Study of Epratuzumab Versus Placebo in Subjects With Moderate to Severe General Systemic Lupus Erythematosus (SLE)
- Registration Number
- NCT01261793
- Lead Sponsor
- UCB Pharma
- Brief Summary
The primary objective of the study is to confirm the clinical efficacy of epratuzumab in the treatment of subjects with Systemic Lupus Erythematosus (SLE).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 791
- Positive antinuclear antibodies (ANA) at Screening (Visit 1)
- Current clinical diagnosis of Systemic Lupus Erythematosus (SLE) by American College of Rheumatology (ACR) criteria such that at least 4 of the 11 criteria are met
- Active moderate to severe SLE activity as demonstrated by the British Isles Lupus Assessment Group Index (BILAG)
- Active moderate to severe SLE disease as demonstrated by SLE disease activity index (SLEDAI) total score
- On stable SLE treatment regimen, including mandatory corticosteroids and immunosuppressants or antimalarials
- Subjects who are breastfeeding, pregnant, or plan to become pregnant
- Subjects with active, severe SLE disease activity which involves the renal system
- Subjects with active, severe, neuropsychiatric SLE, defined as any neuropsychiatric element scoring BILAG level A disease.
- Subjects with the evidence of an immunosuppressive state
- Subjects who, in the opinion of the investigator, are at a particularly high risk of significant infection
- History of malignant cancer, except the following treated cancers: cervical carcinoma in situ, basal cell carcinoma, or dermatological squamous cell carcinoma.
- Subjects receiving any live vaccination within the 8 weeks prior to screening (Visit 1).
- Subjects with history of infections, including but not limited to concurrent acute or chronic viral hepatitis B or C
- Subjects with substance abuse or dependence or other relevant concurrent medical condition
- Subjects with history of thromboembolic events within 1 year of screening Visit.
- Subjects with significant hematologic abnormalities
- Subject has received treatment with other anti- B cell antibodies within 12 months prior to screening (visit 1)
- Subject use of oral anticoagulant (not including) nonsteroidal anti-inflammatory drugs (NSAIDs) within 12 weeks prior to screening (Visit 1)
- Subject has previously participated in this study or has previously received epratuzumab treatment.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Epratuzumab 1200 mg every other week Placebo 1200 mg infusions delivered every other week for a total of 4 weeks (cumulative dose 2400 mg) over four 12-week treatment cycles and placebo infusions delivered every other week for a total of 4 weeks over four 12-week treatment cycles Placebo (Weekly infusion) Placebo Placebo infusions delivered weekly for a total of 4 weeks over four 12-week treatment cycles Epratuzumab 1200 mg every other week Epratuzumab 1200 mg infusions delivered every other week for a total of 4 weeks (cumulative dose 2400 mg) over four 12-week treatment cycles and placebo infusions delivered every other week for a total of 4 weeks over four 12-week treatment cycles Epratuzumab 600 mg per week Epratuzumab 600 mg infusions delivered weekly for a total of 4 weeks (cumulative dose 2400 mg) over four 12 week treatment cycles
- Primary Outcome Measures
Name Time Method The Percent of Subjects Meeting Treatment Response Criteria at Week 48 According to a Combined Response Index At Week 48 Percentages are based on the number of subjects in the relevant treatment group within the Full Analysis Set (FAS). The combined response index incorporated criteria for achievement of responder status from the: British Isles Lupus Assessment Group Index (BILAG-2004)- improvement from study entry or no worsening in other organ systems, Systemic Lupus Erythematosus Disease Activity Index (SLEDAI; Version 2000, also known as SLEDAI-2K) - no worsening compared to study entry, physician's global assessment of disease activity(PGA)- no worsening compared to study entry, and concomitant medications- no changes.
- Secondary Outcome Measures
Name Time Method The Percent of Subjects Meeting Treatment Response Criteria at Week 12 According to a Combined Response Index At Week 12 Percentages are based on the number of subjects in the relevant treatment group within the Full Analysis Set (FAS). The combined response index incorporated criteria for achievement of responder status from the: British Isles Lupus Assessment Group Index (BILAG-2004)- improvement from study entry or no worsening in other organ systems, Systemic Lupus Erythematosus Disease Activity Index (SLEDAI; Version 2000, also known as SLEDAI-2K) - no worsening compared to study entry, physician's global assessment of disease activity(PGA)- no worsening compared to study entry, and concomitant medications- no changes.
The Percent of Subjects Meeting Treatment Response Criteria at Week 36 According to a Combined Response Index At Week 36 Percentages are based on the number of subjects in the relevant treatment group within the Full Analysis Set (FAS). The combined response index incorporated criteria for achievement of responder status from the: British Isles Lupus Assessment Group Index (BILAG-2004)- improvement from study entry or no worsening in other organ systems, Systemic Lupus Erythematosus Disease Activity Index (SLEDAI; Version 2000, also known as SLEDAI-2K) - no worsening compared to study entry, physician's global assessment of disease activity(PGA)- no worsening compared to study entry, and concomitant medications- no changes.
The Percent of Subjects Meeting Treatment Response Criteria at Week 24 According to a Combined Response Index At Week 24 Percentages are based on the number of subjects in the relevant treatment group within the Full Analysis Set (FAS). The combined response index incorporated criteria for achievement of responder status from the: British Isles Lupus Assessment Group Index (BILAG-2004)- improvement from study entry or no worsening in other organ systems, Systemic Lupus Erythematosus Disease Activity Index (SLEDAI; Version 2000, also known as SLEDAI-2K) - no worsening compared to study entry, physician's global assessment of disease activity(PGA)- no worsening compared to study entry, and concomitant medications- no changes.
Change From Baseline in Daily Corticosteroid Dose at Week 24 At Week 24 Participants were grouped into 4 categories: Dose decreased by \>50%, Dose decreased \>0% to ≤50%, No change in dose and Dose increased or missing data.
Change From Baseline in Daily Corticosteroid Dose at Week 48 At Week 48 Participants were grouped into 4 categories: Dose decreased by \>50%, Dose decreased \>0% to ≤50%, No change in dose and Dose increased or missing data.
Trial Locations
- Locations (133)
715
🇭🇺Szeged, Hungary
648
🇮🇹Milano, Italy
646
🇮🇹Roma, Italy
647
🇮🇹Pisa, Italy
976
🇲🇽Mexico City, Mexico
978
🇲🇽Cuauhtémoc, Mexico
981
🇲🇽Torreon, Mexico
743
🇵🇱Bydgoszcz, Poland
746
🇵🇱Katowice, Poland
745
🇵🇱Katowice, Poland
747
🇵🇱Szczecin, Poland
751
🇵🇱Ustron, Poland
761
🇷🇴Iasi, Romania
901
🇿🇦Cape Town, South Africa
903
🇿🇦Stellenbosch, South Africa
902
🇿🇦Durban, South Africa
661
🇪🇸Barcelona, Spain
660
🇪🇸Getafe, Spain
664
🇪🇸Madrid, Spain
662
🇪🇸Las Palmas de Gran Canaria, Spain
663
🇪🇸Santiago de Compostela, Spain
659
🇪🇸Vigo, Spain
679
🇬🇧London, United Kingdom
537
🇺🇸Atlanta, Georgia, United States
563
🇺🇸Houston, Texas, United States
534
🇺🇸Seattle, Washington, United States
557
🇺🇸Little Rock, Arkansas, United States
511
🇺🇸Bridgeport, Connecticut, United States
596
🇺🇸Nashua, New Hampshire, United States
571
🇺🇸Jackson, Tennessee, United States
506
🇨🇦St. John's, Newfoundland and Labrador, Canada
508
🇨🇦Rimouski, Quebec, Canada
717
🇭🇺Debrecen, Hungary
711
🇭🇺Szeged, Hungary
712
🇭🇺Budapest, Hungary
716
🇭🇺Budapest, Hungary
718
🇭🇺Budapest, Hungary
713
🇭🇺Zalaegerszeg, Hungary
852
🇮🇳Ahmedabad, India
853
🇮🇳Bangalore, India
982
🇲🇽Mexico, Mexico
748
🇵🇱Lublin, Poland
744
🇵🇱Czestochowa, Poland
756
🇷🇴Galati, Romania
752
🇵🇱Elblag, Poland
750
🇵🇱Lublin, Poland
742
🇵🇱Poznan, Poland
749
🇵🇱Warsaw, Poland
758
🇷🇴Bucharest, Romania
791
🇺🇦Donetsk, Ukraine
757
🇷🇴Bucharest, Romania
792
🇺🇦Luhansk, Ukraine
779
🇷🇺Moscow, Russian Federation
760
🇷🇴Bucharest, Romania
759
🇷🇴Constanta, Romania
778
🇷🇺Kemerovo, Russian Federation
780
🇷🇺Kemerovo, Russian Federation
790
🇺🇦Kiev, Ukraine
794
🇺🇦Kiev, Ukraine
793
🇺🇦Odessa, Ukraine
797
🇺🇦Kiev, Ukraine
796
🇺🇦Vinnytsya, Ukraine
677
🇬🇧Birmingham, United Kingdom
678
🇬🇧Christchurch, United Kingdom
539
🇺🇸Birmingham, Alabama, United States
532
🇺🇸Denver, Colorado, United States
562
🇺🇸San Antonio, Texas, United States
538
🇺🇸Tampa, Florida, United States
544
🇺🇸Huntington Beach, California, United States
550
🇺🇸La Jolla, California, United States
515
🇺🇸Hemet, California, United States
548
🇺🇸Los Angeles, California, United States
589
🇺🇸San Diego, California, United States
558
🇺🇸Torrance, California, United States
531
🇺🇸San Leandro, California, United States
594
🇺🇸Westlake Village, California, United States
514
🇺🇸Brandon, Florida, United States
518
🇺🇸Plantation, Florida, United States
585
🇺🇸Port Orange, Florida, United States
587
🇺🇸Decatur, Georgia, United States
543
🇺🇸Bowling Green, Kentucky, United States
590
🇺🇸Idaho Falls, Idaho, United States
513
🇺🇸Lansing, Michigan, United States
572
🇺🇸Boston, Massachusetts, United States
599
🇺🇸Lansing, Michigan, United States
575
🇺🇸Florissant, Missouri, United States
549
🇺🇸Saint Louis, Missouri, United States
593
🇺🇸Clifton, New Jersey, United States
568
🇺🇸Freehold, New Jersey, United States
553
🇺🇸Lake Success, New York, United States
545
🇺🇸Manhasset, New York, United States
577
🇺🇸Roslyn, New York, United States
561
🇺🇸Wyomissing, Pennsylvania, United States
598
🇺🇸Myrtle Beach, South Carolina, United States
559
🇺🇸Charlotte, North Carolina, United States
547
🇺🇸Tulsa, Oklahoma, United States
541
🇺🇸Houston, Texas, United States
574
🇺🇸Amarillo, Texas, United States
552
🇺🇸Chesapeake, Virginia, United States
954
🇧🇷Belo Horizonte, Brazil
956
🇧🇷Campinas, Brazil
618
🇫🇷Limoges Cedex, France
955
🇧🇷Goiânia, Brazil
616
🇫🇷Toulouse Cedex 9, France
950
🇧🇷Juiz de Fora, Brazil
952
🇧🇷Rio de Janeiro, Brazil
502
🇨🇦Hamilton, Canada
507
🇨🇦Mississauga, Ontario, Canada
517
🇨🇦Victoria, Canada
500
🇨🇦London, Canada
504
🇨🇦Toronto, Canada
613
🇫🇷Caen, France
617
🇫🇷Montpellier Cedex 5, France
614
🇫🇷Paris, France
628
🇩🇪Berlin, Germany
633
🇩🇪Berlin, Germany
637
🇩🇪Hamburg, Germany
636
🇩🇪Dessau, Germany
631
🇩🇪Zerbst, Germany
629
🇩🇪Kiel, Germany
634
🇩🇪Mainz, Germany
632
🇩🇪Herne, Germany
625
🇩🇪Köln, Germany
626
🇩🇪Leipzig, Germany
627
🇩🇪Münster, Germany
639
🇩🇪Wiesbaden, Germany
533
🇺🇸Fort Lauderdale, Florida, United States
551
🇺🇸Brooklyn, New York, United States
592
🇺🇸Lexington, Kentucky, United States
576
🇺🇸New Orleans, Louisiana, United States
570
🇺🇸Austin, Texas, United States
554
🇺🇸Ann Arbor, Michigan, United States
535
🇺🇸Charleston, South Carolina, United States