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Trial record 67 of 22179 for:    Placebo AND subjects

Study of Epratuzumab Versus Placebo in Subjects With Moderate to Severe General Systemic Lupus Erythematosus (EMBODY1)

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ClinicalTrials.gov Identifier: NCT01262365
Recruitment Status : Completed
First Posted : December 17, 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: Epratuzumab
Drug: Placebo
Enrollment 793
Recruitment Details The study started to enroll patients in December 2010 and concluded in May 2015.
Pre-assignment Details Participant Flow refers to the Randomized Set (RS).
Arm/Group Title Placebo (RS) Epratuzumab 1200 mg Every Other Week (RS) Epratuzumab 600 mg Per Week (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 266 262 265
Completed 176 181 171
Not Completed 90 81 94
Reason Not Completed
Lack of Efficacy             35             30             47
Protocol Violation             3             1             1
Lost to Follow-up             3             7             6
Withdrawal by Subject             17             22             22
Death             1             2             1
Adverse Event             26             16             11
sponsor decision             1             1             0
Randomization error             1             0             2
Non-compliance             1             0             2
Suspected pregnancy             1             0             0
Patient pregnant             1             0             1
Toxicity related to study drug             0             1             0
Cannot tolerate the protocol             0             1             0
Patient unavailable             0             0             1
Arm/Group Title Placebo (Weekly Infusion) Epratuzumab 1200 mg Every Other Week Epratuzumab 600 mg Per Week 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 263 259 264 786
Hide Baseline Analysis Population Description
Baseline Characteristics refers to the Safety Set.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 263 participants 259 participants 264 participants 786 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
252
  95.8%
254
  98.1%
257
  97.3%
763
  97.1%
>=65 years
11
   4.2%
5
   1.9%
7
   2.7%
23
   2.9%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 263 participants 259 participants 264 participants 786 participants
41.4  (12.6) 42.5  (11.8) 42.3  (11.4) 42.1  (12.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 263 participants 259 participants 264 participants 786 participants
Female
250
  95.1%
243
  93.8%
242
  91.7%
735
  93.5%
Male
13
   4.9%
16
   6.2%
22
   8.3%
51
   6.5%
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. 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 study drug, with the exception of 45 subjects who were randomized at Site 071, located in the USA, who were excluded from the FAS.
Arm/Group Title Placebo (Weekly Infusion) FAS Epratuzumab 1200 mg Every Other Week (FAS) Epratuzumab 600 mg Per Week (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 249 244 248
Measure Type: Number
Unit of Measure: percentage of participants
34.1 39.8 37.5
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (Weekly Infusion) FAS, Epratuzumab 1200 mg Every Other Week (FAS)
Comments Odds Ratio: Epratuzumab/Placebo calculated using logistic regression with factors for treatment, region, and baseline disease status.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.175
Comments [Not Specified]
Method Regression, Logistic
Comments p-values have been calculated using logistic regression with factors for treatment, region, and baseline disease status.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.307
Confidence Interval (2-Sided) 95%
0.888 to 1.923
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo (Weekly Infusion) FAS, Epratuzumab 600 mg Per Week (FAS)
Comments Odds Ratio: Epratuzumab/Placebo calculated using logistic regression with factors for treatment, region, and baseline disease status.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.442
Comments [Not Specified]
Method Regression, Logistic
Comments p-values have been calculated using logistic regression with factors for treatment, region, and baseline disease status.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.164
Confidence Interval (2-Sided) 95%
0.790 to 1.714
Estimation Comments [Not Specified]
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. 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 study drug, with the exception of 45 subjects who were randomized at Site 071, located in the USA, who were excluded from the FAS.
Arm/Group Title Placebo (Weekly Infusion) FAS Epratuzumab 1200 mg Every Other Week (FAS) Epratuzumab 600 mg Per Week (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 249 244 248
Measure Type: Number
Unit of Measure: percentage of participants
33.7 43.0 39.1
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. 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 study drug, with the exception of 45 subjects who were randomized at Site 071, located in the USA, who were excluded from the FAS.
Arm/Group Title Placebo (Weekly Infusion) FAS Epratuzumab 1200 mg Every Other Week (FAS) Epratuzumab 600 mg Per Week (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 249 244 248
Measure Type: Number
Unit of Measure: percentage of participants
31.3 42.2 39.9
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. 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 study drug, with the exception of 45 subjects who were randomized at Site 071, located in the USA, who were excluded from the FAS.
Arm/Group Title Placebo (Weekly Infusion) FAS Epratuzumab 1200 mg Every Other Week (FAS) Epratuzumab 600 mg Per Week (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 249 244 248
Measure Type: Number
Unit of Measure: percentage of participants
33.3 41.8 35.1
5.Secondary Outcome
Title Change From Baseline in Daily Corticosteroid Dose at Week 24
Hide Description Subjects with a missing corticosteroid dose at any visit for any reason are counted in the Dose Increased or Missing Data category for that visit.
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 study drug, with the exception of 45 subjects who were randomized at Site 071, located in the USA, who were excluded from the FAS.
Arm/Group Title Placebo (Weekly Infusion) FAS Epratuzumab 1200 mg Every Other Week (FAS) Epratuzumab 600 mg Per Week (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 249 244 248
Measure Type: Number
Unit of Measure: percentage of participants
Dose decreased by >50% 9.2 8.2 6.9
Dose decreased >0% to <=50% 10.8 16.4 14.9
No change in dose 52.2 50.0 50.8
Dose increased or missing data 27.7 25.4 27.4
6.Secondary Outcome
Title Change From Baseline in Daily Corticosteroid Dose at Week 48
Hide Description Subjects with a missing corticosteroid dose at any visit for any reason are counted in the Dose Increased or Missing Data category for that visit.
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 study drug, with the exception of 45 subjects who were randomized at Site 071, located in the USA, who were excluded from the FAS.
Arm/Group Title Placebo (Weekly Infusion) FAS Epratuzumab 1200 mg Every Other Week (FAS) Epratuzumab 600 mg Per Week (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 249 244 248
Measure Type: Number
Unit of Measure: percentage of participants
Dose decreased by >50% 14.1 11.9 10.1
Dose decreased >0% to <=50% 10.4 14.3 12.5
No chnage in dose 38.6 37.7 37.9
Dose increased or missing data 36.9 36.1 39.5
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 4.4 years (starting in December 2010 and concluding in May 2015). The Safety Set (SS) will be utilized for TEAE reporting.
Adverse Event Reporting Description The Safety Set consisted of all enrolled subjects who took at least 1 dose of study drug.
 
Arm/Group Title Placebo (Weekly Infusion) Epratuzumab 1200 mg Every Other Week Epratuzumab 600 mg Per Week
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 Infusion) Epratuzumab 1200 mg Every Other Week Epratuzumab 600 mg Per Week
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/263 (0.38%)      2/259 (0.77%)      2/264 (0.76%)    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo (Weekly Infusion) Epratuzumab 1200 mg Every Other Week Epratuzumab 600 mg Per Week
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   48/263 (18.25%)      44/259 (16.99%)      45/264 (17.05%)    
Blood and lymphatic system disorders       
Anaemia * 1  0/263 (0.00%)  0 2/259 (0.77%)  2 2/264 (0.76%)  2
Neutropenia * 1  0/263 (0.00%)  0 1/259 (0.39%)  1 0/264 (0.00%)  0
Pancytopenia * 1  0/263 (0.00%)  0 1/259 (0.39%)  1 0/264 (0.00%)  0
Thrombocytopenia * 1  0/263 (0.00%)  0 0/259 (0.00%)  0 1/264 (0.38%)  1
Splenomegaly * 1  1/263 (0.38%)  1 0/259 (0.00%)  0 0/264 (0.00%)  0
Cardiac disorders       
Cardiac failure * 1  0/263 (0.00%)  0 1/259 (0.39%)  1 0/264 (0.00%)  0
Cardiac failure congestive * 1  0/263 (0.00%)  0 1/259 (0.39%)  1 0/264 (0.00%)  0
Pericardial effusion * 1  0/263 (0.00%)  0 1/259 (0.39%)  1 0/264 (0.00%)  0
Pericarditis lupus * 1  1/263 (0.38%)  1 1/259 (0.39%)  1 0/264 (0.00%)  0
Pericarditis * 1  1/263 (0.38%)  1 0/259 (0.00%)  0 0/264 (0.00%)  0
Congenital, familial and genetic disorders       
Arteriovenous malformation * 1  1/263 (0.38%)  1 0/259 (0.00%)  0 0/264 (0.00%)  0
Cerebrovascular arteriovenous malformation * 1  1/263 (0.38%)  1 0/259 (0.00%)  0 0/264 (0.00%)  0
Endocrine disorders       
Hyperparathyroidism * 1  0/263 (0.00%)  0 0/259 (0.00%)  0 1/264 (0.38%)  1
Eye disorders       
Retinal detachment * 1  0/263 (0.00%)  0 1/259 (0.39%)  1 0/264 (0.00%)  0
Gastrointestinal disorders       
Abdominal pain upper * 1  0/263 (0.00%)  0 0/259 (0.00%)  0 3/264 (1.14%)  3
Colitis * 1  0/263 (0.00%)  0 1/259 (0.39%)  1 0/264 (0.00%)  0
Gastrointestinal haemorrhage * 1  0/263 (0.00%)  0 1/259 (0.39%)  1 0/264 (0.00%)  0
Impaired gastric emptying * 1  0/263 (0.00%)  0 0/259 (0.00%)  0 1/264 (0.38%)  1
Lower gastrointestinal haemorrhage * 1  0/263 (0.00%)  0 1/259 (0.39%)  1 0/264 (0.00%)  0
Mesenteric artery thrombosis * 1  0/263 (0.00%)  0 1/259 (0.39%)  1 0/264 (0.00%)  0
Nausea * 1  0/263 (0.00%)  0 0/259 (0.00%)  0 1/264 (0.38%)  1
Pancreatitis acute * 1  0/263 (0.00%)  0 1/259 (0.39%)  1 0/264 (0.00%)  0
Vomiting * 1  0/263 (0.00%)  0 0/259 (0.00%)  0 1/264 (0.38%)  2
Abdominal discomfort * 1  1/263 (0.38%)  2 0/259 (0.00%)  0 0/264 (0.00%)  0
Bezoar * 1  1/263 (0.38%)  1 0/259 (0.00%)  0 0/264 (0.00%)  0
Diarrhoea * 1  1/263 (0.38%)  1 0/259 (0.00%)  0 0/264 (0.00%)  0
General disorders       
Chest pain * 1  2/263 (0.76%)  2 0/259 (0.00%)  0 2/264 (0.76%)  2
Inflammation * 1  0/263 (0.00%)  0 1/259 (0.39%)  1 0/264 (0.00%)  0
Pyrexia * 1  0/263 (0.00%)  0 0/259 (0.00%)  0 1/264 (0.38%)  1
Non-cardiac chest pain * 1  2/263 (0.76%)  2 0/259 (0.00%)  0 0/264 (0.00%)  0
Serositis * 1  1/263 (0.38%)  1 0/259 (0.00%)  0 0/264 (0.00%)  0
Hepatobiliary disorders       
Cholelithiasis * 1  1/263 (0.38%)  1 2/259 (0.77%)  3 1/264 (0.38%)  1
Lupus hepatitis * 1  1/263 (0.38%)  1 0/259 (0.00%)  0 0/264 (0.00%)  0
Immune system disorders       
Drug hypersensitivity * 1  1/263 (0.38%)  1 1/259 (0.39%)  1 1/264 (0.38%)  1
Serum sickness * 1  1/263 (0.38%)  1 0/259 (0.00%)  0 0/264 (0.00%)  0
Infections and infestations       
Sepsis * 1  0/263 (0.00%)  0 3/259 (1.16%)  3 3/264 (1.14%)  3
Cellulitis * 1  0/263 (0.00%)  0 3/259 (1.16%)  3 2/264 (0.76%)  2
Urinary tract infection * 1  0/263 (0.00%)  0 0/259 (0.00%)  0 4/264 (1.52%)  4
Pneumonia * 1  4/263 (1.52%)  4 1/259 (0.39%)  1 2/264 (0.76%)  2
Abscess limb * 1  0/263 (0.00%)  0 1/259 (0.39%)  1 1/264 (0.38%)  2
Pyelonephritis * 1  0/263 (0.00%)  0 1/259 (0.39%)  1 1/264 (0.38%)  1
Abscess neck * 1  0/263 (0.00%)  0 0/259 (0.00%)  0 1/264 (0.38%)  1
Appendicitis * 1  0/263 (0.00%)  0 0/259 (0.00%)  0 1/264 (0.38%)  1
Atypical pneumonia * 1  0/263 (0.00%)  0 1/259 (0.39%)  1 0/264 (0.00%)  0
Bacterial pyelonephritis * 1  0/263 (0.00%)  0 1/259 (0.39%)  1 0/264 (0.00%)  0
Bronchopneumonia * 1  0/263 (0.00%)  0 1/259 (0.39%)  1 0/264 (0.00%)  0
Diverticulitis * 1  0/263 (0.00%)  0 1/259 (0.39%)  1 0/264 (0.00%)  0
Erysipelas * 1  1/263 (0.38%)  1 0/259 (0.00%)  0 1/264 (0.38%)  1
Gastroenteritis viral * 1  0/263 (0.00%)  0 0/259 (0.00%)  0 1/264 (0.38%)  1
Herpes zoster * 1  0/263 (0.00%)  0 0/259 (0.00%)  0 1/264 (0.38%)  1
Herpes zoster meningitis * 1  0/263 (0.00%)  0 0/259 (0.00%)  0 1/264 (0.38%)  1
Influenza * 1  0/263 (0.00%)  0 1/259 (0.39%)  1 0/264 (0.00%)  0
Localised infection * 1  0/263 (0.00%)  0 1/259 (0.39%)  1 0/264 (0.00%)  0
Lymphangitis * 1  0/263 (0.00%)  0 1/259 (0.39%)  1 0/264 (0.00%)  0
Myringitis bullous * 1  0/263 (0.00%)  0 0/259 (0.00%)  0 1/264 (0.38%)  1
Pelvic inflammatory disease * 1  0/263 (0.00%)  0 1/259 (0.39%)  1 0/264 (0.00%)  0
Pyelonephritis acute * 1  1/263 (0.38%)  1 1/259 (0.39%)  1 0/264 (0.00%)  0
Pyelonephritis chronic * 1  1/263 (0.38%)  1 1/259 (0.39%)  1 0/264 (0.00%)  0
Pyomyositis * 1  0/263 (0.00%)  0 1/259 (0.39%)  1 0/264 (0.00%)  0
Septic shock * 1  0/263 (0.00%)  0 0/259 (0.00%)  0 1/264 (0.38%)  1
Urinary tract infection pseudomonal * 1  0/263 (0.00%)  0 0/259 (0.00%)  0 1/264 (0.38%)  1
Bronchitis * 1  1/263 (0.38%)  1 0/259 (0.00%)  0 0/264 (0.00%)  0
Diarrhoea infectious * 1  1/263 (0.38%)  1 0/259 (0.00%)  0 0/264 (0.00%)  0
Pneumococcal sepsis * 1  1/263 (0.38%)  1 0/259 (0.00%)  0 0/264 (0.00%)  0
Viral infection * 1  1/263 (0.38%)  1 0/259 (0.00%)  0 0/264 (0.00%)  0
Injury, poisoning and procedural complications       
Ankle fracture * 1  1/263 (0.38%)  1 0/259 (0.00%)  0 0/264 (0.00%)  0
Femoral neck fracture * 1  1/263 (0.38%)  1 0/259 (0.00%)  0 0/264 (0.00%)  0
Fibula fracture * 1  1/263 (0.38%)  1 0/259 (0.00%)  0 0/264 (0.00%)  0
Foot fracture * 1  1/263 (0.38%)  1 0/259 (0.00%)  0 0/264 (0.00%)  0
Investigations       
Hepatic enzyme increased * 1  0/263 (0.00%)  0 0/259 (0.00%)  0 1/264 (0.38%)  1
Weight decreased * 1  0/263 (0.00%)  0 0/259 (0.00%)  0 1/264 (0.38%)  1
Haemoglobin decreased * 1  1/263 (0.38%)  1 0/259 (0.00%)  0 0/264 (0.00%)  0
Metabolism and nutrition disorders       
Dehydration * 1  0/263 (0.00%)  0 0/259 (0.00%)  0 1/264 (0.38%)  1
Hypophosphataemia * 1  0/263 (0.00%)  0 0/259 (0.00%)  0 1/264 (0.38%)  1
Obesity * 1  0/263 (0.00%)  0 0/259 (0.00%)  0 1/264 (0.38%)  1
Hyperglycaemia * 1  2/263 (0.76%)  2 0/259 (0.00%)  0 0/264 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Systemic lupus erythematosus * 1  3/263 (1.14%)  3 5/259 (1.93%)  5 3/264 (1.14%)  3
Costochondritis * 1  0/263 (0.00%)  0 1/259 (0.39%)  1 0/264 (0.00%)  0
Haemarthrosis * 1  0/263 (0.00%)  0 0/259 (0.00%)  0 1/264 (0.38%)  1
Musculoskeletal chest pain * 1  0/263 (0.00%)  0 0/259 (0.00%)  0 1/264 (0.38%)  1
Osteonecrosis * 1  0/263 (0.00%)  0 1/259 (0.39%)  2 0/264 (0.00%)  0
Osteoporotic fracture * 1  0/263 (0.00%)  0 0/259 (0.00%)  0 1/264 (0.38%)  1
Back pain * 1  1/263 (0.38%)  1 0/259 (0.00%)  0 0/264 (0.00%)  0
Cervical spinal stenosis * 1  1/263 (0.38%)  1 0/259 (0.00%)  0 0/264 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Basal cell carcinoma * 1  0/263 (0.00%)  0 1/259 (0.39%)  1 1/264 (0.38%)  1
Colon adenoma * 1  0/263 (0.00%)  0 0/259 (0.00%)  0 1/264 (0.38%)  1
Ovarian adenoma * 1  0/263 (0.00%)  0 0/259 (0.00%)  0 1/264 (0.38%)  1
Squamous cell carcinoma of skin * 1  0/263 (0.00%)  0 0/259 (0.00%)  0 1/264 (0.38%)  3
Nervous system disorders       
Convulsion * 1  1/263 (0.38%)  1 1/259 (0.39%)  1 1/264 (0.38%)  1
Syncope * 1  1/263 (0.38%)  1 1/259 (0.39%)  1 1/264 (0.38%)  1
Carotid artery thrombosis * 1  0/263 (0.00%)  0 0/259 (0.00%)  0 1/264 (0.38%)  1
Ischaemic stroke * 1  0/263 (0.00%)  0 0/259 (0.00%)  0 1/264 (0.38%)  1
Lupus encephalitis * 1  1/263 (0.38%)  1 1/259 (0.39%)  1 0/264 (0.00%)  0
Partial seizures with secondary generalisation * 1  0/263 (0.00%)  0 1/259 (0.39%)  1 0/264 (0.00%)  0
Hemiparesis * 1  1/263 (0.38%)  1 0/259 (0.00%)  0 0/264 (0.00%)  0
Hypoaesthesia * 1  1/263 (0.38%)  1 0/259 (0.00%)  0 0/264 (0.00%)  0
Mononeuropathy multiplex * 1  1/263 (0.38%)  1 0/259 (0.00%)  0 0/264 (0.00%)  0
Subarachnoid haemorrhage * 1  1/263 (0.38%)  1 0/259 (0.00%)  0 0/264 (0.00%)  0
Psychiatric disorders       
Delirium tremens * 1  0/263 (0.00%)  0 1/259 (0.39%)  1 0/264 (0.00%)  0
Suicidal ideation * 1  0/263 (0.00%)  0 0/259 (0.00%)  0 1/264 (0.38%)  1
Bipolar I disorder * 1  1/263 (0.38%)  1 0/259 (0.00%)  0 0/264 (0.00%)  0
Depression * 1  1/263 (0.38%)  1 0/259 (0.00%)  0 0/264 (0.00%)  0
Renal and urinary disorders       
Lupus nephritis * 1  2/263 (0.76%)  2 2/259 (0.77%)  2 1/264 (0.38%)  1
Nephrotic syndrome * 1  1/263 (0.38%)  1 2/259 (0.77%)  4 0/264 (0.00%)  0
Renal failure * 1  0/263 (0.00%)  0 1/259 (0.39%)  1 1/264 (0.38%)  1
Nephrolithiasis * 1  0/263 (0.00%)  0 0/259 (0.00%)  0 1/264 (0.38%)  1
Proteinuria * 1  0/263 (0.00%)  0 0/259 (0.00%)  0 1/264 (0.38%)  1
Renal failure acute * 1  0/263 (0.00%)  0 0/259 (0.00%)  0 1/264 (0.38%)  1
Renal impairment * 1  1/263 (0.38%)  1 0/259 (0.00%)  0 0/264 (0.00%)  0
Urinary retention * 1  2/263 (0.76%)  2 0/259 (0.00%)  0 0/264 (0.00%)  0
Reproductive system and breast disorders       
Breast ulceration * 1  0/263 (0.00%)  0 0/259 (0.00%)  0 1/264 (0.38%)  1
Endometriosis * 1  0/263 (0.00%)  0 0/259 (0.00%)  0 1/264 (0.38%)  1
Ovarian cyst ruptured * 1  1/263 (0.38%)  1 1/259 (0.39%)  1 0/264 (0.00%)  0
Vaginal haemorrhage * 1  0/263 (0.00%)  0 1/259 (0.39%)  1 0/264 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Dyspnoea * 1  0/263 (0.00%)  0 0/259 (0.00%)  0 2/264 (0.76%)  2
Pulmonary alveolar haemorrhage * 1  0/263 (0.00%)  0 1/259 (0.39%)  1 1/264 (0.38%)  1
Pulmonary embolism * 1  0/263 (0.00%)  0 2/259 (0.77%)  2 0/264 (0.00%)  0
Acute respiratory distress syndrome * 1  0/263 (0.00%)  0 0/259 (0.00%)  0 1/264 (0.38%)  1
Asthma * 1  0/263 (0.00%)  0 0/259 (0.00%)  0 1/264 (0.38%)  2
Chronic obstructive pulmonary disease * 1  0/263 (0.00%)  0 1/259 (0.39%)  1 0/264 (0.00%)  0
Pleural effusion * 1  0/263 (0.00%)  0 1/259 (0.39%)  1 0/264 (0.00%)  0
Pneumothorax * 1  0/263 (0.00%)  0 0/259 (0.00%)  0 1/264 (0.38%)  1
Respiratory failure * 1  1/263 (0.38%)  1 0/259 (0.00%)  0 0/264 (0.00%)  0
Skin and subcutaneous tissue disorders       
Cutaneous lupus erythematosus * 1  0/263 (0.00%)  0 0/259 (0.00%)  0 1/264 (0.38%)  1
Hidradenitis * 1  0/263 (0.00%)  0 0/259 (0.00%)  0 1/264 (0.38%)  1
Swelling face * 1  1/263 (0.38%)  1 0/259 (0.00%)  0 0/264 (0.00%)  0
Surgical and medical procedures       
Abortion induced * 1  0/263 (0.00%)  0 0/259 (0.00%)  0 1/264 (0.38%)  1
Vascular disorders       
Hypertension * 1  0/263 (0.00%)  0 0/259 (0.00%)  0 2/264 (0.76%)  2
Thrombophlebitis superficial * 1  0/263 (0.00%)  0 1/259 (0.39%)  1 0/264 (0.00%)  0
Arteriosclerosis * 1  1/263 (0.38%)  1 0/259 (0.00%)  0 0/264 (0.00%)  0
Jugular vein thrombosis * 1  1/263 (0.38%)  1 0/259 (0.00%)  0 0/264 (0.00%)  0
Lupus vasculitis * 1  1/263 (0.38%)  1 0/259 (0.00%)  0 0/264 (0.00%)  0
1
Term from vocabulary, MedDRA17
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo (Weekly Infusion) Epratuzumab 1200 mg Every Other Week Epratuzumab 600 mg Per Week
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   144/263 (54.75%)      153/259 (59.07%)      141/264 (53.41%)    
Gastrointestinal disorders       
Nausea * 1  23/263 (8.75%)  28 30/259 (11.58%)  44 38/264 (14.39%)  49
Diarrhoea * 1  17/263 (6.46%)  19 21/259 (8.11%)  24 19/264 (7.20%)  28
General disorders       
Fatigue * 1  10/263 (3.80%)  10 17/259 (6.56%)  20 12/264 (4.55%)  17
Infections and infestations       
Upper respiratory tract infection * 1  30/263 (11.41%)  36 32/259 (12.36%)  38 32/264 (12.12%)  38
Urinary tract infection * 1  30/263 (11.41%)  41 25/259 (9.65%)  29 27/264 (10.23%)  41
Nasopharyngitis * 1  21/263 (7.98%)  26 20/259 (7.72%)  21 22/264 (8.33%)  29
Sinusitis * 1  13/263 (4.94%)  14 24/259 (9.27%)  24 15/264 (5.68%)  17
Bronchitis * 1  20/263 (7.60%)  23 12/259 (4.63%)  14 15/264 (5.68%)  18
Musculoskeletal and connective tissue disorders       
Arthralgia * 1  14/263 (5.32%)  21 20/259 (7.72%)  28 14/264 (5.30%)  24
Back pain * 1  10/263 (3.80%)  14 19/259 (7.34%)  20 15/264 (5.68%)  17
Pain in extremity * 1  11/263 (4.18%)  13 14/259 (5.41%)  18 9/264 (3.41%)  9
Nervous system disorders       
Headache * 1  29/263 (11.03%)  38 34/259 (13.13%)  42 38/264 (14.39%)  58
Dizziness * 1  11/263 (4.18%)  11 9/259 (3.47%)  10 16/264 (6.06%)  18
Migraine * 1  3/263 (1.14%)  4 16/259 (6.18%)  19 7/264 (2.65%)  8
Respiratory, thoracic and mediastinal disorders       
Cough * 1  12/263 (4.56%)  16 13/259 (5.02%)  14 12/264 (4.55%)  12
Skin and subcutaneous tissue disorders       
Rash * 1  5/263 (1.90%)  5 14/259 (5.41%)  16 8/264 (3.03%)  8
Vascular disorders       
Hypertension * 1  11/263 (4.18%)  12 20/259 (7.72%)  21 13/264 (4.92%)  14
1
Term from vocabulary, MedDRA17
*
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
Name/Title: UCB
Organization: Cares
Phone: +1844 599 ext 2273
Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT01262365     History of Changes
Other Study ID Numbers: SL0009
2010-018563-41 ( EudraCT Number )
First Submitted: December 14, 2010
First Posted: December 17, 2010
Results First Submitted: May 30, 2018
Results First Posted: June 29, 2018
Last Update Posted: September 28, 2018