

Who cannot join

  • Pregnant or nursing.
  • Have received treatment with any of the following: belimumab, either as a marketed product or as an investigational agent; any B cell targeted therapy (for example, rituximab) in the past year; or any biological agent (for example, adalimumab, etanercept, infliximab, or anakinra) in the past 90 days.
  • Have received a live vaccine within the past 30 days.
  • Have severe active lupus kidney disease.
  • Have severe active central nervous system (CNS) lupus.
  • Current or past positive for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C.

Trial locations and contacts

250 sites in 33 countries.

250 sites in 33 countries

United States49 sites

  • GSK Investigational Site

    Anniston, Alabama, 36207

  • GSK Investigational Site

    Arlington, Virginia, 22205-3606

  • GSK Investigational Site

    Beckley, West Virginia, 25801

  • GSK Investigational Site

    Birmingham, Alabama, 35216

  • GSK Investigational Site

    Cedar Rapids, Iowa, 52403

  • GSK Investigational Site

    Chapel Hill, North Carolina, 27599

  • GSK Investigational Site

    Charlotte, North Carolina, 28204

  • GSK Investigational Site

    Charlotte, North Carolina, 28207

  • GSK Investigational Site

    Cincinnati, Ohio, 45229

  • GSK Investigational Site

    Clarksburg, West Virginia, 26301

  • GSK Investigational Site

    Clearwater, Florida, 33756

  • GSK Investigational Site

    Columbus, Ohio, 43203

  • GSK Investigational Site

    Covina, California, 91722

  • GSK Investigational Site

    Cypress, Texas, 77429

  • GSK Investigational Site

    Dallas, Texas, 75246

  • GSK Investigational Site

    Duncansville, Pennsylvania, 16635

  • GSK Investigational Site

    Glendale, Arizona, 85304

  • GSK Investigational Site

    Hialeah, Florida, 33012

  • GSK Investigational Site

    Hixson, Tennessee, 37343-7908

  • GSK Investigational Site

    Houston, Texas, 77004

  • GSK Investigational Site

    Houston, Texas, 77034

  • GSK Investigational Site

    Houston, Texas, 77084

  • GSK Investigational Site

    Huntington Beach, California, 92646

  • GSK Investigational Site

    Huntsville, Alabama, 35801

  • GSK Investigational Site

    Jackson, Mississippi, 39216

  • GSK Investigational Site

    Kalispell, Montana, 59901

  • GSK Investigational Site

    La Mesa, California, 92020

  • GSK Investigational Site

    Las Vegas, Nevada, 89128

  • GSK Investigational Site

    Long Beach, California, 90808

  • GSK Investigational Site

    Los Angeles, California, 90033

  • GSK Investigational Site

    McKinney, Texas, 75071

  • GSK Investigational Site

    Memphis, Tennessee, 38119

  • GSK Investigational Site

    Mesa, Arizona, 85202

  • GSK Investigational Site

    Murrieta, California, 92563

  • GSK Investigational Site

    New York, New York, 10016

  • GSK Investigational Site

    New York, New York, 10032

  • GSK Investigational Site

    Orangeburg, South Carolina, 29118

  • GSK Investigational Site

    Phoenix, Arizona, 85032

  • GSK Investigational Site

    Phoenix, Arizona, 85037

  • GSK Investigational Site

    Rock Hill, South Carolina, 29732

  • GSK Investigational Site

    Sacramento, California, 95816

  • GSK Investigational Site

    Saint Clair Shores, Michigan, 48081

  • GSK Investigational Site

    San Leandro, California, 94578

  • GSK Investigational Site

    Spokane, Washington, 99204

  • GSK Investigational Site

    Summerville, South Carolina, 29486

  • GSK Investigational Site

    Tampa, Florida, 33614

  • GSK Investigational Site

    Webster, Texas, 77450

  • GSK Investigational Site

    West Bloomfield, Michigan, 48322

  • GSK Investigational Site

    Wyomissing, Pennsylvania, 19610

Other trials in United States

Brazil18 sites

  • GSK Investigational Site

    Belo Horizonte, Minas Gerais, 30130-100

  • GSK Investigational Site

    Belo Horizonte, Minas Gerais, 30150-221

  • GSK Investigational Site

    Campinas, 13083-888

  • GSK Investigational Site

    Campo Grande, 79080-190

  • GSK Investigational Site

    Cuiabá, Mato Grosso, 78.040-360

  • GSK Investigational Site

    Curitiba, Paraná, 80440-080

  • GSK Investigational Site

    Goiânia, 74110-120

  • GSK Investigational Site

    Itajaí, Santa Catarina, 88301-220

  • GSK Investigational Site

    Juiz de Fora, Minas Gerais, 36010-570

  • GSK Investigational Site

    Lajeado, 95900-000

  • GSK Investigational Site

    Porto Alegre, Rio Grande do Sul, 90035-903

  • GSK Investigational Site

    Porto Alegre, Rio Grande do Sul, 90560-030

  • GSK Investigational Site

    Rio de Janeiro, 22411-001

  • GSK Investigational Site

    Salvador, 40050-410

  • GSK Investigational Site

    São José do Rio Preto, São Paulo, 15090-000

  • GSK Investigational Site

    São Paulo, São Paulo, 01244-030

  • GSK Investigational Site

    São Paulo, 01323-020

  • GSK Investigational Site

    São Paulo, 04032-060

Other trials in Brazil

Argentina16 sites

  • GSK Investigational Site

    Buenos Aires, C1046AAQ

  • GSK Investigational Site

    Buenos Aires, C1425AGC

  • GSK Investigational Site

    Capital Federal, Buenos Aires, 1425

  • GSK Investigational Site

    Ciudad Autonoma Buenos Aires, Buenos Aires, 1035

  • GSK Investigational Site

    Ciudad Autonoma Buenos Aires, Buenos Aires, C1425ASQ

  • GSK Investigational Site

    Córdoba, 5004

  • GSK Investigational Site

    La Plata, Buenos Aires, 1900

  • GSK Investigational Site

    Lanus, Buenos Aires, B1824KAJ

  • GSK Investigational Site

    Mar del Plata, Buenos Aires, 7600

  • GSK Investigational Site

    Mendoza, 5500

  • GSK Investigational Site

    Rosario, Santa Fe Province, S2000BIF

  • GSK Investigational Site

    Rosario, Santa Fe Province, S2002KDS

  • GSK Investigational Site

    San Miguel de Tucumán, Tucumán Province, T4000BRD

  • GSK Investigational Site

    San Miguel de Tucumán, T4000ICL

  • GSK Investigational Site

    Venado Tuerto, Santa Fe Province, 2600

  • GSK Investigational Site

    Zárate, Buenos Aires, 2800

Other trials in Argentina

Ukraine15 sites

  • GSK Investigational Site

    Chernivtsi, 58001

  • GSK Investigational Site

    Donetsk, 83045

  • GSK Investigational Site

    Donetsk, 83114

  • GSK Investigational Site

    Ivano-Frankivsk, 76018

  • GSK Investigational Site

    Kharkiv, 61176

  • GSK Investigational Site

    Kyiv, 1601

  • GSK Investigational Site

    Kyiv, 4114

  • GSK Investigational Site

    Lviv, 79010

  • GSK Investigational Site

    Odesa, 65026

  • GSK Investigational Site

    Poltava, 36011

  • GSK Investigational Site

    Ternopil, 46002

  • GSK Investigational Site

    Uzhhorod, 88018

  • GSK Investigational Site

    Vinnytsia, 21018

  • GSK Investigational Site

    Vinnytsia, 21029

  • GSK Investigational Site

    Zaporizhzhya, 69600

Other trials in Ukraine

Mexico13 sites

  • GSK Investigational Site

    Cuautitlán Izcalli, State of Mexico, 54769

  • GSK Investigational Site

    D.F, 6726

  • GSK Investigational Site

    Guadalajara, Jalisco, 44158

  • GSK Investigational Site

    Guadalajara, Jalisco, 44690

  • GSK Investigational Site

    Guadalajara, 44620

  • GSK Investigational Site

    Mérida, Yucatán, 97130

  • GSK Investigational Site

    México, 14000

  • GSK Investigational Site

    México, 7760

  • GSK Investigational Site

    Monterrey, Nuevo León, 64718

  • GSK Investigational Site

    San Luis Potosí City, 78200

  • GSK Investigational Site

    San Luis Potosí City, 78240

  • GSK Investigational Site

    Torreón, Coahuila, 27000

  • GSK Investigational Site

    Torreón, 27000

Other trials in Mexico

South Korea13 sites

  • GSK Investigational Site

    Daegu, 700-721

  • GSK Investigational Site

    Daejeon, 301-721

  • GSK Investigational Site

    Daejeon, 302-799

  • GSK Investigational Site

    Gwangju, 501-757

  • GSK Investigational Site

    Incheon, 400-711

  • GSK Investigational Site

    Jeonju, 561-712

  • GSK Investigational Site

    Seoul, 110-744

  • GSK Investigational Site

    Seoul, 120-752

  • GSK Investigational Site

    Seoul, 133-792

  • GSK Investigational Site

    Seoul, 137-701

  • GSK Investigational Site

    Seoul, 143-729

  • GSK Investigational Site

    Suwon, 16247

  • GSK Investigational Site

    Suwon, 443-380

Other trials in South Korea

Spain13 sites

  • GSK Investigational Site

    Barcelona, 8035

  • GSK Investigational Site

    Bilbao, 48013

  • GSK Investigational Site

    Castellon, 12004

  • GSK Investigational Site

    Córdoba, 140044

  • GSK Investigational Site

    Getafe/Madrid, 28905

  • GSK Investigational Site

    Granada, 18012

  • GSK Investigational Site

    Madrid, 28046

  • GSK Investigational Site

    Málaga, 29009

  • GSK Investigational Site

    Seville, 41009

  • GSK Investigational Site

    Seville, 4110

  • GSK Investigational Site

    Valencia, 46017

  • GSK Investigational Site

    Valencia, 46026

  • GSK Investigational Site

    Vilajoyosa, 3570

Other trials in Spain

Bulgaria9 sites

  • GSK Investigational Site

    Pleven, 5800

  • GSK Investigational Site

    Plovdiv, 4000

  • GSK Investigational Site

    Plovdiv, 4002

  • GSK Investigational Site

    Rousse, 7002

  • GSK Investigational Site

    Shumen, 9700

  • GSK Investigational Site

    Sofia, 1612

  • GSK Investigational Site

    Stara Zagora, 6001

  • GSK Investigational Site

    Targovisthe, 7700

  • GSK Investigational Site

    Veliko Tarnovo, 5000

Other trials in Bulgaria

Peru8 sites

  • GSK Investigational Site

    Arequipa, 4017

  • GSK Investigational Site

    Lima, 01

  • GSK Investigational Site

    Lima, 11

  • GSK Investigational Site

    Lima, 15048

  • GSK Investigational Site

    Lima, Lima 29

  • GSK Investigational Site

    Lima, Lima 31

  • GSK Investigational Site

    Lima, Lima 33

  • GSK Investigational Site

    Lima, Lima 41

Other trials in Peru

Philippines8 sites

  • GSK Investigational Site

    Angeles City, Pampanga, 2009

  • 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, 1510

  • GSK Investigational Site

    Quezon City, 1102

Other trials in Philippines

Taiwan8 sites

  • GSK Investigational Site

    Chiayi County, 613

  • GSK Investigational Site

    Gueishan Township,Taoyuan County, 333

  • GSK Investigational Site

    Kaohsiung City, 833

  • GSK Investigational Site

    Taichung, 402

  • GSK Investigational Site

    Taichung, 404

  • GSK Investigational Site

    Taipei, 100

  • GSK Investigational Site

    Taipei, 106

  • GSK Investigational Site

    Taipei, 11490

Other trials in Taiwan

Malaysia7 sites

  • GSK Investigational Site

    Ipoh, 30990

  • GSK Investigational Site

    Kota Bharu, 15586

  • GSK Investigational Site

    Kota Kinabalu, 88586

  • GSK Investigational Site

    Kuala Lumpur, 56000

  • GSK Investigational Site

    Kuala Selangor, 68100

  • GSK Investigational Site

    Kuala Terengganu, 20400

  • GSK Investigational Site

    Seremban, Negeri Sembilan, 70300

Other trials in Malaysia

Portugal7 sites

  • GSK Investigational Site

    Almada, 2801-915

  • GSK Investigational Site

    Coimbra, 3000-075

  • GSK Investigational Site

    Lisbon, 1050-034

  • GSK Investigational Site

    Lisbon, 1649-035

  • GSK Investigational Site

    Porto, 4099-001

  • GSK Investigational Site

    Porto, 4200-319

  • GSK Investigational Site

    Viseu, 3504-509

Other trials in Portugal

Russia7 sites

  • GSK Investigational Site

    Barnaul, 656045

  • GSK Investigational Site

    Kemerovo, 650066

  • GSK Investigational Site

    Kursk, 305007

  • GSK Investigational Site

    Moscow, 119991

  • GSK Investigational Site

    Saint Petersburg, 190068

  • GSK Investigational Site

    Saint Petersburg, 194044

  • GSK Investigational Site

    Saratov, 410053

Other trials in Russia

Colombia6 sites

  • GSK Investigational Site

    Armenia, 55860

  • GSK Investigational Site

    Barranquilla, 080002

  • GSK Investigational Site

    Bogotá, 110111

  • GSK Investigational Site

    Bucaramanga, 680005

  • GSK Investigational Site

    Chía, 250007

  • GSK Investigational Site

    Medellín, 050018

Other trials in Colombia

Hungary6 sites

  • GSK Investigational Site

    Budapest, 1023

  • GSK Investigational Site

    Budapest, 1097

  • GSK Investigational Site

    Debrecen, 4031

  • GSK Investigational Site

    Debrecen, 4032

  • GSK Investigational Site

    Gyula, 5700

  • GSK Investigational Site

    Zalaegerszeg, 8900

Other trials in Hungary

Indonesia5 sites

  • GSK Investigational Site

    Bandung, 40161

  • GSK Investigational Site

    Denpasar, 80114

  • GSK Investigational Site

    Malang, 65111

  • GSK Investigational Site

    Palembang, 30126

  • GSK Investigational Site

    Yogyakarta, 55281

Other trials in Indonesia

Italy5 sites

  • GSK Investigational Site

    Florence, Tuscany, 50134

  • GSK Investigational Site

    Milan, Lombardy, 20132

  • GSK Investigational Site

    Padova, Veneto, 35128

  • GSK Investigational Site

    Pisa, 56126

  • GSK Investigational Site

    Rome, Lazio, 00151

Other trials in Italy

Serbia5 sites

  • GSK Investigational Site

    Belgrade, 11000

  • GSK Investigational Site

    Belgrade, 11080

  • GSK Investigational Site

    Kruševac, 37000

  • GSK Investigational Site

    Niška Banja, 18205

  • GSK Investigational Site

    Šabac, 15000

Other trials in Serbia

Australia4 sites

  • GSK Investigational Site

    Fitzroy, Victoria, 3065

  • GSK Investigational Site

    Garran, Australian Capital Territory, 2605

  • GSK Investigational Site

    Herston, Queensland, 4029

  • GSK Investigational Site

    Sydney, New South Wales, 2153

Other trials in Australia

Czechia4 sites

  • GSK Investigational Site

    Brno, 65691

  • GSK Investigational Site

    Prague, 128 50

  • GSK Investigational Site

    Prague, 150 06

  • GSK Investigational Site

    Zlín, 760 01

Other trials in Czechia

Poland3 sites

  • GSK Investigational Site

    Bydgoszcz, 85-168

  • GSK Investigational Site

    Gdansk, 80-952

  • GSK Investigational Site

    Krakow, 31-066

Other trials in Poland

Romania3 sites

  • GSK Investigational Site

    Bucharest, 020125

  • GSK Investigational Site

    Galati, 800578

  • GSK Investigational Site

    Târgu Mureş, 540142

Other trials in Romania

Thailand3 sites

  • GSK Investigational Site

    Bangkok, 10400

  • GSK Investigational Site

    Bangkok, 10700

  • GSK Investigational Site

    Chiang Mai, 50200

Other trials in Thailand

Canada2 sites

  • GSK Investigational Site

    Brampton, Ontario, L6T 0G1

  • GSK Investigational Site

    Vaughan, Ontario, L4L 4Y7

Other trials in Canada

Chile2 sites

  • GSK Investigational Site

    La Serena, 68650

  • GSK Investigational Site

    Santigo, 7500010

Other trials in Chile

Croatia2 sites

  • GSK Investigational Site

    Osijek, 31000

  • GSK Investigational Site

    Rijeka, 51000

Other trials in Croatia

Hong Kong2 sites

  • GSK Investigational Site

    Hong Kong

  • GSK Investigational Site

    Shatin

Other trials in Hong Kong

New Zealand2 sites

  • GSK Investigational Site

    Auckland, 622

  • GSK Investigational Site

    Wellington, 6011

Other trials in New Zealand

Switzerland2 sites

  • GSK Investigational Site

    Sankt Gallen, 9007

  • GSK Investigational Site

    Zurich, 8006

Other trials in Switzerland

Estonia1 site

  • GSK Investigational Site

    Tallinn, 10117

Other trials in Estonia

Lithuania1 site

  • GSK Investigational Site

    Klaipėda, LT-92288

Other trials in Lithuania

Slovakia1 site

  • GSK Investigational Site

    Piešťany, 921 12

Other trials in Slovakia

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled 52-Week Study to Assess Adverse Events of Special Interest in Adults With Active, Autoantibody-Positive Systemic Lupus Erythematosus Receiving Belimumab

The purpose of this study is to further enhance the existing knowledge regarding the side effects of belimumab when given with other lupus medicines to adults with active systemic lupus erythematosus (SLE). This study mainly focuses on collecting information on serious events that are not that common or may only be seen with long-term treatment. These events include death, serious infections and other infections of interest, cancers, serious mental health problems, including depression and suicide, and serious infusion and hypersensitivity reactions. This study is being done to help understand if treatment with belimumab increases the risk for these types of events. This study will also see if patients receiving belimumab with other lupus medicines can reduce their use of steroids, such as prednisone, over 1 year.

Read the detailed description

Study participants receive standard therapy for SLE in addition to receiving the study drug, either placebo (no active medicine) or belimumab. The controlled period of the study is 52 weeks. The random assignment in this study is "1 to 1" which means that participants have an equal chance of receiving belimumab or placebo. After completion of the 52-week study period, participants will be contacted by phone annually for 4 more years to assess health status.

Following the 52-week controlled period, participants who wish to continue treatment with belimumab may be able to do so by being prescribed commercially available belimumab. If belimumab is not commercially available in the participant's country, the participant may be able to receive belimumab under a separate continuation protocol.

Being tested
Placebo plus standard therapy, Belimumab 10 mg/kg plus standard therapy, Standard therapy
Keywords
Antibodies, Lupus, SLE, Systemic Lupus Erythematosus, Autoimmune Disease, Belimumab
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.

  • Placebo plus standard therapyBiological

    Placebo plus standard therapy

  • Belimumab 10 mg/kg plus standard therapyBiological

    Also called BENLYSTA™

    Belimumab 10 mg/kg plus standard therapy

  • Standard therapyOther

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

Study groups in NCT01705977
Study groupRoleWhat they receive
Placebo plus standard therapyPlacebo comparatorPlacebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through Week 48, with a final evaluation at Week 52 in the double-blind period.
Receives: Biological: Placebo plus standard therapy; Other: Standard therapy
Belimumab 10 mg/kg plus standard therapyExperimentalBelimumab 10 mg/kg IV plus standard therapy; belimumab administered on Days 0, 14, 28, and then every 28 days thereafter through Week 48, with a final evaluation at Week 52 in the double-blind period.
Receives: Biological: Belimumab 10 mg/kg plus standard therapy; Other: Standard therapy

What is being measured

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

  1. Number of Deaths - On Treatment Period (Week 52)

    Number of participants who died during on-treatment period (Week 52) is reported. The on-treatment period was defined as first dose to last dose + 28 days (or death). The As-Treated Population was defined as all participants who were randomized and received at least one dose of study agent,grouped according to the actual treatment administered for the majority (greater than [>]50 percent [%]) of the time. The on-treatment period was the primary analysis period for safety analyses.

    Measured: Up to Week 52 (On-treatment period)

  2. Number of Participants Who Reported Protocol Defined Adverse Events of Special Interest (AESI): On-treatment Period (Week 52)

    A summary of protocol defined AESIs including serious infections, opportunistic infections and other infections of interest (serious and non-serious), non-melanoma skin cancer (NMSC), malignancies (excluding NMSC), psychiatric events suggesting serious mood disorders and anxiety (serious depression), suicidality (using Columbia-Suicide Severity Rating Scale [C-SSRS]) and serious infusion and hypersensitivity reactions (SIHR) is reported. The on-treatment period (Week 52) was defined as first dose to last dose + 28 days (or death). The on-treatment period was the primary analysis period for safety analyses.

    Measured: Up to Week 52 (On-treatment period)

  3. Number of Participants With Serious Adverse Events (SAEs) Reported During On-treatment Period (Week 52)

    An SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, associated with liver injury and impaired liver function or any other situations as per medical or scientific judgement. The on-treatment period (Week 52) was defined as first dose to last dose + 28 days (or death) and was the primary analysis period for safety analyses.

    Measured: Up to Week 52 (On-treatment period)

Secondary outcomes (6)

  1. Number of Deaths Reported - On-study Period (Week 52)

    Number of participants who died during on-study period (Week 52) is reported. The on-study period (which includes on and off treatment data) was defined as first dose to the end of the Week 52 study follow-up (or death). The on-study period was a supportive analysis period for safety analysis.

    Measured: Up to Week 52 (On-study period)

  2. Number of Participants Who Reported Protocol Defined AESI: On-study Period (Week 52)

    A summary of protocol defined AESIs including serious infections, opportunistic infections and other infections of interest (serious and non-serious), NMSC, malignancies (excluding NMSC), psychiatric events suggesting serious mood disorders and anxiety (serious depression), suicidality (using C-SSRS) and SIHR is reported. The on-study period (Week 52) (which includes on and off treatment data) was defined as first dose to the end of the Week 52 study follow-up (or death). The on-study period was a supportive analysis period for safety analysis.

    Measured: Up to Week 52 (On-study period)

  3. Number of Participants With SAEs Reported During On-study Period (Week 52)

    A SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, associated with liver injury and impaired liver function or any other situations as per medical or scientific judgement. The on-study period (Week 52) (which includes on and off treatment data) was defined as first dose to the end of the Week 52 study follow-up (or death) and was a supportive analysis period for safety analyses.

    Measured: Up to Week 52 (On-study period)

  4. Percentage of Participants Whose Average Prednisone (or Equivalent) Dose to Treat SLE Has Been Reduced by >=25% From Baseline to <=7.5 mg/Day During Weeks 40 Through 52

    The average daily prednisone dose during Weeks 40 to 52 is the sum of all prednisone doses to treat SLE from the day following the Week 40 visit date up to but not including the Week 52 study completion date divided by the number of days between Week 40 visit date and study completion date (study completion date - Week 40 visit date). Percentage of participants whose average prednisone dose has been reduced by >=25% from Baseline to <=7.5 mg/day during Weeks 40 through 52 in participants with average prednisone use greater than 7.5 mg/day at Baseline was compared between belimumab and placebo using a logistic regression model including treatment group, Baseline prednisone dose, screening safety of estrogen in lupus national assessment (SELENA) systemic lupus erythematosus disease activity index (SLEDAI) score (<=9 versus >=10) and region. Baseline is defined as the last available value measured prior to dosing on or before the date of first dose (Day 1).

    Measured: Week 40 to Week 52

  5. Number of Participants With All-cause Mortality During Years 2 to 5

    Number of participants with all-cause mortality during years 2 to 5 has been presented.

    Measured: From 2 years to 5 years

  6. Number of Participants With New Primary Malignancies During Years 2 to 5

    Number of participants with new primary malignancies during years 2 to 5 has been presented.

    Measured: From 2 years to 5 years

Timeline

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

  1. First posted15 Oct 2012 (estimated)
  2. Study start27 Nov 2012
  3. Primary completion30 Jul 2018
  4. Study completion10 Aug 2022

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
4,019 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01705977
Sponsor's protocol ID
115467
Other IDs
2011-005667-25, HGS1006-C1113
Acronym
BASE
Status last verified
Jul 2024
First submitted
10 Oct 2012
Last updated
15 Jul 2024
Data monitoring committee
Yes
Individual data sharing
Yes: IPD for this study is available via the Clinical Study Data Request site.

Publications

  • Sheikh S, Scheinberg MA, Wei CC, Tegzova D, Stohl W, Acayaba de Toledo R, Mucenic T, Abello M, Maksimowicz-McKinnon K, Abud Mendoza C, Navarra S, Garcia M, Garcia de la Torre I, Ordi Ros J, Nami A, Levy R, Bass D, Ross J, Punwaney R, Harris J, Pierce A, Thorneloe K, Ji B, Roth D. Mortality and adverse events of special interest in adult patients with active, auto-antibody-positive systemic lupus erythematosus receiving intravenous belimumab (BASE): a global, randomised, double-blind, placebo-controlled, multicentre Phase 4 trial. Lancet Rheumatol. 2020; DOI: 10.1016/S2665-9913(20)30355-6

  • Sheikh SZ, Scheinberg MA, Wei JC, Tegzova D, Stohl W, de Toledo RA, Mucenic T, Banfi MRA, Maksimowicz-McKinnon K, Abud-Mendoza C, Navarra S, Garcia M, Garcia-De La Torre I, Ros JO, Levy RA, Bass DL, Terres JR, Punwaney R, Harris J, Nami A, Pierce A, Thorneloe KS, Ji B, Roth DA. Mortality and adverse events of special interest with intravenous belimumab for adults with active, autoantibody-positive systemic lupus erythematosus (BASE): a multicentre, double-blind, randomised, placebo-controlled, phase 4 trial. Lancet Rheumatol. 2021 Feb;3(2):e122-e130. doi: 10.1016/S2665-9913(20)30355-6. Epub 2020 Dec 15.

    PubMed 38279368

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Belimumab 10 mg/kg plus standard therapy and Standard therapy in people with Systemic Lupus Erythematosus, run by GlaxoSmithKline at 250 sites in 33 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 4 inclusion and 6 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 15 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 250 sites in United States, Brazil, Argentina, Ukraine, Mexico and 28 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 29 Nov 2019). 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?

Number of Deaths - On Treatment Period (Week 52) (time frame: Up to Week 52 (On-treatment period)). The study lists 3 primary outcomes in all. 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 NCT01705977, which also lists 2 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 15 Jul 2024.

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