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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01484496
Other study ID # 112341
Secondary ID 2011-003814-18HG
Status Completed
Phase Phase 3
First received
Last updated
Start date November 16, 2011
Est. completion date October 1, 2015

Study information

Verified date May 2018
Source GlaxoSmithKline
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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).


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.


Recruitment information / eligibility

Status Completed
Enrollment 839
Est. completion date October 1, 2015
Est. primary completion date February 13, 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

Biological:
Placebo
Placebo
Belimumab 200 mg SC
Belimumab 200 mg SC
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.

Locations

Country Name City State
Argentina GSK Investigational Site Ciudad Autonoma Buenos Aires
Argentina GSK Investigational Site Ciudad Autonoma Buenos Aires
Argentina GSK Investigational Site Ciudad Autonoma de Buenos Aires Buenos Aires
Argentina GSK Investigational Site Ciudad Autonoma de Buenos Aires Buenos Aires
Argentina GSK Investigational Site La Plata Buenos Aires
Austria GSK Investigational Site Vienna
Belgium GSK Investigational Site Brussels
Belgium GSK Investigational Site Bruxelles
Belgium GSK Investigational Site Liège
Brazil GSK Investigational Site Cuiaba Mato Grosso
Brazil GSK Investigational Site Curitiba Paraná
Brazil GSK Investigational Site Juiz de Fora Minas Gerais
Brazil GSK Investigational Site Porto Alegre Rio Grande Do Sul
Brazil GSK Investigational Site Porto Alegre Rio Grande Do Sul
Brazil GSK Investigational Site Rio de Janeiro
Brazil GSK Investigational Site Salvador
Brazil GSK Investigational Site São Paulo
Bulgaria GSK Investigational Site Plovdiv
Bulgaria GSK Investigational Site Ruse
Bulgaria GSK Investigational Site Sofia
Chile GSK Investigational Site Santiago Región Metro De Santiago
Chile GSK Investigational Site Santiago
Chile GSK Investigational Site Viña del Mar
Colombia GSK Investigational Site Barranquilla
Colombia GSK Investigational Site Bogota
Colombia GSK Investigational Site Bucaramanga
Colombia GSK Investigational Site Medellin
Croatia GSK Investigational Site Osijek
Croatia GSK Investigational Site Rijeka
Croatia GSK Investigational Site Zagreb
Czechia GSK Investigational Site Praha 2
Czechia GSK Investigational Site Zlin
Denmark GSK Investigational Site Koebenhavn
Denmark GSK Investigational Site Odense C
France GSK Investigational Site Paris
France GSK Investigational Site Paris cedex 13
France GSK Investigational Site Pessac Cedex
France GSK Investigational Site Strasbourg cedex
France GSK Investigational Site Suresnes
France GSK Investigational Site Vandoeuvre les Nancy
Germany GSK Investigational Site Bad Nauheim Hessen
Germany GSK Investigational Site Duesseldorf Nordrhein-Westfalen
Germany GSK Investigational Site Frankfurt
Germany GSK Investigational Site Hamburg
Germany GSK Investigational Site Hannover Niedersachsen
Germany GSK Investigational Site Mainz Rheinland-Pfalz
Germany GSK Investigational Site Wuerzburg Bayern
Hungary GSK Investigational Site Debrecen
Hungary GSK Investigational Site Zalaegerszeg
Italy GSK Investigational Site Genova
Italy GSK Investigational Site Padova Veneto
Italy GSK Investigational Site Pisa Toscana
Japan GSK Investigational Site Fukuoka
Japan GSK Investigational Site Fukuoka
Japan GSK Investigational Site Hokkaido
Japan GSK Investigational Site Hokkaido
Japan GSK Investigational Site Miyagi
Japan GSK Investigational Site Nagasaki
Japan GSK Investigational Site Okinawa
Japan GSK Investigational Site Shizuoka
Japan GSK Investigational Site Tokyo
Japan GSK Investigational Site Tokyo
Japan GSK Investigational Site Tokyo
Malaysia GSK Investigational Site Kuala Lumpur
Malaysia GSK Investigational Site Seremban, Negeri Sembilan
Mexico GSK Investigational Site Cuernavaca Morelos
Mexico GSK Investigational Site Guadalajara Jalisco
Mexico GSK Investigational Site Guadalajara Jalisco
Mexico GSK Investigational Site Merida Yucatán
Mexico GSK Investigational Site Mexico
Mexico GSK Investigational Site Mexico
Mexico GSK Investigational Site San Luis Potosi
Philippines GSK Investigational Site Cebu City
Philippines GSK Investigational Site Davao City
Philippines GSK Investigational Site Iloilo City
Philippines GSK Investigational Site Las Pinas
Philippines GSK Investigational Site Manila
Philippines GSK Investigational Site Manila
Philippines GSK Investigational Site Quezon City
Philippines GSK Investigational Site Quezon City
Poland GSK Investigational Site Bydgoszcz
Poland GSK Investigational Site Katowice
Poland GSK Investigational Site Krakow
Poland GSK Investigational Site Wroclaw
Portugal GSK Investigational Site Almada
Portugal GSK Investigational Site Amadora
Portugal GSK Investigational Site Coimbra
Portugal GSK Investigational Site Lisboa
Portugal GSK Investigational Site Porto
Romania GSK Investigational Site Bucharest
Romania GSK Investigational Site Bucharest
Romania GSK Investigational Site Bucuresti
Russian Federation GSK Investigational Site Moscow
Russian Federation GSK Investigational Site Saint-Petersburg
Russian Federation GSK Investigational Site Yaroslavl
Serbia GSK Investigational Site Belgrade
Serbia GSK Investigational Site Belgrade
Singapore GSK Investigational Site Singapore
Spain GSK Investigational Site Barcelona
Spain GSK Investigational Site Barcelona
Spain GSK Investigational Site Granada
Sweden GSK Investigational Site Göteborg
Sweden GSK Investigational Site Lund
Sweden GSK Investigational Site Stockholm
Taiwan GSK Investigational Site Gueishan Township,Taoyuan County
Taiwan GSK Investigational Site Kaohsiung
Taiwan GSK Investigational Site Kaohsiung
Taiwan GSK Investigational Site Kaohsiung
Taiwan GSK Investigational Site Taichung
Taiwan GSK Investigational Site Taipei
Thailand GSK Investigational Site Bangkok
Thailand GSK Investigational Site Bangkok
Thailand GSK Investigational Site Chiangmai
Thailand GSK Investigational Site Rajathevee
Thailand GSK Investigational Site Ratchatewi
Thailand GSK Investigational Site Songkla
Ukraine GSK Investigational Site Kharkiv
Ukraine GSK Investigational Site Kyiv
Ukraine GSK Investigational Site Odesa
Ukraine GSK Investigational Site Poltava
Ukraine GSK Investigational Site Vinnytsia
Ukraine GSK Investigational Site Zaporizhzhia
United Kingdom GSK Investigational Site Birmingham
United Kingdom GSK Investigational Site Coventry Warwickshire
United Kingdom GSK Investigational Site London
United States GSK Investigational Site Allentown Texas
United States GSK Investigational Site Arlington Virginia
United States GSK Investigational Site Atlanta Georgia
United States GSK Investigational Site Atlanta Georgia
United States GSK Investigational Site Austin Texas
United States GSK Investigational Site Austin Texas
United States GSK Investigational Site Aventura Florida
United States GSK Investigational Site Baltimore Maryland
United States GSK Investigational Site Baton Rouge Louisiana
United States GSK Investigational Site Bethlehem Pennsylvania
United States GSK Investigational Site Birmingham Alabama
United States GSK Investigational Site Boca Raton Florida
United States GSK Investigational Site Boca Raton Florida
United States GSK Investigational Site Boise Idaho
United States GSK Investigational Site Boston Massachusetts
United States GSK Investigational Site Boston Massachusetts
United States GSK Investigational Site Bridgeport Connecticut
United States GSK Investigational Site Brooklyn New York
United States GSK Investigational Site Chapel Hill North Carolina
United States GSK Investigational Site Charleston South Carolina
United States GSK Investigational Site Charleston South Carolina
United States GSK Investigational Site Charlotte North Carolina
United States GSK Investigational Site Charlotte North Carolina
United States GSK Investigational Site Cleveland Ohio
United States GSK Investigational Site Columbus Ohio
United States GSK Investigational Site Coral Gables Florida
United States GSK Investigational Site Cumberland Maryland
United States GSK Investigational Site Dallas Texas
United States GSK Investigational Site Dayton Ohio
United States GSK Investigational Site Detroit Michigan
United States GSK Investigational Site Duluth Georgia
United States GSK Investigational Site Duncansville Pennsylvania
United States GSK Investigational Site Durham North Carolina
United States GSK Investigational Site Fort Lauderdale Florida
United States GSK Investigational Site Greenville North Carolina
United States GSK Investigational Site Greenville South Carolina
United States GSK Investigational Site Hagerstown Maryland
United States GSK Investigational Site Houston Texas
United States GSK Investigational Site Houston Texas
United States GSK Investigational Site Houston Texas
United States GSK Investigational Site Houston Texas
United States GSK Investigational Site Jackson Mississippi
United States GSK Investigational Site Jackson Tennessee
United States GSK Investigational Site Jonesboro Arkansas
United States GSK Investigational Site La Jolla California
United States GSK Investigational Site Lake Success New York
United States GSK Investigational Site Las Cruces New Mexico
United States GSK Investigational Site Lawrenceville Georgia
United States GSK Investigational Site Long Beach California
United States GSK Investigational Site Los Angeles California
United States GSK Investigational Site Manhasset New York
United States GSK Investigational Site Marietta Georgia
United States GSK Investigational Site Memphis Tennessee
United States GSK Investigational Site Miami Florida
United States GSK Investigational Site Milwaukee Wisconsin
United States GSK Investigational Site Nassau Bay Texas
United States GSK Investigational Site New Orleans Louisiana
United States GSK Investigational Site New York New York
United States GSK Investigational Site Oklahoma City Oklahoma
United States GSK Investigational Site Orangeburg South Carolina
United States GSK Investigational Site Orlando Florida
United States GSK Investigational Site Orlando Florida
United States GSK Investigational Site Pennsylvania Wyoming
United States GSK Investigational Site Peoria Arizona
United States GSK Investigational Site Plantation Florida
United States GSK Investigational Site Saint Clair Shores Michigan
United States GSK Investigational Site Saint Louis Missouri
United States GSK Investigational Site San Diego California
United States GSK Investigational Site San Francisco California
United States GSK Investigational Site San Jose California
United States GSK Investigational Site San Leandro California
United States GSK Investigational Site Seattle Washington
United States GSK Investigational Site Smithtown New York
United States GSK Investigational Site Springfield Illinois
United States GSK Investigational Site Tampa Florida
United States GSK Investigational Site Toledo Ohio
United States GSK Investigational Site Tucson Arizona
United States GSK Investigational Site Tucson Arizona
United States GSK Investigational Site Tulsa Oklahoma
United States GSK Investigational Site Tustin California
United States GSK Investigational Site Upland California
United States GSK Investigational Site Wyomissing Pennsylvania

Sponsors (2)

Lead Sponsor Collaborator
Human Genome Sciences Inc., a GSK Company GlaxoSmithKline

Countries where clinical trial is conducted

United States,  Argentina,  Austria,  Belgium,  Brazil,  Bulgaria,  Chile,  Colombia,  Croatia,  Czechia,  Denmark,  France,  Germany,  Hungary,  Italy,  Japan,  Malaysia,  Mexico,  Philippines,  Poland,  Portugal,  Romania,  Russian Federation,  Serbia,  Singapore,  Spain,  Sweden,  Taiwan,  Thailand,  Ukraine,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
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