An Efficacy and Safety Study of Ustekinumab (CNTO 1275) i... | NCT00723528 | Trialant
NCT00723528
Sponsor
Janssen Pharmaceutical K.K.
Status
Completed
Last Update Posted
May 20, 2014Estimated
Enrollment
158Actual
Phase
Phase 3
Conditions
Psoriasis
Interventions
Placebo (CP)
Ustekinumab 45 mg (CP)
Ustekinumab 90 mg (CP)
Placebo A (After CP)
Placebo B (After CP)
Ustekinumab 45 mg (After CP)
Ustekinumab 90 mg (After CP)
Countries
Japan
Protocol Section
Identification Module
NCT ID
NCT00723528
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CR015166
Secondary IDs
ID
Type
Description
Link
JNS009-JPN-02
Brief Title
An Efficacy and Safety Study of Ustekinumab (CNTO 1275) in Participants With Plaque Psoriasis
Official Title
A Placebo-Controlled Double-Blind Comparative Study of CNTO1275 in Patients With Plaque Type Psoriasis
Acronym
Not provided
Organization
Janssen Pharmaceutical K.K.INDUSTRY
Status Module
Record Verification Date
Apr 2014
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Mar 2008
Primary Completion Date
Jan 2009Actual
Completion Date
Mar 2010Actual
First Submitted Date
Jul 24, 2008
First Submission Date that Met QC Criteria
Jul 25, 2008
First Posted Date
Jul 28, 2008Estimated
Results Waived
Not provided
Results First Submitted Date
Dec 2, 2013
Results First Submitted that Met QC Criteria
Apr 22, 2014
Results First Posted Date
May 20, 2014Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Apr 22, 2014
Last Update Posted Date
May 20, 2014Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Janssen Pharmaceutical K.K.INDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of ustekinumab (CNTO 1275) compared with placebo in participants with moderate to severe plaque type psoriasis.
Detailed Description
This is a multicenter (involving more than 1 study center), randomized (study medication assigned by chance), double-blind (neither the invesitigator nor the participant knows the identity of the study medication), placebo- controlled (1 of the study medications is inactive), parallel-group comparative study (different groups of participants will receive different treatments at the same time). The total duration of the study will be 78 weeks which will be comprised of: a screening period (6 weeks); an efficacy assessment period (64 weeks [with a total of 7 treatments at Weeks 0, 4, 12, 16, 28, 40, and 52]) and a follow-up assessment period (8 weeks). The efficacy assessment period will further include: a placebo-controlled treatment period (Weeks 0-12) and an active drug treatment period (Weeks 12-64). During the placebo-controlled treatment period, participants will receive ustekinumab (45 mg or 90 mg) subcutaneously (SC-into the muscles) or placebo SC. During the active drug treatment period, participants will continue treatment with 45 mg or 90 mg SC as assigned during the placebo-controlled treatment period; however, participants in the placebo group will be divided into 2 groups and will receive ustekinumab 45 mg (Placebo A) or 90 mg (Placebo B) SC. Efficacy will be evaluated primarily by analysis of psoriasis area and severity index (PASI) score. Participant safety will also be monitored.
Conditions Module
Conditions
Psoriasis
Keywords
Psoriasis
Ustekinumab
CNTO 1275
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
158Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Placebo (CP)
Placebo Comparator
Placebo 0.5 ml and 1.0 ml will be administered subcutaneously (SC) on Weeks 0 and 4 respectively during the controlled period (Weeks 0-12).
Drug: Placebo (CP)
Ustekinumab 45 mg (CP)
Active Comparator
Ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) will be administered SC on Weeks 0 and 4 during controlled period (Weeks 0-12).
Drug: Ustekinumab 45 mg (CP)
Ustekinumab 90 mg (CP)
Active Comparator
Ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) will be administered SC on Weeks 0 and 4 during controlled period (Weeks 0-12).
Drug: Ustekinumab 90 mg (CP)
Placebo A (After CP)
Placebo Comparator
After the controlled period (that is [i.e.], during the active drug treatment period [Weeks 12-64]), the placebo group will be randomized into 2 groups, including Placebo A, in which ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) will be administered SC at Weeks 12, 16, 28, 40, and 52.
Drug: Placebo A (After CP)
Placebo B (After CP)
Placebo Comparator
After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), the placebo group will be randomized into 2 groups, including Placebo B, in which ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) will be administered SC at Weeks 12, 16, 28, 40, and 52.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Placebo (CP)
Drug
Placebo 0.5 ml and 1.0 ml will be administered subcutaneously (SC) on Weeks 0 and 4 respectively during the controlled period (Weeks 0-12).
Placebo (CP)
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percentage of Participants With Greater Than or Equal to 75 Percent (%) Improvement in Psoriasis Area and Severity Index (PASI) Score
Percentage of participants with >=75% improvement in PASI score at Week 12 from Baseline was reported. PASI is a widely used tool for the measurement of severity of psoriasis. The combination of redness, scaling, and thickness, as well as overall body involvement determine the PASI score. The scale ranges from 0 (best) to 72 (worst). Baseline visit refers to Week 0.
Week 12
Secondary Outcomes
Measure
Description
Time Frame
Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 12
The DLQI is a self-administered 10-item questionnaire that is used to assess 6 different aspects of quality of life: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. Scores range from 0 (no impairment in quality of life) to 30 (most impairment in quality of life).
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Participants diagnosed with psoriasis (psoriasis vulgaris and psoriatic arthritis) at least 6 months before registration
Participants with plaque type psoriasis covering at least 10 percent of total body surface area at the time of informed consent and at registration
Participants with a PASI score of greater than or equal to 12 at the time of informed consent and at registration
Female participants of childbearing potential or males, whose partner can be pregnant, must agree that he/she will continuously take an appropriate contraceptive measure for 1 year from the day of informed consent to termination of the final investigational treatment; in the case of childbearing potential females, pregnancy test at screening must be negative
Participants must agree not to receive Bacillus Calmette-Guérin (BCG) vaccination and live vaccine inoculation for 1 year after final treatment with the investigational product
Exclusion Criteria:
Participants with guttate psoriasis, erythrodermic psoriasis, or pustular psoriasis
Participants with a medical history of tuberculosis infection or suspected tuberculosis infection
Participants with present or past history of chronic or recurrent infection (e.g., chronic or recurrent urinary tract infection or respiratory infection)
Participants with a current serious infection (e.g., sepsis, hepatitis, pneumonia, or pyelonephritis) or those who experienced a serious infection within the 2 month period before registration and including participants who received intravenous administration of antibiotics or antiviral agents within the 2 month period before registration
Participants with a current or past history of malignant tumors (except for basal cell carcinoma, intraepidermal squamous cell carcinoma in the skin and uterine cervical squamous cell carcinoma, whose treatment was completed and no sign suggesting a recurrence has been observed, and squamous cell carcinoma in the skin whose treatment was completed and no sign suggesting a recurrence has been observed in the past 5 years)
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
20 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Janssen Pharmaceutical K.K. Clinical Trial
Janssen Pharmaceutical K.K.
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Asahikawa
Japan
References Module
Citations
Not provided
See Also Links
Label
URL
Week 28 data cut-off Clinical Study Report for a Placebo-Controlled Double-Blind Study of CNTO 1275 in Subjects with Plaque Psoriasis
Placebo 0.5 ml and 1.0 ml was administered subcutaneously (SC) on Weeks 0 and 4 respectively during the controlled period (Weeks 0-12).
FG001
Ustekinumab 45 mg (CP)
Periods
Title
Milestones
Reasons Not Completed
Period 1: Controlled Period (CP)
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
0
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Double
Masking Description
Not provided
Who Masked
ParticipantInvestigator
Drug: Placebo B (After CP)
Ustekinumab 45 mg (After CP)
Active Comparator
After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), participants in the ustekinumab 45 mg group will receive placebo (0.5 ml and 1.0 ml) SC at Week 12 followed by ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) SC at Weeks 16, 28, 40 and 52.
Drug: Ustekinumab 45 mg (After CP)
Ustekinumab 90 mg (After CP)
Active Comparator
After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), participants in the ustekinumab 90 mg group will receive placebo (0.5 ml and 1.0 ml) SC at Week 12 followed by ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) SC at Weeks 16, 28, 40 and 52.
Drug: Ustekinumab 90 mg (After CP)
Ustekinumab 45 mg (CP)
Drug
Ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) will be administered SC on Weeks 0 and 4 during controlled period (Weeks 0-12).
Ustekinumab 45 mg (CP)
Ustekinumab 90 mg (CP)
Drug
Ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) will be administered SC on Weeks 0 and 4 during controlled period (Weeks 0-12).
Ustekinumab 90 mg (CP)
Placebo A (After CP)
Drug
After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), the placebo group will be randomized into 2 groups, including Placebo A, in which ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) will be administered SC at Weeks 12, 16, 28, 40, and 52.
Placebo A (After CP)
Placebo B (After CP)
Drug
After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), the placebo group will be randomized into 2 groups, including Placebo B, in which ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) will be administered SC at Weeks 12, 16, 28, 40, and 52.
Placebo B (After CP)
Ustekinumab 45 mg (After CP)
Drug
After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), participants in the ustekinumab 45 mg group will receive placebo (0.5 ml and 1.0 ml) SC at Week 12 followed by ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) SC at Weeks 16, 28, 40 and 52.
Ustekinumab 45 mg (After CP)
Ustekinumab 90 mg (After CP)
Drug
After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), participants in the ustekinumab 90 mg group will receive placebo (0.5 ml and 1.0 ml) SC at Week 12 followed by ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) SC at Weeks 16, 28, 40 and 52.
Ustekinumab 90 mg (After CP)
Week 12
Psoriasis Area and Severity Index (PASI) Score
PASI is a widely used tool for the measurement of severity of psoriasis. The combination of redness, scaling, and thickness, as well as overall body involvement determine the PASI score. The scale ranges from 0 (best) to 72 (worst).
Week 64
Percentage of Treatment Response Based on Psoriasis Area and Severity Index (PASI) Score
PASI is a widely used tool for the measurement of severity of psoriasis. The combination of redness, scaling, and thickness, as well as overall body involvement determine the PASI score. The scale ranges from 0 (best) to 72 (worst). Percentage of Treatment Response= (Baseline PASI score-PASI score after treatment)/Baseline PASI score x 100. Baseline visit refers to Week 0.
Week 64
Percentage of Participants With Greater Than or Equal to (>=) 50 Percent (%), 90%, and Equal to 100% of Treatment Response Based on PASI Score
PASI is a widely used tool for the measurement of severity of psoriasis. The combination of redness, scaling, and thickness, as well as overall body involvement determine the PASI score. The scale ranges from 0 (best) to 72 (worst). Percentage of Treatment Response= (Baseline PASI score-PASI score after treatment)/Baseline PASI score x 100. Baseline visit refers to Week 0.
Week 64
Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 28, 40, 52 and 64
The DLQI is a self-administered 10-item questionnaire that is used to assess 6 different aspects of quality of life: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. Scores range from 0 (no impairment in quality of life) to 30 (most impairment in quality of life).
Week 28, 40, 52 and 64
Change From Baseline in 36-Item Short Form Health Survey (SF-36) at Week 12, 28, 40, 52 and 64
The SF-36 is a validated instrument measuring health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: (1) physical component summary (PCS)=physical functioning, role-physical, bodily pain, and general health; (2) mental component summary (MCS)=vitality, social functioning, role-emotional, and mental health. There is no total overall score; scoring is done for both sub scores and summary scores. For sub scores and summary scores: 0=worst score and 100=best score.
Week 12, 28, 40, 52 and 64
Change From Baseline in Psoriasis Disability Index (PDI) Score at Week 12, 28, 40, 52 and 64
The PDI questionnaire consists of 15 questions relating to the impact of psoriasis in terms of daily activities, work or school, personal relationships, leisure, and treatment. Each question is scored on a scale of 0 (no impact) to 3 (greatest impact). The PDI is calculated by summing the scores of the questions resulting in a maximum score of 45 (greatest impact) and a minimum score of 0 (no impact).
Week 12, 28, 40, 52 and 64
Treatment Response Based on Nail Psoriasis Severity Index (NAPSI) Score
The NAPSI score is used to evaluate the severity of nail bed psoriasis and nail matrix psoriasis. The nail is divided with into quadrants and given a score for nail bed psoriasis (0-4) and nail matrix psoriasis (0-4) depending on the presence of any of the features of nail psoriasis in that quadrant. Each nail is evaluated, and the sum of all the nails is the total NAPSI score. The sum of the scores from all nails ranges from 0 (no psoriasis) to 80 (psoriasis present in all 4 quadrants of all 10 nails).
Week 12, 28, 40,52 and 64
Change From Baseline in the Number of Nails With Psoriasis Involvement at Week 12, 28, 40, 52 and 64
The number of nails with psoriasis involvement was assessed by a dermatologist.
Week 12, 28, 40, 52 and 64
Change From Baseline in Joint Symptoms Expressed on a Visual Analogue Scale (VAS) at Week 12, 28, 40, 52 and 64
Each participant will assess his/her pain associated with joint symptoms on each assessment day using a 100 mm VAS ranging from 0 mm (no pain) to 100 mm (the worst pain imaginable).
Week 12, 28, 40, 52 and 64
Percentage of Participants With Cleared (0), Cleared or Minimal (0 or 1) and Mild (Less Than or Equal to 2) Physician's Global Assessment (PGA) Score at Week 12
Percentage of participants with PGA score of cleared (0), cleared or minimal (0 or 1) and mild (less than or equal to 2) was reported. The PGA score is a numeric scale which is completed by the physician and is designed to evaluate the physician's overall assessment of the participant's psoriasis. Overall lesions will be graded for induration (I), erythema (E), and scaling (S) as: 0=cleared, 1=minimal, 2=mild, 3=moderate, 4=marked, and 5=severe. The sum of the 3 scores (I + E + S) will be divided by 3 to obtain a final PGA score ranging from 0 [best] to 5 [worst].
Week 12
Percentage of Participants With Cleared (0), Cleared or Minimal (0 or 1) and Mild (Less Than or Equal to 2) Physician's Global Assessment (PGA) Score at Week 64
Percentage of participants with PGA score of cleared (0), cleared or minimal (0 or 1) and mild (less than or equal to 2) was reported. The PGA score is a numeric scale which is completed by the physician and is designed to evaluate the physician's overall assessment of the participant's psoriasis. Overall lesions will be graded for induration (I), erythema (E), and scaling (S) as: 0=cleared, 1=minimal, 2=mild, 3=moderate, 4=marked, and 5=severe. The sum of the 3 scores (I + E + S) will be divided by 3 to obtain a final PGA score ranging from 0 [best] to 5 [worst].
Week 64
Chitose
Japan
Chūō
Japan
Fukuoka
Japan
Fushimi
Japan
Isehara
Japan
Kanazawa
Japan
Kurume
Japan
Kyoto
Japan
Maebashi
Japan
Minato
Japan
Morioka
Japan
Nagasaki
Japan
Nagoya
Japan
Nankoku
Japan
Nishinomiya
Japan
Osaka
Japan
Ōsaka-sayama
Japan
Sagamihara
Japan
Sapporo
Japan
Sendai
Japan
Shigenobu N/A
Japan
Shimotsuke
Japan
Shinjuku
Japan
Suita
Japan
Tokyo
Japan
Tsu
Japan
Ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) was administered SC on Weeks 0 and 4 during the controlled period (Weeks 0-12).
FG002
Ustekinumab 90 mg (CP)
Ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) was administered SC on Weeks 0 and 4 during the controlled period (Weeks 0-12).
FG003
Placebo A (After CP)
After the controlled period (that is [i.e.], during the active drug treatment period [Weeks 12-64]), the placebo group was randomized into 2 groups, including Placebo A, in which ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) was administered SC at Weeks 12, 16, 28, 40, and 52. Participants were then followed until Week 72.
FG004
Placebo B (After CP)
After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), the placebo group was randomized into 2 groups, including Placebo B, in which ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) was administered SC at Weeks 12, 16, 28, 40, and 52. Participants were then followed until Week 72.
FG005
Ustekinumab 45 mg (After CP)
After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), participants in the ustekinumab 45 mg group received placebo (0.5 ml and 1.0 ml) SC at Week 12 followed by ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) SC at Weeks 16, 28, 40 and 52. Participants were then followed until Week 72.
FG006
Ustekinumab 90 mg (After CP)
After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), participants in the ustekinumab 90 mg group received placebo (0.5 ml and 1.0 ml) SC at Week 12 followed by ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) SC at Weeks 16, 28, 40 and 52. Participants were then followed until Week 72.
FG00032 subjects
FG00164 subjects
FG00262 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
COMPLETED
FG00028 subjects
FG00164 subjects
FG00258 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
NOT COMPLETED
FG0004 subjects
FG0010 subjects
FG0024 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
Withdrawal by Subject
FG0002 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Physician Decision
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Onset of Tuberculosis Infection
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Withdrawal due to worsened symptoms
FG0002 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Period 2: After Controlled Period
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG00315 subjects
FG00413 subjects
FG00564 subjects
FG00658 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG00314 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Type
Comment
Reasons
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
"N" (number of participants analyzed) signifies the participants evaluable for this measure.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Placebo (CP)
Placebo 0.5 ml and 1.0 ml was administered subcutaneously (SC) on Weeks 0 and 4 respectively during the controlled period (Weeks 0-12).
BG001
Ustekinumab 45 mg (CP)
Ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) was administered SC on Weeks 0 and 4 during the controlled period (Weeks 0-12).
BG002
Ustekinumab 90 mg (CP)
Ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) was administered SC on Weeks 0 and 4 during the controlled period (Weeks 0-12).
BG003
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00031
BG00164
BG00262
BG003157
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG00048.5± 12.7
BG00146.6± 12.5
BG00246.8± 12.8
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0005
BG00111
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Percentage of Participants With Greater Than or Equal to 75 Percent (%) Improvement in Psoriasis Area and Severity Index (PASI) Score
Percentage of participants with >=75% improvement in PASI score at Week 12 from Baseline was reported. PASI is a widely used tool for the measurement of severity of psoriasis. The combination of redness, scaling, and thickness, as well as overall body involvement determine the PASI score. The scale ranges from 0 (best) to 72 (worst). Baseline visit refers to Week 0.
The full analysis set (FAS) population included all the randomly assigned participants with efficacy data who fulfilled the eligibility criteria and received study medication.
Posted
Number
Percentage of participants
Week 12
ID
Title
Description
OG000
Placebo (CP)
Placebo 0.5 ml and 1.0 ml was administered subcutaneously (SC) on Weeks 0 and 4 respectively during the controlled period (Weeks 0-12).
OG001
Ustekinumab 45 mg (CP)
Ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) was administered SC on Weeks 0 and 4 during the controlled period (Weeks 0-12).
OG002
Ustekinumab 90 mg (CP)
Ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) was administered SC on Weeks 0 and 4 during the controlled period (Weeks 0-12).
Units
Counts
Participants
OG00031
OG00164
OG00262
Title
Denominators
Categories
Title
Measurements
OG0006.5
OG00159.4
OG00267.7
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG001
OG002
Fisher Exact
<0.0001
Fisher's exact test (using Holm's method)
No
Superiority or Other
Secondary
Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 12
The DLQI is a self-administered 10-item questionnaire that is used to assess 6 different aspects of quality of life: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. Scores range from 0 (no impairment in quality of life) to 30 (most impairment in quality of life).
The full analysis set (FAS) population included all the randomly assigned participants with efficacy data who fulfilled the eligibility criteria and received study medication. "N" (number of participants analyzed) signifies the participants evaluable for this measure.
Posted
Mean
Standard Deviation
Units on scale
Week 12
ID
Title
Description
OG000
Placebo (CP)
Placebo 0.5 ml and 1.0 ml was administered subcutaneously (SC) on Weeks 0 and 4 respectively during the controlled period (Weeks 0-12).
OG001
Ustekinumab 45 mg (CP)
Ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) was administered SC on Weeks 0 and 4 during the controlled period (Weeks 0-12).
OG002
Ustekinumab 90 mg (CP)
Ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) was administered SC on Weeks 0 and 4 during the controlled period (Weeks 0-12).
Secondary
Psoriasis Area and Severity Index (PASI) Score
PASI is a widely used tool for the measurement of severity of psoriasis. The combination of redness, scaling, and thickness, as well as overall body involvement determine the PASI score. The scale ranges from 0 (best) to 72 (worst).
The full analysis set (FAS) population included all the randomly assigned participants with efficacy data who fulfilled the eligibility criteria and received study medication. Here,'N' signifies the participants evaluated for this measure.
Posted
Mean
Standard Deviation
Units on a scale
Week 64
ID
Title
Description
OG000
Placebo A (After CP)
After the controlled period (that is [i.e.], during the active drug treatment period [Weeks 12-64]), the placebo group was randomized into 2 groups, including Placebo A, in which ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) was administered SC at Weeks 12, 16, 28, 40, and 52. Participants were then followed until Week 72.
OG001
Placebo B (After CP)
After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), the placebo group was randomized into 2 groups, including Placebo B, in which ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) was administered SC at Weeks 12, 16, 28, 40, and 52.
OG002
Ustekinumab 45 mg (After CP)
Secondary
Percentage of Treatment Response Based on Psoriasis Area and Severity Index (PASI) Score
PASI is a widely used tool for the measurement of severity of psoriasis. The combination of redness, scaling, and thickness, as well as overall body involvement determine the PASI score. The scale ranges from 0 (best) to 72 (worst). Percentage of Treatment Response= (Baseline PASI score-PASI score after treatment)/Baseline PASI score x 100. Baseline visit refers to Week 0.
The full analysis set (FAS) population included all the randomly assigned participants with efficacy data who fulfilled the eligibility criteria and received study medication. Here,'N' signifies the participants evaluated for this measure.
Posted
Mean
Standard Deviation
Percentage of treatment response
Week 64
ID
Title
Description
OG000
Placebo A (After CP)
After the controlled period (that is [i.e.], during the active drug treatment period [Weeks 12-64]), the placebo group was randomized into 2 groups, including Placebo A, in which ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) was administered SC at Weeks 12, 16, 28, 40, and 52. Participants were then followed until Week 72.
OG001
Placebo B (After CP)
After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), the placebo group was randomized into 2 groups, including Placebo B, in which ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) was administered SC at Weeks 12, 16, 28, 40, and 52.
Secondary
Percentage of Participants With Greater Than or Equal to (>=) 50 Percent (%), 90%, and Equal to 100% of Treatment Response Based on PASI Score
PASI is a widely used tool for the measurement of severity of psoriasis. The combination of redness, scaling, and thickness, as well as overall body involvement determine the PASI score. The scale ranges from 0 (best) to 72 (worst). Percentage of Treatment Response= (Baseline PASI score-PASI score after treatment)/Baseline PASI score x 100. Baseline visit refers to Week 0.
The full analysis set (FAS) population included all the randomly assigned participants with efficacy data who fulfilled the eligibility criteria and received study medication. Here, 'N' signifies the participants evaluated for this measure.
Posted
Number
Percentage of participants
Week 64
ID
Title
Description
OG000
Placebo A (After CP)
After the controlled period (that is [i.e.], during the active drug treatment period [Weeks 12-64]), the placebo group was randomized into 2 groups, including Placebo A, in which ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) was administered SC at Weeks 12, 16, 28, 40, and 52. Participants were then followed until Week 72.
OG001
Placebo B (After CP)
After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), the placebo group was randomized into 2 groups, including Placebo B, in which ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) was administered SC at Weeks 12, 16, 28, 40, and 52.
Secondary
Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 28, 40, 52 and 64
The DLQI is a self-administered 10-item questionnaire that is used to assess 6 different aspects of quality of life: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. Scores range from 0 (no impairment in quality of life) to 30 (most impairment in quality of life).
The full analysis set (FAS) population included all the randomly assigned participants with efficacy data who fulfilled the eligibility criteria and received study medication. Here,'N' signifies the participants evaluated for this measure and 'n' signifies the participants evaluated for this measure at a particular time point.
Posted
Mean
Standard Deviation
Unit on scale
Week 28, 40, 52 and 64
ID
Title
Description
OG000
Placebo A (After CP)
After the controlled period (that is [i.e.], during the active drug treatment period [Weeks 12-64]), the placebo group was randomized into 2 groups, including Placebo A, in which ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) was administered SC at Weeks 12, 16, 28, 40, and 52. Participants were then followed until Week 72.
OG001
Placebo B (After CP)
After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), the placebo group was randomized into 2 groups, including Placebo B, in which ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) was administered SC at Weeks 12, 16, 28, 40, and 52.
Secondary
Change From Baseline in 36-Item Short Form Health Survey (SF-36) at Week 12, 28, 40, 52 and 64
The SF-36 is a validated instrument measuring health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: (1) physical component summary (PCS)=physical functioning, role-physical, bodily pain, and general health; (2) mental component summary (MCS)=vitality, social functioning, role-emotional, and mental health. There is no total overall score; scoring is done for both sub scores and summary scores. For sub scores and summary scores: 0=worst score and 100=best score.
The full analysis set (FAS) population included all the randomly assigned participants with efficacy data who fulfilled the eligibility criteria and received study medication. Here, 'N' signifies the participants evaluated for this measure and 'n' signifies the participants evaluated for this measure at a particular time point.
Posted
Mean
Standard Deviation
Unit on scale
Week 12, 28, 40, 52 and 64
ID
Title
Description
OG000
Placebo A (After CP)
After the controlled period (that is [i.e.], during the active drug treatment period [Weeks 12-64]), the placebo group was randomized into 2 groups, including Placebo A, in which ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) was administered SC at Weeks 12, 16, 28, 40, and 52. Participants were then followed until Week 72.
OG001
Placebo B (After CP)
After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), the placebo group was randomized into 2 groups, including Placebo B, in which ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) was administered SC at Weeks 12, 16, 28, 40, and 52.
Secondary
Change From Baseline in Psoriasis Disability Index (PDI) Score at Week 12, 28, 40, 52 and 64
The PDI questionnaire consists of 15 questions relating to the impact of psoriasis in terms of daily activities, work or school, personal relationships, leisure, and treatment. Each question is scored on a scale of 0 (no impact) to 3 (greatest impact). The PDI is calculated by summing the scores of the questions resulting in a maximum score of 45 (greatest impact) and a minimum score of 0 (no impact).
The full analysis set (FAS) population included all the randomly assigned participants with efficacy data who fulfilled the eligibility criteria and received study medication. Here, 'N' signifies the participants evaluated for this measure and 'n' signifies the participants evaluated for this measure at a particular time point.
Posted
Mean
Standard Deviation
Unit on scale
Week 12, 28, 40, 52 and 64
ID
Title
Description
OG000
Placebo A (After CP)
After the controlled period (that is [i.e.], during the active drug treatment period [Weeks 12-64]), the placebo group was randomized into 2 groups, including Placebo A, in which ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) was administered SC at Weeks 12, 16, 28, 40, and 52. Participants were then followed until Week 72.
OG001
Placebo B (After CP)
After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), the placebo group was randomized into 2 groups, including Placebo B, in which ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) was administered SC at Weeks 12, 16, 28, 40, and 52.
Secondary
Treatment Response Based on Nail Psoriasis Severity Index (NAPSI) Score
The NAPSI score is used to evaluate the severity of nail bed psoriasis and nail matrix psoriasis. The nail is divided with into quadrants and given a score for nail bed psoriasis (0-4) and nail matrix psoriasis (0-4) depending on the presence of any of the features of nail psoriasis in that quadrant. Each nail is evaluated, and the sum of all the nails is the total NAPSI score. The sum of the scores from all nails ranges from 0 (no psoriasis) to 80 (psoriasis present in all 4 quadrants of all 10 nails).
The full analysis set (FAS) population included all the randomly assigned participants with efficacy data who fulfilled the eligibility criteria and received study medication. Here, 'N' signifies the participants evaluated for this measure and 'n' signifies the participants evaluated for this measure at a particular time point.
Posted
Mean
Standard Deviation
Unit on scale
Week 12, 28, 40,52 and 64
ID
Title
Description
OG000
Placebo A (After CP)
After the controlled period (that is [i.e.], during the active drug treatment period [Weeks 12-64]), the placebo group was randomized into 2 groups, including Placebo A, in which ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) was administered SC at Weeks 12, 16, 28, 40, and 52. Participants were then followed until Week 72.
OG001
Placebo B (After CP)
After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), the placebo group was randomized into 2 groups, including Placebo B, in which ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) was administered SC at Weeks 12, 16, 28, 40, and 52.
Secondary
Change From Baseline in the Number of Nails With Psoriasis Involvement at Week 12, 28, 40, 52 and 64
The number of nails with psoriasis involvement was assessed by a dermatologist.
The full analysis set (FAS) population included all the randomly assigned participants with efficacy data who fulfilled the eligibility criteria and received study medication. Here, 'N' signifies the participants evaluated for this measure and 'n' signifies the participants evaluated for this measure at a particular time point.
Posted
Mean
Standard Deviation
Nails
Week 12, 28, 40, 52 and 64
ID
Title
Description
OG000
Placebo A (After CP)
After the controlled period (that is [i.e.], during the active drug treatment period [Weeks 12-64]), the placebo group was randomized into 2 groups, including Placebo A, in which ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) was administered SC at Weeks 12, 16, 28, 40, and 52. Participants were then followed until Week 72.
OG001
Placebo B (After CP)
After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), the placebo group was randomized into 2 groups, including Placebo B, in which ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) was administered SC at Weeks 12, 16, 28, 40, and 52.
OG002
Ustekinumab 45 mg (After CP)
Secondary
Change From Baseline in Joint Symptoms Expressed on a Visual Analogue Scale (VAS) at Week 12, 28, 40, 52 and 64
Each participant will assess his/her pain associated with joint symptoms on each assessment day using a 100 mm VAS ranging from 0 mm (no pain) to 100 mm (the worst pain imaginable).
The full analysis set (FAS) population included all the randomly assigned participants with efficacy data who fulfilled the eligibility criteria and received study medication. Here, 'N' signifies the participants evaluated for this measure and 'n' signifies the participants evaluated for this measure at a particular time point.
Posted
Mean
Standard Deviation
Unit on scale
Week 12, 28, 40, 52 and 64
ID
Title
Description
OG000
Placebo A (After CP)
After the controlled period (that is [i.e.], during the active drug treatment period [Weeks 12-64]), the placebo group was randomized into 2 groups, including Placebo A, in which ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) was administered SC at Weeks 12, 16, 28, 40, and 52. Participants were then followed until Week 72.
OG001
Placebo B (After CP)
After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), the placebo group was randomized into 2 groups, including Placebo B, in which ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) was administered SC at Weeks 12, 16, 28, 40, and 52.
Secondary
Percentage of Participants With Cleared (0), Cleared or Minimal (0 or 1) and Mild (Less Than or Equal to 2) Physician's Global Assessment (PGA) Score at Week 12
Percentage of participants with PGA score of cleared (0), cleared or minimal (0 or 1) and mild (less than or equal to 2) was reported. The PGA score is a numeric scale which is completed by the physician and is designed to evaluate the physician's overall assessment of the participant's psoriasis. Overall lesions will be graded for induration (I), erythema (E), and scaling (S) as: 0=cleared, 1=minimal, 2=mild, 3=moderate, 4=marked, and 5=severe. The sum of the 3 scores (I + E + S) will be divided by 3 to obtain a final PGA score ranging from 0 [best] to 5 [worst].
The full analysis set (FAS) population included all the randomly assigned participants with efficacy data who fulfilled the eligibility criteria and received study medication.
Posted
Number
Percentage of participants
Week 12
ID
Title
Description
OG000
Placebo (CP)
Placebo 0.5 ml and 1.0 ml was administered subcutaneously (SC) on Weeks 0 and 4 respectively during the controlled period (Weeks 0-12).
OG001
Ustekinumab 45 mg (CP)
Ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) was administered SC on Weeks 0 and 4 during the controlled period (Weeks 0-12).
OG002
Secondary
Percentage of Participants With Cleared (0), Cleared or Minimal (0 or 1) and Mild (Less Than or Equal to 2) Physician's Global Assessment (PGA) Score at Week 64
Percentage of participants with PGA score of cleared (0), cleared or minimal (0 or 1) and mild (less than or equal to 2) was reported. The PGA score is a numeric scale which is completed by the physician and is designed to evaluate the physician's overall assessment of the participant's psoriasis. Overall lesions will be graded for induration (I), erythema (E), and scaling (S) as: 0=cleared, 1=minimal, 2=mild, 3=moderate, 4=marked, and 5=severe. The sum of the 3 scores (I + E + S) will be divided by 3 to obtain a final PGA score ranging from 0 [best] to 5 [worst].
The full analysis set (FAS) population included all the randomly assigned participants with efficacy data who fulfilled the eligibility criteria and received study medication. Here, 'N' signifies the participants evaluated for this measure.
Posted
Number
Percentage of participants
Week 64
ID
Title
Description
OG000
Placebo A (After CP)
After the controlled period (that is [i.e.], during the active drug treatment period [Weeks 12-64]), the placebo group was randomized into 2 groups, including Placebo A, in which ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) was administered SC at Weeks 12, 16, 28, 40, and 52. Participants were then followed until Week 72.
OG001
Placebo B (After CP)
After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), the placebo group was randomized into 2 groups, including Placebo B, in which ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) was administered SC at Weeks 12, 16, 28, 40, and 52.
Time Frame
Baseline up to Week 72
Description
Safety population included all randomized participants who received at least one dose of the study drug.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Placebo (CP)
Placebo 0.5 ml and 1.0 ml was administered subcutaneously (SC) on Weeks 0 and 4 respectively during the controlled period (Weeks 0-12).
2
32
20
32
EG001
Ustekinumab 45 mg (CP)
Ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) was administered SC on Weeks 0 and 4 during the controlled period (Weeks 0-12).
0
64
42
64
EG002
Ustekinumab 90 mg (CP)
Ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) was administered SC on Weeks 0 and 4 during the controlled period (Weeks 0-12).
3
62
36
62
EG003
Placebo A (After CP)
After the controlled period (that is [i.e.], during the active drug treatment period [Weeks 12-64]), the placebo group was randomized into 2 groups, including Placebo A, in which ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) was administered SC at Weeks 12, 16, 28, 40, and 52. Participants were then followed until Week 72.
1
15
14
15
EG004
Placebo B (After CP)
After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), the placebo group was randomized into 2 groups, including Placebo B, in which ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) was administered SC at Weeks 12, 16, 28, 40, and 52.
1
13
13
13
EG005
Ustekinumab 45 mg (After CP)
After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), participants in the ustekinumab 45 mg group received placebo (0.5 ml and 1.0 ml) SC at Week 12 followed by ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) SC at Weeks 16, 28, 40 and 52.
5
64
61
64
EG006
Ustekinumab 90 mg (After CP)
After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), participants in the ustekinumab 90 mg group received placebo (0.5 ml and 1.0 ml) SC at Week 12 followed by ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) SC at Weeks 16, 28, 40 and 52.
4
62
60
62
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Cellulitis
Infections and infestations
MedDRA V11.1
Non-systematic Assessment
EG0000 affected32 at risk
EG0010 affected64 at risk
EG0020 affected62 at risk
EG0030 affected15 at risk
EG0040 affected13 at risk
EG0051 affected64 at risk
EG0060 affected62 at risk
Pharyngitis
Infections and infestations
MedDRA V11.1
Non-systematic Assessment
EG0000 affected32 at risk
EG0010 affected64 at risk
EG0020 affected62 at risk
EG003
Pneumonia
Infections and infestations
MedDRA V11.1
Non-systematic Assessment
EG0000 affected32 at risk
EG0010 affected64 at risk
EG0020 affected62 at risk
EG003
Prostate cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA V11.1
Non-systematic Assessment
EG0000 affected32 at risk
EG0010 affected64 at risk
EG0020 affected62 at risk
EG003
Cervix carcinoma stage 0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA V11.1
Non-systematic Assessment
EG0000 affected32 at risk
EG0010 affected64 at risk
EG0020 affected62 at risk
EG003
Diabetes mellitus
Metabolism and nutrition disorders
MedDRA V11.1
Non-systematic Assessment
EG0000 affected32 at risk
EG0010 affected64 at risk
EG0020 affected62 at risk
EG003
Cerebral haemorrhage
Nervous system disorders
MedDRA V11.1
Non-systematic Assessment
EG0000 affected32 at risk
EG0010 affected64 at risk
EG0020 affected62 at risk
EG003
Cataract
Eye disorders
MedDRA V11.1
Non-systematic Assessment
EG0000 affected32 at risk
EG0010 affected64 at risk
EG0020 affected62 at risk
EG003
Cardiac failure congestive
Cardiac disorders
MedDRA V11.1
Non-systematic Assessment
EG0001 affected32 at risk
EG0010 affected64 at risk
EG0020 affected62 at risk
EG003
Colonic polyp
Gastrointestinal disorders
MedDRA V11.1
Non-systematic Assessment
EG0000 affected32 at risk
EG0010 affected64 at risk
EG0020 affected62 at risk
EG003
Psoriasis
Skin and subcutaneous tissue disorders
MedDRA V11.1
Non-systematic Assessment
EG0001 affected32 at risk
EG0010 affected64 at risk
EG0021 affected62 at risk
EG003
Dermatitis exfoliative
Skin and subcutaneous tissue disorders
MedDRA V11.1
Non-systematic Assessment
EG0001 affected32 at risk
EG0010 affected64 at risk
EG0020 affected62 at risk
EG003
Lumbar spinal stenosis
Musculoskeletal and connective tissue disorders
MedDRA V11.1
Non-systematic Assessment
EG0000 affected32 at risk
EG0010 affected64 at risk
EG0020 affected62 at risk
EG003
Osteonecrosis
Musculoskeletal and connective tissue disorders
MedDRA V11.1
Non-systematic Assessment
EG0000 affected32 at risk
EG0010 affected64 at risk
EG0021 affected62 at risk
EG003
Electrocardiogram abnormal
Investigations
MedDRA V11.1
Non-systematic Assessment
EG0000 affected32 at risk
EG0010 affected64 at risk
EG0021 affected62 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA V11.1
Non-systematic Assessment
EG0000 affected32 at risk
EG0010 affected64 at risk
EG0020 affected62 at risk
EG003
Dislocation of joint prosthesis
Injury, poisoning and procedural complications
MedDRA V11.1
Non-systematic Assessment
EG0000 affected32 at risk
EG0010 affected64 at risk
EG0020 affected62 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Nasopharyngitis
Infections and infestations
MedDRA V11.1
Non-systematic Assessment
EG0003 affected32 at risk
EG00110 affected64 at risk
EG00210 affected62 at risk
EG0038 affected15 at risk
EG0049 affected13 at risk
EG00535 affected64 at risk
EG00629 affected62 at risk
Psoriasis
Skin and subcutaneous tissue disorders
MedDRA V11.1
Non-systematic Assessment
EG0007 affected32 at risk
EG0011 affected64 at risk
EG0022 affected62 at risk
EG003
Blood triglycerides increased
Investigations
MedDRA V11.1
Non-systematic Assessment
EG0001 affected32 at risk
EG0017 affected64 at risk
EG0020 affected62 at risk
EG003
Eosinophil count increased
Investigations
MedDRA V11.1
Non-systematic Assessment
EG0001 affected32 at risk
EG0013 affected64 at risk
EG0024 affected62 at risk
EG003
Liver function test abnormal
Investigations
MedDRA V11.1
Non-systematic Assessment
EG0002 affected32 at risk
EG0010 affected64 at risk
EG0021 affected62 at risk
EG003
Tinea pedis
Infections and infestations
MedDRA V11.1
Non-systematic Assessment
EG0000 affected32 at risk
EG0010 affected64 at risk
EG0020 affected62 at risk
EG003
Influenza
Infections and infestations
MedDRA V11.1
Non-systematic Assessment
EG0000 affected32 at risk
EG0010 affected64 at risk
EG0020 affected62 at risk
EG003
Folliculitis
Infections and infestations
MedDRA V11.1
Non-systematic Assessment
EG0000 affected32 at risk
EG0011 affected64 at risk
EG0022 affected62 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA V11.1
Non-systematic Assessment
EG0000 affected32 at risk
EG0010 affected64 at risk
EG0020 affected62 at risk
EG003
Rhinitis
Infections and infestations
MedDRA V11.1
Non-systematic Assessment
EG0000 affected32 at risk
EG0010 affected64 at risk
EG0020 affected62 at risk
EG003
Hordeolum
Infections and infestations
MedDRA V11.1
Non-systematic Assessment
EG0000 affected32 at risk
EG0010 affected64 at risk
EG0020 affected62 at risk
EG003
Tinea cruris
Infections and infestations
MedDRA V11.1
Non-systematic Assessment
EG0000 affected32 at risk
EG0011 affected64 at risk
EG0020 affected62 at risk
EG003
Infected epidermal cyst
Infections and infestations
MedDRA V11.1
Non-systematic Assessment
EG0000 affected32 at risk
EG0011 affected64 at risk
EG0020 affected62 at risk
EG003
Seasonal allergy
Immune system disorders
MedDRA V11.1
Non-systematic Assessment
EG0000 affected32 at risk
EG0010 affected64 at risk
EG0020 affected62 at risk
EG003
Hyperlipidaemia
Metabolism and nutrition disorders
MedDRA V11.1
Non-systematic Assessment
EG0000 affected32 at risk
EG0010 affected64 at risk
EG0020 affected62 at risk
EG003
Hypercholesterolaemia
Metabolism and nutrition disorders
MedDRA V11.1
Non-systematic Assessment
EG0000 affected32 at risk
EG0010 affected64 at risk
EG0020 affected62 at risk
EG003
Hypertriglyceridaemia
Metabolism and nutrition disorders
MedDRA V11.1
Non-systematic Assessment
EG0000 affected32 at risk
EG0010 affected64 at risk
EG0020 affected62 at risk
EG003
Depression
Psychiatric disorders
MedDRA V11.1
Non-systematic Assessment
EG0000 affected32 at risk
EG0010 affected64 at risk
EG0020 affected62 at risk
EG003
Headache
Nervous system disorders
MedDRA V11.1
Non-systematic Assessment
EG0000 affected32 at risk
EG0010 affected64 at risk
EG0020 affected62 at risk
EG003
Tinnitus
Ear and labyrinth disorders
MedDRA V11.1
Non-systematic Assessment
EG0000 affected32 at risk
EG0010 affected64 at risk
EG0020 affected62 at risk
EG003
Arrhythmia
Cardiac disorders
MedDRA V11.1
Non-systematic Assessment
EG0000 affected32 at risk
EG0010 affected64 at risk
EG0020 affected62 at risk
EG003
Hypertension
Vascular disorders
MedDRA V11.1
Non-systematic Assessment
EG0000 affected32 at risk
EG0010 affected64 at risk
EG0020 affected62 at risk
EG003
Rhinitis allergic
Respiratory, thoracic and mediastinal disorders
MedDRA V11.1
Non-systematic Assessment
EG0000 affected32 at risk
EG0010 affected64 at risk
EG0020 affected62 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA V11.1
Non-systematic Assessment
EG0000 affected32 at risk
EG0010 affected64 at risk
EG0020 affected62 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA V11.1
Non-systematic Assessment
EG0000 affected32 at risk
EG0010 affected64 at risk
EG0020 affected62 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA V11.1
Non-systematic Assessment
EG0000 affected32 at risk
EG0010 affected64 at risk
EG0020 affected62 at risk
EG003
Upper respiratory tract inflammation
Respiratory, thoracic and mediastinal disorders
MedDRA V11.1
Non-systematic Assessment
EG0000 affected32 at risk
EG0010 affected64 at risk
EG0020 affected62 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA V11.1
Non-systematic Assessment
EG0000 affected32 at risk
EG0010 affected64 at risk
EG0020 affected62 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA V11.1
Non-systematic Assessment
EG0000 affected32 at risk
EG0010 affected64 at risk
EG0020 affected62 at risk
EG003
Periodontal disease
Gastrointestinal disorders
MedDRA V11.1
Non-systematic Assessment
EG0000 affected32 at risk
EG0010 affected64 at risk
EG0020 affected62 at risk
EG003
Tooth disorder
Gastrointestinal disorders
MedDRA V11.1
Non-systematic Assessment
EG0000 affected32 at risk
EG0010 affected64 at risk
EG0020 affected62 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA V11.1
Non-systematic Assessment
EG0000 affected32 at risk
EG0010 affected64 at risk
EG0020 affected62 at risk
EG003
Periodontitis
Gastrointestinal disorders
MedDRA V11.1
Non-systematic Assessment
EG0000 affected32 at risk
EG0010 affected64 at risk
EG0020 affected62 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA V11.1
Non-systematic Assessment
EG0000 affected32 at risk
EG0010 affected64 at risk
EG0020 affected62 at risk
EG003
Cheilitis
Gastrointestinal disorders
MedDRA V11.1
Non-systematic Assessment
EG0000 affected32 at risk
EG0010 affected64 at risk
EG0020 affected62 at risk
EG003
Colitis ischaemic
Gastrointestinal disorders
MedDRA V11.1
Non-systematic Assessment
EG0000 affected32 at risk
EG0010 affected64 at risk
EG0020 affected62 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA V11.1
Non-systematic Assessment
EG0000 affected32 at risk
EG0010 affected64 at risk
EG0020 affected62 at risk
EG003
Stomach discomfort
Gastrointestinal disorders
MedDRA V11.1
Non-systematic Assessment
EG0000 affected32 at risk
EG0010 affected64 at risk
EG0020 affected62 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA V11.1
Non-systematic Assessment
EG0000 affected32 at risk
EG0010 affected64 at risk
EG0020 affected62 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA V11.1
Non-systematic Assessment
EG0000 affected32 at risk
EG0010 affected64 at risk
EG0020 affected62 at risk
EG003
Hepatic function abnormal
Hepatobiliary disorders
MedDRA V11.1
Non-systematic Assessment
EG0000 affected32 at risk
EG0010 affected64 at risk
EG0020 affected62 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDRA V11.1
Non-systematic Assessment
EG0000 affected32 at risk
EG0011 affected64 at risk
EG0022 affected62 at risk
EG003
Dermatitis contact
Skin and subcutaneous tissue disorders
MedDRA V11.1
Non-systematic Assessment
EG0001 affected32 at risk
EG0010 affected64 at risk
EG0020 affected62 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA V11.1
Non-systematic Assessment
EG0000 affected32 at risk
EG0010 affected64 at risk
EG0020 affected62 at risk
EG003
Acne
Skin and subcutaneous tissue disorders
MedDRA V11.1
Non-systematic Assessment
EG0000 affected32 at risk
EG0010 affected64 at risk
EG0020 affected62 at risk
EG003
Xeroderma
Skin and subcutaneous tissue disorders
MedDRA V11.1
Non-systematic Assessment
EG0000 affected32 at risk
EG0010 affected64 at risk
EG0020 affected62 at risk
EG003
Dyshidrosis
Skin and subcutaneous tissue disorders
MedDRA V11.1
Non-systematic Assessment
EG0000 affected32 at risk
EG0010 affected64 at risk
EG0020 affected62 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA V11.1
Non-systematic Assessment
EG0000 affected32 at risk
EG0011 affected64 at risk
EG0020 affected62 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA V11.1
Non-systematic Assessment
EG0000 affected32 at risk
EG0010 affected64 at risk
EG0020 affected62 at risk
EG003
Rash papular
Skin and subcutaneous tissue disorders
MedDRA V11.1
Non-systematic Assessment
EG0000 affected32 at risk
EG0010 affected64 at risk
EG0020 affected62 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA V11.1
Non-systematic Assessment
EG0000 affected32 at risk
EG0010 affected64 at risk
EG0020 affected62 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA V11.1
Non-systematic Assessment
EG0000 affected32 at risk
EG0010 affected64 at risk
EG0020 affected62 at risk
EG003
Periarthritis
Musculoskeletal and connective tissue disorders
MedDRA V11.1
Non-systematic Assessment
EG0000 affected32 at risk
EG0010 affected64 at risk
EG0020 affected62 at risk
EG003
Lumbar spinal stenosis
Musculoskeletal and connective tissue disorders
MedDRA V11.1
Non-systematic Assessment
EG0000 affected32 at risk
EG0010 affected64 at risk
EG0020 affected62 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA V11.1
Non-systematic Assessment
EG0000 affected32 at risk
EG0010 affected64 at risk
EG0020 affected62 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA V11.1
Non-systematic Assessment
EG0000 affected32 at risk
EG0010 affected64 at risk
EG0020 affected62 at risk
EG003
Calculus ureteric
Renal and urinary disorders
MedDRA V11.1
Non-systematic Assessment
EG0000 affected32 at risk
EG0010 affected64 at risk
EG0020 affected62 at risk
EG003
Calculus urethral
Renal and urinary disorders
MedDRA V11.1
Non-systematic Assessment
EG0000 affected32 at risk
EG0010 affected64 at risk
EG0020 affected62 at risk
EG003
Renal atrophy
Renal and urinary disorders
MedDRA V11.1
Non-systematic Assessment
EG0000 affected32 at risk
EG0010 affected64 at risk
EG0020 affected62 at risk
EG003
Acquired hydrocele
Reproductive system and breast disorders
MedDRA V11.1
Non-systematic Assessment
EG0000 affected32 at risk
EG0010 affected64 at risk
EG0020 affected62 at risk
EG003
Dysmenorrhoea
Reproductive system and breast disorders
MedDRA V11.1
Non-systematic Assessment
EG0000 affected32 at risk
EG0010 affected64 at risk
EG0020 affected62 at risk
EG003
Pyrexia
General disorders
MedDRA V11.1
Non-systematic Assessment
EG0000 affected32 at risk
EG0010 affected64 at risk
EG0020 affected62 at risk
EG003
Fatigue
General disorders
MedDRA V11.1
Non-systematic Assessment
EG0000 affected32 at risk
EG0010 affected64 at risk
EG0020 affected62 at risk
EG003
Feeling abnormal
General disorders
MedDRA V11.1
Non-systematic Assessment
EG0000 affected32 at risk
EG0010 affected64 at risk
EG0020 affected62 at risk
EG003
Blood creatine phosphokinase increased
Investigations
MedDRA V11.1
Non-systematic Assessment
EG0000 affected32 at risk
EG0010 affected64 at risk
EG0020 affected62 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA V11.1
Non-systematic Assessment
EG0000 affected32 at risk
EG0010 affected64 at risk
EG0020 affected62 at risk
EG003
White blood cell count increased
Investigations
MedDRA V11.1
Non-systematic Assessment
EG0000 affected32 at risk
EG0010 affected64 at risk
EG0020 affected62 at risk
EG003
Blood lactate dehydrogenase increased
Investigations
MedDRA V11.1
Non-systematic Assessment
EG0000 affected32 at risk
EG0011 affected64 at risk
EG0020 affected62 at risk
EG003
Glucose urine present
Investigations
MedDRA V11.1
Non-systematic Assessment
EG0000 affected32 at risk
EG0010 affected64 at risk
EG0020 affected62 at risk
EG003
Lymphocyte count decreased
Investigations
MedDRA V11.1
Non-systematic Assessment
EG0000 affected32 at risk
EG0013 affected64 at risk
EG0020 affected62 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA V11.1
Non-systematic Assessment
EG0000 affected32 at risk
EG0010 affected64 at risk
EG0021 affected62 at risk
EG003
Blood cholesterol increased
Investigations
MedDRA V11.1
Non-systematic Assessment
EG0000 affected32 at risk
EG0010 affected64 at risk
EG0020 affected62 at risk
EG003
C-reactive protein increased
Investigations
MedDRA V11.1
Non-systematic Assessment
EG0000 affected32 at risk
EG0010 affected64 at risk
EG0020 affected62 at risk
EG003
Blood amylase increased
Investigations
MedDRA V11.1
Non-systematic Assessment
EG0000 affected32 at risk
EG0010 affected64 at risk
EG0020 affected62 at risk
EG003
Red blood cell count increased
Investigations
MedDRA V11.1
Non-systematic Assessment
EG0000 affected32 at risk
EG0010 affected64 at risk
EG0020 affected62 at risk
EG003
Blood phosphorus decreased
Investigations
MedDRA V11.1
Non-systematic Assessment
EG0000 affected32 at risk
EG0010 affected64 at risk
EG0020 affected62 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA V11.1
Non-systematic Assessment
EG0000 affected32 at risk
EG0010 affected64 at risk
EG0020 affected62 at risk
EG003
Blood cholesterol decreased
Investigations
MedDRA V11.1
Non-systematic Assessment
EG0000 affected32 at risk
EG0010 affected64 at risk
EG0020 affected62 at risk
EG003
Blood pressure increased
Investigations
MedDRA V11.1
Non-systematic Assessment
EG0000 affected32 at risk
EG0010 affected64 at risk
EG0021 affected62 at risk
EG003
Blood pressure decreased
Investigations
MedDRA V11.1
Non-systematic Assessment
EG0000 affected32 at risk
EG0010 affected64 at risk
EG0020 affected62 at risk
EG003
Fibrin D dimer increased
Investigations
MedDRA V11.1
Non-systematic Assessment
EG0000 affected32 at risk
EG0010 affected64 at risk
EG0020 affected62 at risk
EG003
Haemoglobin increased
Investigations
MedDRA V11.1
Non-systematic Assessment
EG0000 affected32 at risk
EG0010 affected64 at risk
EG0020 affected62 at risk
EG003
Arthropod sting
Injury, poisoning and procedural complications
MedDRA V11.1
Non-systematic Assessment
EG0000 affected32 at risk
EG0010 affected64 at risk
EG0020 affected62 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA V11.1
Non-systematic Assessment
EG0000 affected32 at risk
EG0010 affected64 at risk
EG0020 affected62 at risk
EG003
Wound
Injury, poisoning and procedural complications
MedDRA V11.1
Non-systematic Assessment
EG0000 affected32 at risk
EG0010 affected64 at risk
EG0020 affected62 at risk
EG003
Joint sprain
Injury, poisoning and procedural complications
MedDRA V11.1
Non-systematic Assessment
EG0000 affected32 at risk
EG0010 affected64 at risk
EG0020 affected62 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
MedDRA V11.1
Non-systematic Assessment
EG0000 affected32 at risk
EG0010 affected64 at risk
EG0020 affected62 at risk
EG003
Post procedural swelling
Injury, poisoning and procedural complications
MedDRA V11.1
Non-systematic Assessment
EG0000 affected32 at risk
EG0010 affected64 at risk
EG0020 affected62 at risk
EG003
Tonsillitis
Infections and infestations
MedDRA V11.1
Non-systematic Assessment
EG0000 affected32 at risk
EG0010 affected64 at risk
EG0020 affected62 at risk
EG003
Cellulitis
Infections and infestations
MedDRA V11.1
Non-systematic Assessment
EG0001 affected32 at risk
EG0010 affected64 at risk
EG0020 affected62 at risk
EG003
Molluscum contagiosum
Infections and infestations
MedDRA V11.1
Non-systematic Assessment
EG0001 affected32 at risk
EG0010 affected64 at risk
EG0020 affected62 at risk
EG003
Sinusitis
Infections and infestations
MedDRA V11.1
Non-systematic Assessment
EG0001 affected32 at risk
EG0010 affected64 at risk
EG0020 affected62 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA V11.1
Non-systematic Assessment
EG0000 affected32 at risk
EG0011 affected64 at risk
EG0020 affected62 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA V11.1
Non-systematic Assessment
EG0000 affected32 at risk
EG0010 affected64 at risk
EG0021 affected62 at risk
EG003
Otitis externa
Infections and infestations
MedDRA V11.1
Non-systematic Assessment
EG0000 affected32 at risk
EG0010 affected64 at risk
EG0021 affected62 at risk
EG003
Paronychia
Infections and infestations
MedDRA V11.1
Non-systematic Assessment
EG0000 affected32 at risk
EG0010 affected64 at risk
EG0021 affected62 at risk
EG003
Heat rash
Skin and subcutaneous tissue disorders
MedDRA V11.1
Non-systematic Assessment
EG0000 affected32 at risk
EG0011 affected64 at risk
EG0021 affected62 at risk
EG003
Neurodermatitis
Skin and subcutaneous tissue disorders
MedDRA V11.1
Non-systematic Assessment
EG0000 affected32 at risk
EG0011 affected64 at risk
EG0020 affected62 at risk
EG003
Seborrhoeic dermatitis
Skin and subcutaneous tissue disorders
MedDRA V11.1
Non-systematic Assessment
EG0000 affected32 at risk
EG0011 affected64 at risk
EG0020 affected62 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA V11.1
Non-systematic Assessment
EG0001 affected32 at risk
EG0011 affected64 at risk
EG0021 affected62 at risk
EG003
Blood creatine phosphokinase increased
Investigations
MedDRA V11.1
Non-systematic Assessment
EG0001 affected32 at risk
EG0011 affected64 at risk
EG0020 affected62 at risk
EG003
Basophil count increased
Investigations
MedDRA V11.1
Non-systematic Assessment
EG0000 affected32 at risk
EG0012 affected64 at risk
EG0020 affected62 at risk
EG003
Blood uric acid increased
Investigations
MedDRA V11.1
Non-systematic Assessment
EG0000 affected32 at risk
EG0011 affected64 at risk
EG0022 affected62 at risk
EG003
Protein urine present
Investigations
MedDRA V11.1
Non-systematic Assessment
EG0000 affected32 at risk
EG0010 affected64 at risk
EG0022 affected62 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA V11.1
Non-systematic Assessment
EG0000 affected32 at risk
EG0010 affected64 at risk
EG0021 affected62 at risk
EG003
Blood albumin decreased
Investigations
MedDRA V11.1
Non-systematic Assessment
EG0000 affected32 at risk
EG0010 affected64 at risk
EG0021 affected62 at risk
EG003
Pruritus generalised
Skin and subcutaneous tissue disorders
MedDRA V11.1
Non-systematic Assessment
EG0000 affected32 at risk
EG0011 affected64 at risk
EG0020 affected62 at risk
EG003
Blood urea decreased
Investigations
MedDRA V11.1
Non-systematic Assessment
EG0000 affected32 at risk
EG0011 affected64 at risk
EG0021 affected62 at risk
EG003
Photodermatosis
Skin and subcutaneous tissue disorders
MedDRA V11.1
Non-systematic Assessment
EG0000 affected32 at risk
EG0011 affected64 at risk
EG0021 affected62 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
The disclosure restriction on Principle investigator is that the sponsor can review results communications prior to public release and can embargo communications regarding results for a period as the sponsor requires.
Point of Contact
Title
Organization
Phone
Extension
Email
Senior Director, Clinical Development
Janssen Research & Development, LLC
793-7633
215
ID
Term
D011565
Psoriasis
Ancestor Terms
ID
Term
D017444
Skin Diseases, Papulosquamous
D012871
Skin Diseases
D017437
Skin and Connective Tissue Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
D000069549
Ustekinumab
Ancestor Terms
ID
Term
D061067
Antibodies, Monoclonal, Humanized
D000911
Antibodies, Monoclonal
D000906
Antibodies
D007136
Immunoglobulins
D007162
Immunoproteins
D001798
Blood Proteins
D011506
Proteins
D000602
Amino Acids, Peptides, and Proteins
D012712
Serum Globulins
D005916
Globulins
Browse Leaves
Not provided
Browse Branches
Not provided
0 subjects
FG0050 subjects
FG0060 subjects
0 subjects
FG0050 subjects
FG0060 subjects
0 subjects
FG0050 subjects
FG0060 subjects
0 subjects
FG0050 subjects
FG0060 subjects
11 subjects
FG00558 subjects
FG00654 subjects
2 subjects
FG0056 subjects
FG0064 subjects
1 subjects
FG0040 subjects
FG0051 subjects
FG0061 subjects
Onset of tuberculosis infection
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0051 subjects
FG0060 subjects
Other
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0041 subjects
FG0054 subjects
FG0060 subjects
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0041 subjects
FG0050 subjects
FG0061 subjects
Use of prohibited concomitant medication
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0061 subjects
Withdrawal due to worsened symptoms
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0061 subjects
47.0
± 12.6
15
BG00331
Male
BG00026
BG00153
BG00247
BG003126
Units
Counts
Participants
OG00031
OG00162
OG00261
Title
Denominators
Categories
Title
Measurements
OG000-0.3± 5.25
OG001-8.0± 6.45
OG002-7.4± 6.52
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG001
OG002
t-test, 2 sided
<0.0001
2-sample t-test (using Holm's method)
No
Superiority or Other
After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), participants in the ustekinumab 45 mg group received placebo (0.5 ml and 1.0 ml) SC at Week 12 followed by ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) SC at Weeks 16, 28, 40 and 52.
OG003
Ustekinumab 90 mg (After CP)
After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), participants in the ustekinumab 90 mg group received placebo (0.5 ml and 1.0 ml) SC at Week 12 followed by ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) SC at Weeks 16, 28, 40 and 52.
Units
Counts
Participants
OG00015
OG00114
OG00260
OG00356
Title
Denominators
Categories
Title
Measurements
OG00010.83± 16.149
OG0018.29± 9.975
OG0026.60± 9.060
OG0034.94± 7.493
OG002
Ustekinumab 45 mg (After CP)
After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), participants in the ustekinumab 45 mg group received placebo (0.5 ml and 1.0 ml) SC at Week 12 followed by ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) SC at Weeks 16, 28, 40 and 52.
OG003
Ustekinumab 90 mg (After CP)
After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), participants in the ustekinumab 90 mg group received placebo (0.5 ml and 1.0 ml) SC at Week 12 followed by ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) SC at Weeks 16, 28, 40 and 52.
Units
Counts
Participants
OG00015
OG00114
OG00260
OG00356
Title
Denominators
Categories
Title
Measurements
OG00070.78± 38.816
OG00163.07± 43.608
OG00278.86± 25.910
OG00382.36± 26.798
OG002
Ustekinumab 45 mg (After CP)
After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), participants in the ustekinumab 45 mg group received placebo (0.5 ml and 1.0 ml) SC at Week 12 followed by ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) SC at Weeks 16, 28, 40 and 52.
OG003
Ustekinumab 90 mg (After CP)
After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), participants in the ustekinumab 90 mg group received placebo (0.5 ml and 1.0 ml) SC at Week 12 followed by ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) SC at Weeks 16, 28, 40 and 52.
Units
Counts
Participants
OG00015
OG00114
OG00260
OG00356
Title
Denominators
Categories
>= 50% Treatment Response
Title
Measurements
OG00080
OG00171.4
OG00291.7
OG00389.3
>= 90% Treatment Response
Title
Measurements
OG00060
OG00150
OG00250
OG003
100% Treatment Response
Title
Measurements
OG00013.3
OG00121.4
OG00218.3
OG003
OG002
Ustekinumab 45 mg (After CP)
After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), participants in the ustekinumab 45 mg group received placebo (0.5 ml and 1.0 ml) SC at Week 12 followed by ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) SC at Weeks 16, 28, 40 and 52.
OG003
Ustekinumab 90 mg (After CP)
After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), participants in the ustekinumab 90 mg group received placebo (0.5 ml and 1.0 ml) SC at Week 12 followed by ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) SC at Weeks 16, 28, 40 and 52.
Units
Counts
Participants
OG00015
OG00115
OG00264
OG00359
Title
Denominators
Categories
Change at Week 28 (n=15,15,64,59)
Title
Measurements
OG000-6.4± 6.74
OG001-6.2± 6.14
OG002-7.5± 6.46
OG003-7.6± 6.59
Change at Week 40 (n=15,15,61,56)
Title
Measurements
OG000-6.5± 6.46
OG001-6.5± 6.08
OG002-7.7± 6.98
OG003
Change at Week 52 (n=15,14,60,57)
Title
Measurements
OG000-6.3± 5.92
OG001-5.5± 6.60
OG002-7.3± 7.01
OG003
Change at Week 64 (n=15,14,60,56)
Title
Measurements
OG000-5.8± 6.05
OG001-5.7± 6.96
OG002-7.4± 6.92
OG003
OG002
Ustekinumab 45 mg (After CP)
After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), participants in the ustekinumab 45 mg group received placebo (0.5 ml and 1.0 ml) SC at Week 12 followed by ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) SC at Weeks 16, 28, 40 and 52.
OG003
Ustekinumab 90 mg (After CP)
After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), participants in the ustekinumab 90 mg group received placebo (0.5 ml and 1.0 ml) SC at Week 12 followed by ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) SC at Weeks 16, 28, 40 and 52.
Units
Counts
Participants
OG00015
OG00116
OG00264
OG00361
Title
Denominators
Categories
Change at Week 12: PCS(n=15,16,62,61)
Title
Measurements
OG000-.88± 11.141
OG001-1.03± 8.328
OG0027.76± 14.536
OG0035.14± 12.036
Change at Week 12: MCS(n=15,16,62,61)
Title
Measurements
OG0001.16± 5.263
OG0012.84± 7.994
OG0025.28± 9.797
OG003
Change at Week 28: PCS(n=15,15,64,59)
Title
Measurements
OG0002.22± 15.064
OG0016.42± 16.113
OG0028.54± 14.538
OG003
Change at Week 28: MCS(n=15,15,64,59)
Title
Measurements
OG0006.19± 7.069
OG0013.22± 6.621
OG0026.84± 10.086
OG003
Change at Week 40: PCS(n=15,15,61,57)
Title
Measurements
OG0002.12± 19.683
OG0016.18± 15.914
OG0028.95± 15.476
OG003
Change at Week 40: MCS(n=15,15,61,57)
Title
Measurements
OG0004.90± 5.453
OG0015.27± 11.303
OG0026.61± 9.674
OG003
Change at Week 52: PCS(n=15,14,60,56)
Title
Measurements
OG0004.03± 16.426
OG0016.58± 16.496
OG0028.33± 16.365
OG003
Change at Week 52: MCS(n=15,14,60,56)
Title
Measurements
OG0004.44± 5.198
OG0015.93± 9.755
OG0025± 10.386
OG003
Change at Week 64: PCS(n=15,14,60,56)
Title
Measurements
OG0003.79± 15.519
OG0016.10± 16.164
OG0028.27± 15.468
OG003
Change at Week 64: MCS(n=15,14,60,56)
Title
Measurements
OG0004.67± 5.362
OG0015.21± 7.958
OG0025.11± 10.504
OG003
OG002
Ustekinumab 45 mg (After CP)
After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), participants in the ustekinumab 45 mg group received placebo (0.5 ml and 1.0 ml) SC at Week 12 followed by ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) SC at Weeks 16, 28, 40 and 52.
OG003
Ustekinumab 90 mg (After CP)
After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), participants in the ustekinumab 90 mg group received placebo (0.5 ml and 1.0 ml) SC at Week 12 followed by ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) SC at Weeks 16, 28, 40 and 52.
Units
Counts
Participants
OG00015
OG00116
OG00264
OG00361
Title
Denominators
Categories
Change at Week 12 (n=15,16,62,61)
Title
Measurements
OG0000.1± 3.70
OG0010.1± 4.76
OG002-8.6± 9.63
OG003-12.0± 11.80
Change at Week 28 (n=15,15,64,59)
Title
Measurements
OG000-10.0± 9.52
OG001-8.1± 8.90
OG002-10.8± 9.45
OG003
Change at Week 40 (n=15,15,61,57)
Title
Measurements
OG000-9.4± 9.07
OG001-8.5± 9.67
OG002-11.3± 9.92
OG003
Change at Week 52 (n=15,14,60,56)
Title
Measurements
OG000-10.4± 8.60
OG001-6.5± 10.86
OG002-10.6± 9.06
OG003
Change at Week 64 (n=15,14,60,56)
Title
Measurements
OG000-10.6± 9.12
OG001-7.6± 10.10
OG002-10.7± 9.71
OG003
OG002
Ustekinumab 45 mg (After CP)
After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), participants in the ustekinumab 45 mg group received placebo (0.5 ml and 1.0 ml) SC at Week 12 followed by ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) SC at Weeks 16, 28, 40 and 52.
OG003
Ustekinumab 90 mg (After CP)
After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), participants in the ustekinumab 90 mg group received placebo (0.5 ml and 1.0 ml) SC at Week 12 followed by ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) SC at Weeks 16, 28, 40 and 52.
Units
Counts
Participants
OG0009
OG0018
OG00244
OG00340
Title
Denominators
Categories
NAPSI Score at Week 12 (n=9,8,43,40)
Title
Measurements
OG00011.1± 33.33
OG0016.3± 17.68
OG0027.7± 95.14
OG00310.0± 66.06
NAPSI Score at Week 28 (n=9,7,44,38)
Title
Measurements
OG00034.9± 42.17
OG00134.5± 44.21
OG00252.0± 39.59
OG003
NAPSI Score at Week 40 (n=9,7,42,36)
Title
Measurements
OG00031.6± 40.17
OG00138.1± 48.80
OG00259.9± 45.87
OG003
NAPSI Score at Week 52 (n=9,7,42,37)
Title
Measurements
OG00048.0± 47.62
OG00138.1± 48.80
OG00260.0± 45.96
OG003
NAPSI Score at Week 64 (n=9,7,42,36)
Title
Measurements
OG00051.5± 45.20
OG00139.3± 45.32
OG00256.6± 43.24
OG003
After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), participants in the ustekinumab 45 mg group received placebo (0.5 ml and 1.0 ml) SC at Week 12 followed by ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) SC at Weeks 16, 28, 40 and 52.
OG003
Ustekinumab 90 mg (After CP)
After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), participants in the ustekinumab 90 mg group received placebo (0.5 ml and 1.0 ml) SC at Week 12 followed by ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) SC at Weeks 16, 28, 40 and 52.
Units
Counts
Participants
OG00015
OG00116
OG00264
OG00361
Title
Denominators
Categories
Change at Week 12 (n=15,16,62,61)
Title
Measurements
OG0000.9± 2.64
OG001-0.1± 0.25
OG0020± 1.96
OG0030± 1.83
Change at Week 28 (n=15,15,64,59)
Title
Measurements
OG000-0.1± 2.80
OG001-0.1± 1.13
OG002-1.8± 2.89
OG003
Change at Week 40 (n=15,15,61,56)
Title
Measurements
OG000-1.5± 2.77
OG001-1.1± 3.20
OG002-2.6± 3.18
OG003
Change at Week 52 (n=15,14,60,57)
Title
Measurements
OG000-1.8± 3.23
OG001-1.4± 3.34
OG002-2.8± 3.32
OG003
Change at Week 64 (n=15,14,60,56)
Title
Measurements
OG000-1.3± 2.92
OG001-1.1± 3.32
OG002-2.6± 3.38
OG003
OG002
Ustekinumab 45 mg (After CP)
After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), participants in the ustekinumab 45 mg group received placebo (0.5 ml and 1.0 ml) SC at Week 12 followed by ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) SC at Weeks 16, 28, 40 and 52.
OG003
Ustekinumab 90 mg (After CP)
After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), participants in the ustekinumab 90 mg group received placebo (0.5 ml and 1.0 ml) SC at Week 12 followed by ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) SC at Weeks 16, 28, 40 and 52.
Units
Counts
Participants
OG0002
OG0011
OG0026
OG00313
Title
Denominators
Categories
Change at Week 12 (n=2,1,6,13)
Title
Measurements
OG0000.5± 0.71
OG00123.0± NAStandard deviation was not estimable because number of participant analyzed for this time point is 1
OG002-38.5± 28.93
OG003-9.3± 18.23
Change at Week 28 (n=2,0,6,12)
Title
Measurements
OG000-8.0± 11.31
OG001NA± NANo participant was found with joint symptoms for which pain assessment could be conducted for this treatment group
OG002-30.0± 37.97
OG003
Change at Week 40 (n=2,0,6,11)
Title
Measurements
OG000-16.0± 22.63
OG001NA± NANo participant was found with joint symptoms for which pain assessment could be conducted for this treatment group
OG002-29.3± 33.17
OG003
Change at Week 52 (n=2,0,6,11)
Title
Measurements
OG000-4.0± 5.66
OG001NA± NANo participant was found with joint symptoms for which pain assessment could be conducted for this treatment group
OG002-35.0± 35.49
OG003
Change at Week 64 (n=2,0,6,11)
Title
Measurements
OG000-7.5± 10.61
OG001NA± NANo participant was found with joint symptoms for which pain assessment could be conducted for this treatment group
OG002-35.3± 38.55
OG003
Ustekinumab 90 mg (CP)
Ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) was administered SC on Weeks 0 and 4 during the controlled period (Weeks 0-12).
Units
Counts
Participants
OG00031
OG00164
OG00262
Title
Denominators
Categories
Title
Measurements
OG0009.7
OG00157.8
OG00269.4
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG001
OG002
Fisher Exact
<0.0001
Fisher's exact test (using Holm's method)
No
Superiority or Other
OG002
Ustekinumab 45 mg (After CP)
After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), participants in the ustekinumab 45 mg group received placebo (0.5 ml and 1.0 ml) SC at Week 12 followed by ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) SC at Weeks 16, 28, 40 and 52.
OG003
Ustekinumab 90 mg (After CP)
After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), participants in the ustekinumab 90 mg group received placebo (0.5 ml and 1.0 ml) SC at Week 12 followed by ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) SC at Weeks 16, 28, 40 and 52.