Open Label Extension Study of Epratuzumab in Subjects With Systemic Lupus Erythematosus



Status:Completed
Conditions:Lupus
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:10/5/2018
Start Date:July 2011
End Date:February 2016

Use our guide to learn which trials are right for you!

A Phase 3, Multicenter, Open-label, Extension Study to Assess the Safety and Tolerability of Epratuzumab Treatment in Systemic Lupus Erythematosus Subjects

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

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

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
We found this trial at
67
sites
864
mi
from 43215
Vero Beach, FL
Click here to add this to my saved trials
1078
mi
from 43215
Amarillo, TX
Click here to add this to my saved trials
436
mi
from 43215
Atlanta, GA
Click here to add this to my saved trials
1154
mi
from 43215
Aurora, CO
Click here to add this to my saved trials
1069
mi
from 43215
Austin, TX
Click here to add this to my saved trials
981
mi
from 43215
Aventura, FL
Click here to add this to my saved trials
492
mi
from 43215
Birmingham, AL
Click here to add this to my saved trials
831
mi
from 43215
Brandon, FL
Click here to add this to my saved trials
522
mi
from 43215
Bridgeport, CT
Click here to add this to my saved trials
478
mi
from 43215
Brooklyn, NY
Click here to add this to my saved trials
9459
mi
from 43215
Camperdown,
Click here to add this to my saved trials
Charleston, South Carolina 29412
527
mi
from 43215
Charleston, SC
Click here to add this to my saved trials
Charlotte, North Carolina 28207
350
mi
from 43215
Charlotte, NC
Click here to add this to my saved trials
274
mi
from 43215
Chicago, IL
Click here to add this to my saved trials
830
mi
from 43215
Clearwater, FL
Click here to add this to my saved trials
Colorado Springs, Colorado 80910
1161
mi
from 43215
Colorado Springs, CO
Click here to add this to my saved trials
6
mi
from 43215
Columbus, OH
Click here to add this to my saved trials
910
mi
from 43215
Dallas, TX
Click here to add this to my saved trials
772
mi
from 43215
Debary, FL
Click here to add this to my saved trials
1162
mi
from 43215
Denver, CO
Click here to add this to my saved trials
416
mi
from 43215
Duluth, GA
Click here to add this to my saved trials
Duncansville, Pennsylvania 16635
243
mi
from 43215
Duncansville, PA
Click here to add this to my saved trials
354
mi
from 43215
Durham, NC
Click here to add this to my saved trials
545
mi
from 43215
Farmington, CT
Click here to add this to my saved trials
398
mi
from 43215
Florissant, MO
Click here to add this to my saved trials
970
mi
from 43215
Fort Lauderdale, FL
Click here to add this to my saved trials
462
mi
from 43215
Freehold, NJ
Click here to add this to my saved trials
492
mi
from 43215
Great Neck, NY
Click here to add this to my saved trials
1913
mi
from 43215
Hemet, CA
Click here to add this to my saved trials
991
mi
from 43215
Houston, TX
Click here to add this to my saved trials
Huntington Beach, California 92646
1967
mi
from 43215
Huntington Beach, CA
Click here to add this to my saved trials
1508
mi
from 43215
Idaho Falls, ID
Click here to add this to my saved trials
166
mi
from 43215
Indianapolis, IN
Click here to add this to my saved trials
431
mi
from 43215
Jackson, TN
Click here to add this to my saved trials
916
mi
from 43215
Jupiter, FL
Click here to add this to my saved trials
1926
mi
from 43215
La Jolla, CA
Click here to add this to my saved trials
206
mi
from 43215
Lansing, MI
Click here to add this to my saved trials
1421
mi
from 43215
Las Cruces, NM
Click here to add this to my saved trials
622
mi
from 43215
Little Rock, AR
Click here to add this to my saved trials
1972
mi
from 43215
Los Angeles, CA
Click here to add this to my saved trials
493
mi
from 43215
Manhasset, NY
Click here to add this to my saved trials
508
mi
from 43215
Memphis, TN
Click here to add this to my saved trials
902
mi
from 43215
Mesquite, TX
Click here to add this to my saved trials
116
mi
from 43215
Middleburg Heights, OH
Click here to add this to my saved trials
Myrtle Beach, South Carolina 29572
487
mi
from 43215
Myrtle Beach, SC
Click here to add this to my saved trials
629
mi
from 43215
Nashua, NH
Click here to add this to my saved trials
481
mi
from 43215
New York, NY
Click here to add this to my saved trials
849
mi
from 43215
Oklahoma City, OK
Click here to add this to my saved trials
745
mi
from 43215
Ormond Beach, FL
Click here to add this to my saved trials
821
mi
from 43215
Palm Harbor, FL
Click here to add this to my saved trials
416
mi
from 43215
Philadelphia, PA
Click here to add this to my saved trials
162
mi
from 43215
Pittsburgh, PA
Click here to add this to my saved trials
970
mi
from 43215
Plantation, FL
Click here to add this to my saved trials
757
mi
from 43215
Port Orange, FL
Click here to add this to my saved trials
496
mi
from 43215
Roslyn, NY
Click here to add this to my saved trials
175
mi
from 43215
Saint Clair Shores, MI
Click here to add this to my saved trials
394
mi
from 43215
Saint Louis, MO
Click here to add this to my saved trials
1144
mi
from 43215
San Antonio, TX
Click here to add this to my saved trials
2094
mi
from 43215
San Leandro, CA
Click here to add this to my saved trials
2005
mi
from 43215
Seattle, WA
Click here to add this to my saved trials
789
mi
from 43215
Shreveport, LA
Click here to add this to my saved trials
831
mi
from 43215
Tampa, FL
Click here to add this to my saved trials
Thousand Oaks, California 91360
2003
mi
from 43215
Thousand Oaks, CA
Click here to add this to my saved trials
1983
mi
from 43215
Torrance, CA
Click here to add this to my saved trials
436
mi
from 43215
Trenton, NJ
Click here to add this to my saved trials
752
mi
from 43215
Tulsa, OK
Click here to add this to my saved trials
Wilmington, North Carolina 28401
484
mi
from 43215
Wilmington, NC
Click here to add this to my saved trials