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Trial record 20 of 1891 for:    "Depressive Disorder" [DISEASE] AND Rating AND Major Depressive Disorder

An Efficacy and Safety Study of Sirukumab in Participants With Major Depressive Disorder

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ClinicalTrials.gov Identifier: NCT02473289
Recruitment Status : Completed
First Posted : June 16, 2015
Results First Posted : June 11, 2019
Last Update Posted : June 11, 2019
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Depressive Disorder, Major
Interventions Drug: Sirukumab 50 mg
Drug: Placebo
Enrollment 193
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo Sirukumab 50 mg
Hide Arm/Group Description Participants received placebo subcutaneous (SC) injection on Day 1, Day 28 and Day 56, while continuing their baseline oral monoaminergic antidepressant(s). Participants received sirukumab 50 milligram (mg) on Day 1, Day 28 and Day 56, while continuing their baseline oral monoaminergic antidepressant(s).
Period Title: Overall Study
Started 99 94
Completed 88 81
Not Completed 11 13
Reason Not Completed
Adverse Event             2             3
Lost to Follow-up             1             1
Protocol Violation             0             1
Withdrawal of consent             6             7
Treatment Unblinded + Adverse event             0             1
Other             2             0
Arm/Group Title Placebo Sirukumab 50 mg Total
Hide Arm/Group Description Participants received placebo subcutaneous (SC) injection on Day 1, Day 28 and Day 56, while continuing their baseline oral monoaminergic antidepressant(s). Participants received sirukumab 50 milligram (mg) on Day 1, Day 28 and Day 56, while continuing their baseline oral monoaminergic antidepressant(s). Total of all reporting groups
Overall Number of Baseline Participants 99 94 193
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 99 participants 94 participants 193 participants
44.1  (11.73) 45.4  (10.83) 44.7  (11.29)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 99 participants 94 participants 193 participants
Female
75
  75.8%
74
  78.7%
149
  77.2%
Male
24
  24.2%
20
  21.3%
44
  22.8%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 99 participants 94 participants 193 participants
Hispanic or Latino
4
   4.0%
5
   5.3%
9
   4.7%
Not Hispanic or Latino
95
  96.0%
89
  94.7%
184
  95.3%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 99 participants 94 participants 193 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
   1.0%
1
   1.1%
2
   1.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
10
  10.1%
5
   5.3%
15
   7.8%
White
86
  86.9%
87
  92.6%
173
  89.6%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
2
   2.0%
1
   1.1%
3
   1.6%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 99 participants 94 participants 193 participants
Asian
1
   1.0%
1
   1.1%
2
   1.0%
Black or African American
10
  10.1%
5
   5.3%
15
   7.8%
Hispanic or Latino
4
   4.0%
4
   4.3%
8
   4.1%
Other
2
   2.0%
1
   1.1%
3
   1.6%
White Non-Hispanic
82
  82.8%
83
  88.3%
165
  85.5%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 99 participants 94 participants 193 participants
CANADA
5
   5.1%
2
   2.1%
7
   3.6%
POLAND
21
  21.2%
19
  20.2%
40
  20.7%
RUSSIAN FEDERATION
48
  48.5%
47
  50.0%
95
  49.2%
UNITED KINGDOM
2
   2.0%
1
   1.1%
3
   1.6%
UNITED STATES
23
  23.2%
25
  26.6%
48
  24.9%
1.Primary Outcome
Title Change From Baseline in Hamilton Depression Rating Scale (HDRS-17) Total Score at Week 12
Hide Description The HDRS-17 is a clinician-administered rating scale designed to assess the severity of symptoms in participants diagnosed with depression with a score range of 0 to 52. Each of the 17 items is rated by the clinician on either a 3-point (0 to 2) or a 5-point scale (0 to 4). The point scale used a rating of 0 (absent), 1 (doubtful to mild), 2 (mild to moderate), 3 (moderate to severe), and 4 (very severe). A total score (0 to 52) was calculated by adding the scores of all 17 items. For each item as well as the total score, a higher score represents a more severe condition. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Intent-to-treat 1 (mITT1) analysis set: all randomized participants with high sensitivity c-reactive protein (hsCRP) >= 3.00 milligram per liter (mg/L) at screening and baseline who receive at least 1 dose of study drug and have both baseline and at least one postbaseline HDRS-17 total score in double-blind (DB) treatment period.
Arm/Group Title Placebo Sirukumab 50 mg
Hide Arm/Group Description:
Participants received placebo subcutaneous (SC) injection on Day 1, Day 28 and Day 56, while continuing their baseline oral monoaminergic antidepressant(s).
Participants received sirukumab 50 milligram (mg) on Day 1, Day 28 and Day 56, while continuing their baseline oral monoaminergic antidepressant(s).
Overall Number of Participants Analyzed 42 44
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
-10.6  (1.43) -11.4  (1.52)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Sirukumab 50 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.310
Comments 1-sided
Method MMRM
Comments Here 'MMRM' refers to Mixed-effect Model Using Repeated Measures.
Method of Estimation Estimation Parameter Difference of Least Square (LS) Means
Estimated Value -0.8
Confidence Interval (2-Sided) 75%
-2.77 to 1.10
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.67
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline in HDRS-17 Total Score at Weeks 1, 4 and 8
Hide Description The HDRS-17 is a clinician-administered rating scale designed to assess the severity of symptoms in participants diagnosed with depression with a score range of 0 to 52. Each of the 17 items is rated by the clinician on either a 3-point (0 to 2) or a 5-point scale (0 to 4). The point scale used a rating of 0 (absent), 1 (doubtful to mild), 2 (mild to moderate), 3 (moderate to severe), and 4 (very severe). A total score (0 to 52) was calculated by adding the scores of all 17 items. For each item as well as the total score, a higher score represents a more severe condition.
Time Frame Baseline, Weeks 1, 4 and 8
Hide Outcome Measure Data
Hide Analysis Population Description
mITT1 analysis set: all randomized participants with hsCRP >= 3.00 mg/L at screening and baseline who receive at least 1 dose of study drug and have both baseline and at least one postbaseline HDRS-17 total score in DB treatment period. 'n' (number of participants analyzed)- number of participants analyzed at each specified timepoint, for each arm.
Arm/Group Title Placebo Sirukumab 50 mg
Hide Arm/Group Description:
Participants received placebo subcutaneous (SC) injection on Day 1, Day 28 and Day 56, while continuing their baseline oral monoaminergic antidepressant(s).
Participants received sirukumab 50 milligram (mg) on Day 1, Day 28 and Day 56, while continuing their baseline oral monoaminergic antidepressant(s).
Overall Number of Participants Analyzed 47 47
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
Change at Week 1 Number Analyzed 46 participants 47 participants
-5.1  (1.03) -4.6  (1.15)
Change at Week 4 Number Analyzed 46 participants 45 participants
-7.5  (1.21) -7.8  (1.33)
Change at Week 8 Number Analyzed 42 participants 45 participants
-7.9  (1.29) -11.0  (1.39)
3.Secondary Outcome
Title Percentage of Participants With Remission as Assessed by HDRS-17 Total Score at Week 12
Hide Description Remission- Percentage of participants with HDRS-17 total score less than or equal to (<=) 7 were considered as remitters. HDRS-17 defined as clinician-administered rating scale designed to assess severity of symptoms in participants diagnosed with depression with score range of 0 to 52. Each of 17 items is rated by clinician on either a 3-point (0 to 2) or a 5-point scale (0 to 4). The point scale used a rating of 0 (absent), 1 (doubtful to mild), 2 (mild to moderate), 3 (moderate to severe), and 4 (very severe). A total score (0 to 52) was calculated by adding scores of all 17 items. For each item as well as total score, a higher score represents a more severe condition.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
mITT1 analysis set: all randomized participants with hsCRP >=3.00 mg/L at screening and baseline who receive at least 1 dose of study drug and have both baseline and at least one postbaseline HDRS-17 total score in DB treatment period. 'N' (number of participants analyzed)- number of participants who were evaluable for this outcome measure.
Arm/Group Title Placebo Sirukumab 50 mg
Hide Arm/Group Description:
Participants received placebo subcutaneous (SC) injection on Day 1, Day 28 and Day 56, while continuing their baseline oral monoaminergic antidepressant(s).
Participants received sirukumab 50 milligram (mg) on Day 1, Day 28 and Day 56, while continuing their baseline oral monoaminergic antidepressant(s).
Overall Number of Participants Analyzed 42 44
Measure Type: Number
Unit of Measure: Percentage of participants
19.0 15.9
4.Secondary Outcome
Title Percentage of Participants With Response as Assessed by HDRS-17 Total Score at Week 12
Hide Description Response- Percentage of participants with greater than or equal to (>=) 50 percent (%) improvement on the HDRS-17 total score from baseline at Week 12 were considered as responders. The HDRS-17 defined as clinician-administered rating scale designed to assess the severity of symptoms in participants diagnosed with depression with a score range of 0 to 52. Each of the 17 items is rated by the clinician on either a 3-point (0 to 2) or a 5-point scale (0 to 4). The point scale used a rating of 0 (absent), 1 (doubtful to mild), 2 (mild to moderate), 3 (moderate to severe), and 4 (very severe). A total score (0 to 52) was calculated by adding the scores of all 17 items. For each item as well as the total score, a higher score represents a more severe condition.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
mITT1 analysis set: all randomized participants with hsCRP >= 3.00 mg/L at screening and baseline who receive at least 1 dose of study drug and have both baseline and at least one postbaseline HDRS-17 total score in DB treatment period. 'N' (number of participants analyzed)- number of participants who were evaluable for this outcome measure.
Arm/Group Title Placebo Sirukumab 50 mg
Hide Arm/Group Description:
Participants received placebo subcutaneous (SC) injection on Day 1, Day 28 and Day 56, while continuing their baseline oral monoaminergic antidepressant(s).
Participants received sirukumab 50 milligram (mg) on Day 1, Day 28 and Day 56, while continuing their baseline oral monoaminergic antidepressant(s).
Overall Number of Participants Analyzed 42 44
Measure Type: Number
Unit of Measure: Percentage of participants
33.3 34.1
5.Secondary Outcome
Title Change From Baseline in Clinical Global Impression - Severity (CGI-S) Total Score at Weeks 1, 4, 8, 12, 16, and 22
Hide Description CGI-S defined as clinician-rated scale that assesses the severity of mental illness on a scale of 0 to 7. Considering total clinical experience, a participant was assessed on severity of mental illness at the time of rating according to:1: normal, not at all ill; 2: borderline mentally ill; 3: mildly ill; 4: moderately ill; 5: markedly ill; 6: severely ill; 7: among the most extremely ill patients. A higher score implies a more severe condition.
Time Frame Baseline and Weeks 1, 4, 8, 12, 16, and 22
Hide Outcome Measure Data
Hide Analysis Population Description
mITT1 analysis set: all randomized participants with hsCRP >= 3.00 mg/L at screening and baseline who receive at least 1 dose of study drug and have both baseline and at least one postbaseline HDRS-17 total score in DB treatment period. 'n' (number of participants analyzed)- number of participants analyzed at each specified timepoint, for each arm.
Arm/Group Title Placebo Sirukumab 50 mg
Hide Arm/Group Description:
Participants received placebo subcutaneous (SC) injection on Day 1, Day 28 and Day 56, while continuing their baseline oral monoaminergic antidepressant(s).
Participants received sirukumab 50 milligram (mg) on Day 1, Day 28 and Day 56, while continuing their baseline oral monoaminergic antidepressant(s).
Overall Number of Participants Analyzed 47 47
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
Change at Week 1 Number Analyzed 46 participants 47 participants
-0.6  (0.14) -0.7  (0.15)
Change at Week 4 Number Analyzed 46 participants 45 participants
-1.1  (0.16) -1.0  (0.17)
Change at Week 8 Number Analyzed 42 participants 45 participants
-1.4  (0.18) -1.5  (0.19)
Change at Week 12 Number Analyzed 44 participants 44 participants
-1.5  (0.21) -1.9  (0.22)
Change at Week 16 Number Analyzed 42 participants 44 participants
-1.9  (0.23) -2.1  (0.24)
Change at Week 22 Number Analyzed 42 participants 43 participants
-2.0  (0.24) -2.3  (0.25)
6.Secondary Outcome
Title Change From Baseline in Patient Health Questionnaire (PHQ-9) Total Score at Weeks 1, 4, 8, 12, 16, and 22
Time Frame Baseline and Weeks 1, 4, 8, 12, 16, and 22
Hide Outcome Measure Data
Hide Analysis Population Description
mITT1 analysis set: all randomized participants with hsCRP >= 3.00 mg/L at screening and baseline who receive at least 1 dose of study drug and have both baseline and at least one postbaseline HDRS-17 total score in DB treatment period. 'n' (number of participants analyzed)- number of participants analyzed at each specified timepoint, for each arm.
Arm/Group Title Placebo Sirukumab 50 mg
Hide Arm/Group Description:
Participants received placebo subcutaneous (SC) injection on Day 1, Day 28 and Day 56, while continuing their baseline oral monoaminergic antidepressant(s).
Participants received sirukumab 50 milligram (mg) on Day 1, Day 28 and Day 56, while continuing their baseline oral monoaminergic antidepressant(s).
Overall Number of Participants Analyzed 47 47
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
Change at Week 1 Number Analyzed 45 participants 47 participants
-2.5  (0.58) -3.1  (0.61)
Change at Week 4 Number Analyzed 45 participants 45 participants
-4.4  (0.75) -5.3  (0.79)
Change at Week 8 Number Analyzed 41 participants 45 participants
-5.6  (0.86) -7.6  (0.87)
Change at Week 12 Number Analyzed 43 participants 44 participants
-7.5  (0.98) -8.9  (1.00)
Change at Week 16 Number Analyzed 42 participants 44 participants
-8.2  (0.98) -9.6  (1.00)
Change at Week 22 Number Analyzed 41 participants 43 participants
-9.1  (1.04) -10.7  (1.05)
7.Secondary Outcome
Title Change From Baseline in Snaith Hamilton Pleasure Scale (SHAPS) Total Score (Definition 1) at Weeks 1, 4, 8, 12, 16, and 22
Hide Description The Snaith–Hamilton Pleasure Scale (SHAPS) is short, 14-item instrument to measure anhedonia. Each of the 14 items has a set of four response categories (Definition 1): Definitely Agree (=1), Agree (= 2), Disagree (= 3), and Definitely Disagree (= 4). A SHAPS total score was calculated as the sum of the 14 item scores with a total score range from 14 to 56. A higher total score indicates higher levels of state anhedonia.
Time Frame Baseline and Weeks 1, 4, 8, 12, 16, and 22
Hide Outcome Measure Data
Hide Analysis Population Description
mITT1 analysis set: all randomized participants with hsCRP >= 3.00 mg/L at screening and baseline who receive at least 1 dose of study drug and have both baseline and at least one postbaseline HDRS-17 total score in DB treatment period. 'n' (number of participants analyzed)- number of participants analyzed at each specified timepoint, for each arm.
Arm/Group Title Placebo Sirukumab 50 mg
Hide Arm/Group Description:
Participants received placebo subcutaneous (SC) injection on Day 1, Day 28 and Day 56, while continuing their baseline oral monoaminergic antidepressant(s).
Participants received sirukumab 50 milligram (mg) on Day 1, Day 28 and Day 56, while continuing their baseline oral monoaminergic antidepressant(s).
Overall Number of Participants Analyzed 47 47
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
Change at Week 1 Number Analyzed 45 participants 47 participants
-1.4  (0.72) -3.3  (0.74)
Change at Week 4 Number Analyzed 45 participants 45 participants
-3.9  (0.75) -5.1  (0.78)
Change at Week 8 Number Analyzed 41 participants 45 participants
-5.8  (0.87) -7.0  (0.88)
Change at Week 12 Number Analyzed 43 participants 44 participants
-5.9  (1.00) -8.9  (1.02)
Change at Week 16 Number Analyzed 42 participants 44 participants
-7.0  (1.11) -8.8  (1.12)
Change at Week 22 Number Analyzed 41 participants 43 participants
-7.8  (1.11) -10.6  (1.12)
8.Secondary Outcome
Title Change From Baseline in Snaith Hamilton Pleasure Scale (SHAPS) Total Score (Definition 2) at Weeks 1, 4, 8, 12, 16, and 22
Hide Description The Snaith–Hamilton Pleasure Scale (SHAPS) is short, 14-item instrument to measure anhedonia. Each of the 14 items has a set of four response categories (Definition 2): Definitely Agree (= 0), Agree (= 0), Disagree (= 1), and Definitely Disagree (= 1). A SHAPS total score was calculated as the sum of the 14 item scores with a score range from 0 to 14. A higher total score indicates higher levels of state anhedonia.
Time Frame Baseline and Weeks 1, 4, 8, 12, 16, and 22
Hide Outcome Measure Data
Hide Analysis Population Description
mITT1 analysis set: all randomized participants with hsCRP >= 3.00 mg/L at screening and baseline who receive at least 1 dose of study drug and have both baseline and at least one postbaseline HDRS-17 total score in DB treatment period. 'n' (number of participants analyzed)- number of participants analyzed at each specified timepoint, for each arm.
Arm/Group Title Placebo Sirukumab 50 mg
Hide Arm/Group Description:
Participants received placebo subcutaneous (SC) injection on Day 1, Day 28 and Day 56, while continuing their baseline oral monoaminergic antidepressant(s).
Participants received sirukumab 50 milligram (mg) on Day 1, Day 28 and Day 56, while continuing their baseline oral monoaminergic antidepressant(s).
Overall Number of Participants Analyzed 47 47
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
Change at Week 1 Number Analyzed 45 participants 47 participants
-1.2  (0.45) -2.0  (0.47)
Change at Week 4 Number Analyzed 45 participants 45 participants
-2.2  (0.49) -3.3  (0.51)
Change at Week 8 Number Analyzed 41 participants 45 participants
-3.6  (0.57) -4.4  (0.57)
Change at Week 12 Number Analyzed 43 participants 44 participants
-3.7  (0.64) -5.4  (0.66)
Change at Week 16 Number Analyzed 42 participants 44 participants
-4.1  (0.69) -5.6  (0.70)
Change at Week 22 Number Analyzed 41 participants 43 participants
-4.6  (0.71) -6.8  (0.72)
9.Secondary Outcome
Title Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Total Score at Weeks 1, 4, 8, 12, 16, and 22
Hide Description The FACIT-Fatigue is a questionnaire that assesses self-reported tiredness, weakness, and difficulty conducting usual activities due to fatigue. The subscale consists 13-item instrument to measure fatigue. Each of the 13 items has a set of five response categories: Not at all (=0), A little bit (=1), Somewhat (=2), Quite a bit (=3) and Very much (=4). A total FACIT-Fatigue subscale score was calculated as the sum of the 13 item scores (reserved scores [4 – score] for all except for 2 items: “I have energy” and “I am able to do my usual activities”), and ranges from 0 to 52, with a higher score indicating less fatigue.
Time Frame Baseline and Weeks 1, 4, 8, 12, 16, and 22
Hide Outcome Measure Data
Hide Analysis Population Description
mITT1 analysis set: all randomized participants with hsCRP >= 3.00 mg/L at screening and baseline who receive at least 1 dose of study drug and have both baseline and at least one postbaseline HDRS-17 total score in DB treatment period. 'n' (number of participants analyzed)- number of participants analyzed at each specified timepoint, for each arm.
Arm/Group Title Placebo Sirukumab 50 mg
Hide Arm/Group Description:
Participants received placebo subcutaneous (SC) injection on Day 1, Day 28 and Day 56, while continuing their baseline oral monoaminergic antidepressant(s).
Participants received sirukumab 50 milligram (mg) on Day 1, Day 28 and Day 56, while continuing their baseline oral monoaminergic antidepressant(s).
Overall Number of Participants Analyzed 47 47
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Change at Week 1 Number Analyzed 45 participants 47 participants
1.75  (4.671) 4.91  (10.097)
Change at Week 4 Number Analyzed 45 participants 45 participants
6.87  (10.119) 6.44  (9.633)
Change at Week 8 Number Analyzed 41 participants 45 participants
8.93  (9.913) 10.09  (10.346)
Change at Week 12 Number Analyzed 43 participants 44 participants
11.65  (13.476) 13.82  (11.486)
Change at Week 16 Number Analyzed 42 participants 44 participants
13.55  (12.029) 13.95  (12.066)
Change at Week 22 Number Analyzed 41 participants 43 participants
14.54  (13.585) 17.23  (12.051)
Time Frame Approximately 26 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Sirukumab 50 mg
Hide Arm/Group Description Participants received placebo subcutaneous (SC) injection on Day 1, Day 28 and Day 56, while continuing their baseline oral monoaminergic antidepressant(s). Participants received sirukumab 50 milligram (mg) on Day 1, Day 28 and Day 56, while continuing their baseline oral monoaminergic antidepressant(s).
All-Cause Mortality
Placebo Sirukumab 50 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   0/99 (0.00%)   0/94 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Sirukumab 50 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   2/99 (2.02%)   3/94 (3.19%) 
Cardiac disorders     
Acute Myocardial Infarction * 1  0/99 (0.00%)  1/94 (1.06%) 
Infections and infestations     
Cellulitis * 1  0/99 (0.00%)  1/94 (1.06%) 
Investigations     
Transaminases Increased * 1  1/99 (1.01%)  0/94 (0.00%) 
Psychiatric disorders     
Depression Suicidal * 1  0/99 (0.00%)  1/94 (1.06%) 
Suicide Attempt * 1  1/99 (1.01%)  0/94 (0.00%) 
1
Term from vocabulary, MedDRA Version 20.0
*
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 Sirukumab 50 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   13/99 (13.13%)   19/94 (20.21%) 
General disorders     
Injection Site Erythema * 1  0/99 (0.00%)  11/94 (11.70%) 
Injection Site Pain * 1  1/99 (1.01%)  5/94 (5.32%) 
Nervous system disorders     
Headache * 1  12/99 (12.12%)  5/94 (5.32%) 
1
Term from vocabulary, MedDRA Version 20.0
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days.
Results Point of Contact
Name/Title: ASSOCIATE DIRECTOR
Organization: Janssen Research & Development, LLC
Phone: 844-434-4210
Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT02473289     History of Changes
Other Study ID Numbers: CR107171
CNTO136MDD2001 ( Other Identifier: Janssen Research & Development, LLC )
2014-005206-37 ( EudraCT Number )
First Submitted: June 12, 2015
First Posted: June 16, 2015
Results First Submitted: May 21, 2019
Results First Posted: June 11, 2019
Last Update Posted: June 11, 2019