ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study of the Safety and Efficacy of Ustekinumab in Adolescent Patients With Psoriasis (CADMUS)

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: NCT01090427
Recruitment Status : Completed
First Posted : March 22, 2010
Results First Posted : December 18, 2014
Last Update Posted : January 29, 2015
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Psoriasis
Interventions Drug: Ustekinumab - Half-Standard Dosage
Drug: Ustekinumab - Standard Dosage
Other: Placebo
Enrollment 110
Recruitment Details A total of 110 volunteers from 10 countries were randomized and treated in this study.
Pre-assignment Details A total of 110 participants started and completed the first period in the study (ie, controlled period [CP] and entered the 2nd period (ie, After the Controlled Period [after CP]); however, only 101 of the 110 participants completed the 2nd period (after CP) of the study.
Arm/Group Title Placebo (CP) Ustekinumab Half-Standard Dosage (CP) Ustekinumab Standard Dosage (CP) Placebo -> Ustekinumab Half-Standard Dosage (After CP) Placebo -> Ustekinumab Standard Dosage (After CP) Ustekinumab Half-Standard Dosage (After CP) Ustekinumab Standard Dosage (After CP)
Hide Arm/Group Description Controlled period (Week 0-12) - Placebo Subcutaneous (SC) injections at Week 0 and 4. Controlled period (Week 0-12) - Ustekinumab Subcutaneous (SC) injections of 0.375 mg/kg for participants with weight <= 60kg, 22.5 mg for participants with weight > 60 to <= 100kg, and 45 mg for participants with weight > 100kg. Controlled period (Week 0-12) - Ustekinumab Subcutaneous (SC) injections of 0.75 mg/kg for participants with weight <= 60kg, 45 mg for participants with weight > 60 to <= 100kg, and 90 mg for participants with weight > 100kg. After Controlled period (Week 12-60) – participants receiving Placebo at Weeks 0 and 4 -> receiving Ustekinumab Half-Standard Dosage at Week 12 and 16 then q12w with the last dose at Week 40. After Controlled period (Week 12-60) – participants receiving Placebo at Weeks 0 and 4 -> receiving Ustekinumab Standard Dosage at Week 12 and 16 then q12wk with last dose at Week 40. After Controlled period (Week 12-60) – participants receiving Ustekinumab Half-Standard Dosage at Weeks 0 and 4 -> receiving Ustekinumab Half-Standard Dosage q12wk with the last dose at Week 40. After Controlled period (Week 12-60) – participants receiving Ustekinumab Standard Dosage at Weeks 0 and 4 -> receiving Ustekinumab Standard Dosage q12wk with last dose at Week 40.
Period Title: Controlled Period
Started 37 37 36 0 [1] 0 [1] 0 [1] 0 [1]
Completed 37 37 36 0 0 0 0
Not Completed 0 0 0 0 0 0 0
[1]
"0" in column indicates this reporting group is not relevant to Control Period.
Period Title: After Controlled Period
Started 0 [1] 0 [1] 0 [1] 19 18 37 36
Completed 0 0 0 17 18 32 34
Not Completed 0 0 0 2 0 5 2
Reason Not Completed
Death             0             0             0             0             0             1             0
Lack of Efficacy             0             0             0             0             0             3             2
Adverse Event             0             0             0             2             0             1             0
[1]
"0" in column indicates this reporting group is not relevant to after Control Period.
Arm/Group Title Placebo Ustekinumab Half-Standard Dosage Ustekinumab Standard Dosage Total
Hide Arm/Group Description Participants received a subcutaneous (SC) injection of Placebo at Weeks 0 and 4 then crossover to ustekinumab half-standard dosage (0.375 mg/kg, 22.5 mg, or 45 mg based on body weight) OR ustekinumab standard dosage (0.75 mg/kg, 45 mg, or 90 mg based on body weight) SC injection at Weeks 12, 16, 28, and 40. Participants received ustekinumab subcutaneous (SC) injections (0.375 mg/kg, 22.5 mg, or 45 mg based on body weight) at Weeks 0, 16, 28, and 40. In addition, all participants received a single SC dose of placebo at Week 12. Participants received ustekinumab (0.75 mg/kg, 45 mg, or 90 mg based on body weight) subcutaneous (SC) injections at Weeks 0, 4, 16, 28, and 40. In addition, all participants received a single SC dose of placebo at Week 12. Total of all reporting groups
Overall Number of Baseline Participants 37 37 36 110
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 37 participants 37 participants 36 participants 110 participants
15.6  (1.46) 15.1  (1.7) 14.8  (1.73) 15.2  (1.65)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 37 participants 37 participants 36 participants 110 participants
Female
17
  45.9%
19
  51.4%
20
  55.6%
56
  50.9%
Male
20
  54.1%
18
  48.6%
16
  44.4%
54
  49.1%
Age  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 37 participants 37 participants 36 participants 110 participants
12-15 years 15 20 20 55
16-17 years 22 17 16 55
1.Primary Outcome
Title The Percentage of Participants Achieving a Physician's Global Assessment (PGA) Score of Cleared (0) or Minimal (1) at Week 12
Hide Description The PGA documents the physician’s assessment of the participant’s psoriasis status according to the following categories: induration, scaling, and erythema. The participant's psoriasis is assessed as 5-point scale as follows: cleared (0), minimal (1), mild (2), moderate (3), or severe (4); higher score indicates worse disease. The table below shows the percentage of participants who achieved a PGA score of 0 or 1 at Week 12 in each treatment group.
Time Frame Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The primary efficacy analysis was performed using the all randomized subjects analysis set defined as the population of all participants who were randomized to any treatment group.
Arm/Group Title Placebo Ustekinumab Half-Standard Dosage Ustekinumab Standard Dosage
Hide Arm/Group Description:
Participants received a subcutaneous (SC) injection of Placebo at Weeks 0 and 4 then crossover to ustekinumab half-standard dosage (0.375 mg/kg, 22.5 mg, or 45 mg based on body weight) OR ustekinumab standard dosage (0.75 mg/kg, 45 mg, or 90 mg based on body weight) SC injection at Weeks 12, 16, 28, and 40.
Participants received ustekinumab subcutaneous (SC) injections (0.375 mg/kg, 22.5 mg, or 45 mg based on body weight) at Weeks 0, 16, 28, and 40. In addition, all participants received a single SC dose of placebo at Week 12.
Participants received ustekinumab (0.75 mg/kg, 45 mg, or 90 mg based on body weight) subcutaneous (SC) injections at Weeks 0, 4, 16, 28, and 40. In addition, all participants received a single SC dose of placebo at Week 12.
Overall Number of Participants Analyzed 37 37 36
Measure Type: Number
Unit of Measure: Percentage of Participants
5.4 67.6 69.4
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Ustekinumab Half-Standard Dosage
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Stratified by body weight (less than or equal to 60 kg vs greater than 60 kg).
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Ustekinumab Standard Dosage
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Stratified by body weight (less than or equal to 60 kg vs greater than 60 kg).
2.Secondary Outcome
Title The Percentage of Participants Achieving a Psoriasis Area and Severity Index (PASI) 75 Response at Week 12
Hide Description The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. The PASI produces a numeric score that can range from 0 to 72, with higher scores indicating worse disease. A PASI 75 response is defined as a equal to or greater than (=>) 75% improvement in PASI score from baseline. The table below shows the percentage of participants who achieved a PASI 75 response at Week 12 in each treatment group.
Time Frame Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis of the PASI 75 response at Week 12 was performed using the all randomized subjects analysis set defined as the population of all participants who were randomized to any treatment group.
Arm/Group Title Placebo Ustekinumab Half-Standard Dosage Ustekinumab Standard Dosage
Hide Arm/Group Description:
Participants received a subcutaneous (SC) injection of Placebo at Weeks 0 and 4 then crossover to ustekinumab half-standard dosage (0.375 mg/kg, 22.5 mg, or 45 mg based on body weight) OR ustekinumab standard dosage (0.75 mg/kg, 45 mg, or 90 mg based on body weight) SC injection at Weeks 12, 16, 28, and 40.
Participants received ustekinumab subcutaneous (SC) injections (0.375 mg/kg, 22.5 mg, or 45 mg based on body weight) at Weeks 0, 16, 28, and 40. In addition, all participants received a single SC dose of placebo at Week 12.
Participants received ustekinumab (0.75 mg/kg, 45 mg, or 90 mg based on body weight) subcutaneous (SC) injections at Weeks 0, 4, 16, 28, and 40. In addition, all participants received a single SC dose of placebo at Week 12.
Overall Number of Participants Analyzed 37 37 36
Measure Type: Number
Unit of Measure: Percentage of Participants
10.8 78.4 80.6
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Ustekinumab Half-Standard Dosage
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Stratified by body weight (less than or equal to 60 kg vs greater than 60 kg).
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Ustekinumab Standard Dosage
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Stratified by body weight (less than or equal to 60 kg vs greater than 60 kg).
3.Secondary Outcome
Title Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) Score at Week 12 Compared Between the Placebo Group and the Ustekinumab Treatment Groups
Hide Description The CDLQI is a dermatology-specific quality of life instrument designed to assess the impact of the disease on a child’s quality of life. The CDLQI, a 10-item questionnaire has 4 items response options and a recall period of 1 week. In addition to evaluating overall quality of life, the CDLQI can be used to assess 6 different aspects that may affect quality of life: symptoms and feelings, leisure, School or holidays, personal relationships, sleep, and treatment. The CDLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0; the higher the score, the greater impairment in quality of life. The table below shows the mean change in CDLQI score from baseline at Week 12 for each treatment group.
Time Frame Baseline; Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Evaluable participants for CDLQI are the subsets of all randomized participants with evaluable outcome measurements.
Arm/Group Title Placebo Ustekinumab Half-Standard Dosage Ustekinumab Standard Dosage
Hide Arm/Group Description:
Participants received a subcutaneous (SC) injection of Placebo at Weeks 0 and 4 then crossover to ustekinumab half-standard dosage (0.375 mg/kg, 22.5 mg, or 45 mg based on body weight) OR ustekinumab standard dosage (0.75 mg/kg, 45 mg, or 90 mg based on body weight) SC injection at Weeks 12, 16, 28, and 40.
Participants received ustekinumab subcutaneous (SC) injections (0.375 mg/kg, 22.5 mg, or 45 mg based on body weight) at Weeks 0, 16, 28, and 40. In addition, all participants received a single SC dose of placebo at Week 12.
Participants received ustekinumab (0.75 mg/kg, 45 mg, or 90 mg based on body weight) subcutaneous (SC) injections at Weeks 0, 4, 16, 28, and 40. In addition, all participants received a single SC dose of placebo at Week 12.
Overall Number of Participants Analyzed 32 35 32
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-1.5  (3.18) -5.6  (6.43) -6.7  (5.63)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Ustekinumab Half-Standard Dosage
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments [Not Specified]
Method ANOVA on van der Waerden normal Score
Comments Treatment and baseline weight [less than or equal to 60 kg vs greater than 60 kg] will be used as factors in the model.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Ustekinumab Standard Dosage
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANOVA on van der Waerden normal Score
Comments Treatment and baseline weight [less than or equal to 60 kg vs greater than 60 kg] will be used as factors in the model.
4.Secondary Outcome
Title The Percentage of Participants Achieving a Psoriasis Area and Severity Index (PASI) 90 Response at Week 12 Compared Between the Placebo Group and the Ustekinumab Treatment Groups
Hide Description The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. The PASI produces a numeric score that can range from 0 to 72, with higher scores indicating worse disease. The table below shows the percentage of participants who achieved a PASI 90 response defined as achieving a greater than or equal to (≥) 90% improvement in PASI score from baseline.
Time Frame Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis of the PASI 90 response at Week 12 was performed using the all randomized subjects analysis set defined as the population of all participants who were randomized to any treatment group.
Arm/Group Title Placebo Ustekinumab Half-Standard Dosage Ustekinumab Standard Dosage
Hide Arm/Group Description:
Participants received a subcutaneous (SC) injection of Placebo at Weeks 0 and 4 then crossover to ustekinumab half-standard dosage (0.375 mg/kg, 22.5 mg, or 45 mg based on body weight) OR ustekinumab standard dosage (0.75 mg/kg, 45 mg, or 90 mg based on body weight) SC injection at Weeks 12, 16, 28, and 40.
Participants received ustekinumab subcutaneous (SC) injections (0.375 mg/kg, 22.5 mg, or 45 mg based on body weight) at Weeks 0, 16, 28, and 40. In addition, all participants received a single SC dose of placebo at Week 12.
Participants received ustekinumab (0.75 mg/kg, 45 mg, or 90 mg based on body weight) subcutaneous (SC) injections at Weeks 0, 4, 16, 28, and 40. In addition, all participants received a single SC dose of placebo at Week 12.
Overall Number of Participants Analyzed 37 37 36
Measure Type: Number
Unit of Measure: Percentage of Participants
5.4 54.1 61.1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Ustekinumab Half-Standard Dosage
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Stratified by body weight (less than or equal to 60 kg vs greater than 60 kg).
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Ustekinumab Standard Dosage
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Stratified by body weight (less than or equal to 60 kg vs greater than 60 kg).
5.Secondary Outcome
Title The Percentage of Participants Achieving a Physician's Global Assessment (PGA) Score of Cleared (0) and PGA Score of Mild or Better (<=2) at Week 12
Hide Description The PGA documents the physician’s assessment of the participant’s psoriasis status according to the following categories: induration, scaling, and erythema. The participant's psoriasis is assessed as 5-point scale as follows: cleared (0), minimal (1), mild (2), moderate (3), or severe (4); higher score indicates worse disease. The table below shows the percentage of participants who achieved a PGA score of 0 and the percentage of participants who achieved a PGA score of 0, 1, or 2 at Week 12 in each treatment group.
Time Frame Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Efficacy evaluable subjects defined as the subset of all randomized participants with evaluable outcome measurements.
Arm/Group Title Placebo Ustekinumab Half-Standard Dosage Ustekinumab Standard Dosage
Hide Arm/Group Description:
Participants received a subcutaneous (SC) injection of Placebo at Weeks 0 and 4 then crossover to ustekinumab half-standard dosage (0.375 mg/kg, 22.5 mg, or 45 mg based on body weight) OR ustekinumab standard dosage (0.75 mg/kg, 45 mg, or 90 mg based on body weight) SC injection at Weeks 12, 16, 28, and 40.
Participants received ustekinumab subcutaneous (SC) injections (0.375 mg/kg, 22.5 mg, or 45 mg based on body weight) at Weeks 0, 16, 28, and 40. In addition, all participants received a single SC dose of placebo at Week 12.
Participants received ustekinumab (0.75 mg/kg, 45 mg, or 90 mg based on body weight) subcutaneous (SC) injections at Weeks 0, 4, 16, 28, and 40. In addition, all participants received a single SC dose of placebo at Week 12.
Overall Number of Participants Analyzed 37 37 36
Measure Type: Number
Unit of Measure: Percentage of participants
PGA of 0 2.7 32.4 47.2
PGA of 0, 1, or 2 32.4 81.1 83.3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Ustekinumab Half-Standard Dosage
Comments PGA of 0
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Stratified by body weight (less than or equal to 60 kg vs greater than 60 kg).
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Ustekinumab Standard Dosage
Comments PGA of 0
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Stratified by body weight (less than or equal to 60 kg vs greater than 60 kg).
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Ustekinumab Half-Standard Dosage
Comments PGA of 0, 1, or 2
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Stratified by body weight (less than or equal to 60 kg vs greater than 60 kg).
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Ustekinumab Standard Dosage
Comments PGA of 0, 1, or 2
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Stratified by body weight (less than or equal to 60 kg vs greater than 60 kg).
6.Secondary Outcome
Title The Percentage of Participants Who Were PASI 50 Responders and the Percentage of Participants With a PASI Score of 0 at Week 12
Hide Description The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. The PASI produces a numeric score that can range from 0 (no disease) to 72 (maximal disease). The table below shows the percentage of participants in each treatment group who were PASI 50 responders at Week 12 defined as participants who achieved a greater than or equal to (>=) 50% improvement in PASI score from baseline as well as the percentage of participants with a PASI score of 0.
Time Frame Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Efficacy evaluable subjects defined as the subset of all randomized participants with evaluable outcome measurements.
Arm/Group Title Placebo Ustekinumab Half-Standard Dosage Ustekinumab Standard Dosage
Hide Arm/Group Description:
Participants received a subcutaneous (SC) injection of Placebo at Weeks 0 and 4 then crossover to ustekinumab half-standard dosage (0.375 mg/kg, 22.5 mg, or 45 mg based on body weight) OR ustekinumab standard dosage (0.75 mg/kg, 45 mg, or 90 mg based on body weight) SC injection at Weeks 12, 16, 28, and 40.
Participants received ustekinumab subcutaneous (SC) injections (0.375 mg/kg, 22.5 mg, or 45 mg based on body weight) at Weeks 0, 16, 28, and 40. In addition, all participants received a single SC dose of placebo at Week 12.
Participants received ustekinumab (0.75 mg/kg, 45 mg, or 90 mg based on body weight) subcutaneous (SC) injections at Weeks 0, 4, 16, 28, and 40. In addition, all participants received a single SC dose of placebo at Week 12.
Overall Number of Participants Analyzed 37 37 36
Measure Type: Number
Unit of Measure: Percentage of participants
PASI 50 responders 29.7 81.1 88.9
Participants with PASI score of 0 2.7 21.6 38.9
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Ustekinumab Half-Standard Dosage
Comments PASI 50 responders
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Stratified by body weight (less than or equal to 60 kg vs greater than 60 kg).
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Ustekinumab Standard Dosage
Comments PASI 50 responders
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Stratified by body weight (less than or equal to 60 kg vs greater than 60 kg).
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Ustekinumab Half-Standard Dosage
Comments Participants with PASI score of 0
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.014
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Stratified by body weight (less than or equal to 60 kg vs greater than 60 kg).
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Ustekinumab Standard Dosage
Comments Participants with PASI score of 0
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Stratified by body weight (less than or equal to 60 kg vs greater than 60 kg).
7.Secondary Outcome
Title The Change From Baseline in Pediatric Quality of Life Inventory (PedsQL) Total Scale Score, Psychosocial Health Summary Score, and Physical Health Summary Score at Week 12
Hide Description The PedsQL is a general health-related quality of life measure developed for use in children and adolescent populations. The Generic Core Scale contains 23 items and is comprised of 4 domains: physical, social, emotional, and school functioning. Each domain can be scored independently. Additionally, a Psychosocial Health and Physical Health Summary Score can be calculated as well as a total score. The measure distinguishes between healthy children and children with acute and chronic health conditions and disease severity within a chronic health condition. The measure is applicable for healthy school and community populations, as well as with pediatric populations with acute and chronic health conditions and has versions for both parent and teen report. Scores range from 0 to 100, and higher scores indicate better health related quality of life.
Time Frame Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Efficacy evaluable subjects defined as the subset of all randomized participants with evaluable outcome measurements available.
Arm/Group Title Placebo Ustekinumab Half-Standard Dosage Ustekinumab Standard Dosage
Hide Arm/Group Description:
Participants received a subcutaneous (SC) injection of Placebo at Weeks 0 and 4 then crossover to ustekinumab half-standard dosage (0.375 mg/kg, 22.5 mg, or 45 mg based on body weight) OR ustekinumab standard dosage (0.75 mg/kg, 45 mg, or 90 mg based on body weight) SC injection at Weeks 12, 16, 28, and 40.
Participants received ustekinumab subcutaneous (SC) injections (0.375 mg/kg, 22.5 mg, or 45 mg based on body weight) at Weeks 0, 16, 28, and 40. In addition, all participants received a single SC dose of placebo at Week 12.
Participants received ustekinumab (0.75 mg/kg, 45 mg, or 90 mg based on body weight) subcutaneous (SC) injections at Weeks 0, 4, 16, 28, and 40. In addition, all participants received a single SC dose of placebo at Week 12.
Overall Number of Participants Analyzed 36 36 36
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
PedsQL Total scale score 3.35  (10.044) 10.81  (12.882) 8.03  (10.436)
PedsQL Psychosocial health summary score 3.66  (9.610) 12.13  (15.153) 8.43  (11.812)
PedsQL Physical health summary score 2.86  (12.860) 8.33  (11.378) 7.29  (13.446)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Ustekinumab Half-Standard Dosage
Comments PedsQL Total Scale Score
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments [Not Specified]
Method ANOVA on van der Waerden normal Score
Comments Treatment and baseline weight [less than or equal to 60 kg vs greater than 60 kg] were used as factors in the model.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Ustekinumab Standard Dosage
Comments PedsQL Total Scale Score
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.028
Comments [Not Specified]
Method ANOVA on van der Waerden normal Score
Comments Treatment and baseline weight [less than or equal to 60 kg vs greater than 60 kg] were used as factors in the model.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Ustekinumab Half-Standard Dosage
Comments PedsQL Psychosocial health summary score
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.005
Comments [Not Specified]
Method ANOVA on van der Waerden normal Score
Comments Treatment and baseline weight [less than or equal to 60 kg vs greater than 60 kg] were used as factors in the model.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Ustekinumab Standard Dosage
Comments PedsQL Psychosocial health summary score
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.063
Comments [Not Specified]
Method ANOVA on van der Waerden normal Score
Comments Treatment and baseline weight [less than or equal to 60 kg vs greater than 60 kg] were used as factors in the model.
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, Ustekinumab Half-Standard Dosage
Comments PedsQL Physical health summary score
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.007
Comments [Not Specified]
Method ANOVA on van der Waerden normal Score
Comments Treatment and baseline weight [less than or equal to 60 kg vs greater than 60 kg] were used as factors in the model.
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, Ustekinumab Standard Dosage
Comments PedsQL Physical health summary score
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.020
Comments [Not Specified]
Method ANOVA on van der Waerden normal Score
Comments Treatment and baseline weight [less than or equal to 60 kg vs greater than 60 kg] were used as factors in the model.
8.Secondary Outcome
Title The Percentage of Participants With CDLQI Scores of 0 or 1 at Week 12 for Randomized Participants With a Baseline CDLQI Score > 1
Hide Description [Not Specified]
Time Frame Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Efficacy evaluable subjects defined as the subset of all randomized participants with evaluable outcome measurements. In addition, this analysis was limited to participants with a CDLQI of 0 or 1 at baseline.
Arm/Group Title Placebo Ustekinumab Half-Standard Dosage Ustekinumab Standard Dosage
Hide Arm/Group Description:
Participants received a subcutaneous (SC) injection of Placebo at Weeks 0 and 4 then crossover to ustekinumab half-standard dosage (0.375 mg/kg, 22.5 mg, or 45 mg based on body weight) OR ustekinumab standard dosage (0.75 mg/kg, 45 mg, or 90 mg based on body weight) SC injection at Weeks 12, 16, 28, and 40.
Participants received ustekinumab subcutaneous (SC) injections (0.375 mg/kg, 22.5 mg, or 45 mg based on body weight) at Weeks 0, 16, 28, and 40. In addition, all participants received a single SC dose of placebo at Week 12.
Participants received ustekinumab (0.75 mg/kg, 45 mg, or 90 mg based on body weight) subcutaneous (SC) injections at Weeks 0, 4, 16, 28, and 40. In addition, all participants received a single SC dose of placebo at Week 12.
Overall Number of Participants Analyzed 30 31 30
Measure Type: Number
Unit of Measure: Percentage of participants
13.3 38.7 56.7
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Ustekinumab Half-Standard Dosage
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.027
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Stratified by body weight (less than or equal to 60 kg vs greater than 60 kg).
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Ustekinumab Standard Dosage
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Stratified by body weight (less than or equal to 60 kg vs greater than 60 kg).
Time Frame Through Week 60
Adverse Event Reporting Description Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
 
Arm/Group Title Placebo (CP) Ustekinumab Half-Standard Dosage (CP) Ustekinumab Standard Dosage (CP) Placebo -> Ustekinumab Half-Standard Dosage (After CP) Placebo -> Ustekinumab Standard Dosage (After CP) Ustekinumab Half-Standard Dosage (After CP) Ustekinumab Standard Dosage (After CP)
Hide Arm/Group Description Controlled period (Week 0-12) - Placebo Subcutaneous (SC) injections at Week 0 and 4. Controlled period (Week 0-12) - Ustekinumab Subcutaneous (SC) injections of 0.375 mg/kg for participants with weight <= 60kg, 22.5 mg for participants with weight > 60 to <= 100kg, and 45 mg for participants with weight > 100kg. Controlled period (Week 0-12) - Ustekinumab Subcutaneous (SC) injections of 0.75 mg/kg for participants with weight <= 60kg, 45 mg for participants with weight > 60 to <= 100kg, and 90 mg for participants with weight > 100kg. After Controlled period (Week 12-60) – participants receiving Placebo at Weeks 0 and 4 -> receiving Ustekinumab Half-Standard Dosage at Week 12 and 16 then q12w with the last dose at Week 40. After Controlled period (Week 12-60) – participants receiving Placebo at Weeks 0 and 4 -> receiving Ustekinumab Standard Dosage at Week 12 and 16 then q12wk with last dose at Week 40. After Controlled period (Week 12-60) – participants receiving Ustekinumab Half-Standard Dosage at Weeks 0 and 4 -> receiving Ustekinumab Half-Standard Dosage q12wk with the last dose at Week 40. After Controlled period (Week 12-60) – participants receiving Ustekinumab Standard Dosage at Weeks 0 and 4 -> receiving Ustekinumab Standard Dosage q12wk with last dose at Week 40.
All-Cause Mortality
Placebo (CP) Ustekinumab Half-Standard Dosage (CP) Ustekinumab Standard Dosage (CP) Placebo -> Ustekinumab Half-Standard Dosage (After CP) Placebo -> Ustekinumab Standard Dosage (After CP) Ustekinumab Half-Standard Dosage (After CP) Ustekinumab Standard Dosage (After CP)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo (CP) Ustekinumab Half-Standard Dosage (CP) Ustekinumab Standard Dosage (CP) Placebo -> Ustekinumab Half-Standard Dosage (After CP) Placebo -> Ustekinumab Standard Dosage (After CP) Ustekinumab Half-Standard Dosage (After CP) Ustekinumab Standard Dosage (After CP)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/37 (0.00%)   1/37 (2.70%)   0/36 (0.00%)   0/19 (0.00%)   0/18 (0.00%)   5/37 (13.51%)   1/36 (2.78%) 
Blood and lymphatic system disorders               
Leukopenia * 1  0/37 (0.00%)  0/37 (0.00%)  0/36 (0.00%)  0/19 (0.00%)  0/18 (0.00%)  1/37 (2.70%)  0/36 (0.00%) 
Infections and infestations               
Ear Infection * 1  0/37 (0.00%)  0/37 (0.00%)  0/36 (0.00%)  0/19 (0.00%)  0/18 (0.00%)  0/37 (0.00%)  1/36 (2.78%) 
Pyelonephritis * 1  0/37 (0.00%)  0/37 (0.00%)  0/36 (0.00%)  0/19 (0.00%)  0/18 (0.00%)  1/37 (2.70%)  0/36 (0.00%) 
Injury, poisoning and procedural complications               
Injury * 1  0/37 (0.00%)  0/37 (0.00%)  0/36 (0.00%)  0/19 (0.00%)  0/18 (0.00%)  1/37 (2.70%)  0/36 (0.00%) 
Skin and subcutaneous tissue disorders               
Dermatitis Contact * 1  0/37 (0.00%)  0/37 (0.00%)  0/36 (0.00%)  0/19 (0.00%)  0/18 (0.00%)  1/37 (2.70%)  0/36 (0.00%) 
Psoriasis * 1  0/37 (0.00%)  1/37 (2.70%)  0/36 (0.00%)  0/19 (0.00%)  0/18 (0.00%)  1/37 (2.70%)  0/36 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA Version 16.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo (CP) Ustekinumab Half-Standard Dosage (CP) Ustekinumab Standard Dosage (CP) Placebo -> Ustekinumab Half-Standard Dosage (After CP) Placebo -> Ustekinumab Standard Dosage (After CP) Ustekinumab Half-Standard Dosage (After CP) Ustekinumab Standard Dosage (After CP)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   17/37 (45.95%)   15/37 (40.54%)   13/36 (36.11%)   15/19 (78.95%)   13/18 (72.22%)   28/37 (75.68%)   23/36 (63.89%) 
Blood and lymphatic system disorders               
Lymphadenopathy * 1  2/37 (5.41%)  0/37 (0.00%)  0/36 (0.00%)  0/19 (0.00%)  1/18 (5.56%)  1/37 (2.70%)  0/36 (0.00%) 
Monocytosis * 1  0/37 (0.00%)  0/37 (0.00%)  0/36 (0.00%)  1/19 (5.26%)  0/18 (0.00%)  0/37 (0.00%)  0/36 (0.00%) 
Eye disorders               
Blepharitis * 1  0/37 (0.00%)  0/37 (0.00%)  0/36 (0.00%)  1/19 (5.26%)  0/18 (0.00%)  0/37 (0.00%)  0/36 (0.00%) 
Conjunctivitis * 1  0/37 (0.00%)  0/37 (0.00%)  0/36 (0.00%)  1/19 (5.26%)  0/18 (0.00%)  0/37 (0.00%)  0/36 (0.00%) 
Eye Pruritus * 1  0/37 (0.00%)  0/37 (0.00%)  0/36 (0.00%)  1/19 (5.26%)  0/18 (0.00%)  0/37 (0.00%)  0/36 (0.00%) 
Gastrointestinal disorders               
Abdominal Discomfort * 1  0/37 (0.00%)  0/37 (0.00%)  0/36 (0.00%)  0/19 (0.00%)  1/18 (5.56%)  0/37 (0.00%)  1/36 (2.78%) 
Abdominal Pain * 1  0/37 (0.00%)  1/37 (2.70%)  0/36 (0.00%)  0/19 (0.00%)  0/18 (0.00%)  3/37 (8.11%)  2/36 (5.56%) 
Abdominal Pain Lower * 1  0/37 (0.00%)  0/37 (0.00%)  0/36 (0.00%)  0/19 (0.00%)  1/18 (5.56%)  0/37 (0.00%)  0/36 (0.00%) 
Abdominal Pain Upper * 1  0/37 (0.00%)  1/37 (2.70%)  0/36 (0.00%)  1/19 (5.26%)  0/18 (0.00%)  1/37 (2.70%)  0/36 (0.00%) 
Dental Caries * 1  0/37 (0.00%)  1/37 (2.70%)  0/36 (0.00%)  1/19 (5.26%)  0/18 (0.00%)  1/37 (2.70%)  0/36 (0.00%) 
Diarrhoea * 1  0/37 (0.00%)  0/37 (0.00%)  2/36 (5.56%)  0/19 (0.00%)  0/18 (0.00%)  0/37 (0.00%)  2/36 (5.56%) 
Food Poisoning * 1  0/37 (0.00%)  0/37 (0.00%)  0/36 (0.00%)  0/19 (0.00%)  1/18 (5.56%)  0/37 (0.00%)  0/36 (0.00%) 
Gastrooesophageal Reflux Disease * 1  0/37 (0.00%)  0/37 (0.00%)  1/36 (2.78%)  0/19 (0.00%)  1/18 (5.56%)  0/37 (0.00%)  0/36 (0.00%) 
Lip Oedema * 1  0/37 (0.00%)  0/37 (0.00%)  0/36 (0.00%)  1/19 (5.26%)  0/18 (0.00%)  0/37 (0.00%)  0/36 (0.00%) 
Nausea * 1  0/37 (0.00%)  0/37 (0.00%)  0/36 (0.00%)  0/19 (0.00%)  0/18 (0.00%)  3/37 (8.11%)  1/36 (2.78%) 
Odynophagia * 1  0/37 (0.00%)  0/37 (0.00%)  0/36 (0.00%)  1/19 (5.26%)  0/18 (0.00%)  0/37 (0.00%)  0/36 (0.00%) 
Tooth Deposit * 1  0/37 (0.00%)  0/37 (0.00%)  0/36 (0.00%)  1/19 (5.26%)  0/18 (0.00%)  0/37 (0.00%)  0/36 (0.00%) 
Tooth Impacted * 1  1/37 (2.70%)  0/37 (0.00%)  0/36 (0.00%)  0/19 (0.00%)  1/18 (5.56%)  0/37 (0.00%)  0/36 (0.00%) 
General disorders               
Fatigue * 1  2/37 (5.41%)  1/37 (2.70%)  1/36 (2.78%)  1/19 (5.26%)  0/18 (0.00%)  0/37 (0.00%)  0/36 (0.00%) 
Oedema Peripheral * 1  1/37 (2.70%)  0/37 (0.00%)  0/36 (0.00%)  0/19 (0.00%)  1/18 (5.56%)  1/37 (2.70%)  0/36 (0.00%) 
Pyrexia * 1  0/37 (0.00%)  0/37 (0.00%)  0/36 (0.00%)  1/19 (5.26%)  0/18 (0.00%)  1/37 (2.70%)  1/36 (2.78%) 
Infections and infestations               
Bacterial Rhinitis * 1  0/37 (0.00%)  0/37 (0.00%)  0/36 (0.00%)  1/19 (5.26%)  1/18 (5.56%)  0/37 (0.00%)  1/36 (2.78%) 
Body Tinea * 1  0/37 (0.00%)  0/37 (0.00%)  0/36 (0.00%)  0/19 (0.00%)  1/18 (5.56%)  0/37 (0.00%)  0/36 (0.00%) 
Bronchitis * 1  1/37 (2.70%)  0/37 (0.00%)  1/36 (2.78%)  1/19 (5.26%)  0/18 (0.00%)  0/37 (0.00%)  1/36 (2.78%) 
Gastroenteritis * 1  1/37 (2.70%)  1/37 (2.70%)  0/36 (0.00%)  1/19 (5.26%)  0/18 (0.00%)  0/37 (0.00%)  1/36 (2.78%) 
Gingivitis * 1  0/37 (0.00%)  0/37 (0.00%)  0/36 (0.00%)  1/19 (5.26%)  0/18 (0.00%)  1/37 (2.70%)  0/36 (0.00%) 
Herpes Simplex * 1  0/37 (0.00%)  0/37 (0.00%)  0/36 (0.00%)  0/19 (0.00%)  1/18 (5.56%)  0/37 (0.00%)  0/36 (0.00%) 
Herpes Zoster * 1  0/37 (0.00%)  0/37 (0.00%)  0/36 (0.00%)  1/19 (5.26%)  0/18 (0.00%)  0/37 (0.00%)  0/36 (0.00%) 
Influenza * 1  0/37 (0.00%)  0/37 (0.00%)  1/36 (2.78%)  1/19 (5.26%)  1/18 (5.56%)  0/37 (0.00%)  0/36 (0.00%) 
Laryngitis * 1  0/37 (0.00%)  0/37 (0.00%)  0/36 (0.00%)  0/19 (0.00%)  1/18 (5.56%)  0/37 (0.00%)  1/36 (2.78%) 
Nasopharyngitis * 1  10/37 (27.03%)  5/37 (13.51%)  1/36 (2.78%)  5/19 (26.32%)  10/18 (55.56%)  11/37 (29.73%)  11/36 (30.56%) 
Oral Herpes * 1  0/37 (0.00%)  1/37 (2.70%)  0/36 (0.00%)  1/19 (5.26%)  0/18 (0.00%)  1/37 (2.70%)  0/36 (0.00%) 
Otitis Externa * 1  1/37 (2.70%)  0/37 (0.00%)  0/36 (0.00%)  1/19 (5.26%)  0/18 (0.00%)  0/37 (0.00%)  0/36 (0.00%) 
Pharyngitis * 1  0/37 (0.00%)  3/37 (8.11%)  1/36 (2.78%)  1/19 (5.26%)  1/18 (5.56%)  2/37 (5.41%)  2/36 (5.56%) 
Pharyngitis Streptococcal * 1  0/37 (0.00%)  0/37 (0.00%)  1/36 (2.78%)  0/19 (0.00%)  0/18 (0.00%)  0/37 (0.00%)  2/36 (5.56%) 
Rhinitis * 1  0/37 (0.00%)  0/37 (0.00%)  0/36 (0.00%)  0/19 (0.00%)  1/18 (5.56%)  2/37 (5.41%)  2/36 (5.56%) 
Tooth Abscess * 1  0/37 (0.00%)  0/37 (0.00%)  0/36 (0.00%)  0/19 (0.00%)  0/18 (0.00%)  1/37 (2.70%)  2/36 (5.56%) 
Tooth Infection * 1  0/37 (0.00%)  0/37 (0.00%)  0/36 (0.00%)  1/19 (5.26%)  0/18 (0.00%)  0/37 (0.00%)  0/36 (0.00%) 
Toxoplasmosis * 1  0/37 (0.00%)  0/37 (0.00%)  0/36 (0.00%)  1/19 (5.26%)  0/18 (0.00%)  0/37 (0.00%)  0/36 (0.00%) 
Upper Respiratory Tract Infection * 1  2/37 (5.41%)  1/37 (2.70%)  3/36 (8.33%)  2/19 (10.53%)  3/18 (16.67%)  4/37 (10.81%)  3/36 (8.33%) 
Injury, poisoning and procedural complications               
Arthropod Bite * 1  0/37 (0.00%)  0/37 (0.00%)  0/36 (0.00%)  1/19 (5.26%)  0/18 (0.00%)  0/37 (0.00%)  0/36 (0.00%) 
Joint Injury * 1  0/37 (0.00%)  0/37 (0.00%)  0/36 (0.00%)  1/19 (5.26%)  0/18 (0.00%)  0/37 (0.00%)  0/36 (0.00%) 
Muscle Strain * 1  0/37 (0.00%)  0/37 (0.00%)  0/36 (0.00%)  0/19 (0.00%)  1/18 (5.56%)  0/37 (0.00%)  1/36 (2.78%) 
Skin Injury * 1  0/37 (0.00%)  0/37 (0.00%)  0/36 (0.00%)  0/19 (0.00%)  1/18 (5.56%)  0/37 (0.00%)  0/36 (0.00%) 
Sunburn * 1  0/37 (0.00%)  0/37 (0.00%)  0/36 (0.00%)  1/19 (5.26%)  0/18 (0.00%)  0/37 (0.00%)  0/36 (0.00%) 
Thermal Burn * 1  0/37 (0.00%)  0/37 (0.00%)  0/36 (0.00%)  1/19 (5.26%)  0/18 (0.00%)  0/37 (0.00%)  1/36 (2.78%) 
Investigations               
Haematocrit Decreased * 1  0/37 (0.00%)  0/37 (0.00%)  0/36 (0.00%)  1/19 (5.26%)  0/18 (0.00%)  0/37 (0.00%)  0/36 (0.00%) 
Haemoglobin Decreased * 1  0/37 (0.00%)  0/37 (0.00%)  0/36 (0.00%)  1/19 (5.26%)  0/18 (0.00%)  0/37 (0.00%)  0/36 (0.00%) 
Lymph Node Palpable * 1  0/37 (0.00%)  0/37 (0.00%)  0/36 (0.00%)  0/19 (0.00%)  1/18 (5.56%)  0/37 (0.00%)  0/36 (0.00%) 
Musculoskeletal and connective tissue disorders               
Arthralgia * 1  0/37 (0.00%)  0/37 (0.00%)  0/36 (0.00%)  1/19 (5.26%)  2/18 (11.11%)  1/37 (2.70%)  0/36 (0.00%) 
Back Pain * 1  0/37 (0.00%)  1/37 (2.70%)  0/36 (0.00%)  0/19 (0.00%)  1/18 (5.56%)  2/37 (5.41%)  2/36 (5.56%) 
Musculoskeletal Pain * 1  0/37 (0.00%)  0/37 (0.00%)  0/36 (0.00%)  1/19 (5.26%)  0/18 (0.00%)  0/37 (0.00%)  0/36 (0.00%) 
Psoriatic Arthropathy * 1  1/37 (2.70%)  0/37 (0.00%)  0/36 (0.00%)  0/19 (0.00%)  1/18 (5.56%)  0/37 (0.00%)  0/36 (0.00%) 
Tendonitis * 1  0/37 (0.00%)  0/37 (0.00%)  0/36 (0.00%)  0/19 (0.00%)  1/18 (5.56%)  2/37 (5.41%)  0/36 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)               
Skin Papilloma * 1  0/37 (0.00%)  0/37 (0.00%)  0/36 (0.00%)  0/19 (0.00%)  2/18 (11.11%)  1/37 (2.70%)  0/36 (0.00%) 
Nervous system disorders               
Convulsion * 1  0/37 (0.00%)  0/37 (0.00%)  0/36 (0.00%)  1/19 (5.26%)  0/18 (0.00%)  0/37 (0.00%)  0/36 (0.00%) 
Headache * 1  2/37 (5.41%)  4/37 (10.81%)  3/36 (8.33%)  2/19 (10.53%)  3/18 (16.67%)  9/37 (24.32%)  2/36 (5.56%) 
Migraine * 1  1/37 (2.70%)  0/37 (0.00%)  0/36 (0.00%)  0/19 (0.00%)  1/18 (5.56%)  0/37 (0.00%)  0/36 (0.00%) 
Psychiatric disorders               
Depression * 1  0/37 (0.00%)  0/37 (0.00%)  0/36 (0.00%)  1/19 (5.26%)  0/18 (0.00%)  0/37 (0.00%)  0/36 (0.00%) 
Insomnia * 1  0/37 (0.00%)  0/37 (0.00%)  0/36 (0.00%)  0/19 (0.00%)  1/18 (5.56%)  0/37 (0.00%)  0/36 (0.00%) 
Reproductive system and breast disorders               
Dysmenorrhoea * 1  0/37 (0.00%)  0/37 (0.00%)  2/36 (5.56%)  1/19 (5.26%)  0/18 (0.00%)  0/37 (0.00%)  3/36 (8.33%) 
Gynaecomastia * 1  0/37 (0.00%)  0/37 (0.00%)  1/36 (2.78%)  1/19 (5.26%)  0/18 (0.00%)  0/37 (0.00%)  0/36 (0.00%) 
Respiratory, thoracic and mediastinal disorders               
Cough * 1  0/37 (0.00%)  0/37 (0.00%)  1/36 (2.78%)  0/19 (0.00%)  0/18 (0.00%)  3/37 (8.11%)  1/36 (2.78%) 
Dyspnoea Exertional * 1  0/37 (0.00%)  0/37 (0.00%)  0/36 (0.00%)  0/19 (0.00%)  1/18 (5.56%)  0/37 (0.00%)  0/36 (0.00%) 
Epistaxis * 1  0/37 (0.00%)  0/37 (0.00%)  0/36 (0.00%)  1/19 (5.26%)  1/18 (5.56%)  0/37 (0.00%)  0/36 (0.00%) 
Oropharyngeal Pain * 1  0/37 (0.00%)  1/37 (2.70%)  1/36 (2.78%)  3/19 (15.79%)  0/18 (0.00%)  3/37 (8.11%)  0/36 (0.00%) 
Rhinitis Allergic * 1  1/37 (2.70%)  0/37 (0.00%)  0/36 (0.00%)  1/19 (5.26%)  0/18 (0.00%)  0/37 (0.00%)  0/36 (0.00%) 
Rhinorrhoea * 1  0/37 (0.00%)  0/37 (0.00%)  0/36 (0.00%)  2/19 (10.53%)  0/18 (0.00%)  0/37 (0.00%)  0/36 (0.00%) 
Upper-Airway Cough Syndrome * 1  0/37 (0.00%)  0/37 (0.00%)  0/36 (0.00%)  0/19 (0.00%)  1/18 (5.56%)  0/37 (0.00%)  0/36 (0.00%) 
Skin and subcutaneous tissue disorders               
Acne * 1  0/37 (0.00%)  1/37 (2.70%)  0/36 (0.00%)  0/19 (0.00%)  1/18 (5.56%)  0/37 (0.00%)  1/36 (2.78%) 
Erythema Multiforme * 1  0/37 (0.00%)  0/37 (0.00%)  0/36 (0.00%)  0/19 (0.00%)  1/18 (5.56%)  0/37 (0.00%)  0/36 (0.00%) 
Night Sweats * 1  0/37 (0.00%)  0/37 (0.00%)  0/36 (0.00%)  1/19 (5.26%)  0/18 (0.00%)  0/37 (0.00%)  0/36 (0.00%) 
Pruritus * 1  0/37 (0.00%)  1/37 (2.70%)  1/36 (2.78%)  0/19 (0.00%)  0/18 (0.00%)  2/37 (5.41%)  0/36 (0.00%) 
Psoriasis * 1  2/37 (5.41%)  0/37 (0.00%)  0/36 (0.00%)  1/19 (5.26%)  1/18 (5.56%)  3/37 (8.11%)  1/36 (2.78%) 
Vascular disorders               
Orthostatic Hypotension * 1  0/37 (0.00%)  0/37 (0.00%)  0/36 (0.00%)  1/19 (5.26%)  0/18 (0.00%)  0/37 (0.00%)  0/36 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA Version 16.0
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.
Generally, the only disclosure restriction on the PI is that the sponsor has 60 days to review results communications prior to public release and can embargo communications regarding trial results for a period that does not exceed 180 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
Name/Title: VICE PRESIDENT IMMUNOLOGY
Organization: Janssen Research & Development, LLC
Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT01090427     History of Changes
Obsolete Identifiers: NCT02166203
Other Study ID Numbers: CR017053
CNTO1275PSO3006 ( Other Identifier: Janssen Research & Development, LLC )
CADMUS ( Other Identifier: Janssen Research & Development, LLC )
2009-014368-20 ( EudraCT Number )
First Submitted: March 18, 2010
First Posted: March 22, 2010
Results First Submitted: December 10, 2014
Results First Posted: December 18, 2014
Last Update Posted: January 29, 2015