We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Phase IIB Dose Ranging Study in Subjects With Moderate to Severe Rheumatoid Arthritis

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: NCT02015520
Recruitment Status : Completed
First Posted : December 19, 2013
Results First Posted : April 19, 2021
Last Update Posted : May 12, 2021
Sponsor:
Information provided by (Responsible Party):
CSL Behring

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Rheumatoid Arthritis
Interventions Drug: Clazakizumab
Drug: Placebo (Matching with Clazakizumab)
Enrollment 143
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo + Methotrexate (MTX) Clazakizumab (1 mg) + MTX Clazakizumab (5 mg) + MTX Clazakizumab (25 mg) + MTX
Hide Arm/Group Description Placebo (5% dextrose) subcutaneous (SC) administration once every 4 weeks for 12 weeks plus background methotrexate (MTX) Clazakizumab (1 mg) SC administration once every 4 weeks for 12 weeks + background Methotrexate Clazakizumab (5 mg) SC administration once every 4 weeks for 12 weeks + background Methotrexate Clazakizumab (25 mg) SC administration once every 4 weeks for 12 weeks + background Methotrexate
Period Title: Overall Study
Started 40 21 42 40
Completed 35 17 35 36
Not Completed 5 4 7 4
Reason Not Completed
Lack of Efficacy             1             0             3             2
Adverse Event             0             0             0             1
Withdrawal by Subject             2             2             1             0
Death             1             0             0             0
Lost to Follow-up             0             0             1             0
Subject Request to Discontinue Study Treatment             1             1             2             1
Subject no Longer Meets Study Criteria             0             1             0             0
Arm/Group Title Placebo + Methotrexate (MTX) Clazakizumab (1 mg) + MTX Clazakizumab (5 mg) + MTX Clazakizumab (25 mg) + MTX Total
Hide Arm/Group Description Placebo (5% dextrose) subcutaneous (SC) administration once every 4 weeks for 12 weeks plus background methotrexate (MTX) Clazakizumab (1 mg) SC administration once every 4 weeks for 12 weeks + background Methotrexate Clazakizumab (5 mg) SC administration once every 4 weeks for 12 weeks + background Methotrexate Clazakizumab (25 mg) SC administration once every 4 weeks for 12 weeks + background Methotrexate Total of all reporting groups
Overall Number of Baseline Participants 40 21 42 40 143
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants 21 participants 42 participants 40 participants 143 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
32
  80.0%
15
  71.4%
35
  83.3%
32
  80.0%
114
  79.7%
>=65 years
8
  20.0%
6
  28.6%
7
  16.7%
8
  20.0%
29
  20.3%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 40 participants 21 participants 42 participants 40 participants 143 participants
54.4  (11.21) 55.8  (11.20) 53.4  (13.75) 52.6  (13.21) 53.8  (12.48)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants 21 participants 42 participants 40 participants 143 participants
Female
35
  87.5%
18
  85.7%
33
  78.6%
35
  87.5%
121
  84.6%
Male
5
  12.5%
3
  14.3%
9
  21.4%
5
  12.5%
22
  15.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 40 participants 21 participants 42 participants 40 participants 143 participants
Canada 1 1 3 0 5
Argentina 4 4 4 6 18
Hungary 7 3 7 5 22
United States 11 7 11 9 38
Japan 4 3 5 4 16
Italy 1 0 0 0 1
Mexico 8 1 8 12 29
South Africa 4 2 2 4 12
France 0 0 2 0 2
1.Primary Outcome
Title Change From Baseline in Disease Activity Score in 28 Joints - C-reactive Protein (DAS28-CRP) at Week 12
Hide Description

DAS28-CRP describes severity of rheumatoid arthritis. The components of the joint count assessment are shoulder, elbow, wrist, metacarpophalangeal joints 1 through 5, proximal interphalangeal joints 1 through 5, and the knee joints on the right and left sides, whereby the number of affected joints, tender and swollen, respectively, are counted. The formula used to calculate the score is: DAS28-CRP=0.56 \times \sqrt{TEN28} + 0.28 \times \sqrt{SW28} + 0.36 \times \ln(CRP+1) + 0.014 \times SA+0.96 with:

TEN28: number of joints with tenderness upon touching SW28: number of swollen joints CRP: C-reactive Protein SA: subjective assessment of disease activity by the patient during the preceding 7 days on a scale between 0 and 100 ("0":no activity, "100": highest activity possible).

DAS-CRP score range is 0.49 to 9.07 A DAS-CRP value >5.1 corresponds to a high disease activity A DAS-28 reduction by 0.6 represents a moderate improvement. A reduction >1.2 represents a major improvement

Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Intent-to-Treat (mITT) Analysis Population: All randomized subjects who received at least 1 dose of the study medication.
Arm/Group Title Placebo + Methotrexate (MTX) Clazakizumab (1 mg) + MTX Clazakizumab (5 mg) + MTX Clazakizumab (25 mg) + MTX
Hide Arm/Group Description:
Placebo (5% dextrose) subcutaneous (SC) administration once every 4 weeks for 12 weeks plus background methotrexate (MTX)
Clazakizumab (1 mg) SC administration once every 4 weeks for 12 weeks + background Methotrexate
Clazakizumab (5 mg) SC administration once every 4 weeks for 12 weeks + background Methotrexate
Clazakizumab (25 mg) SC administration once every 4 weeks for 12 weeks + background Methotrexate
Overall Number of Participants Analyzed 34 15 35 37
Mean (Standard Error)
Unit of Measure: score on a scale
-0.75  (0.22) -1.10  (0.33) -2.10  (0.22) -2.43  (0.22)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo + Methotrexate (MTX), Clazakizumab (1 mg) + MTX
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.38
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo + Methotrexate (MTX), Clazakizumab (5 mg) + MTX
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo + Methotrexate (MTX), Clazakizumab (25 mg) + MTX
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
2.Secondary Outcome
Title American College of Rheumatology (ACR) 20/50/70 Response Rates
Hide Description The ACR20/50/70 is a composite measure defined as both improvement of 20%, 50% or 70% in the number of tender and number of swollen joints, and a 20%, 50% or 70% improvement in three of the following five criteria: patient global assessment, physician global assessment, functional ability measure [most often Health Assessment Questionnaire (HAQ)], visual analog pain scale, and erythrocyte sedimentation rate or C-reactive protein (CRP).
Time Frame At week 12
Hide Outcome Measure Data
Hide Analysis Population Description
mITT
Arm/Group Title Placebo + Methotrexate (MTX) Clazakizumab (1 mg) + MTX Clazakizumab (5 mg) + MTX Clazakizumab (25 mg) + MTX
Hide Arm/Group Description:
Placebo (5% dextrose) subcutaneous (SC) administration once every 4 weeks for 12 weeks plus background methotrexate (MTX)
Clazakizumab (1 mg) SC administration once every 4 weeks for 12 weeks + background Methotrexate
Clazakizumab (5 mg) SC administration once every 4 weeks for 12 weeks + background Methotrexate
Clazakizumab (25 mg) SC administration once every 4 weeks for 12 weeks + background Methotrexate
Overall Number of Participants Analyzed 40 21 42 40
Measure Type: Number
Unit of Measure: percentage of responders
ARC20 responders 27.5 14.3 50.0 47.5
ARC50 responders 7.5 14.3 21.4 22.5
ARC70 responders 2.5 4.8 9.5 15.0
3.Secondary Outcome
Title Change From Baseline in Clinical Disease Activity Index (CDAI) Score at Week 12
Hide Description

CDAI is a composite index for assessing disease activity. CDAI is based on the simple summation of the count of swollen joint count (SCJ) (0-28) and tender joint count (TJC) (0-28) along with patient global assessment (0-10) Scale and physician global assessment (0-10) for estimating disease activity where 10 means maximal activity. The CDAI has a range from 0 to 76.

CDAI <= 2.8 = Remission CDAI > 2.8 and <= 10 = Low Disease Activity CDAI > 10 and <= 22 = Moderate Disease Activity CDAI > 22 = High Disease Activity

Time Frame Baseline and week 12
Hide Outcome Measure Data
Hide Analysis Population Description
mITT
Arm/Group Title Placebo + Methotrexate (MTX) Clazakizumab (1 mg) + MTX Clazakizumab (5 mg) + MTX Clazakizumab (25 mg) + MTX
Hide Arm/Group Description:
Placebo (5% dextrose) subcutaneous (SC) administration once every 4 weeks for 12 weeks plus background methotrexate (MTX)
Clazakizumab (1 mg) SC administration once every 4 weeks for 12 weeks + background Methotrexate
Clazakizumab (5 mg) SC administration once every 4 weeks for 12 weeks + background Methotrexate
Clazakizumab (25 mg) SC administration once every 4 weeks for 12 weeks + background Methotrexate
Overall Number of Participants Analyzed 32 14 36 37
Mean (Standard Error)
Unit of Measure: score on a scale
-9.9  (2.656) -12.8  (3.961) -17.4  (2.545) -21.6  (2.539)
4.Secondary Outcome
Title Change From Baseline in Simplified Disease Activity Index (SDAI) at Week 12
Hide Description

SDAI is a composite index for assessing disease activity. CDAI is based on the simple summation of the count of swollen joint count (0-28) and tender joint count (0-28) along with patient global assessment (0-10) Scale and physician global assessment (0-10) for estimating disease activity where 10 means maximal activity and C-reactive protein (0-10). The SDAI has a range from 0 to 86.

0.0 - 3.3 = Remission 3.4 - 11.0 = Low Activity 11.1 - 26.0 = Moderate Activity 26.1 - 86.0 = High Activity

Time Frame Baseline and week 12
Hide Outcome Measure Data
Hide Analysis Population Description
mITT
Arm/Group Title Placebo + Methotrexate (MTX) Clazakizumab (1 mg) + MTX Clazakizumab (5 mg) + MTX Clazakizumab (25 mg) + MTX
Hide Arm/Group Description:
Placebo (5% dextrose) subcutaneous (SC) administration once every 4 weeks for 12 weeks plus background methotrexate (MTX)
Clazakizumab (1 mg) SC administration once every 4 weeks for 12 weeks + background Methotrexate
Clazakizumab (5 mg) SC administration once every 4 weeks for 12 weeks + background Methotrexate
Clazakizumab (25 mg) SC administration once every 4 weeks for 12 weeks + background Methotrexate
Overall Number of Participants Analyzed 32 14 35 37
Mean (Standard Error)
Unit of Measure: score on a scale
-9.68  (2.6846) -13.08  (4.0011) -20.15  (2.5928) -24.02  (2.5677)
5.Secondary Outcome
Title Boolean Remission at Week 12
Hide Description

Boolean-based definition:

At any time point, a patient must satisfy all of the following:

TJC ≤1 (0-28) SJC ≤1 (0-28) CRP ≤1 mg/dl Patient Global Assessment ≤1 (on a 0-10 scale)

Time Frame At week 12
Hide Outcome Measure Data
Hide Analysis Population Description
mITT
Arm/Group Title Placebo + Methotrexate (MTX) Clazakizumab (1 mg) + MTX Clazakizumab (5 mg) + MTX Clazakizumab (25 mg) + MTX
Hide Arm/Group Description:
Placebo (5% dextrose) subcutaneous (SC) administration once every 4 weeks for 12 weeks plus background methotrexate (MTX)
Clazakizumab (1 mg) SC administration once every 4 weeks for 12 weeks + background Methotrexate
Clazakizumab (5 mg) SC administration once every 4 weeks for 12 weeks + background Methotrexate
Clazakizumab (25 mg) SC administration once every 4 weeks for 12 weeks + background Methotrexate
Overall Number of Participants Analyzed 40 21 42 40
Measure Type: Number
Unit of Measure: percentage of participants
5.0 4.8 2.4 5.0
6.Secondary Outcome
Title Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Week 12
Hide Description Patients report the amount of difficulty they have in performing 8 categories. Each category is scored on a scale ranging from 0 (performed without any difficulty) to 3 (cannot be done at all). The HAQ-DI is then calculated by summing the scores and dividing by the number of categories answered. Total score is between 0-3.0. Increasing scores indicate worse functioning with 0 indicating no functional impairment and 3 indicating complete impairment. The HAQ-DI cannot be calculated if the subject does not have scores for at least 6 categories. A response was defined as a subject with a reduction from baseline in HAQ-DI of at least 0.22.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
mITT
Arm/Group Title Placebo + Methotrexate (MTX) Clazakizumab (1 mg) + MTX Clazakizumab (5 mg) + MTX Clazakizumab (25 mg) + MTX
Hide Arm/Group Description:
Placebo (5% dextrose) subcutaneous (SC) administration once every 4 weeks for 12 weeks plus background methotrexate (MTX)
Clazakizumab (1 mg) SC administration once every 4 weeks for 12 weeks + background Methotrexate
Clazakizumab (5 mg) SC administration once every 4 weeks for 12 weeks + background Methotrexate
Clazakizumab (25 mg) SC administration once every 4 weeks for 12 weeks + background Methotrexate
Overall Number of Participants Analyzed 35 16 36 36
Mean (Standard Error)
Unit of Measure: score on a scale
-0.25  (0.0906) -0.09  (0.1307) -0.31  (0.0889) -0.46  (0.0905)
7.Secondary Outcome
Title Percent of Participants With a DAS28-Erythrocyte Sedimentation Rate (ESR) <2.6
Hide Description DAS28- ESR = Disease Activity Scores 28 based on erythrocyte sedimentation rate. A DAS28-ESR below 2.6 is interpreted as remission.
Time Frame At week 12
Hide Outcome Measure Data
Hide Analysis Population Description
mITT
Arm/Group Title Placebo + Methotrexate (MTX) Clazakizumab (1 mg) + MTX Clazakizumab (5 mg) + MTX Clazakizumab (25 mg) + MTX
Hide Arm/Group Description:
Placebo (5% dextrose) subcutaneous (SC) administration once every 4 weeks for 12 weeks plus background methotrexate (MTX)
Clazakizumab (1 mg) SC administration once every 4 weeks for 12 weeks + background Methotrexate
Clazakizumab (5 mg) SC administration once every 4 weeks for 12 weeks + background Methotrexate
Clazakizumab (25 mg) SC administration once every 4 weeks for 12 weeks + background Methotrexate
Overall Number of Participants Analyzed 40 21 42 40
Measure Type: Number
Unit of Measure: percentage of participants
2.5 4.8 7.1 15.0
8.Secondary Outcome
Title Percent of Participants With a DAS28-C Reactive Protein (CRP) <2.6
Hide Description DAS28-CRP = Disease Activity Scores 28 based on C Reactive Protein. A DAS28-CRP below 2.6 is interpreted as remission.
Time Frame At week 12
Hide Outcome Measure Data
Hide Analysis Population Description
mITT
Arm/Group Title Placebo + Methotrexate (MTX) Clazakizumab (1 mg) + MTX Clazakizumab (5 mg) + MTX Clazakizumab (25 mg) + MTX
Hide Arm/Group Description:
Placebo (5% dextrose) subcutaneous (SC) administration once every 4 weeks for 12 weeks plus background methotrexate (MTX)
Clazakizumab (1 mg) SC administration once every 4 weeks for 12 weeks + background Methotrexate
Clazakizumab (5 mg) SC administration once every 4 weeks for 12 weeks + background Methotrexate
Clazakizumab (25 mg) SC administration once every 4 weeks for 12 weeks + background Methotrexate
Overall Number of Participants Analyzed 40 21 42 40
Measure Type: Number
Unit of Measure: percentage of participants
5.0 9.5 14.3 15.0
Time Frame Up to 12 weeks for each participant
Adverse Event Reporting Description As-Treated Analysis Population: All subjects who received at least 1 dose of study medication.
 
Arm/Group Title Placebo + Methotrexate (MTX) Clazakizumab (1 mg) + MTX Clazakizumab (5 mg) + MTX Clazakizumab (25 mg) + MTX
Hide Arm/Group Description Placebo (5% dextrose) subcutaneous (SC) administration once every 4 weeks for 12 weeks plus background methotrexate (MTX) Clazakizumab (1 mg) SC administration once every 4 weeks for 12 weeks + background Methotrexate Clazakizumab (5 mg) SC administration once every 4 weeks for 12 weeks + background Methotrexate Clazakizumab (25 mg) SC administration once every 4 weeks for 12 weeks + background Methotrexate
All-Cause Mortality
Placebo + Methotrexate (MTX) Clazakizumab (1 mg) + MTX Clazakizumab (5 mg) + MTX Clazakizumab (25 mg) + MTX
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/40 (2.50%)   0/21 (0.00%)   0/42 (0.00%)   0/40 (0.00%) 
Hide Serious Adverse Events
Placebo + Methotrexate (MTX) Clazakizumab (1 mg) + MTX Clazakizumab (5 mg) + MTX Clazakizumab (25 mg) + MTX
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/40 (2.50%)   0/21 (0.00%)   0/42 (0.00%)   1/40 (2.50%) 
General disorders         
SUDDEN DEATH  1  1/40 (2.50%)  0/21 (0.00%)  0/42 (0.00%)  0/40 (0.00%) 
Infections and infestations         
VIRAL INFECTION  1  0/40 (0.00%)  0/21 (0.00%)  0/42 (0.00%)  1/40 (2.50%) 
Renal and urinary disorders         
RENAL IMPAIRMENT  1  1/40 (2.50%)  0/21 (0.00%)  0/42 (0.00%)  0/40 (0.00%) 
1
Term from vocabulary, MedDRA
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo + Methotrexate (MTX) Clazakizumab (1 mg) + MTX Clazakizumab (5 mg) + MTX Clazakizumab (25 mg) + MTX
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   14/40 (35.00%)   5/21 (23.81%)   24/42 (57.14%)   28/40 (70.00%) 
Blood and lymphatic system disorders         
LEUKOPENIA  1  0/40 (0.00%)  0/21 (0.00%)  1/42 (2.38%)  3/40 (7.50%) 
NEUTROPENIA  1  0/40 (0.00%)  0/21 (0.00%)  0/42 (0.00%)  3/40 (7.50%) 
EOSINOPHILIA  1  0/40 (0.00%)  0/21 (0.00%)  0/42 (0.00%)  1/40 (2.50%) 
THROMBOCYTOPENIA  1  0/40 (0.00%)  0/21 (0.00%)  0/42 (0.00%)  1/40 (2.50%) 
Ear and labyrinth disorders         
EAR PAIN  1  0/40 (0.00%)  0/21 (0.00%)  0/42 (0.00%)  1/40 (2.50%) 
TINNITUS  1  0/40 (0.00%)  0/21 (0.00%)  0/42 (0.00%)  1/40 (2.50%) 
Eye disorders         
EYE PAIN  1  0/40 (0.00%)  0/21 (0.00%)  1/42 (2.38%)  0/40 (0.00%) 
Gastrointestinal disorders         
DIARRHOEA  1  1/40 (2.50%)  0/21 (0.00%)  2/42 (4.76%)  0/40 (0.00%) 
CONSTIPATION  1  1/40 (2.50%)  0/21 (0.00%)  1/42 (2.38%)  0/40 (0.00%) 
NAUSEA  1  0/40 (0.00%)  0/21 (0.00%)  2/42 (4.76%)  0/40 (0.00%) 
ABDOMINAL PAIN  1  0/40 (0.00%)  0/21 (0.00%)  0/42 (0.00%)  1/40 (2.50%) 
ABDOMINAL PAIN UPPER  1  0/40 (0.00%)  0/21 (0.00%)  1/42 (2.38%)  0/40 (0.00%) 
ANAL FISSURE  1  0/40 (0.00%)  0/21 (0.00%)  1/42 (2.38%)  0/40 (0.00%) 
DENTAL CARIES  1  0/40 (0.00%)  0/21 (0.00%)  0/42 (0.00%)  1/40 (2.50%) 
DYSPEPSIA  1  0/40 (0.00%)  0/21 (0.00%)  1/42 (2.38%)  0/40 (0.00%) 
GASTRITIS  1  1/40 (2.50%)  0/21 (0.00%)  0/42 (0.00%)  0/40 (0.00%) 
IRRITABLE BOWEL SYNDROME  1  0/40 (0.00%)  0/21 (0.00%)  0/42 (0.00%)  1/40 (2.50%) 
STOMATITIS  1  0/40 (0.00%)  0/21 (0.00%)  0/42 (0.00%)  1/40 (2.50%) 
General disorders         
FATIGUE  1  1/40 (2.50%)  1/21 (4.76%)  2/42 (4.76%)  0/40 (0.00%) 
INJECTION SITE REACTION  1  0/40 (0.00%)  0/21 (0.00%)  1/42 (2.38%)  3/40 (7.50%) 
INJECTION SITE RASH  1  1/40 (2.50%)  1/21 (4.76%)  0/42 (0.00%)  1/40 (2.50%) 
AXILLARY PAIN  1  0/40 (0.00%)  0/21 (0.00%)  1/42 (2.38%)  0/40 (0.00%) 
DRUG INTOLERANCE  1  1/40 (2.50%)  0/21 (0.00%)  0/42 (0.00%)  0/40 (0.00%) 
INFLUENZA LIKE ILLNESS  1  0/40 (0.00%)  1/21 (4.76%)  0/42 (0.00%)  0/40 (0.00%) 
INJECTION SITE BRUISING  1  0/40 (0.00%)  1/21 (4.76%)  0/42 (0.00%)  0/40 (0.00%) 
INJECTION SITE ERYTHEMA  1  0/40 (0.00%)  0/21 (0.00%)  0/42 (0.00%)  1/40 (2.50%) 
INJECTION SITE PRURITUS  1  0/40 (0.00%)  0/21 (0.00%)  0/42 (0.00%)  1/40 (2.50%) 
INJECTION SITE VESICLES  1  0/40 (0.00%)  0/21 (0.00%)  0/42 (0.00%)  1/40 (2.50%) 
PYREXIA  1  0/40 (0.00%)  0/21 (0.00%)  1/42 (2.38%)  0/40 (0.00%) 
VACCINATION SITE REACTION  1  1/40 (2.50%)  0/21 (0.00%)  0/42 (0.00%)  0/40 (0.00%) 
Hepatobiliary disorders         
HEPATIC FUNCTION ABNORMAL  1  0/40 (0.00%)  0/21 (0.00%)  2/42 (4.76%)  1/40 (2.50%) 
HEPATIC STEATOSIS  1  0/40 (0.00%)  0/21 (0.00%)  0/42 (0.00%)  1/40 (2.50%) 
Immune system disorders         
SEASONAL ALLERGY  1  0/40 (0.00%)  0/21 (0.00%)  1/42 (2.38%)  0/40 (0.00%) 
Infections and infestations         
NASOPHARYNGITIS  1  3/40 (7.50%)  0/21 (0.00%)  1/42 (2.38%)  1/40 (2.50%) 
URINARY TRACT INFECTION  1  0/40 (0.00%)  1/21 (4.76%)  2/42 (4.76%)  1/40 (2.50%) 
BRONCHITIS  1  0/40 (0.00%)  1/21 (4.76%)  1/42 (2.38%)  1/40 (2.50%) 
SINUSITIS  1  2/40 (5.00%)  0/21 (0.00%)  1/42 (2.38%)  0/40 (0.00%) 
UPPER RESPIRATORY TRACT INFECTION  1  1/40 (2.50%)  0/21 (0.00%)  1/42 (2.38%)  1/40 (2.50%) 
CONJUNCTIVITIS  1  0/40 (0.00%)  0/21 (0.00%)  2/42 (4.76%)  0/40 (0.00%) 
ORAL HERPES  1  2/40 (5.00%)  0/21 (0.00%)  0/42 (0.00%)  0/40 (0.00%) 
EAR INFECTION  1  1/40 (2.50%)  0/21 (0.00%)  0/42 (0.00%)  0/40 (0.00%) 
GASTROENTERITIS  1  0/40 (0.00%)  0/21 (0.00%)  1/42 (2.38%)  0/40 (0.00%) 
GASTROENTERITIS VIRAL  1  0/40 (0.00%)  0/21 (0.00%)  0/42 (0.00%)  1/40 (2.50%) 
HERPES ZOSTER  1  0/40 (0.00%)  0/21 (0.00%)  0/42 (0.00%)  1/40 (2.50%) 
LABYRINTHITIS  1  0/40 (0.00%)  0/21 (0.00%)  0/42 (0.00%)  1/40 (2.50%) 
SKIN CANDIDA  1  0/40 (0.00%)  0/21 (0.00%)  0/42 (0.00%)  1/40 (2.50%) 
TOOTH ABSCESS  1  0/40 (0.00%)  0/21 (0.00%)  1/42 (2.38%)  0/40 (0.00%) 
TOOTH INFECTION  1  0/40 (0.00%)  0/21 (0.00%)  0/42 (0.00%)  1/40 (2.50%) 
VULVOVAGINAL MYCOTIC INFECTION  1  1/40 (2.50%)  0/21 (0.00%)  0/42 (0.00%)  0/40 (0.00%) 
Injury, poisoning and procedural complications         
CONTUSION  1  2/40 (5.00%)  1/21 (4.76%)  0/42 (0.00%)  0/40 (0.00%) 
LIMB INJURY  1  1/40 (2.50%)  0/21 (0.00%)  0/42 (0.00%)  1/40 (2.50%) 
ARTHROPOD BITE  1  0/40 (0.00%)  0/21 (0.00%)  1/42 (2.38%)  0/40 (0.00%) 
FALL  1  0/40 (0.00%)  0/21 (0.00%)  1/42 (2.38%)  0/40 (0.00%) 
FOOT FRACTURE  1  1/40 (2.50%)  0/21 (0.00%)  0/42 (0.00%)  0/40 (0.00%) 
JOINT INJURY  1  0/40 (0.00%)  0/21 (0.00%)  0/42 (0.00%)  1/40 (2.50%) 
LACERATION  1  0/40 (0.00%)  0/21 (0.00%)  0/42 (0.00%)  1/40 (2.50%) 
SKIN ABRASION  1  1/40 (2.50%)  0/21 (0.00%)  0/42 (0.00%)  0/40 (0.00%) 
Investigations         
ALANINE AMINOTRANSFERASE INCREASED  1  0/40 (0.00%)  0/21 (0.00%)  1/42 (2.38%)  2/40 (5.00%) 
BLOOD CHOLESTEROL INCREASED  1  0/40 (0.00%)  0/21 (0.00%)  1/42 (2.38%)  1/40 (2.50%) 
HEPATIC ENZYME INCREASED  1  0/40 (0.00%)  0/21 (0.00%)  1/42 (2.38%)  1/40 (2.50%) 
BLOOD UREA INCREASED  1  0/40 (0.00%)  0/21 (0.00%)  1/42 (2.38%)  0/40 (0.00%) 
LOW DENSITY LIPOPROTEIN INCREASED  1  0/40 (0.00%)  0/21 (0.00%)  1/42 (2.38%)  0/40 (0.00%) 
NEUTROPHIL COUNT INCREASED  1  1/40 (2.50%)  0/21 (0.00%)  0/42 (0.00%)  0/40 (0.00%) 
PLATELET COUNT DECREASED  1  0/40 (0.00%)  0/21 (0.00%)  1/42 (2.38%)  0/40 (0.00%) 
WHITE BLOOD CELL COUNT INCREASED  1  1/40 (2.50%)  0/21 (0.00%)  0/42 (0.00%)  0/40 (0.00%) 
Metabolism and nutrition disorders         
DYSLIPIDAEMIA  1  0/40 (0.00%)  0/21 (0.00%)  1/42 (2.38%)  2/40 (5.00%) 
HYPERTRIGLYCERIDAEMIA  1  0/40 (0.00%)  1/21 (4.76%)  2/42 (4.76%)  0/40 (0.00%) 
HYPERCHOLESTEROLAEMIA  1  0/40 (0.00%)  1/21 (4.76%)  1/42 (2.38%)  0/40 (0.00%) 
DIABETES MELLITUS  1  0/40 (0.00%)  0/21 (0.00%)  0/42 (0.00%)  1/40 (2.50%) 
HYPERKALAEMIA  1  0/40 (0.00%)  0/21 (0.00%)  1/42 (2.38%)  0/40 (0.00%) 
HYPERURICAEMIA  1  0/40 (0.00%)  1/21 (4.76%)  0/42 (0.00%)  0/40 (0.00%) 
HYPOKALAEMIA  1  0/40 (0.00%)  0/21 (0.00%)  1/42 (2.38%)  0/40 (0.00%) 
Musculoskeletal and connective tissue disorders         
ARTHRALGIA  1  1/40 (2.50%)  0/21 (0.00%)  0/42 (0.00%)  0/40 (0.00%) 
BACK PAIN  1  0/40 (0.00%)  0/21 (0.00%)  1/42 (2.38%)  0/40 (0.00%) 
PAIN IN EXTREMITY  1  1/40 (2.50%)  0/21 (0.00%)  0/42 (0.00%)  0/40 (0.00%) 
TEMPOROMANDIBULAR JOINT SYNDROME  1  0/40 (0.00%)  0/21 (0.00%)  1/42 (2.38%)  0/40 (0.00%) 
TENOSYNOVITIS  1  1/40 (2.50%)  0/21 (0.00%)  0/42 (0.00%)  0/40 (0.00%) 
Nervous system disorders         
DIZZINESS  1  2/40 (5.00%)  0/21 (0.00%)  0/42 (0.00%)  1/40 (2.50%) 
HEADACHE  1  1/40 (2.50%)  0/21 (0.00%)  0/42 (0.00%)  0/40 (0.00%) 
HYPOAESTHESIA  1  0/40 (0.00%)  0/21 (0.00%)  1/42 (2.38%)  0/40 (0.00%) 
LETHARGY  1  0/40 (0.00%)  0/21 (0.00%)  1/42 (2.38%)  0/40 (0.00%) 
TENSION HEADACHE  1  0/40 (0.00%)  0/21 (0.00%)  0/42 (0.00%)  1/40 (2.50%) 
TREMOR  1  0/40 (0.00%)  0/21 (0.00%)  1/42 (2.38%)  0/40 (0.00%) 
Reproductive system and breast disorders         
VULVOVAGINAL DISCOMFORT  1  0/40 (0.00%)  0/21 (0.00%)  0/42 (0.00%)  1/40 (2.50%) 
Respiratory, thoracic and mediastinal disorders         
COUGH  1  0/40 (0.00%)  1/21 (4.76%)  0/42 (0.00%)  0/40 (0.00%) 
OROPHARYNGEAL PAIN  1  0/40 (0.00%)  0/21 (0.00%)  1/42 (2.38%)  0/40 (0.00%) 
RHINITIS ALLERGIC  1  0/40 (0.00%)  0/21 (0.00%)  0/42 (0.00%)  1/40 (2.50%) 
THROAT IRRITATION  1  0/40 (0.00%)  0/21 (0.00%)  0/42 (0.00%)  1/40 (2.50%) 
WHEEZING  1  0/40 (0.00%)  0/21 (0.00%)  1/42 (2.38%)  0/40 (0.00%) 
Skin and subcutaneous tissue disorders         
RASH  1  0/40 (0.00%)  0/21 (0.00%)  2/42 (4.76%)  0/40 (0.00%) 
RASH MACULO-PAPULAR  1  0/40 (0.00%)  0/21 (0.00%)  1/42 (2.38%)  0/40 (0.00%) 
RASH VESICULAR  1  0/40 (0.00%)  0/21 (0.00%)  0/42 (0.00%)  1/40 (2.50%) 
SKIN HYPERPIGMENTATION  1  0/40 (0.00%)  0/21 (0.00%)  0/42 (0.00%)  1/40 (2.50%) 
SKIN ULCER  1  0/40 (0.00%)  0/21 (0.00%)  1/42 (2.38%)  0/40 (0.00%) 
Vascular disorders         
HYPOTENSION  1  1/40 (2.50%)  0/21 (0.00%)  0/42 (0.00%)  0/40 (0.00%) 
SECONDARY HYPERTENSION  1  0/40 (0.00%)  0/21 (0.00%)  1/42 (2.38%)  0/40 (0.00%) 
1
Term from vocabulary, MedDRA
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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: Study Director
Organization: CSL Behring
Phone: 610-878-4000
EMail: clinicaltrials@cslbehring.com
Layout table for additonal information
Responsible Party: CSL Behring
ClinicalTrials.gov Identifier: NCT02015520    
Other Study ID Numbers: IM133-066
2013-003780-65 ( EudraCT Number )
First Submitted: December 6, 2013
First Posted: December 19, 2013
Results First Submitted: March 22, 2021
Results First Posted: April 19, 2021
Last Update Posted: May 12, 2021