Clinical trial NCT01408576: Open Label Extension Study of Epratuzumab in Subjects With Systemic Lupus Erythematosus
Official title: A Phase 3, Multicenter, Open-label, Extension Study to Assess the Safety and Tolerability of Epratuzumab Treatment in Systemic Lupus Erythematosus Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Systemic Lupus Erythematosus
Keywords: Lupus
Monoclonal antibody
B-Cell immunotherapy
Epratuzumab
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2011-08-03
Enrollment: 1250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of the study is assess the safety and tolerability of long-term epratuzumab treatment in subjects with Systemic Lupus Erythematosus (SLE)

Detailed description: Treatment period was extended by 2 years to a total of 4 years and an amendment was prepared accordingly.

Eligibility criteria: Inclusion Criteria:

* Subject has completed the double-blind study SL0009 (NCT01262365) or SL0010 (NCT01261793) or terminated prematurely at Week 16 or later in SL0009 or SL0010 due to lack of efficacy and would, in the opinion of the investigator, continue to benefit from continued epratuzumab treatment
* Subject has completed open-label study SL0006 (NCT00383513) or SL0008 (NCT00660881), and would, in the opinion of the investigator, continue to benefit from continued epratuzumab treatment
* Women of childbearing potential must agree to use an acceptable method of birth control

Exclusion Criteria:

* Subjects with active, severe, neuropsychiatric SLE, defined as any neuropsychiatric element scoring British Isles Lupus Assessment Group Index (BILAG) level A disease
* Subjects with active, severe SLE disease activity which involves the renal system
* Subjects with concurrent relevant medical conditions like defined chronic infections or high risk of new significant infections
* Substance abuse or dependence
* History of malignant cancer
* Subjects with any other condition which, in the investigator's judgment, would make the subject unsuitable for inclusion

Primary outcomes:
measure: Number of Subjects Prematurely Discontinuing Due to a Treatment-emergent Adverse Event (TEAE) During the Treatment Period (Maximum 96 Weeks)
timeFrame: During the treatment period (through Week 96)
measure: Percentage of Subjects Prematurely Discontinuing Due to a Treatment-emergent Adverse Event (TEAE) During the Treatment Period (Maximum 96 Weeks)
timeFrame: During the treatment period (through Week 96)
measure: Number of Subjects Reporting at Least 1 Serious Adverse Event (SAE) During the Treatment Period (Maximum 96 Weeks)
timeFrame: During the treatment period (through Week 96)
measure: Percentage of Subjects Reporting at Least 1 Serious Adverse Event (SAE) During the Treatment Period (Maximum 96 Weeks)
timeFrame: During the treatment period (through Week 96)
Secondary outcomes:
measure: Number of Subjects Meeting Treatment Response Criteria According to a Combined Response Index
timeFrame: At Week 48
measure: Percentage of Subjects Meeting Treatment Response Criteria According to a Combined Response Index
timeFrame: Week 48
measure: Number of Subjects Meeting Treatment Response Criteria According to a Combined Response Index
timeFrame: Week 96
measure: The Percent of Subjects Meeting Treatment Response Criteria According to a Combined Response Index
timeFrame: Week 96
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: 539
state: Alabama
city: Little Rock
country: United States
facility: 557
state: Arkansas
city: Hemet
country: United States
facility: 515
state: California
city: Huntington Beach
country: United States
facility: 544
state: California
city: La Jolla
country: United States
facility: 550
state: California
city: Los Angeles
country: United States
facility: 031
state: California
city: Los Angeles
country: United States
facility: 051
state: California
city: Los Angeles
country: United States
facility: 089
state: California
city: San Leandro
country: United States
facility: 531
state: California
city: Thousand Oaks
country: United States
facility: 594
state: California
city: Torrance
country: United States
facility: 558
state: California
city: Aurora
country: United States
facility: 048
state: Colorado
city: Colorado Springs
country: United States
facility: 037
state: Colorado
city: Denver
country: United States
facility: 532
state: Colorado
city: Bridgeport
country: United States
facility: 511
state: Connecticut
city: Farmington
country: United States
facility: 039
state: Connecticut
city: Aventura
country: United States
facility: 042
state: Florida
city: Brandon
country: United States
facility: 514
state: Florida
city: Clearwater
country: United States
facility: 090
state: Florida
city: DeBary
country: United States
facility: 092
state: Florida
city: Fort Lauderdale
country: United States
facility: 533
state: Florida
city: Jupiter
country: United States
facility: 064
state: Florida
city: Ormond Beach
country: United States
facility: 070
state: Florida
city: Palm Harbor
country: United States
facility: 084
state: Florida
city: Plantation
country: United States
facility: 518
state: Florida
city: Port Orange
country: United States
facility: 585
state: Florida
city: Tampa
country: United States
facility: 050
state: Florida
city: Tampa
country: United States
facility: 538
state: Florida
city: Vero Beach
country: United States
facility: 087
state: Florida
city: Atlanta
country: United States
facility: 537
state: Georgia
city: Duluth
country: United States
facility: 044
state: Georgia
city: Idaho Falls
country: United States
facility: 590
state: Idaho
city: Chicago
country: United States
facility: 052
state: Illinois
city: Indianapolis
country: United States
facility: 096
state: Indiana
city: Shreveport
country: United States
facility: 060
state: Louisiana
city: Lansing
country: United States
facility: 513
state: Michigan
city: Lansing
country: United States
facility: 599
state: Michigan
city: Saint Clair Shores
country: United States
facility: 047
state: Michigan
city: Florissant
country: United States
facility: 575
state: Missouri
city: Saint Louis
country: United States
facility: 549
state: Missouri
city: Nashua
country: United States
facility: 596
state: New Hampshire
city: Freehold
country: United States
facility: 568
state: New Jersey
city: Trenton
country: United States
facility: 593
state: New Jersey
city: Las Cruces
country: United States
facility: 067
state: New Mexico
city: Brooklyn
country: United States
facility: 551
state: New York
city: Great Neck
country: United States
facility: 553
state: New York
city: Manhasset
country: United States
facility: 545
state: New York
city: New York
country: United States
facility: 053
state: New York
city: Roslyn
country: United States
facility: 577
state: New York
city: Charlotte
country: United States
facility: 077
state: North Carolina
city: Charlotte
country: United States
facility: 559
state: North Carolina
city: Durham
country: United States
facility: 058
state: North Carolina
city: Wilmington
country: United States
facility: 075
state: North Carolina
city: Columbus
country: United States
facility: 061
state: Ohio
city: Middleburg Heights
country: United States
facility: 071
state: Ohio
city: Oklahoma City
country: United States
facility: 041
state: Oklahoma
city: Oklahoma City
country: United States
facility: 076
state: Oklahoma
city: Oklahoma City
country: United States
facility: 097
state: Oklahoma
city: Tulsa
country: United States
facility: 547
state: Oklahoma
city: Duncansville
country: United States
facility: 032
state: Pennsylvania
city: Philadelphia
country: United States
facility: 093
state: Pennsylvania
city: Pittsburgh
country: United States
facility: 073
state: Pennsylvania
city: Pittsburgh
country: United States
facility: 094
state: Pennsylvania
city: Charleston
country: United States
facility: 535
state: South Carolina
city: Myrtle Beach
country: United States
facility: 598
state: South Carolina
city: Jackson
country: United States
facility: 571
state: Tennessee
city: Memphis
country: United States
facility: 057
state: Tennessee
city: Amarillo
country: United States
facility: 574
state: Texas
city: Austin
country: United States
facility: 078
state: Texas
city: Austin
country: United States
facility: 098
state: Texas
city: Austin
country: United States
facility: 570
state: Texas
city: Dallas
country: United States
facility: 079
state: Texas
city: Houston
country: United States
facility: 541
state: Texas
city: Houston
country: United States
facility: 563
state: Texas
city: Mesquite
country: United States
facility: 036
state: Texas
city: San Antonio
country: United States
facility: 066
state: Texas
city: San Antonio
country: United States
facility: 562
state: Texas
city: Seattle
country: United States
facility: 534
state: Washington
city: Camperdown
country: Australia
facility: 429
city: Clayton
country: Australia
facility: 427
city: Liverpool
country: Australia
facility: 430
city: Malvern
country: Australia
facility: 425
city: Maroochydore
country: Australia
facility: 426
city: Brussels
country: Belgium
facility: 106
city: Brussels
country: Belgium
facility: 107
city: Leuven
country: Belgium
facility: 105
city: Liege
country: Belgium
facility: 104
city: Belo Horizonte
country: Brazil
facility: 954
city: Campinas
country: Brazil
facility: 956
city: Goiânia
country: Brazil
facility: 955
city: Juiz de Fora
country: Brazil
facility: 950
city: Porto Alegre
country: Brazil
facility: 453
city: Recife
country: Brazil
facility: 451
city: Rio de Janeiro
country: Brazil
facility: 450
city: Rio de Janeiro
country: Brazil
facility: 952
city: Salvador
country: Brazil
facility: 452
city: Sao Paulo
country: Brazil
facility: 454
city: Sofia
country: Bulgaria
facility: 200
city: Sofia
country: Bulgaria
facility: 202
city: Sofia
country: Bulgaria
facility: 203
city: Sofia
country: Bulgaria
facility: 204
city: Sofia
country: Bulgaria
facility: 205
city: London
country: Canada
facility: 500
state: Ontario
city: Hamilton
country: Canada
facility: 502
city: Mississauga
country: Canada
facility: 507
city: Rimouski
country: Canada
facility: 508
city: St. John's
country: Canada
facility: 506
city: Toronto
country: Canada
facility: 504
city: Olomouc
country: Czechia
facility: 218
city: Praha 2
country: Czechia
facility: 216
city: Zlin
country: Czechia
facility: 215
city: Tallinn
country: Estonia
facility: 226
city: Lille Cedex
country: France
facility: 113
city: Limoges Cedex
country: France
facility: 618
city: Montpellier Cedex 5
country: France
facility: 617
city: Paris
country: France
facility: 614
city: Pessac
country: France
facility: 116
city: Toulouse Cedex 9
country: France
facility: 616
city: Berlin
country: Germany
facility: 127
city: Berlin
country: Germany
facility: 628
city: Berlin
country: Germany
facility: 633
city: Frankfurt
country: Germany
facility: 128
city: Freiburg
country: Germany
facility: 126
city: Hamburg
country: Germany
facility: 637
city: Herne
country: Germany
facility: 632
city: Koln
country: Germany
facility: 625
city: Leipzig
country: Germany
facility: 626
city: Mainz
country: Germany
facility: 634
city: Munster
country: Germany
facility: 627
city: Plochingen
country: Germany
facility: 129
city: Roßlau
country: Germany
facility: 636
city: Zerbst
country: Germany
facility: 631
city: Shatin
country: Hong Kong
facility: 349
city: Budapest
country: Hungary
facility: 712
city: Budapest
country: Hungary
facility: 716
city: Budapest
country: Hungary
facility: 718
city: Debrecen
country: Hungary
facility: 717
city: Szeged
country: Hungary
facility: 711
city: Szeged
country: Hungary
facility: 715
city: Zalaegerszeg
country: Hungary
facility: 713
city: Ashkelon
country: Israel
facility: 378
city: Beer Sheva
country: Israel
facility: 376
city: Haifa
country: Israel
facility: 375
city: Haifa
country: Israel
facility: 377
city: Jerusalem
country: Israel
facility: 381
city: Kfar Saba
country: Israel
facility: 382
city: Rehovot
country: Israel
facility: 380
city: Tel Aviv
country: Israel
facility: 379
city: Tel-Hashomer
country: Israel
facility: 383
city: Ferrara
country: Italy
facility: 149
city: Milano
country: Italy
facility: 648
city: Padova
country: Italy
facility: 148
city: Pisa
country: Italy
facility: 647
city: Roma
country: Italy
facility: 646
city: Torino
country: Italy
facility: 147
city: Busan
country: Korea, Republic of
facility: 306
city: Daegu
country: Korea, Republic of
facility: 303
city: Daejeon
country: Korea, Republic of
facility: 308
city: Incheon
country: Korea, Republic of
facility: 301
city: Seoul
country: Korea, Republic of
facility: 307
city: Suwon
country: Korea, Republic of
facility: 302
city: Kaunas
country: Lithuania
facility: 242
city: Klaipeda
country: Lithuania
facility: 244
city: Vilnius
country: Lithuania
facility: 243
city: Guadalajara
country: Mexico
facility: 478
city: Merida
country: Mexico
facility: 480
city: Mexico City
country: Mexico
facility: 976
city: Mexico City
country: Mexico
facility: 982
city: Torreon
country: Mexico
facility: 981
city: Bydgoszcz
country: Poland
facility: 743
city: Czestochowa
country: Poland
facility: 744
city: Elblag
country: Poland
facility: 752
city: Elbląg
country: Poland
facility: 754
city: Katowice
country: Poland
facility: 746
city: Lublin
country: Poland
facility: 748
city: Lublin
country: Poland
facility: 750
city: Poznan
country: Poland
facility: 742
city: Szczecin
country: Poland
facility: 747
city: Ustron
country: Poland
facility: 751
city: Warsaw
country: Poland
facility: 749
city: Brasov
country: Romania
facility: 263
city: Bucharest
country: Romania
facility: 260
city: Bucharest
country: Romania
facility: 262
city: Bucharest
country: Romania
facility: 264
city: Bucharest
country: Romania
facility: 757
city: Bucharest
country: Romania
facility: 758
city: Cluj-Napoca
country: Romania
facility: 261
city: Constanta
country: Romania
facility: 759
city: Galati
country: Romania
facility: 756
city: Iasi
country: Romania
facility: 761
city: Ekaterinburg
country: Russian Federation
facility: 281
city: Moscow
country: Russian Federation
facility: 779
city: Petrozavodsk
country: Russian Federation
facility: 285
city: Saint Petersburg
country: Russian Federation
facility: 284
city: Cape Town
country: South Africa
facility: 901
city: Durban
country: South Africa
facility: 902
city: Stellenbosch
country: South Africa
facility: 903
city: Barcelona
country: Spain
facility: 161
city: Barcelona
country: Spain
facility: 661
city: Bilbao
country: Spain
facility: 164
city: Getafe
country: Spain
facility: 660
city: La Laguna
country: Spain
facility: 165
city: Las Palmas de Gran Canaria
country: Spain
facility: 662
city: Madrid
country: Spain
facility: 162
city: Madrid
country: Spain
facility: 163
city: Madrid
country: Spain
facility: 664
city: Malaga
country: Spain
facility: 166
city: Santander
country: Spain
facility: 177
city: Santiago de Compostela
country: Spain
facility: 663
city: Sevilla
country: Spain
facility: 160
city: Vigo
country: Spain
facility: 659
city: Changhua
country: Taiwan
facility: 325
city: Chiayi City
country: Taiwan
facility: 326
city: Kaohsiung City
country: Taiwan
facility: 328
city: Taipei
country: Taiwan
facility: 330
city: Donetsk
country: Ukraine
facility: 791
city: Ivano-Frankivsk
country: Ukraine
facility: 799
city: Kiev
country: Ukraine
facility: 790
city: Kiev
country: Ukraine
facility: 794
city: Kiev
country: Ukraine
facility: 797
city: Lugansk
country: Ukraine
facility: 792
city: Odessa
country: Ukraine
facility: 793
city: Vinnytsya
country: Ukraine
facility: 796
city: Birmingham
country: United Kingdom
facility: 677
city: Brighton
country: United Kingdom
facility: 178
city: Doncaster
country: United Kingdom
facility: 182
city: Leeds
country: United Kingdom
facility: 179
city: Romford
country: United Kingdom
facility: 181
Study officials:
affiliation: UCB Pharma
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References: