A Study to Evaluate the Efficacy and Safety of Belimumab Administered in Combination With Rituximab to Adult Subjects With Systemic Lupus Erythematosus (SLE) - BLISS-BELIEVE

PHASE3CompletedINTERVENTIONAL
Enrollment

292

Participants

Timeline

Start Date

March 1, 2018

Primary Completion Date

May 29, 2020

Study Completion Date

July 7, 2021

Conditions
Systemic Lupus Erythematosus
Interventions
DRUG

Belimumab

Belimumab will be administered as SC injection once weekly via autoinjector in thigh or abdomen

DRUG

Rituximab

Rituximab will be administered as IV infusion of 1000mg at Week 4 and Week 6

DRUG

Rituximab-placebo

Saline will be administered as IV infusions at Week 4 and Week 6

DRUG

Standard therapy (Including Immunosuppressants)

Standard therapy will contain stable SLE medications including immunosuppressant to be administered from baseline through Week 104.

DRUG

Standard therapy (Excluding Immunosuppressants)

Standard therapy excluding Immunosuppressant will contain anti-malarials, NSAIDs, and/or corticosteroids with prednisone dose equivalent to \<= 5 mg/day will administered through Week 104.

DRUG

Steroid Taper

Steroid taper will include prednisone doses equivalent to =\< 5 mg/day in all Arms through Week 104.

Trial Locations (79)

10016

GSK Investigational Site, New York

10032

GSK Investigational Site, New York

11030

GSK Investigational Site, Manhasset

15224

GSK Investigational Site, Pittsburgh

24105

GSK Investigational Site, Kiel

28204

GSK Investigational Site, Charlotte

29486

GSK Investigational Site, Summerville

29609

GSK Investigational Site, Brest

30625

GSK Investigational Site, Hanover

33136

GSK Investigational Site, Miami

33180

GSK Investigational Site, Aventura

33321

GSK Investigational Site, Tamarac

33604

GSK Investigational Site, Pessac

33613

GSK Investigational Site, Tampa

33614

GSK Investigational Site, Tampa

35294

GSK Investigational Site, Birmingham

36214

GSK Investigational Site, Vigo (Pontevedra)

45070

GSK Investigational Site, Zapopan

45377

GSK Investigational Site, Vandalia

46017

GSK Investigational Site, Valencia

47010

GSK Investigational Site, Valladolid

48116

GSK Investigational Site, Brighton

48910

GSK Investigational Site, Lansing

48917

GSK Investigational Site, Lansing

53217

GSK Investigational Site, Glendale

59037

GSK Investigational Site, Lille

60590

GSK Investigational Site, Frankfurt

67091

GSK Investigational Site, Strasbourg

73102

GSK Investigational Site, Oklahoma City

75013

GSK Investigational Site, Paris

75571

GSK Investigational Site, Paris

77573

GSK Investigational Site, League City

78731

GSK Investigational Site, Austin

80230

GSK Investigational Site, Denver

88011

GSK Investigational Site, Las Cruces

91786

GSK Investigational Site, Upland

92020

GSK Investigational Site, La Mesa

94578

GSK Investigational Site, San Leandro

97070

GSK Investigational Site, Mérida

99204

GSK Investigational Site, Spokane

119435

GSK Investigational Site, Moscow

150030

GSK Investigational Site, Yaroslavl

185019

GSK Investigational Site, Petrozavodsk

190068

GSK Investigational Site, Saint Petersburg

390026

GSK Investigational Site, Ryazan

420097

GSK Investigational Site, Kazan'

432063

GSK Investigational Site, Ulyanovsk

450005

GSK Investigational Site, Ufa

454076

GSK Investigational Site, Chelyabinsk

630117

GSK Investigational Site, Novosibirsk

644111

GSK Investigational Site, Omsk

650066

GSK Investigational Site, Kemerovo

32806-6264

GSK Investigational Site, Orlando

48109-5542

GSK Investigational Site, Ann Arbor

C1046AAQ

GSK Investigational Site, Ciudad Autonoma de Buenos Aires

B1904CFH,

GSK Investigational Site, La Plata

T4000AXL

GSK Investigational Site, San Miguel de Tucumán

40.150-150

GSK Investigational Site, Salvador

78043-142

GSK Investigational Site, Cuiabá

36010-570

GSK Investigational Site, Juiz de Fora

15090-000

GSK Investigational Site, São José do Rio Preto

L8S 4K1

GSK Investigational Site, Hamilton

M5T 2S8

GSK Investigational Site, Toronto

G8Z 1Y2

GSK Investigational Site, Trois-Rivières

S7K 0H6

GSK Investigational Site, Saskatoon

3813 TZ

GSK Investigational Site, Amersfoort

9713 GZ

GSK Investigational Site, Groningen

2333 ZA

GSK Investigational Site, Leiden

2545 AA

GSK Investigational Site, The Hague

3584 CX

GSK Investigational Site, Utrecht

700-721

GSK Investigational Site, Daegu

501-757

GSK Investigational Site, Gwangju

400-711

GSK Investigational Site, Incheon

03080

GSK Investigational Site, Seoul

133-792

GSK Investigational Site, Seoul

137-701

GSK Investigational Site, Seoul

443-380

GSK Investigational Site, Suwon

08916

GSK Investigational Site, Badalona

08035

GSK Investigational Site, Barcelona

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY

NCT03312907 - A Study to Evaluate the Efficacy and Safety of Belimumab Administered in Combination With Rituximab to Adult Subjects With Systemic Lupus Erythematosus (SLE) - BLISS-BELIEVE | Biotech Hunter | Biotech Hunter