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A Study to Evaluate the Efficacy and Safety of Sifalimumab in Adults With Systemic Lupus Erythematosus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01283139
Recruitment Status : Completed
First Posted : January 25, 2011
Results First Posted : July 11, 2016
Last Update Posted : April 19, 2018
Sponsor:
Information provided by (Responsible Party):
MedImmune LLC

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Systemic Lupus Erythematosus
Interventions Biological: Sifalimumab 200 mg
Biological: Sifalimumab 600 mg
Biological: Sifalimumab 1,200 mg
Other: Placebo
Enrollment 834
Recruitment Details  
Pre-assignment Details A total of 834 participants were screened out of which 402 participants did not meet eligibility criteria and were considered screen failures, and 432 participants were randomized into the study.
Arm/Group Title Placebo Sifalimumab 200 Milligram (mg) Sifalimumab 600 mg Sifalimumab 1,200 mg
Hide Arm/Group Description Placebo matching to sifalimumab administered by intravenous infusion at a fixed dose of every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses. Sifalimumab 200 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses. Sifalimumab 600 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses. Sifalimumab 1,200 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
Period Title: Overall Study
Started 108 108 109 107
Completed 91 90 91 92
Not Completed 17 18 18 15
Reason Not Completed
Lost to Follow-up             5             2             3             1
Withdrawal by Subject             8             8             6             8
Death             2             0             2             2
Lack of Efficacy             1             2             2             1
Early termination due to AE/SAE             1             1             0             0
Participant's refusal to continue             0             3             1             1
Pregnancy             0             1             1             0
Missed follow-up visit             0             1             2             2
Participant randomized in error             0             0             1             0
Arm/Group Title Placebo Sifalimumab 200 Milligram (mg) Sifalimumab 600 mg Sifalimumab 1,200 mg Total
Hide Arm/Group Description Placebo matching to sifalimumab administered by intravenous infusion at a fixed dose of every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses. Sifalimumab 200 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses. Sifalimumab 600 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses. Sifalimumab 1,200 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses. Total of all reporting groups
Overall Number of Baseline Participants 108 108 109 107 432
Hide Baseline Analysis Population Description
Intent-to-treat (ITT) population included all participants who were randomized into the study.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 108 participants 108 participants 109 participants 107 participants 432 participants
38.4  (12.3) 39.9  (11.4) 40.1  (11.3) 39.4  (12.1) 39.4  (11.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 108 participants 108 participants 109 participants 107 participants 432 participants
Female
101
  93.5%
103
  95.4%
98
  89.9%
97
  90.7%
399
  92.4%
Male
7
   6.5%
5
   4.6%
11
  10.1%
10
   9.3%
33
   7.6%
1.Primary Outcome
Title Percentage of Participants Achieving a Response in Systemic Lupus Erythematosus Responder Index 4 (SRI [4])
Hide Description SRI (4) responder is defined as: 1) a reduction in baseline Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) disease activity score of greater than or equal to (>=) 4 points (with increased deoxyribonucleic acid [DNA] binding item of SLEDAI-2K score based on the ANA Multi-Lyte® ANA-II Plus Test System); 2) no worsening in Physician Global Assessment (MDGA) (worsening is defined as an increase of >=0.3 from baseline on a 0-3 visual analogue scale) and 3) no worsening in British Isles Lupus Assessment Group (BILAG-2004) (worsening is defined as at least 1 new 'A' score or 2 new 'B' scores on the BILAG-2004 compared with baseline).
Time Frame Day 365
Hide Outcome Measure Data
Hide Analysis Population Description
The modified intent-to-treat (mITT) population included all randomized participants who received any investigational product and had a baseline primary efficacy measurement.
Arm/Group Title Placebo Sifalimumab 200 Milligram (mg) Sifalimumab 600 mg Sifalimumab 1,200 mg
Hide Arm/Group Description:
Placebo matching to sifalimumab administered by intravenous infusion at a fixed dose of every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
Sifalimumab 200 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
Sifalimumab 600 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
Sifalimumab 1,200 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
Overall Number of Participants Analyzed 108 108 108 107
Measure Type: Number
Unit of Measure: percentage of participants
45.4 58.3 56.5 59.8
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Sifalimumab 200 Milligram (mg)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.057
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.71
Confidence Interval (2-Sided) 90%
1.03 to 2.71
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Sifalimumab 600 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.094
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.60
Confidence Interval (2-Sided) 90%
1.01 to 2.54
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Sifalimumab 1,200 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.031
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.84
Confidence Interval (2-Sided) 90%
1.16 to 2.94
Estimation Comments [Not Specified]
2.Primary Outcome
Title Percentage of Participants Achieving a Positive Response in SRI (4) in 4-Gene Interferon Test High Participants
Hide Description SRI (4) responder is defined as: 1) a reduction in baseline SLEDAI-2K disease activity score of >=4 points (with increased DNA binding item of SLEDAI-2K score based on the ANA Multi-Lyte® ANA-II Plus Test System); 2) no worsening in Physician Global Assessment (MDGA) (worsening is defined as an increase of >=0.3 from baseline on a 0-3 visual analogue scale) and 3) no worsening in BILAG-2004 (worsening is defined as at least 1 new 'A' score or 2 new 'B' scores on the BILAG-2004 compared with baseline).
Time Frame Day 365
Hide Outcome Measure Data
Hide Analysis Population Description
The mITT population included all randomized participants who received any investigational product and had a baseline primary efficacy measurement. Here, "N" signifies number of participants with positive diagnostic test.
Arm/Group Title Placebo Sifalimumab 200 Milligram (mg) Sifalimumab 600 mg Sifalimumab 1,200 mg
Hide Arm/Group Description:
Placebo matching to sifalimumab administered by intravenous infusion at a fixed dose of every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
Sifalimumab 200 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
Sifalimumab 600 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
Sifalimumab 1,200 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
Overall Number of Participants Analyzed 88 87 88 87
Measure Type: Number
Unit of Measure: percentage of participants
42.0 57.5 50.0 57.5
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Sifalimumab 200 Milligram (mg)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.042
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.88
Confidence Interval (2-Sided) 90%
1.13 to 3.14
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Sifalimumab 600 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.264
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.41
Confidence Interval (2-Sided) 90%
0.85 to 2.35
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Sifalimumab 1,200 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.038
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.91
Confidence Interval (2-Sided) 90%
1.14 to 3.19
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Percentage of Participants on Greater Than or Equal to 10 mg/Day Oral Prednisone (or Equivalent) at Baseline Who Were Able to Reduce to Less Than or Equal to (<=) 7.5 mg/Day
Hide Description Percentage of participants on >=10 mg/day oral corticosteroids (OCS) at baseline who were able to taper it to <=7.5 mg/day by Day 365 were recorded.
Time Frame Day 365
Hide Outcome Measure Data
Hide Analysis Population Description
The mITT population included all randomized participants who received any investigational product and had a baseline primary efficacy measurement. Here, "N" signifies number of participants on >=10 mg/day oral prednisone (or equivalent) at baseline.
Arm/Group Title Placebo Sifalimumab 200 Milligram (mg) Sifalimumab 600 mg Sifalimumab 1,200 mg
Hide Arm/Group Description:
Placebo matching to sifalimumab administered by intravenous infusion at a fixed dose of every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
Sifalimumab 200 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
Sifalimumab 600 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
Sifalimumab 1,200 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
Overall Number of Participants Analyzed 62 61 53 65
Measure Type: Number
Unit of Measure: percentage of participants
Reduce OCS to <=7.5 mg/day: Yes 6.5 8.2 9.4 6.2
Reduce OCS to <=7.5 mg/day: No 93.5 91.8 90.6 93.8
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Sifalimumab 200 Milligram (mg)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.808
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.19
Confidence Interval (2-Sided) 90%
0.37 to 3.81
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Sifalimumab 600 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.598
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.45
Confidence Interval (2-Sided) 90%
0.45 to 4.66
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Sifalimumab 1,200 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.884
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.90
Confidence Interval (2-Sided) 90%
0.27 to 3.02
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Percentage of Participants With a Cutaneous Lupus Erythematosus Disease Activity and Severity Index (CLASI) Activity Score Greater Than or Equal to (>=) 10 at Baseline Who Achieved a >= 4-point Reduction
Hide Description The CLASI consists of two scores, the first summarizes the activity of the disease while the second is a measure of the damage done by the disease. Activity is scored on the basis of erythema, scale/hyperkeratosis, mucous membrane involvement, acute hair loss and non-scarring alopecia. Damage is scored in terms of dyspigmentation and scarring, including scarring alopecia. The percentage of participants with a CLASI activity score >=10 at baseline who achieved a clinically significant (>=4-point) reduction at Day 365 were reported.
Time Frame Day 365
Hide Outcome Measure Data
Hide Analysis Population Description
The mITT population included all randomized participants who received any investigational product and had a baseline primary efficacy measurement. Here, "N" signifies number of participants with a CLASI activity score >=10 at baseline.
Arm/Group Title Placebo Sifalimumab 200 Milligram (mg) Sifalimumab 600 mg Sifalimumab 1,200 mg
Hide Arm/Group Description:
Placebo matching to sifalimumab administered by intravenous infusion at a fixed dose of every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
Sifalimumab 200 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
Sifalimumab 600 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
Sifalimumab 1,200 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
Overall Number of Participants Analyzed 35 33 33 26
Measure Type: Number
Unit of Measure: percentage of participants
Achieved >=4-point reduction: Yes 48.6 72.7 57.6 73.1
Achieved >=4-point reduction: No 51.4 27.3 42.4 26.9
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Sifalimumab 200 Milligram (mg)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.044
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.92
Confidence Interval (2-Sided) 90%
1.22 to 7.01
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Sifalimumab 600 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.498
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.40
Confidence Interval (2-Sided) 90%
0.62 to 3.19
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Sifalimumab 1,200 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.049
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 3.03
Confidence Interval (2-Sided) 90%
1.20 to 7.68
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Percentage of Participants Who Achieved a Greater Than 3-Point Improvement in the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale
Hide Description FACIT-F is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (not at all) to 4 (very much). Larger the participant's response to the questions (with the exception of 2 negatively stated), greater was the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score).
Time Frame Day 365
Hide Outcome Measure Data
Hide Analysis Population Description
The mITT population included all randomized participants who received any investigational product and had a baseline primary efficacy measurement. Here, "N" signifies number of participants with a FACIT-fatigue score <49 at baseline.
Arm/Group Title Placebo Sifalimumab 200 Milligram (mg) Sifalimumab 600 mg Sifalimumab 1,200 mg
Hide Arm/Group Description:
Placebo matching to sifalimumab administered by intravenous infusion at a fixed dose of every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
Sifalimumab 200 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
Sifalimumab 600 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
Sifalimumab 1,200 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
Overall Number of Participants Analyzed 105 105 102 101
Measure Type: Number
Unit of Measure: percentage of participants
Achieved > 3-point improvement: Yes 30.5 38.1 42.2 35.6
Achieved > 3-point improvement: No 69.5 61.9 57.8 64.4
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Sifalimumab 200 Milligram (mg)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.270
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.39
Confidence Interval (2-Sided) 90%
0.85 to 2.25
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Sifalimumab 600 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.077
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.69
Confidence Interval (2-Sided) 90%
1.04 to 2.74
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Sifalimumab 1,200 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.453
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.25
Confidence Interval (2-Sided) 90%
0.76 to 2.05
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (TESAEs)
Hide Description An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent defined as events present at baseline that worsened in intensity after administration of investigational product or events absent at baseline that emerged after administration of investigational product, for the period extending until the end of participant participation in the study.
Time Frame Day 1 up to Week 74
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population included all participants who received any investigational product.
Arm/Group Title Placebo Sifalimumab 200 Milligram (mg) Sifalimumab 600 mg Sifalimumab 1,200 mg
Hide Arm/Group Description:
Placebo matching to sifalimumab administered by intravenous infusion at a fixed dose of every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
Sifalimumab 200 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
Sifalimumab 600 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
Sifalimumab 1,200 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
Overall Number of Participants Analyzed 108 108 108 107
Measure Type: Number
Unit of Measure: participants
TEAE 94 97 97 93
TESAE 19 16 22 21
7.Secondary Outcome
Title Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs)
Hide Description Laboratory investigations included hematology, serum chemistries and urinalysis parameters. Participants with clinically significant abnormalities in these laboratory investigations recorded as TEAEs were reported.
Time Frame Day 1 up to Week 61
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population included all participants who received any investigational product.
Arm/Group Title Placebo Sifalimumab 200 Milligram (mg) Sifalimumab 600 mg Sifalimumab 1,200 mg
Hide Arm/Group Description:
Placebo matching to sifalimumab administered by intravenous infusion at a fixed dose of every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
Sifalimumab 200 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
Sifalimumab 600 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
Sifalimumab 1,200 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
Overall Number of Participants Analyzed 108 108 108 107
Measure Type: Number
Unit of Measure: participants
Anaemia 1 4 4 2
White blood cell count increased 3 1 2 3
Neutrophil count increased 3 1 2 2
Iron deficiency anaemia 1 2 0 2
Haemoglobin decreased 0 1 0 1
Lymphocyte count decreased 2 1 1 0
White blood cell count decreased 1 0 1 1
Autoimmune haemolytic anaemia 1 1 0 0
Eosinophilia 0 0 0 1
Haematocrit increased 0 0 1 0
Haemoglobin increased 0 0 1 0
Leukopenia 0 1 0 0
Lymphopenia 1 1 0 0
Neutropenia 3 0 0 1
Neutrophil count decreased 1 0 0 1
Platelet count increased 0 0 1 0
Red blood cell count decreased 0 0 0 1
Thrombocytopenia 0 1 0 0
Platelet count decreased 2 0 0 0
Monocyte count increased 1 0 0 0
Hypokalaemia 4 1 4 5
Alanine aminotransferase increased 5 1 1 3
Gamma-glutamyltransferase increased 5 0 1 4
Hypertriglyceridaemia 2 1 1 3
Dyslipidaemia 2 0 2 2
Hepatic enzyme increased 2 2 2 0
Aspartate aminotransferase increased 2 1 0 2
Blood creatine phosphokinase increased 2 0 2 0
Blood creatinine increased 0 1 0 1
Blood glucose increased 1 0 0 2
Hyperglycaemia 1 0 0 2
Transaminases increased 1 0 1 1
Blood potassium decreased 0 1 1 0
Low density lipoprotein increased 0 1 1 0
Blood albumin decreased 0 0 1 0
Blood alkaline phosphatase decreased 1 0 0 1
Blood calcium increased 1 0 1 0
Blood cholesterol increased 0 0 1 0
Blood homocysteine increased 0 0 1 0
Liver function test abnormal 1 0 1 0
Hyperlipidaemia 0 0 0 1
Hypoalbuminaemia 2 0 1 0
Hypoglycaemia 0 0 0 1
Blood bilirubin increased 1 0 0 0
Hypocalcaemia 1 0 0 0
Blood triglycerides increased 1 0 1 0
Hyperbilirubinaemia 0 0 1 0
Hypertransaminasaemia 0 0 1 0
8.Secondary Outcome
Title Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events (TEAEs)
Hide Description Vital sign assessments included blood pressure, pulse rate, temperature, weight and respiratory rate. Vital signs abnormalities recorded as TEAEs were reported.
Time Frame Day 1 up to Week 61
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population included all participants who received any investigational product.
Arm/Group Title Placebo Sifalimumab 200 Milligram (mg) Sifalimumab 600 mg Sifalimumab 1,200 mg
Hide Arm/Group Description:
Placebo matching to sifalimumab administered by intravenous infusion at a fixed dose of every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
Sifalimumab 200 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
Sifalimumab 600 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
Sifalimumab 1,200 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
Overall Number of Participants Analyzed 108 108 108 107
Measure Type: Number
Unit of Measure: participants
Pyrexia 3 2 6 7
Hypertension 7 4 5 4
Weight increased 0 1 2 2
Blood pressure increased 1 2 1 0
Chills 1 2 0 1
Hypertensive crisis 0 0 0 1
Orthostatic hypotension 1 0 0 1
Weight decreased 1 0 0 1
Hypotension 1 0 0 0
9.Secondary Outcome
Title Number of Participants With Abnormal Electrocardiogram (ECG) Findings Reported as TEAEs
Hide Description The 12-lead ECG data were summarized and evaluated. Number of participants with clinically significant abnormal ECG findings as assessed by cardiologist were recorded and reported as TEAEs.
Time Frame Day 1 up to Week 56
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population included all participants who received any investigational product.
Arm/Group Title Placebo Sifalimumab 200 Milligram (mg) Sifalimumab 600 mg Sifalimumab 1,200 mg
Hide Arm/Group Description:
Placebo matching to sifalimumab administered by intravenous infusion at a fixed dose of every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
Sifalimumab 200 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
Sifalimumab 600 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
Sifalimumab 1,200 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
Overall Number of Participants Analyzed 108 108 108 107
Measure Type: Number
Unit of Measure: participants
2 0 1 0
Time Frame Day 1 up to Week 74
Adverse Event Reporting Description TEAE defined as events present at baseline that worsened in intensity after administration of investigational product or events absent at baseline that emerged after administration of investigational product, for the period extending until the end of participant participation in the study.
 
Arm/Group Title Placebo Sifalimumab 200 mg Sifalimumab 600 mg Sifalimumab 1200 mg
Hide Arm/Group Description Placebo matching to sifalimumab administered intravenously for 48 weeks (Day 337). Sifalimumab 200 milligram (mg) administered intravenously for 48 weeks (Day 337). Sifalimumab 600 mg administered intravenously for 48 weeks (Day 337). Sifalimumab 1,200 mg administered intravenously for 48 weeks (Day 337).
All-Cause Mortality
Placebo Sifalimumab 200 mg Sifalimumab 600 mg Sifalimumab 1200 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Hide Serious Adverse Events
Placebo Sifalimumab 200 mg Sifalimumab 600 mg Sifalimumab 1200 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   19/108 (17.59%)      16/108 (14.81%)      22/108 (20.37%)      21/107 (19.63%)    
Blood and lymphatic system disorders         
Anaemia † 1  0/108 (0.00%)  0 1/108 (0.93%)  1 0/108 (0.00%)  0 2/107 (1.87%)  2
Neutropenia † 1  0/108 (0.00%)  0 0/108 (0.00%)  0 0/108 (0.00%)  0 1/107 (0.93%)  1
Cardiac disorders         
Acute myocardial infarction † 1  0/108 (0.00%)  0 0/108 (0.00%)  0 2/108 (1.85%)  2 0/107 (0.00%)  0
Angina pectoris † 1  0/108 (0.00%)  0 0/108 (0.00%)  0 1/108 (0.93%)  1 0/107 (0.00%)  0
Cardiac arrest † 1  0/108 (0.00%)  0 0/108 (0.00%)  0 0/108 (0.00%)  0 1/107 (0.93%)  1
Cardio-respiratory arrest † 1  0/108 (0.00%)  0 0/108 (0.00%)  0 1/108 (0.93%)  1 0/107 (0.00%)  0
Mitral valve incompetence † 1  0/108 (0.00%)  0 0/108 (0.00%)  0 1/108 (0.93%)  1 0/107 (0.00%)  0
Gastrointestinal disorders         
Ascites † 1  1/108 (0.93%)  1 0/108 (0.00%)  0 0/108 (0.00%)  0 0/107 (0.00%)  0
Diverticulum oesophageal † 1  0/108 (0.00%)  0 0/108 (0.00%)  0 1/108 (0.93%)  1 0/107 (0.00%)  0
Gastritis † 1  0/108 (0.00%)  0 0/108 (0.00%)  0 0/108 (0.00%)  0 1/107 (0.93%)  1
Gastritis haemorrhagic † 1  0/108 (0.00%)  0 1/108 (0.93%)  1 0/108 (0.00%)  0 0/107 (0.00%)  0
Intussusception † 1  1/108 (0.93%)  1 0/108 (0.00%)  0 0/108 (0.00%)  0 0/107 (0.00%)  0
Irritable bowel syndrome † 1  1/108 (0.93%)  1 0/108 (0.00%)  0 0/108 (0.00%)  0 0/107 (0.00%)  0
Lip ulceration † 1  0/108 (0.00%)  0 0/108 (0.00%)  0 0/108 (0.00%)  0 1/107 (0.93%)  1
Salivary gland calculus † 1  0/108 (0.00%)  0 0/108 (0.00%)  0 1/108 (0.93%)  1 0/107 (0.00%)  0
Small intestinal perforation † 1  1/108 (0.93%)  1 0/108 (0.00%)  0 0/108 (0.00%)  0 0/107 (0.00%)  0
Tongue oedema † 1  0/108 (0.00%)  0 0/108 (0.00%)  0 1/108 (0.93%)  1 0/107 (0.00%)  0
Infections and infestations         
Appendicitis † 1  0/108 (0.00%)  0 0/108 (0.00%)  0 0/108 (0.00%)  0 1/107 (0.93%)  1
Bronchitis † 1  1/108 (0.93%)  1 1/108 (0.93%)  1 0/108 (0.00%)  0 0/107 (0.00%)  0
Cellulitis † 1  1/108 (0.93%)  1 1/108 (0.93%)  1 1/108 (0.93%)  1 0/107 (0.00%)  0
Corneal infection † 1  0/108 (0.00%)  0 1/108 (0.93%)  1 0/108 (0.00%)  0 0/107 (0.00%)  0
Encephalitis viral † 1  0/108 (0.00%)  0 0/108 (0.00%)  0 1/108 (0.93%)  1 0/107 (0.00%)  0
Enterocolitis bacterial † 1  0/108 (0.00%)  0 1/108 (0.93%)  1 0/108 (0.00%)  0 0/107 (0.00%)  0
Epiglottitis † 1  0/108 (0.00%)  0 0/108 (0.00%)  0 1/108 (0.93%)  1 0/107 (0.00%)  0
Erysipelas † 1  0/108 (0.00%)  0 1/108 (0.93%)  1 0/108 (0.00%)  0 0/107 (0.00%)  0
Gastroenteritis † 1  1/108 (0.93%)  1 0/108 (0.00%)  0 0/108 (0.00%)  0 0/107 (0.00%)  0
Herpes zoster † 1  0/108 (0.00%)  0 0/108 (0.00%)  0 0/108 (0.00%)  0 1/107 (0.93%)  1
Infectious colitis † 1  0/108 (0.00%)  0 0/108 (0.00%)  0 0/108 (0.00%)  0 1/107 (0.93%)  1
Influenza † 1  0/108 (0.00%)  0 1/108 (0.93%)  1 0/108 (0.00%)  0 0/107 (0.00%)  0
Lobar pneumonia † 1  1/108 (0.93%)  1 0/108 (0.00%)  0 0/108 (0.00%)  0 1/107 (0.93%)  1
Lower respiratory tract infection † 1  0/108 (0.00%)  0 0/108 (0.00%)  0 0/108 (0.00%)  0 1/107 (0.93%)  1
Ludwig angina † 1  0/108 (0.00%)  0 0/108 (0.00%)  0 1/108 (0.93%)  1 0/107 (0.00%)  0
Meningitis bacterial † 1  0/108 (0.00%)  0 0/108 (0.00%)  0 0/108 (0.00%)  0 1/107 (0.93%)  1
Ophthalmic herpes zoster † 1  0/108 (0.00%)  0 0/108 (0.00%)  0 0/108 (0.00%)  0 1/107 (0.93%)  1
Parotitis † 1  0/108 (0.00%)  0 0/108 (0.00%)  0 0/108 (0.00%)  0 1/107 (0.93%)  1
Peritonitis † 1  1/108 (0.93%)  1 0/108 (0.00%)  0 0/108 (0.00%)  0 0/107 (0.00%)  0
Pneumonia † 1  1/108 (0.93%)  1 1/108 (0.93%)  1 0/108 (0.00%)  0 2/107 (1.87%)  2
Progressive multifocal leukoencephalopathy † 1  1/108 (0.93%)  1 0/108 (0.00%)  0 0/108 (0.00%)  0 0/107 (0.00%)  0
Pyelonephritis † 1  0/108 (0.00%)  0 0/108 (0.00%)  0 1/108 (0.93%)  1 0/107 (0.00%)  0
Pyelonephritis acute † 1  1/108 (0.93%)  1 2/108 (1.85%)  2 0/108 (0.00%)  0 0/107 (0.00%)  0
Respiratory tract infection † 1  0/108 (0.00%)  0 0/108 (0.00%)  0 1/108 (0.93%)  1 0/107 (0.00%)  0
Sepsis † 1  0/108 (0.00%)  0 0/108 (0.00%)  0 1/108 (0.93%)  1 1/107 (0.93%)  1
Septic embolus † 1  0/108 (0.00%)  0 0/108 (0.00%)  0 1/108 (0.93%)  1 0/107 (0.00%)  0
Septic shock † 1  2/108 (1.85%)  2 0/108 (0.00%)  0 0/108 (0.00%)  0 0/107 (0.00%)  0
Soft tissue infection † 1  0/108 (0.00%)  0 0/108 (0.00%)  0 1/108 (0.93%)  1 0/107 (0.00%)  0
Upper respiratory tract infection † 1  1/108 (0.93%)  1 0/108 (0.00%)  0 0/108 (0.00%)  0 0/107 (0.00%)  0
Urinary tract infection † 1  1/108 (0.93%)  1 0/108 (0.00%)  0 1/108 (0.93%)  1 0/107 (0.00%)  0
Injury, poisoning and procedural complications         
Fall † 1  0/108 (0.00%)  0 0/108 (0.00%)  0 1/108 (0.93%)  1 0/107 (0.00%)  0
Fracture † 1  1/108 (0.93%)  1 0/108 (0.00%)  0 0/108 (0.00%)  0 0/107 (0.00%)  0
Head injury † 1  0/108 (0.00%)  0 0/108 (0.00%)  0 1/108 (0.93%)  1 0/107 (0.00%)  0
Humerus fracture † 1  0/108 (0.00%)  0 0/108 (0.00%)  0 1/108 (0.93%)  1 0/107 (0.00%)  0
Infusion related reaction † 1  1/108 (0.93%)  1 0/108 (0.00%)  0 0/108 (0.00%)  0 0/107 (0.00%)  0
Meniscus injury † 1  0/108 (0.00%)  0 0/108 (0.00%)  0 1/108 (0.93%)  1 0/107 (0.00%)  0
Muscle rupture † 1  0/108 (0.00%)  0 0/108 (0.00%)  0 1/108 (0.93%)  1 0/107 (0.00%)  0
Spinal compression fracture † 1  1/108 (0.93%)  1 0/108 (0.00%)  0 0/108 (0.00%)  0 0/107 (0.00%)  0
Stab wound † 1  0/108 (0.00%)  0 0/108 (0.00%)  0 0/108 (0.00%)  0 1/107 (0.93%)  1
Musculoskeletal and connective tissue disorders         
Back pain † 1  0/108 (0.00%)  0 0/108 (0.00%)  0 0/108 (0.00%)  0 1/107 (0.93%)  1
Flank pain † 1  0/108 (0.00%)  0 1/108 (0.93%)  1 0/108 (0.00%)  0 0/107 (0.00%)  0
Foot deformity † 1  0/108 (0.00%)  0 0/108 (0.00%)  0 0/108 (0.00%)  0 1/107 (0.93%)  1
Osteonecrosis † 1  0/108 (0.00%)  0 1/108 (0.93%)  1 2/108 (1.85%)  3 0/107 (0.00%)  0
Systemic lupus erythematosus † 1  3/108 (2.78%)  3 4/108 (3.70%)  4 7/108 (6.48%)  9 3/107 (2.80%)  4
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Lung neoplasm malignant † 1  0/108 (0.00%)  0 0/108 (0.00%)  0 0/108 (0.00%)  0 1/107 (0.93%)  1
Nervous system disorders         
Ischaemic stroke † 1  0/108 (0.00%)  0 1/108 (0.93%)  1 0/108 (0.00%)  0 0/107 (0.00%)  0
Simple partial seizures † 1  1/108 (0.93%)  1 0/108 (0.00%)  0 0/108 (0.00%)  0 0/107 (0.00%)  0
Syncope † 1  1/108 (0.93%)  1 0/108 (0.00%)  0 0/108 (0.00%)  0 0/107 (0.00%)  0
Transient ischaemic attack † 1  0/108 (0.00%)  0 0/108 (0.00%)  0 1/108 (0.93%)  1 1/107 (0.93%)  1
Vasculitis cerebral † 1  0/108 (0.00%)  0 1/108 (0.93%)  1 0/108 (0.00%)  0 0/107 (0.00%)  0
Pregnancy, puerperium and perinatal conditions         
Abortion spontaneous † 1  0/108 (0.00%)  0 0/108 (0.00%)  0 1/108 (0.93%)  1 0/107 (0.00%)  0
Abortion spontaneous incomplete † 1  0/108 (0.00%)  0 0/108 (0.00%)  0 0/108 (0.00%)  0 1/107 (0.93%)  1
Ectopic pregnancy † 1  0/108 (0.00%)  0 0/108 (0.00%)  0 0/108 (0.00%)  0 1/107 (0.93%)  1
Renal and urinary disorders         
Renal failure acute † 1  0/108 (0.00%)  0 0/108 (0.00%)  0 1/108 (0.93%)  1 0/107 (0.00%)  0
Reproductive system and breast disorders         
Cervical dysplasia † 1  0/108 (0.00%)  0 0/108 (0.00%)  0 0/108 (0.00%)  0 1/107 (0.93%)  1
Respiratory, thoracic and mediastinal disorders         
Asthma † 1  0/108 (0.00%)  0 0/108 (0.00%)  0 0/108 (0.00%)  0 1/107 (0.93%)  1
Epistaxis † 1  1/108 (0.93%)  1 0/108 (0.00%)  0 0/108 (0.00%)  0 0/107 (0.00%)  0
Laryngeal polyp † 1  0/108 (0.00%)  0 0/108 (0.00%)  0 1/108 (0.93%)  1 0/107 (0.00%)  0
Pulmonary embolism † 1  0/108 (0.00%)  0 0/108 (0.00%)  0 1/108 (0.93%)  1 0/107 (0.00%)  0
Pulmonary hypertension † 1  0/108 (0.00%)  0 0/108 (0.00%)  0 1/108 (0.93%)  1 0/107 (0.00%)  0
Skin and subcutaneous tissue disorders         
Skin ulcer † 1  1/108 (0.93%)  1 0/108 (0.00%)  0 0/108 (0.00%)  0 0/107 (0.00%)  0
Surgical and medical procedures         
Abortion induced † 1  1/108 (0.93%)  1 0/108 (0.00%)  0 0/108 (0.00%)  0 0/107 (0.00%)  0
Vascular disorders         
Hypertension † 1  0/108 (0.00%)  0 0/108 (0.00%)  0 0/108 (0.00%)  0 1/107 (0.93%)  1
Ischaemic limb pain † 1  1/108 (0.93%)  1 0/108 (0.00%)  0 0/108 (0.00%)  0 0/107 (0.00%)  0
Peripheral artery thrombosis † 1  0/108 (0.00%)  0 1/108 (0.93%)  1 0/108 (0.00%)  0 0/107 (0.00%)  0
Peripheral embolism † 1  0/108 (0.00%)  0 1/108 (0.93%)  1 0/108 (0.00%)  0 0/107 (0.00%)  0
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Placebo Sifalimumab 200 mg Sifalimumab 600 mg Sifalimumab 1200 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   93/108 (86.11%)      94/108 (87.04%)      96/108 (88.89%)      92/107 (85.98%)    
Blood and lymphatic system disorders         
Anaemia † 1  1/108 (0.93%)  1 3/108 (2.78%)  3 4/108 (3.70%)  4 1/107 (0.93%)  1
Gastrointestinal disorders         
Abdominal pain † 1  2/108 (1.85%)  2 0/108 (0.00%)  0 6/108 (5.56%)  7 4/107 (3.74%)  4
Abdominal pain upper † 1  4/108 (3.70%)  5 1/108 (0.93%)  1 5/108 (4.63%)  5 4/107 (3.74%)  4
Constipation † 1  2/108 (1.85%)  2 1/108 (0.93%)  1 2/108 (1.85%)  2 5/107 (4.67%)  5
Diarrhoea † 1  8/108 (7.41%)  9 7/108 (6.48%)  7 9/108 (8.33%)  9 5/107 (4.67%)  5
Dyspepsia † 1  3/108 (2.78%)  3 3/108 (2.78%)  3 1/108 (0.93%)  1 4/107 (3.74%)  4
Gastritis † 1  0/108 (0.00%)  0 3/108 (2.78%)  3 3/108 (2.78%)  5 3/107 (2.80%)  3
Nausea † 1  8/108 (7.41%)  12 4/108 (3.70%)  5 7/108 (6.48%)  11 5/107 (4.67%)  7
Vomiting † 1  5/108 (4.63%)  5 1/108 (0.93%)  1 6/108 (5.56%)  8 3/107 (2.80%)  3
General disorders         
Pyrexia † 1  3/108 (2.78%)  4 2/108 (1.85%)  3 6/108 (5.56%)  10 7/107 (6.54%)  10
Infections and infestations         
Bronchitis † 1  8/108 (7.41%)  8 11/108 (10.19%)  15 4/108 (3.70%)  7 15/107 (14.02%)  20
Conjunctivitis † 1  4/108 (3.70%)  5 4/108 (3.70%)  5 1/108 (0.93%)  1 2/107 (1.87%)  2
Gastroenteritis † 1  5/108 (4.63%)  6 5/108 (4.63%)  6 5/108 (4.63%)  6 4/107 (3.74%)  4
Herpes zoster † 1  1/108 (0.93%)  1 5/108 (4.63%)  6 4/108 (3.70%)  4 8/107 (7.48%)  8
Influenza † 1  4/108 (3.70%)  4 3/108 (2.78%)  3 1/108 (0.93%)  1 5/107 (4.67%)  5
Nasopharyngitis † 1  10/108 (9.26%)  17 12/108 (11.11%)  14 13/108 (12.04%)  15 9/107 (8.41%)  12
Oral herpes † 1  5/108 (4.63%)  6 3/108 (2.78%)  7 3/108 (2.78%)  4 4/107 (3.74%)  5
Pharyngitis † 1  4/108 (3.70%)  5 3/108 (2.78%)  3 6/108 (5.56%)  9 12/107 (11.21%)  12
Respiratory tract infection † 1  3/108 (2.78%)  5 1/108 (0.93%)  1 3/108 (2.78%)  3 3/107 (2.80%)  4
Sinusitis † 1  3/108 (2.78%)  3 2/108 (1.85%)  2 4/108 (3.70%)  4 5/107 (4.67%)  7
Upper respiratory tract infection † 1  9/108 (8.33%)  12 10/108 (9.26%)  16 17/108 (15.74%)  27 15/107 (14.02%)  23
Urinary tract infection † 1  14/108 (12.96%)  19 22/108 (20.37%)  25 17/108 (15.74%)  22 18/107 (16.82%)  25
Injury, poisoning and procedural complications         
Contusion † 1  3/108 (2.78%)  4 2/108 (1.85%)  2 3/108 (2.78%)  3 1/107 (0.93%)  1
Infusion related reaction † 1  5/108 (4.63%)  10 8/108 (7.41%)  17 7/108 (6.48%)  9 5/107 (4.67%)  10
Investigations         
Alanine aminotransferase increased † 1  5/108 (4.63%)  7 1/108 (0.93%)  1 1/108 (0.93%)  1 3/107 (2.80%)  5
Gamma-glutamyltransferase increased † 1  5/108 (4.63%)  7 0/108 (0.00%)  0 1/108 (0.93%)  2 4/107 (3.74%)  5
White blood cell count increased † 1  3/108 (2.78%)  4 1/108 (0.93%)  1 2/108 (1.85%)  4 3/107 (2.80%)  5
Metabolism and nutrition disorders         
Diabetes mellitus † 1  2/108 (1.85%)  2 2/108 (1.85%)  2 3/108 (2.78%)  4 2/107 (1.87%)  2
Hypokalaemia † 1  4/108 (3.70%)  5 1/108 (0.93%)  1 4/108 (3.70%)  5 5/107 (4.67%)  7
Musculoskeletal and connective tissue disorders         
Arthralgia † 1  3/108 (2.78%)  6 2/108 (1.85%)  3 9/108 (8.33%)  11 5/107 (4.67%)  5
Back pain † 1  3/108 (2.78%)  3 3/108 (2.78%)  3 8/108 (7.41%)  8 5/107 (4.67%)  5
Systemic lupus erythematosus † 1  35/108 (32.41%)  56 34/108 (31.48%)  42 31/108 (28.70%)  46 26/107 (24.30%)  46
Nervous system disorders         
Dizziness † 1  5/108 (4.63%)  5 5/108 (4.63%)  6 2/108 (1.85%)  2 5/107 (4.67%)  5
Headache † 1  15/108 (13.89%)  24 16/108 (14.81%)  18 15/108 (13.89%)  37 12/107 (11.21%)  13
Psychiatric disorders         
Anxiety † 1  3/108 (2.78%)  3 6/108 (5.56%)  6 2/108 (1.85%)  2 7/107 (6.54%)  8
Insomnia † 1  4/108 (3.70%)  4 7/108 (6.48%)  8 3/108 (2.78%)  3 1/107 (0.93%)  1
Respiratory, thoracic and mediastinal disorders         
Cough † 1  7/108 (6.48%)  7 7/108 (6.48%)  7 5/108 (4.63%)  5 6/107 (5.61%)  6
Epistaxis † 1  1/108 (0.93%)  1 4/108 (3.70%)  4 2/108 (1.85%)  3 2/107 (1.87%)  2
Oropharyngeal pain † 1  4/108 (3.70%)  5 4/108 (3.70%)  4 1/108 (0.93%)  1 0/107 (0.00%)  0
Skin and subcutaneous tissue disorders         
Pruritus † 1  2/108 (1.85%)  2 7/108 (6.48%)  8 3/108 (2.78%)  3 5/107 (4.67%)  8
Rash † 1  1/108 (0.93%)  1 1/108 (0.93%)  1 2/108 (1.85%)  2 6/107 (5.61%)  6
Vascular disorders         
Hypertension † 1  7/108 (6.48%)  8 4/108 (3.70%)  4 5/108 (4.63%)  5 3/107 (2.80%)  3
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.0
[Not Specified]
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.
MedImmune has 60 days to review results communications prior to public release and may delete information that compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome. The PIs also agree for data to be presented first as a joint, multi-center publication.
Results Point of Contact
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Name/Title: Gabor Illei, MD, Senior Director, Clinical Development
Organization: MedImmune, LLC
Phone: 301-398-0000
EMail: IlleiG@Medimmune.com
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: MedImmune LLC
ClinicalTrials.gov Identifier: NCT01283139    
Other Study ID Numbers: CD-IA-MEDI-545-1067
2010-024069-30 ( EudraCT Number )
First Submitted: January 20, 2011
First Posted: January 25, 2011
Results First Submitted: June 1, 2016
Results First Posted: July 11, 2016
Last Update Posted: April 19, 2018