Open Label Extension Study of Epratuzumab in Subjects With Systemic Lupus Erythematosus
- Registration Number
- NCT01408576
- Lead Sponsor
- UCB Pharma
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1250
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Epratuzumab 600 mg per week Epratuzumab 600 mg infusions delivered weekly for a total of 4 consecutive weeks (cumulative dose 2400 mg) over sixteen 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 sixteen 12 week treatment cycles
- Primary Outcome Measures
Name Time Method Number of Subjects Prematurely Discontinuing Due to a Treatment-emergent Adverse Event (TEAE) During the Treatment Period (Maximum 96 Weeks) During the treatment period (through Week 96) A TEAE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment.
Percentage of Subjects Prematurely Discontinuing Due to a Treatment-emergent Adverse Event (TEAE) During the Treatment Period (Maximum 96 Weeks) During the treatment period (through Week 96) A TEAE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment.
Number of Subjects Reporting at Least 1 Serious Adverse Event (SAE) During the Treatment Period (Maximum 96 Weeks) During the treatment period (through Week 96) A SAE is a treatment-emergent adverse event (TEAE) that the investigator classifies as serious. This includes:
* Death
* Life-threatening
* Significant or persistent disability/incapacity
* Congenital anomaly/birth defect (including that occurring in a fetus)
* Important medical event that, based upon appropriate medical judgment, may jeopardize the patient or subject and may require medical or surgical intervention to prevent 1 of the other outcomes listed in the definition of serious
* Initial inpatient hospitalization or prolongation of hospitalizationPercentage of Subjects Reporting at Least 1 Serious Adverse Event (SAE) During the Treatment Period (Maximum 96 Weeks) During the treatment period (through Week 96) A SAE is a treatment-emergent adverse event (TEAE) that the investigator classifies as serious. This includes:
* Death
* Life-threatening
* Significant or persistent disability/incapacity
* Congenital anomaly/birth defect (including that occurring in a fetus)
* Important medical event that, based upon appropriate medical judgment, may jeopardize the patient or subject and may require medical or surgical intervention to prevent 1 of the other outcomes listed in the definition of serious
* Initial inpatient hospitalization or prolongation of hospitalization
- Secondary Outcome Measures
Name Time Method Number of Subjects Meeting Treatment Response Criteria According to a Combined Response Index Week 96 Combined response index is a response variable (yes/no) incorporating the following criteria for achievement of responder status (ie, all criteria must be met to achieve responder status): (1) British Isles Lupus Activity Group (BILAG) improvement, (2) No worsening in Systemic Lupus Erythematosus Activity Index (SLEDAI), (3) No worsening in Physician's Global Assessment of Disease, and (4) No disallowed changes in concomitant medications, with disallowed changes including mainly increases in corticosteroids, immunosuppressants, and antimalarials.
Percentage of Subjects Meeting Treatment Response Criteria According to a Combined Response Index Week 48 Combined response index is a response variable (yes/no) incorporating the following criteria for achievement of responder status (ie, all criteria must be met to achieve responder status): (1) British Isles Lupus Activity Group (BILAG) improvement, (2) No worsening in Systemic Lupus Erythematosus Activity Index (SLEDAI), (3) No worsening in Physician's Global Assessment of Disease, and (4) No disallowed changes in concomitant medications, with disallowed changes including mainly increases in corticosteroids, immunosuppressants, and antimalarials.
The Percent of Subjects Meeting Treatment Response Criteria According to a Combined Response Index Week 96 Combined response index is a response variable (yes/no) incorporating the following criteria for achievement of responder status (ie, all criteria must be met to achieve responder status): (1) British Isles Lupus Activity Group (BILAG) improvement, (2) No worsening in Systemic Lupus Erythematosus Activity Index (SLEDAI), (3) No worsening in Physician's Global Assessment of Disease, and (4) No disallowed changes in concomitant medications, with disallowed changes including mainly increases in corticosteroids, immunosuppressants, and antimalarials.
Trial Locations
- Locations (228)
053
🇺🇸New York, New York, United States
381
🇮🇱Jerusalem, Israel
285
🇷🇺Petrozavodsk, Russian Federation
515
🇺🇸Hemet, California, United States
537
🇺🇸Atlanta, Georgia, United States
073
🇺🇸Pittsburgh, Pennsylvania, United States
541
🇺🇸Houston, Texas, United States
037
🇺🇸Colorado Springs, Colorado, United States
717
ðŸ‡ðŸ‡ºDebrecen, Hungary
518
🇺🇸Plantation, Florida, United States
377
🇮🇱Haifa, Israel
147
🇮🇹Torino, Italy
982
🇲🇽Mexico City, Mexico
981
🇲🇽Torreon, Mexico
260
🇷🇴Bucharest, Romania
262
🇷🇴Bucharest, Romania
757
🇷🇴Bucharest, Romania
060
🇺🇸Shreveport, Louisiana, United States
042
🇺🇸Aventura, Florida, United States
383
🇮🇱Tel-Hashomer, Israel
742
🇵🇱Poznan, Poland
070
🇺🇸Ormond Beach, Florida, United States
500
🇨🇦London, Ontario, Canada
614
🇫🇷Paris, France
625
🇩🇪Koln, Germany
626
🇩🇪Leipzig, Germany
631
🇩🇪Zerbst, Germany
284
🇷🇺Saint Petersburg, Russian Federation
797
🇺🇦Kiev, Ukraine
533
🇺🇸Fort Lauderdale, Florida, United States
064
🇺🇸Jupiter, Florida, United States
637
🇩🇪Hamburg, Germany
718
ðŸ‡ðŸ‡ºBudapest, Hungary
047
🇺🇸Saint Clair Shores, Michigan, United States
511
🇺🇸Bridgeport, Connecticut, United States
090
🇺🇸Clearwater, Florida, United States
039
🇺🇸Farmington, Connecticut, United States
513
🇺🇸Lansing, Michigan, United States
084
🇺🇸Palm Harbor, Florida, United States
596
🇺🇸Nashua, New Hampshire, United States
599
🇺🇸Lansing, Michigan, United States
149
🇮🇹Ferrara, Italy
242
🇱🇹Kaunas, Lithuania
568
🇺🇸Freehold, New Jersey, United States
504
🇨🇦Toronto, Canada
618
🇫🇷Limoges Cedex, France
648
🇮🇹Milano, Italy
743
🇵🇱Bydgoszcz, Poland
759
🇷🇴Constanta, Romania
756
🇷🇴Galati, Romania
307
🇰🇷Seoul, Korea, Republic of
646
🇮🇹Roma, Italy
261
🇷🇴Cluj-Napoca, Romania
325
🇨🇳Changhua, Taiwan
048
🇺🇸Aurora, Colorado, United States
535
🇺🇸Charleston, South Carolina, United States
078
🇺🇸Austin, Texas, United States
098
🇺🇸Austin, Texas, United States
570
🇺🇸Austin, Texas, United States
634
🇩🇪Mainz, Germany
557
🇺🇸Little Rock, Arkansas, United States
550
🇺🇸La Jolla, California, United States
089
🇺🇸Los Angeles, California, United States
544
🇺🇸Huntington Beach, California, United States
514
🇺🇸Brandon, Florida, United States
585
🇺🇸Port Orange, Florida, United States
087
🇺🇸Vero Beach, Florida, United States
052
🇺🇸Chicago, Illinois, United States
574
🇺🇸Amarillo, Texas, United States
094
🇺🇸Pittsburgh, Pennsylvania, United States
598
🇺🇸Myrtle Beach, South Carolina, United States
107
🇧🇪Brussels, Belgium
427
🇦🇺Clayton, Australia
429
🇦🇺Camperdown, Australia
057
🇺🇸Memphis, Tennessee, United States
571
🇺🇸Jackson, Tennessee, United States
079
🇺🇸Dallas, Texas, United States
104
🇧🇪Liege, Belgium
955
🇧🇷Goiânia, Brazil
451
🇧🇷Recife, Brazil
452
🇧🇷Salvador, Brazil
453
🇧🇷Porto Alegre, Brazil
563
🇺🇸Houston, Texas, United States
534
🇺🇸Seattle, Washington, United States
106
🇧🇪Brussels, Belgium
956
🇧🇷Campinas, Brazil
205
🇧🇬Sofia, Bulgaria
430
🇦🇺Liverpool, Australia
425
🇦🇺Malvern, Australia
105
🇧🇪Leuven, Belgium
954
🇧🇷Belo Horizonte, Brazil
950
🇧🇷Juiz de Fora, Brazil
203
🇧🇬Sofia, Bulgaria
508
🇨🇦Rimouski, Canada
450
🇧🇷Rio de Janeiro, Brazil
952
🇧🇷Rio de Janeiro, Brazil
454
🇧🇷Sao Paulo, Brazil
202
🇧🇬Sofia, Bulgaria
204
🇧🇬Sofia, Bulgaria
502
🇨🇦Hamilton, Canada
200
🇧🇬Sofia, Bulgaria
507
🇨🇦Mississauga, Canada
506
🇨🇦St. John's, Canada
226
🇪🇪Tallinn, Estonia
647
🇮🇹Pisa, Italy
218
🇨🇿Olomouc, Czechia
215
🇨🇿Zlin, Czechia
113
🇫🇷Lille Cedex, France
216
🇨🇿Praha 2, Czechia
127
🇩🇪Berlin, Germany
633
🇩🇪Berlin, Germany
126
🇩🇪Freiburg, Germany
716
ðŸ‡ðŸ‡ºBudapest, Hungary
129
🇩🇪Plochingen, Germany
711
ðŸ‡ðŸ‡ºSzeged, Hungary
715
ðŸ‡ðŸ‡ºSzeged, Hungary
378
🇮🇱Ashkelon, Israel
375
🇮🇱Haifa, Israel
148
🇮🇹Padova, Italy
306
🇰🇷Busan, Korea, Republic of
303
🇰🇷Daegu, Korea, Republic of
301
🇰🇷Incheon, Korea, Republic of
244
🇱🇹Klaipeda, Lithuania
480
🇲🇽Merida, Mexico
747
🇵🇱Szczecin, Poland
749
🇵🇱Warsaw, Poland
976
🇲🇽Mexico City, Mexico
754
🇵🇱Elbląg, Poland
751
🇵🇱Ustron, Poland
746
🇵🇱Katowice, Poland
750
🇵🇱Lublin, Poland
263
🇷🇴Brasov, Romania
758
🇷🇴Bucharest, Romania
281
🇷🇺Ekaterinburg, Russian Federation
660
🇪🇸Getafe, Spain
165
🇪🇸La Laguna, Spain
326
🇨🇳Chiayi City, Taiwan
796
🇺🇦Vinnytsya, Ukraine
779
🇷🇺Moscow, Russian Federation
164
🇪🇸Bilbao, Spain
662
🇪🇸Las Palmas de Gran Canaria, Spain
163
🇪🇸Madrid, Spain
791
🇺🇦Donetsk, Ukraine
328
🇨🇳Kaohsiung City, Taiwan
179
🇬🇧Leeds, United Kingdom
181
🇬🇧Romford, United Kingdom
097
🇺🇸Oklahoma City, Oklahoma, United States
532
🇺🇸Denver, Colorado, United States
539
🇺🇸Birmingham, Alabama, United States
531
🇺🇸San Leandro, California, United States
066
🇺🇸San Antonio, Texas, United States
562
🇺🇸San Antonio, Texas, United States
041
🇺🇸Oklahoma City, Oklahoma, United States
162
🇪🇸Madrid, Spain
096
🇺🇸Indianapolis, Indiana, United States
036
🇺🇸Mesquite, Texas, United States
426
🇦🇺Maroochydore, Australia
794
🇺🇦Kiev, Ukraine
051
🇺🇸Los Angeles, California, United States
594
🇺🇸Thousand Oaks, California, United States
031
🇺🇸Los Angeles, California, United States
558
🇺🇸Torrance, California, United States
092
🇺🇸DeBary, Florida, United States
050
🇺🇸Tampa, Florida, United States
538
🇺🇸Tampa, Florida, United States
590
🇺🇸Idaho Falls, Idaho, United States
044
🇺🇸Duluth, Georgia, United States
575
🇺🇸Florissant, Missouri, United States
551
🇺🇸Brooklyn, New York, United States
549
🇺🇸Saint Louis, Missouri, United States
593
🇺🇸Trenton, New Jersey, United States
545
🇺🇸Manhasset, New York, United States
553
🇺🇸Great Neck, New York, United States
077
🇺🇸Charlotte, North Carolina, United States
577
🇺🇸Roslyn, New York, United States
061
🇺🇸Columbus, Ohio, United States
075
🇺🇸Wilmington, North Carolina, United States
058
🇺🇸Durham, North Carolina, United States
559
🇺🇸Charlotte, North Carolina, United States
076
🇺🇸Oklahoma City, Oklahoma, United States
547
🇺🇸Tulsa, Oklahoma, United States
071
🇺🇸Middleburg Heights, Ohio, United States
093
🇺🇸Philadelphia, Pennsylvania, United States
032
🇺🇸Duncansville, Pennsylvania, United States
616
🇫🇷Toulouse Cedex 9, France
632
🇩🇪Herne, Germany
617
🇫🇷Montpellier Cedex 5, France
116
🇫🇷Pessac, France
628
🇩🇪Berlin, Germany
128
🇩🇪Frankfurt, Germany
636
🇩🇪Roßlau, Germany
627
🇩🇪Munster, Germany
712
ðŸ‡ðŸ‡ºBudapest, Hungary
713
ðŸ‡ðŸ‡ºZalaegerszeg, Hungary
376
🇮🇱Beer Sheva, Israel
382
🇮🇱Kfar Saba, Israel
379
🇮🇱Tel Aviv, Israel
380
🇮🇱Rehovot, Israel
308
🇰🇷Daejeon, Korea, Republic of
302
🇰🇷Suwon, Korea, Republic of
243
🇱🇹Vilnius, Lithuania
478
🇲🇽Guadalajara, Mexico
752
🇵🇱Elblag, Poland
744
🇵🇱Czestochowa, Poland
748
🇵🇱Lublin, Poland
761
🇷🇴Iasi, Romania
264
🇷🇴Bucharest, Romania
901
🇿🇦Cape Town, South Africa
902
🇿🇦Durban, South Africa
661
🇪🇸Barcelona, Spain
903
🇿🇦Stellenbosch, South Africa
161
🇪🇸Barcelona, Spain
166
🇪🇸Malaga, Spain
177
🇪🇸Santander, Spain
663
🇪🇸Santiago de Compostela, Spain
664
🇪🇸Madrid, Spain
160
🇪🇸Sevilla, Spain
659
🇪🇸Vigo, Spain
790
🇺🇦Kiev, Ukraine
330
🇨🇳Taipei, Taiwan
799
🇺🇦Ivano-Frankivsk, Ukraine
792
🇺🇦Lugansk, Ukraine
182
🇬🇧Doncaster, United Kingdom
793
🇺🇦Odessa, Ukraine
677
🇬🇧Birmingham, United Kingdom
178
🇬🇧Brighton, United Kingdom
067
🇺🇸Las Cruces, New Mexico, United States
349
ðŸ‡ðŸ‡°Shatin, Hong Kong