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Trial record 1 of 1 for:    NCT01261793
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Study of Epratuzumab Versus Placebo in Subjects With Moderate to Severe General Systemic Lupus Erythematosus (SLE) (EMBODY2)

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ClinicalTrials.gov Identifier: NCT01261793
Recruitment Status : Completed
First Posted : December 16, 2010
Results First Posted : June 29, 2018
Last Update Posted : September 28, 2018
Sponsor:
Information provided by (Responsible Party):
UCB Pharma

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Systemic Lupus Erythematosus
Interventions Drug: Placebo
Drug: Epratuzumab
Enrollment 791
Recruitment Details The study started to enroll patients in December 2010 and concluded in June 2015.
Pre-assignment Details Participant Flow refers to the Randomized Set (RS).
Arm/Group Title Placebo Weekly (RS) Epratuzumab 1200 mg Every Other Week (RS) Epratuzumab 600 mg Weekly (RS)
Hide Arm/Group Description Placebo infusions delivered weekly for a total of 4 weeks over four 12-week treatment cycles 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 600 mg infusions delivered weekly for a total of 4 weeks (cumulative dose 2400 mg) over four 12 week treatment cycles
Period Title: Overall Study
Started 263 262 266
Completed 178 171 184
Not Completed 85 91 82
Reason Not Completed
Lack of Efficacy             44             37             32
Protocol Violation             3             5             6
Lost to Follow-up             10             3             7
Withdrawal by Subject             12             14             14
Death             3             1             0
Adverse Event             9             24             19
Patient non-availability             1             1             1
Suspected pregnancy             1             1             0
Patient non-compliance             1             0             1
Patient pregnant             1             0             0
Outside the study area             0             2             1
Lack of efficacy & patient not available             0             1             0
Patient withdrew after cardiology visit             0             1             0
Randomization error             0             1             0
Patient unable to start IV line             0             0             1
Arm/Group Title Placebo Weekly (SS) Epratuzumab 1200 mg Every Other Week (SS) Epratuzumab 600 mg Weekly (SS) Total Title
Hide Arm/Group Description Placebo infusions delivered weekly for a total of 4 weeks over four 12-week treatment cycles 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 600 mg infusions delivered weekly for a total of 4 weeks (cumulative dose 2400 mg) over four 12 week treatment cycles [Not Specified]
Overall Number of Baseline Participants 263 261 264 788
Hide Baseline Analysis Population Description
Baseline Characteristics refers to the Safety Set (SS).
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 263 participants 261 participants 264 participants 788 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
254
  96.6%
257
  98.5%
254
  96.2%
765
  97.1%
>=65 years
9
   3.4%
4
   1.5%
10
   3.8%
23
   2.9%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 263 participants 261 participants 264 participants 788 participants
41.1  (11.8) 40.8  (11.5) 41.2  (12.7) 41.0  (12.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 263 participants 261 participants 264 participants 788 participants
Female
18
   6.8%
14
   5.4%
19
   7.2%
51
   6.5%
Male
245
  93.2%
247
  94.6%
245
  92.8%
737
  93.5%
1.Primary Outcome
Title The Percent of Subjects Meeting Treatment Response Criteria at Week 48 According to a Combined Response Index
Hide Description 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.
Time Frame At Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of the study drug.
Arm/Group Title Placebo Weekly (FAS) Epratuzumab 1200 mg Every Other Week (FAS) Epratuzumab 600 mg Weekly (FAS)
Hide Arm/Group Description:
Placebo infusions delivered weekly for a total of 4 weeks over four 12-week treatment cycles
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
600 mg infusions delivered weekly for a total of 4 weeks (cumulative dose 2400 mg) over four 12 week treatment cycles
Overall Number of Participants Analyzed 263 261 264
Measure Type: Number
Unit of Measure: Percentage of responders
33.5 34.1 35.2
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Weekly (FAS), Epratuzumab 1200 mg Every Other Week (FAS)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.899
Comments p-values for the comparison of treatment groups have been calculated using logistic regression with factors for treatment, pooled region, and baseline disease status.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.024
Confidence Interval (2-Sided) 95%
0.710 to 1.477
Estimation Comments Odds ratio: Epratuzumab/Placebo calculated using logistic regression with factors for treatment, pooled region, and baseline disease status.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo Weekly (FAS), Epratuzumab 600 mg Weekly (FAS)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.716
Comments p-values for the comparison of treatment groups have been calculated using logistic regression with factors for treatment, pooled region, and baseline disease status.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.070
Confidence Interval (2-Sided) 95%
0.743 to 1.539
Estimation Comments Odds ratio: Epratuzumab/Placebo calculated using logistic regression with factors for treatment, pooled region, and baseline disease status.
2.Secondary Outcome
Title The Percent of Subjects Meeting Treatment Response Criteria at Week 24 According to a Combined Response Index
Hide Description 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.
Time Frame At Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of the study drug.
Arm/Group Title Placebo Weekly (FAS) Epratuzumab 1200 mg Every Other Week (FAS) Epratuzumab 600 mg Weekly (FAS)
Hide Arm/Group Description:
Placebo infusions delivered weekly for a total of 4 weeks over four 12-week treatment cycles
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
600 mg infusions delivered weekly for a total of 4 weeks (cumulative dose 2400 mg) over four 12 week treatment cycles
Overall Number of Participants Analyzed 263 261 264
Measure Type: Number
Unit of Measure: Percentage of responders
32.3 33.0 43.6
3.Secondary Outcome
Title The Percent of Subjects Meeting Treatment Response Criteria at Week 12 According to a Combined Response Index
Hide Description 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.
Time Frame At Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of the study drug.
Arm/Group Title Placebo Weekly (FAS) Epratuzumab 1200 mg Every Other Week (FAS) Epratuzumab 600 mg Weekly (FAS)
Hide Arm/Group Description:
Placebo infusions delivered weekly for a total of 4 weeks over four 12-week treatment cycles
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
600 mg infusions delivered weekly for a total of 4 weeks (cumulative dose 2400 mg) over four 12 week treatment cycles
Overall Number of Participants Analyzed 263 261 264
Measure Type: Number
Unit of Measure: Percentage of responders
30.0 32.2 40.9
4.Secondary Outcome
Title The Percent of Subjects Meeting Treatment Response Criteria at Week 36 According to a Combined Response Index
Hide Description 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.
Time Frame At Week 36
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of the study drug.
Arm/Group Title Placebo Weekly (FAS) Epratuzumab 1200 mg Every Other Week (FAS) Epratuzumab 600 mg Weekly (FAS)
Hide Arm/Group Description:
Placebo infusions delivered weekly for a total of 4 weeks over four 12-week treatment cycles
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
600 mg infusions delivered weekly for a total of 4 weeks (cumulative dose 2400 mg) over four 12 week treatment cycles
Overall Number of Participants Analyzed 263 261 264
Measure Type: Number
Unit of Measure: Percentage of responders
32.7 33.0 36.7
5.Secondary Outcome
Title Change From Baseline in Daily Corticosteroid Dose at Week 24
Hide Description 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.
Time Frame At Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of the study drug.
Arm/Group Title Placebo Weekly (FAS) Epratuzumab 1200 mg Every Other Week (FAS) Epratuzumab 600 mg Weekly (FAS)
Hide Arm/Group Description:
Placebo infusions delivered weekly for a total of 4 weeks over four 12-week treatment cycles
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
600 mg infusions delivered weekly for a total of 4 weeks (cumulative dose 2400 mg) over four 12 week treatment cycles
Overall Number of Participants Analyzed 263 261 264
Measure Type: Number
Unit of Measure: Percentage of subjects
Dose decreased by >50% 4.6 10.0 8.7
Dose decreased >0% to ≤50% 20.9 18.0 18.2
No change in dose 48.3 46.7 52.7
Dose increased or missing data 26.2 25.3 20.5
6.Secondary Outcome
Title Change From Baseline in Daily Corticosteroid Dose at Week 48
Hide Description 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.
Time Frame At Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of the study drug.
Arm/Group Title Placebo Weekly (FAS) Epratuzumab 1200 mg Every Other Week (FAS) Epratuzumab 600 mg Weekly (FAS)
Hide Arm/Group Description:
Placebo infusions delivered weekly for a total of 4 weeks over four 12-week treatment cycles
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
600 mg infusions delivered weekly for a total of 4 weeks (cumulative dose 2400 mg) over four 12 week treatment cycles
Overall Number of Participants Analyzed 263 261 264
Measure Type: Number
Unit of Measure: Percentage of participants
Dose decreased by >50% 6.5 13.8 14.8
Dose decreased >0% to ≤50% 20.9 13.4 15.9
No change in dose 35.7 35.6 36.7
Dose increased or missing data 36.9 37.2 32.6
Time Frame Treatment-emergent Adverse Events (TEAEs) were collected throughout the study (on or after first infusion of study drug and within 75 days of the last infusion), for an average of 4.5 years (starting in December 2010 and concluding in June 2015). The Safety Set will be utilized for TEAE reporting.
Adverse Event Reporting Description The Safety Set (SS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug.
 
Arm/Group Title Placebo Weekly (SS) Epratuzumab 1200 mg Every Other Week (SS) Epratuzumab 600 mg Weekly (SS)
Hide Arm/Group Description Placebo infusions delivered weekly for a total of 4 weeks over four 12-week treatment cycles 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 600 mg infusions delivered weekly for a total of 4 weeks (cumulative dose 2400 mg) over four 12 week treatment cycles
All-Cause Mortality
Placebo Weekly (SS) Epratuzumab 1200 mg Every Other Week (SS) Epratuzumab 600 mg Weekly (SS)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3/263 (1.14%)      1/261 (0.38%)      0/264 (0.00%)    
Hide Serious Adverse Events
Placebo Weekly (SS) Epratuzumab 1200 mg Every Other Week (SS) Epratuzumab 600 mg Weekly (SS)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   45/263 (17.11%)      45/261 (17.24%)      50/264 (18.94%)    
Blood and lymphatic system disorders       
Anaemia * 1  1/263 (0.38%)  1 2/261 (0.77%)  2 0/264 (0.00%)  0
Leukopenia * 1  1/263 (0.38%)  1 0/261 (0.00%)  0 2/264 (0.76%)  2
Pancytopenia * 1  0/263 (0.00%)  0 1/261 (0.38%)  1 1/264 (0.38%)  1
Antiphospholipid syndrome * 1  0/263 (0.00%)  0 0/261 (0.00%)  0 1/264 (0.38%)  1
Thrombocytopenia * 1  0/263 (0.00%)  0 1/261 (0.38%)  1 0/264 (0.00%)  0
Cardiac disorders       
Angina pectoris * 1  0/263 (0.00%)  0 2/261 (0.77%)  2 0/264 (0.00%)  0
Angina unstable * 1  0/263 (0.00%)  0 0/261 (0.00%)  0 1/264 (0.38%)  1
Atrial fibrillation * 1  0/263 (0.00%)  0 1/261 (0.38%)  1 0/264 (0.00%)  0
Coronary artery disease * 1  0/263 (0.00%)  0 0/261 (0.00%)  0 1/264 (0.38%)  1
Palpitations * 1  0/263 (0.00%)  0 1/261 (0.38%)  1 0/264 (0.00%)  0
Sinus tachycardia * 1  0/263 (0.00%)  0 0/261 (0.00%)  0 1/264 (0.38%)  1
Cardiac failure congestive * 1  1/263 (0.38%)  1 0/261 (0.00%)  0 0/264 (0.00%)  0
Lupus myocarditis * 1  1/263 (0.38%)  1 0/261 (0.00%)  0 0/264 (0.00%)  0
Mitral valve incompetence * 1  1/263 (0.38%)  1 0/261 (0.00%)  0 0/264 (0.00%)  0
Myocardial infarction * 1  1/263 (0.38%)  1 0/261 (0.00%)  0 0/264 (0.00%)  0
Congenital, familial and genetic disorders       
Talipes * 1  0/263 (0.00%)  0 1/261 (0.38%)  1 0/264 (0.00%)  0
Endocrine disorders       
Goitre * 1  0/263 (0.00%)  0 0/261 (0.00%)  0 1/264 (0.38%)  1
Eye disorders       
Necrotising retinitis * 1  0/263 (0.00%)  0 1/261 (0.38%)  1 0/264 (0.00%)  0
Visual impairment * 1  0/263 (0.00%)  0 0/261 (0.00%)  0 1/264 (0.38%)  1
Cataract * 1  1/263 (0.38%)  1 0/261 (0.00%)  0 0/264 (0.00%)  0
Retinal degeneration * 1  1/263 (0.38%)  1 0/261 (0.00%)  0 0/264 (0.00%)  0
Gastrointestinal disorders       
Pancreatitis acute * 1  0/263 (0.00%)  0 1/261 (0.38%)  1 1/264 (0.38%)  1
Abdominal distension * 1  0/263 (0.00%)  0 1/261 (0.38%)  1 0/264 (0.00%)  0
Abdominal pain * 1  2/263 (0.76%)  2 0/261 (0.00%)  0 1/264 (0.38%)  1
Abdominal pain upper * 1  0/263 (0.00%)  0 0/261 (0.00%)  0 1/264 (0.38%)  1
Mechanical ileus * 1  0/263 (0.00%)  0 1/261 (0.38%)  2 0/264 (0.00%)  0
Pancreatitis * 1  0/263 (0.00%)  0 0/261 (0.00%)  0 1/264 (0.38%)  1
Reflux gastritis * 1  0/263 (0.00%)  0 0/261 (0.00%)  0 1/264 (0.38%)  1
Vomiting * 1  1/263 (0.38%)  2 0/261 (0.00%)  0 1/264 (0.38%)  1
Diarrhoea * 1  1/263 (0.38%)  1 0/261 (0.00%)  0 0/264 (0.00%)  0
Diverticulum intestinal * 1  1/263 (0.38%)  1 0/261 (0.00%)  0 0/264 (0.00%)  0
Enteritis * 1  1/263 (0.38%)  1 0/261 (0.00%)  0 0/264 (0.00%)  0
Gastrointestinal hypomotility * 1  1/263 (0.38%)  1 0/261 (0.00%)  0 0/264 (0.00%)  0
Nausea * 1  1/263 (0.38%)  1 0/261 (0.00%)  0 0/264 (0.00%)  0
General disorders       
Chest pain * 1  2/263 (0.76%)  2 4/261 (1.53%)  5 3/264 (1.14%)  4
Asthenia * 1  1/263 (0.38%)  1 0/261 (0.00%)  0 1/264 (0.38%)  1
Oedema peripheral * 1  0/263 (0.00%)  0 1/261 (0.38%)  1 0/264 (0.00%)  0
Pyrexia * 1  0/263 (0.00%)  0 0/261 (0.00%)  0 1/264 (0.38%)  1
Hepatobiliary disorders       
Bile duct stenosis * 1  0/263 (0.00%)  0 1/261 (0.38%)  1 0/264 (0.00%)  0
Cholecystitis * 1  1/263 (0.38%)  1 0/261 (0.00%)  0 0/264 (0.00%)  0
Cholelithiasis * 1  3/263 (1.14%)  3 0/261 (0.00%)  0 0/264 (0.00%)  0
Hepatic steatosis * 1  1/263 (0.38%)  1 0/261 (0.00%)  0 0/264 (0.00%)  0
Liver injury * 1  1/263 (0.38%)  1 0/261 (0.00%)  0 0/264 (0.00%)  0
Immune system disorders       
Anaphylactic reaction * 1  0/263 (0.00%)  0 1/261 (0.38%)  1 1/264 (0.38%)  1
Drug hypersensitivity * 1  0/263 (0.00%)  0 1/261 (0.38%)  1 0/264 (0.00%)  0
Infections and infestations       
Pneumonia * 1  3/263 (1.14%)  3 2/261 (0.77%)  2 4/264 (1.52%)  4
Urinary tract infection * 1  2/263 (0.76%)  2 0/261 (0.00%)  0 3/264 (1.14%)  3
Sepsis * 1  0/263 (0.00%)  0 2/261 (0.77%)  2 0/264 (0.00%)  0
Abdominal abscess * 1  0/263 (0.00%)  0 1/261 (0.38%)  1 0/264 (0.00%)  0
Arthritis infective * 1  0/263 (0.00%)  0 1/261 (0.38%)  1 0/264 (0.00%)  0
Cellulitis * 1  1/263 (0.38%)  1 1/261 (0.38%)  1 0/264 (0.00%)  0
Cytomegalovirus chorioretinitis * 1  0/263 (0.00%)  0 1/261 (0.38%)  1 0/264 (0.00%)  0
Cytomegalovirus viraemia * 1  0/263 (0.00%)  0 1/261 (0.38%)  1 0/264 (0.00%)  0
Dengue fever * 1  0/263 (0.00%)  0 0/261 (0.00%)  0 1/264 (0.38%)  1
Dermatitis infected * 1  0/263 (0.00%)  0 1/261 (0.38%)  1 0/264 (0.00%)  0
Gastroenteritis * 1  3/263 (1.14%)  3 0/261 (0.00%)  0 1/264 (0.38%)  1
Gastroenteritis viral * 1  1/263 (0.38%)  1 1/261 (0.38%)  1 0/264 (0.00%)  0
Herpes zoster * 1  1/263 (0.38%)  1 0/261 (0.00%)  0 1/264 (0.38%)  1
Infected skin ulcer * 1  0/263 (0.00%)  0 0/261 (0.00%)  0 1/264 (0.38%)  1
Infection * 1  0/263 (0.00%)  0 1/261 (0.38%)  1 0/264 (0.00%)  0
Meningitis aseptic * 1  0/263 (0.00%)  0 0/261 (0.00%)  0 1/264 (0.38%)  1
Pulmonary tuberculosis * 1  0/263 (0.00%)  0 0/261 (0.00%)  0 1/264 (0.38%)  1
Sialoadenitis * 1  0/263 (0.00%)  0 0/261 (0.00%)  0 1/264 (0.38%)  1
Skin bacterial infection * 1  0/263 (0.00%)  0 0/261 (0.00%)  0 1/264 (0.38%)  1
Viral infection * 1  0/263 (0.00%)  0 1/261 (0.38%)  1 0/264 (0.00%)  0
Appendicitis * 1  1/263 (0.38%)  1 0/261 (0.00%)  0 0/264 (0.00%)  0
Eye infection toxoplasmal * 1  1/263 (0.38%)  1 0/261 (0.00%)  0 0/264 (0.00%)  0
Lobar pneumonia * 1  1/263 (0.38%)  1 0/261 (0.00%)  0 0/264 (0.00%)  0
Meningitis bacterial * 1  1/263 (0.38%)  1 0/261 (0.00%)  0 0/264 (0.00%)  0
Pseudomonas infection * 1  1/263 (0.38%)  1 0/261 (0.00%)  0 0/264 (0.00%)  0
Pyelonephritis * 1  1/263 (0.38%)  1 0/261 (0.00%)  0 0/264 (0.00%)  0
Respiratory tract infection * 1  1/263 (0.38%)  1 0/261 (0.00%)  0 0/264 (0.00%)  0
Injury, poisoning and procedural complications       
Radius fracture * 1  1/263 (0.38%)  1 0/261 (0.00%)  0 1/264 (0.38%)  1
Rib fracture * 1  0/263 (0.00%)  0 1/261 (0.38%)  1 0/264 (0.00%)  0
Tendon rupture * 1  0/263 (0.00%)  0 1/261 (0.38%)  1 0/264 (0.00%)  0
Ulna fracture * 1  0/263 (0.00%)  0 0/261 (0.00%)  0 1/264 (0.38%)  1
Femur fracture * 1  1/263 (0.38%)  1 0/261 (0.00%)  0 0/264 (0.00%)  0
Post lumbar puncture syndrome * 1  1/263 (0.38%)  1 0/261 (0.00%)  0 0/264 (0.00%)  0
Investigations       
Blood creatinine decreased * 1  0/263 (0.00%)  0 1/261 (0.38%)  1 0/264 (0.00%)  0
Blood pressure increased * 1  0/263 (0.00%)  0 0/261 (0.00%)  0 1/264 (0.38%)  1
Metabolism and nutrition disorders       
Dehydration * 1  0/263 (0.00%)  0 1/261 (0.38%)  1 0/264 (0.00%)  0
Diabetes mellitus * 1  0/263 (0.00%)  0 0/261 (0.00%)  0 1/264 (0.38%)  1
Hypokalaemia * 1  1/263 (0.38%)  1 0/261 (0.00%)  0 0/264 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Systemic lupus erythematosus * 1  7/263 (2.66%)  7 6/261 (2.30%)  6 6/264 (2.27%)  6
Osteonecrosis * 1  0/263 (0.00%)  0 1/261 (0.38%)  1 1/264 (0.38%)  1
Arthralgia * 1  1/263 (0.38%)  1 1/261 (0.38%)  1 0/264 (0.00%)  0
Compartment syndrome * 1  0/263 (0.00%)  0 1/261 (0.38%)  1 0/264 (0.00%)  0
Flank pain * 1  0/263 (0.00%)  0 0/261 (0.00%)  0 1/264 (0.38%)  1
Foot deformity * 1  0/263 (0.00%)  0 1/261 (0.38%)  1 0/264 (0.00%)  0
Muscular weakness * 1  0/263 (0.00%)  0 0/261 (0.00%)  0 1/264 (0.38%)  1
Musculoskeletal chest pain * 1  0/263 (0.00%)  0 0/261 (0.00%)  0 1/264 (0.38%)  1
Musculoskeletal pain * 1  0/263 (0.00%)  0 1/261 (0.38%)  1 0/264 (0.00%)  0
Musculoskeletal stiffness * 1  0/263 (0.00%)  0 1/261 (0.38%)  1 0/264 (0.00%)  0
Myositis * 1  0/263 (0.00%)  0 1/261 (0.38%)  1 0/264 (0.00%)  0
Pain in extremity * 1  0/263 (0.00%)  0 1/261 (0.38%)  1 0/264 (0.00%)  0
Periarthritis * 1  0/263 (0.00%)  0 1/261 (0.38%)  1 0/264 (0.00%)  0
Rhabdomyolysis * 1  0/263 (0.00%)  0 1/261 (0.38%)  1 0/264 (0.00%)  0
Synovitis * 1  0/263 (0.00%)  0 0/261 (0.00%)  0 1/264 (0.38%)  1
Joint swelling * 1  1/263 (0.38%)  1 0/261 (0.00%)  0 0/264 (0.00%)  0
Neck pain * 1  1/263 (0.38%)  1 0/261 (0.00%)  0 0/264 (0.00%)  0
Patellofemoral pain syndrome * 1  1/263 (0.38%)  1 0/261 (0.00%)  0 0/264 (0.00%)  0
Spinal pain * 1  1/263 (0.38%)  1 0/261 (0.00%)  0 0/264 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Adenocarcinoma * 1  0/263 (0.00%)  0 0/261 (0.00%)  0 1/264 (0.38%)  1
Colon adenoma * 1  0/263 (0.00%)  0 1/261 (0.38%)  1 0/264 (0.00%)  0
Papillary thyroid cancer * 1  0/263 (0.00%)  0 0/261 (0.00%)  0 1/264 (0.38%)  1
Squamous cell carcinoma of skin * 1  0/263 (0.00%)  0 1/261 (0.38%)  1 0/264 (0.00%)  0
Ovarian adenoma * 1  1/263 (0.38%)  1 0/261 (0.00%)  0 0/264 (0.00%)  0
Nervous system disorders       
Aphasia * 1  0/263 (0.00%)  0 1/261 (0.38%)  1 0/264 (0.00%)  0
Cerebral infarction * 1  0/263 (0.00%)  0 1/261 (0.38%)  1 0/264 (0.00%)  0
Cerebrovascular accident * 1  0/263 (0.00%)  0 0/261 (0.00%)  0 1/264 (0.38%)  2
Convulsion * 1  1/263 (0.38%)  1 1/261 (0.38%)  3 0/264 (0.00%)  0
Dizziness * 1  0/263 (0.00%)  0 0/261 (0.00%)  0 1/264 (0.38%)  1
Dysarthria * 1  0/263 (0.00%)  0 1/261 (0.38%)  1 0/264 (0.00%)  0
Headache * 1  3/263 (1.14%)  3 0/261 (0.00%)  0 1/264 (0.38%)  1
Lupus encephalitis * 1  0/263 (0.00%)  0 1/261 (0.38%)  1 0/264 (0.00%)  0
Memory impairment * 1  0/263 (0.00%)  0 0/261 (0.00%)  0 1/264 (0.38%)  1
Migraine * 1  0/263 (0.00%)  0 1/261 (0.38%)  1 0/264 (0.00%)  0
Myoclonus * 1  0/263 (0.00%)  0 0/261 (0.00%)  0 1/264 (0.38%)  1
Nerve compression * 1  0/263 (0.00%)  0 0/261 (0.00%)  0 1/264 (0.38%)  1
Syncope * 1  0/263 (0.00%)  0 1/261 (0.38%)  1 0/264 (0.00%)  0
Transient ischaemic attack * 1  0/263 (0.00%)  0 1/261 (0.38%)  1 0/264 (0.00%)  0
VIIth nerve paralysis * 1  0/263 (0.00%)  0 1/261 (0.38%)  1 0/264 (0.00%)  0
Vasculitis cerebral * 1  0/263 (0.00%)  0 0/261 (0.00%)  0 1/264 (0.38%)  1
Hemiparesis * 1  1/263 (0.38%)  1 0/261 (0.00%)  0 0/264 (0.00%)  0
Noninfectious myelitis * 1  1/263 (0.38%)  1 0/261 (0.00%)  0 0/264 (0.00%)  0
Optic neuritis * 1  1/263 (0.38%)  2 0/261 (0.00%)  0 0/264 (0.00%)  0
Paraesthesia * 1  1/263 (0.38%)  1 0/261 (0.00%)  0 0/264 (0.00%)  0
Pregnancy, puerperium and perinatal conditions       
Pregnancy * 1  1/263 (0.38%)  1 1/261 (0.38%)  1 0/264 (0.00%)  0
Pregnancy on contraceptive * 1  0/263 (0.00%)  0 1/261 (0.38%)  1 0/264 (0.00%)  0
Psychiatric disorders       
Anxiety * 1  0/263 (0.00%)  0 0/261 (0.00%)  0 1/264 (0.38%)  1
Confusional state * 1  0/263 (0.00%)  0 1/261 (0.38%)  1 0/264 (0.00%)  0
Depression * 1  0/263 (0.00%)  0 0/261 (0.00%)  0 1/264 (0.38%)  2
Generalised anxiety disorder * 1  0/263 (0.00%)  0 0/261 (0.00%)  0 1/264 (0.38%)  1
Suicide attempt * 1  0/263 (0.00%)  0 1/261 (0.38%)  1 0/264 (0.00%)  0
Renal and urinary disorders       
Lupus nephritis * 1  2/263 (0.76%)  2 1/261 (0.38%)  1 0/264 (0.00%)  0
Nephrotic syndrome * 1  2/263 (0.76%)  2 1/261 (0.38%)  1 0/264 (0.00%)  0
Proteinuria * 1  1/263 (0.38%)  1 0/261 (0.00%)  0 0/264 (0.00%)  0
Renal impairment * 1  1/263 (0.38%)  1 0/261 (0.00%)  0 0/264 (0.00%)  0
Reproductive system and breast disorders       
Cervical dysplasia * 1  0/263 (0.00%)  0 0/261 (0.00%)  0 1/264 (0.38%)  1
Respiratory, thoracic and mediastinal disorders       
Dyspnoea * 1  0/263 (0.00%)  0 0/261 (0.00%)  0 4/264 (1.52%)  4
Bronchiectasis * 1  0/263 (0.00%)  0 0/261 (0.00%)  0 1/264 (0.38%)  1
Emphysema * 1  0/263 (0.00%)  0 0/261 (0.00%)  0 1/264 (0.38%)  1
Hypoxia * 1  0/263 (0.00%)  0 0/261 (0.00%)  0 1/264 (0.38%)  1
Interstitial lung disease * 1  0/263 (0.00%)  0 0/261 (0.00%)  0 1/264 (0.38%)  2
Lupus pleurisy * 1  0/263 (0.00%)  0 1/261 (0.38%)  1 0/264 (0.00%)  0
Lupus pneumonitis * 1  0/263 (0.00%)  0 1/261 (0.38%)  1 0/264 (0.00%)  0
Pleurisy * 1  0/263 (0.00%)  0 1/261 (0.38%)  1 0/264 (0.00%)  0
Pulmonary alveolar haemorrhage * 1  0/263 (0.00%)  0 1/261 (0.38%)  1 0/264 (0.00%)  0
Pulmonary hypertension * 1  0/263 (0.00%)  0 0/261 (0.00%)  0 1/264 (0.38%)  1
Pulmonary mass * 1  0/263 (0.00%)  0 0/261 (0.00%)  0 1/264 (0.38%)  1
Pneumothorax * 1  1/263 (0.38%)  1 0/261 (0.00%)  0 0/264 (0.00%)  0
Skin and subcutaneous tissue disorders       
Cutaneous lupus erythematosus * 1  0/263 (0.00%)  0 0/261 (0.00%)  0 1/264 (0.38%)  1
Purpura * 1  0/263 (0.00%)  0 0/261 (0.00%)  0 1/264 (0.38%)  1
Rash * 1  1/263 (0.38%)  1 0/261 (0.00%)  0 1/264 (0.38%)  1
Stevens-Johnson syndrome * 1  0/263 (0.00%)  0 1/261 (0.38%)  1 0/264 (0.00%)  0
Angioedema * 1  1/263 (0.38%)  1 0/261 (0.00%)  0 0/264 (0.00%)  0
Cutaneous vasculitis * 1  1/263 (0.38%)  1 0/261 (0.00%)  0 0/264 (0.00%)  0
Surgical and medical procedures       
Abortion induced * 1  0/263 (0.00%)  0 1/261 (0.38%)  1 0/264 (0.00%)  0
Vascular disorders       
Hypertensive crisis * 1  0/263 (0.00%)  0 2/261 (0.77%)  2 1/264 (0.38%)  1
Hypertension * 1  0/263 (0.00%)  0 2/261 (0.77%)  2 0/264 (0.00%)  0
Lymphoedema * 1  0/263 (0.00%)  0 0/261 (0.00%)  0 1/264 (0.38%)  1
Raynaud's phenomenon * 1  0/263 (0.00%)  0 0/261 (0.00%)  0 1/264 (0.38%)  1
Temporal arteritis * 1  0/263 (0.00%)  0 0/261 (0.00%)  0 1/264 (0.38%)  1
Deep vein thrombosis * 1  1/263 (0.38%)  1 0/261 (0.00%)  0 0/264 (0.00%)  0
1
Term from vocabulary, MedDRA17.0
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Weekly (SS) Epratuzumab 1200 mg Every Other Week (SS) Epratuzumab 600 mg Weekly (SS)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   151/263 (57.41%)      145/261 (55.56%)      158/264 (59.85%)    
Gastrointestinal disorders       
Nausea * 1  36/263 (13.69%)  51 32/261 (12.26%)  41 25/264 (9.47%)  38
Diarrhoea * 1  19/263 (7.22%)  24 15/261 (5.75%)  15 25/264 (9.47%)  41
Vomiting * 1  16/263 (6.08%)  18 12/261 (4.60%)  14 16/264 (6.06%)  23
General disorders       
Fatigue * 1  14/263 (5.32%)  17 15/261 (5.75%)  31 15/264 (5.68%)  18
Pyrexia * 1  17/263 (6.46%)  19 8/261 (3.07%)  9 13/264 (4.92%)  18
Infections and infestations       
Upper respiratory tract infection * 1  37/263 (14.07%)  46 38/261 (14.56%)  49 37/264 (14.02%)  47
Urinary tract infection * 1  44/263 (16.73%)  66 37/261 (14.18%)  45 38/264 (14.39%)  54
Nasopharyngitis * 1  21/263 (7.98%)  23 15/261 (5.75%)  23 24/264 (9.09%)  31
Sinusitis * 1  19/263 (7.22%)  23 12/261 (4.60%)  17 20/264 (7.58%)  23
Bronchitis * 1  23/263 (8.75%)  24 13/261 (4.98%)  13 11/264 (4.17%)  13
Musculoskeletal and connective tissue disorders       
Back pain * 1  19/263 (7.22%)  20 14/261 (5.36%)  16 14/264 (5.30%)  14
Nervous system disorders       
Headache * 1  42/263 (15.97%)  68 29/261 (11.11%)  39 33/264 (12.50%)  50
Dizziness * 1  13/263 (4.94%)  20 10/261 (3.83%)  15 14/264 (5.30%)  16
Psychiatric disorders       
Depression * 1  15/263 (5.70%)  16 10/261 (3.83%)  11 9/264 (3.41%)  10
Respiratory, thoracic and mediastinal disorders       
Cough * 1  12/263 (4.56%)  12 12/261 (4.60%)  12 16/264 (6.06%)  19
Vascular disorders       
Hypertension * 1  12/263 (4.56%)  12 13/261 (4.98%)  15 17/264 (6.44%)  17
1
Term from vocabulary, MedDRA17.0
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: UCB
Organization: Care
Phone: +1844599 ext 2273
EMail: UCBCares@ucb.com
Layout table for additonal information
Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT01261793    
Other Study ID Numbers: SL0010
2010-018565-26 ( EudraCT Number )
First Submitted: December 14, 2010
First Posted: December 16, 2010
Results First Submitted: May 30, 2018
Results First Posted: June 29, 2018
Last Update Posted: September 28, 2018