Study of Epratuzumab Versus Placebo in Subjects With Moderate to Severe General Systemic Lupus Erythematosus (EMBODY 1)

Tracking Information
First Submitted Date ICMJE	December 14, 2010
First Posted Date ICMJE	December 17, 2010
Last Update Posted Date	February 5, 2016
Study Start Date ICMJE	December 2010
Actual Primary Completion Date	May 2015 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: December 15, 2010)	The percent of subjects meeting treatment response criteria at Week 48 according to a combined response index [ Time Frame: Week 48 ]; The percent of subjects meeting treatment response criteria at Week 48 according to a combined response index
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01262365 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: December 15, 2010)	The percent of subjects meeting treatment response criteria at Week 24 according to a combined response index [ Time Frame: Week 24 ]The percent of subjects meeting treatment response criteria at Week 24 according to a combined response index; The percent of subjects meeting treatment response criteria at Week 12 according to a combined response index [ Time Frame: Week 12 ]The percent of subjects meeting treatment response criteria at Week 12 according to a combined response index; The percent of subjects meeting treatment response criteria at Week 36 according to a combined response index [ Time Frame: Week 36 ]The percent of subjects meeting treatment response criteria at Week 36 according to a combined response index; Change from Baseline in daily corticosteroid dose at week 24 [ Time Frame: Baseline, Week 24 ]Change from Baseline in daily corticosteroid dose at week 24; Change from Baseline in daily corticosteroid dose at week 48 [ Time Frame: Baseline, Week 48 ]Change from Baseline in daily corticosteroid dose at week 48
Original Secondary Outcome Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Study of Epratuzumab Versus Placebo in Subjects With Moderate to Severe General Systemic Lupus Erythematosus
Official Title ICMJE	A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of the Efficacy and Safety of Four 12-week Treatment Cycles (48 Weeks Total) of Epratuzumab in Systemic Lupus Erythematosus Subjects With Moderate to Severe Disease
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 Provided
Study Type ICMJE	Interventional
Study Phase	Phase 3
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition ICMJE	Systemic Lupus Erythematosus
Intervention ICMJE	Drug: Epratuzumab 600 mg infusions delivered weekly for a total of 4 weeks (cumulative dose 2400 mg) over four 12- week treatment cycles; Drug: Epratuzumab 1200 mg infusions delivered every other week for a total of 4 weeks (cumulative dose 2400 mg) over four 12-week treatment cycles; Drug: Placebo Placebo infusions delivered weekly for 4 weeks over four 12-week treatment cycles
Study Arms	Placebo Comparator: Placebo (Weekly infusion) Placebo infusions delivered weekly for a total of 4 weeks over four 12-week treatment cycles Intervention: Drug: Placebo; Experimental: Epratuzumab 600 mg per week 600 mg infusions delivered weekly for a total of 4 weeks (cumulative dose 2400 mg) over four 12-week treatment cycles Intervention: Drug: Epratuzumab; Experimental: Epratuzumab 1200 mg every other week 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 Interventions: Drug: Epratuzumab Drug: Placebo
Publications *	Gottenberg JE, Dörner T, Bootsma H, Devauchelle-Pensec V, Bowman SJ, Mariette X, Bartz H, Oortgiesen M, Shock A, Koetse W, Galateanu C, Bongardt S, Wegener WA, Goldenberg DM, Meno-Tetang G, Kosutic G, Gordon C. Efficacy of Epratuzumab, an Anti-CD22 Monoclonal IgG Antibody, in Systemic Lupus Erythematosus Patients With Associated Sjögren's Syndrome: Post Hoc Analyses From the EMBODY Trials. Arthritis Rheumatol. 2018 May;70(5):763-773. doi: 10.1002/art.40425. Epub 2018 Apr 12.; Clowse ME, Wallace DJ, Furie RA, Petri MA, Pike MC, Leszczyński P, Neuwelt CM, Hobbs K, Keiserman M, Duca L, Kalunian KC, Galateanu C, Bongardt S, Stach C, Beaudot C, Kilgallen B, Gordon C; EMBODY Investigator Group. Efficacy and Safety of Epratuzumab in Moderately to Severely Active Systemic Lupus Erythematosus: Results From Two Phase III Randomized, Double-Blind, Placebo-Controlled Trials. Arthritis Rheumatol. 2017 Feb;69(2):362-375. doi: 10.1002/art.39856.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: July 7, 2015)	793
Original Estimated Enrollment ICMJE; (submitted: December 15, 2010)	780
Actual Study Completion Date	May 2015
Actual Primary Completion Date	May 2015 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	Inclusion Criteria: 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 SLEDAI total score.; On stable SLE treatment regimen, including mandatory corticosteroids and immunosuppressants or antimalarials Exclusion Criteria: 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.
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Older Adult)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Australia, Belgium, Brazil, Bulgaria, Czech Republic, Estonia, France, Germany, India, Israel, Italy, Korea, Republic of, Lithuania, Mexico, Puerto Rico, Romania, Russian Federation, Spain, Taiwan, United Kingdom, United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT01262365
Other Study ID Numbers ICMJE	SL0009; 2010-018563-41 ( EudraCT Number )
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	UCB Pharma
Study Sponsor ICMJE	UCB Pharma
Collaborators ICMJE	Not Provided
Investigators ICMJE	Study Director: UCb Clinical Trial Call Center +1 877 822 9493 (UCB)
PRS Account	UCB Pharma
Verification Date	January 2016
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP