A Study of the Safety and Effectiveness of Ustekinumab in... | NCT01009086 | Trialant
NCT01009086
Sponsor
Janssen Research & Development, LLC
Status
Completed
Last Update Posted
Mar 3, 2015Estimated
Enrollment
615Actual
Phase
Phase 3
Conditions
Arthritis, Psoriatic
Interventions
Placebo
Ustekinumab 45 mg
Ustekinumab 90 mg
Countries
United States
Australia
Austria
Canada
Finland
Germany
Hungary
Latvia
Lithuania
New Zealand
Poland
Russia
Spain
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT01009086
Obsolete or Duplicate NCT IDs
NCT01902706
Organization Study
CR016315
Secondary IDs
ID
Type
Description
Link
CNTO1275PSA3001
Other Identifier
Janssen Research & Development, LLC
2009-012264-14
EudraCT Number
Brief Title
A Study of the Safety and Effectiveness of Ustekinumab in Patients With Psoriatic Arthritis
Official Title
A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Ustekinumab, a Fully Human Aanti-IL-12/23p40 Monoclonal Antibody, Administered Subcutaneously, in Subjects With Active Psoriatic Arthritis
Acronym
Not provided
Organization
Janssen Research & Development, LLCINDUSTRY
Status Module
Record Verification Date
Feb 2015
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
Dec 2009
Primary Completion Date
Oct 2011Actual
Completion Date
May 2013Actual
First Submitted Date
Nov 5, 2009
First Submission Date that Met QC Criteria
Nov 5, 2009
First Posted Date
Nov 6, 2009Estimated
Results Waived
Not provided
Results First Submitted Date
Oct 11, 2013
Results First Submitted that Met QC Criteria
Jan 28, 2014
Results First Posted Date
Mar 13, 2014Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Oct 16, 2012
Certification/Extension First Submitted that Passed QC Review
Oct 16, 2012
Certification/Extension First Posted Date
Oct 17, 2012Estimated
Last Update Submitted Date
Feb 11, 2015
Last Update Posted Date
Mar 3, 2015Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Janssen Research & Development, LLCINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
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 effectiveness (improvement of signs and symptoms) and safety of ustekinumab in participants with active psoriatic arthritis.
Detailed Description
This is a randomized (participants are assigned different treatments based on chance), double-blind (neither the participant nor the physician knows whether drug or placebo is being taken, or at what dosage), parallel-group (each group of participants will be treated at the same time), and multicenter (study conducted at multiple sites) study. Approximately, 615 participants will participate in this study. Participants will be assigned to one of three treatment groups: Group I: ustekinumab 45 mg, Group II: ustekinumab 90 mg, and Group III: placebo group (an inactive substance). Participants will receive either 45 mg ustekinumab or 90 mg ustekinumab at Weeks 0, 4, and every 12 weeks until Week 88 as randomized to respective groups. Participants in placebo group will receive placebo at Weeks 0, 4, 16, and 20 and 45 mg ustekinumab at Weeks 24 and 28 followed by every 12 weeks dosing until Week 88. Participants who do not have greater than or equal to 5 percentage improvement in their disease (tender and swollen joints) will be eligible for an early escape. Specifically, during early escape at Week 16, participants in Group I will receive 90 mg ustekinumab, for participants in Group II same dosing schedule will be continued, and participants in placebo group will receive 45 mg ustekinumab. Safety evaluations will include assessments of adverse events, clinical laboratory tests, and physical examination. The maximum study duration will be approximately 108 weeks.
Conditions Module
Conditions
Arthritis, Psoriatic
Keywords
Arthritis, Psoriatic
Ustekinumab
CNTO 1275
Stelara
Psoriasis
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
615Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Placebo
Experimental
Participants will receive subcutaneous (SC) injections of placebo at Weeks 0, 4, 16, and 20. At Week 24 participants will cross over to receive SC injections of ustekinumab 45 mg at Weeks 24 and 28 and every 12 weeks thereafter with the last dose at Week 88. If early escape, SC injections of 45 mg ustekinumab will be given at Weeks 16, 20, and 28 and every 12 weeks thereafter with the last dose at Week 88. For participants entering early escape, a SC placebo injection will be given at Week 24 to maintain the blind.
Drug: Placebo
Ustekinumab 45 mg
Experimental
Participants will receive SC injections of ustekinumab 45 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 88. If early escape, SC injections of 90 mg ustekinumab will be given at Week 16 and every 12 weeks thereafter with the last dose at Week 88. Participants will receive SC injections of placebo at Weeks 20 and 24 to maintain the blind.
Drug: Placebo
Drug: Ustekinumab 45 mg
Drug: Ustekinumab 90 mg
Ustekinumab 90 mg
Experimental
Participants will receive SC injections of ustekinumab 90 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 88. If early escape, the same dosage schedule will continue. Participants will receive SC injections of placebo at Weeks 20 and 24 to maintain the blind.
Drug: Placebo
Drug: Ustekinumab 90 mg
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Placebo
Drug
SC injections
Placebo
Ustekinumab 45 mg
Ustekinumab 90 mg
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percentage of Participants With American College of Rheumatology (ACR) 20 Response at Week 24.
An ACR 20 response is defined as a greater than or equal to 20 percent improvement from baseline in swollen (66 joints) and tender (68 joints) joint counts and greater than or equal to 20 percent improvement in 3 of the following 5 assessments: 1) Participant's assessment of pain by Visual Analog Scale (VAS) (0-10 cm), 2) Participant's global assessment of disease activity by VAS (0-10 cm), 3) Physician's global assessment of disease activity by VAS (0-10 centimeters [cm]) 4) Participant's assessment of physical function as measured by the "Disability Index of the Health Assessment Questionnaire" (HAQ-DI) (score of 0-3 in 8 functional areas) and 5) C reactive protein.
Week 24
Secondary Outcomes
Measure
Description
Time Frame
Change From Baseline to Week 24 in the Disability Index Score as Measured With the "Disability Index of the Health Assessment Questionnaire" (HAQ-DI)
The HAQ-DI is 20-question instrument that assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area are scored from 0 (no difficulty), to 3 (inability to perform a task in that area). The average score across the functional areas yields an overall HAQ-DI score which ranges from 0 (no disability) to 3 (completely disabled). In psoriatic arthritis, a decrease in score of 0.30 indicates clinically meaningful improvement.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Have had a documented diagnosis of psoriatic arthritis (PsA) at least 6 months
Have a diagnosis of active PsA at the time of entry into the study
If the participant is using methotrexate they should have started treatment at a dose not to exceed 25 milligram per week at least 3 months prior to the beginning of the study and should have no serious toxic side effects attributable to methotrexate. Methotrexate route of administration and doses should be stable for at least 4 weeks prior to the first administration of study agent. If currently not using methotrexate, must have not received methotrexate for at least 4 weeks prior to the first administration of the study agent
Exclusion Criteria:
Have other inflammatory diseases, including but not limited to rheumatoid arthritis, ankylosing spondylitis, systemic lupus erythematosus, or Lyme disease
Have used any therapeutic agent targeted at reducing interleukin (IL)-12 or IL-23, including but not limited to ustekinumab and briakinumab (ABT-874)
Have used any biologic agents that are targeted for reducing tumor necrosis factor-alpha, including but not limited to infliximab, etanercept, adalimumab, and golimumab
Have a medical history of latent or active granulomatous infection
Have any known malignancy or have a history of malignancy (with the exception of basal cell carcinoma, squamous cell carcinoma in situ of the skin, or cervical carcinoma in situ that has been treated with no evidence of recurrence, or squamous cell carcinoma of the skin that has been treated with no evidence of recurrence within 5 years of the beginning of the study
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 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 Research & Development, LLC Clinical Trial
Placebo Subcutaneous (SC) injections at Weeks 0, 4, 16 and 20. If Early Escape then participants would receive Ustekinumab 45 mg injections starting Week 16 with the last dose at Week 88. If Crossover then participants would receive Ustekinumab 45 milligram (mg) injections starting Week 24 with the last dose at Week 88.
Percentage of Participants (With >= 3% Baseline Body Surface Area (BSA) Psoriatic Involvement) Who Achieved a Psoriasis Area and Severity Index 75 (PASI 75) Response at Week 24
The PASI is a physician-administered assessment tool 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). A PASI 75 response is defined as greater than or equal to 75 percent improvement in PASI score from baseline.
Week 24
Percentage of Participants With American College of Rheumatology (ACR) 50 Response at Week 24
An ACR 50 response is defined as a greater than or equal to 50 percent improvement from baseline in swollen (66 joints) and tender (68 joints) joint counts and greater than or equal to 50 percent improvement in 3 of the following 5 assessments: 1) Participant's assessment of pain by Visual Analog Scale (VAS) (0-10 cm), 2) Participant's global assessment of disease activity by VAS (0-10 cm), 3) Physician's global assessment of disease activity by VAS (0-10 cm) 4)Participant's assessment of physical function as measured by the "Disability Index of the Health Assessment Questionnaire" (HAQ-DI) (score of 0-3 in 8 functional areas) and 5) C reactive protein.
Week 24
Percentage of Participants With American College of Rheumatology (ACR) 70 Response at Week 24
An ACR 70 response is defined as a greater than or equal to 70 percent improvement from baseline in swollen (66 joints) and tender (68 joints) joint counts and greater than or equal to 70 percent improvement in 3 of the following 5 assessments: 1) Participant's assessment of pain by Visual Analog Scale (VAS) (0-10 cm), 2) Participant's global assessment of disease activity by VAS (0-10 cm), 3) Physician's global assessment of disease activity by VAS (0-10 cm) 4) Participant's assessment of physical function as measured by the "Disability Index of the Health Assessment Questionnaire" (HAQ-DI) (score of 0-3 in 8 functional areas) and 5) C reactive protein.
Week 24
Change From Baseline to Week 24 in Total Modified Van Der Heijde-Sharp (vdH-S) Score for the Combined Radiographic Data From Studies CNTO1275PSA3001 and CNTO1275PSA3002
The modified vdH-S score is a radiographic evaluation of hand and feet erosions and joint space narrowing (JSN) for 20 joints per hand and 6 joints per foot with a total score ranging from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score and positive score changes indicate more radiographic damage and radiographic progression, respectively. As per protocol, analysis for this outcome measure used pooled data from 2 studies (CNTO1275PSA3001 and PSA3002) because initial power assumptions showed that 900 participants would be required to evaluate impact of ustekinumab on structural damage (SD) progression. The 2 studies, (which had similar study designs and dosing regimens with difference to prior exposure to anti-tumor necrosis factor alpha (TNFα) therapies), were intended to independently measure efficacy in terms of signs, symptoms and physical function, while effects on SD progression is provided from an integrated analysis.
Helliwell PS, Gladman DD, Chakravarty SD, Kafka S, Karyekar CS, You Y, Campbell K, Sweet K, Kavanaugh A, Gensler LS. Effects of ustekinumab on spondylitis-associated endpoints in TNFi-naive active psoriatic arthritis patients with physician-reported spondylitis: pooled results from two phase 3, randomised, controlled trials. RMD Open. 2020 Feb;6(1):e001149. doi: 10.1136/rmdopen-2019-001149.
Ghosh S, Gensler LS, Yang Z, Gasink C, Chakravarty SD, Farahi K, Ramachandran P, Ott E, Strober BE. Ustekinumab Safety in Psoriasis, Psoriatic Arthritis, and Crohn's Disease: An Integrated Analysis of Phase II/III Clinical Development Programs. Drug Saf. 2019 Jun;42(6):751-768. doi: 10.1007/s40264-019-00797-3.
Rahman P, Puig L, Gottlieb AB, Kavanaugh A, McInnes IB, Ritchlin C, Li S, Wang Y, Song M, Mendelsohn A, Han C; PSUMMIT 1 and 2 Study Groups. Ustekinumab Treatment and Improvement of Physical Function and Health-Related Quality of Life in Patients With Psoriatic Arthritis. Arthritis Care Res (Hoboken). 2016 Dec;68(12):1812-1822. doi: 10.1002/acr.23000. Epub 2016 Oct 21.
Kavanaugh A, Puig L, Gottlieb AB, Ritchlin C, You Y, Li S, Song M, Randazzo B, Rahman P, McInnes IB. Efficacy and safety of ustekinumab in psoriatic arthritis patients with peripheral arthritis and physician-reported spondylitis: post-hoc analyses from two phase III, multicentre, double-blind, placebo-controlled studies (PSUMMIT-1/PSUMMIT-2). Ann Rheum Dis. 2016 Nov;75(11):1984-1988. doi: 10.1136/annrheumdis-2015-209068. Epub 2016 Apr 20.
Kavanaugh A, Puig L, Gottlieb AB, Ritchlin C, Li S, Wang Y, Mendelsohn AM, Song M, Zhu Y, Rahman P, McInnes IB; PSUMMIT 1 Study Group. Maintenance of Clinical Efficacy and Radiographic Benefit Through Two Years of Ustekinumab Therapy in Patients With Active Psoriatic Arthritis: Results From a Randomized, Placebo-Controlled Phase III Trial. Arthritis Care Res (Hoboken). 2015 Dec;67(12):1739-49. doi: 10.1002/acr.22645.
McInnes IB, Kavanaugh A, Gottlieb AB, Puig L, Rahman P, Ritchlin C, Brodmerkel C, Li S, Wang Y, Mendelsohn AM, Doyle MK; PSUMMIT 1 Study Group. Efficacy and safety of ustekinumab in patients with active psoriatic arthritis: 1 year results of the phase 3, multicentre, double-blind, placebo-controlled PSUMMIT 1 trial. Lancet. 2013 Aug 31;382(9894):780-9. doi: 10.1016/S0140-6736(13)60594-2. Epub 2013 Jun 13.
FG001
Group 2: USTEKINUMAB 45 MG
Ustekinumab Subcutaneous (SC) injections of 45 mg starting at Week 0 with the last dose at Week 88. If Early Escape then participants would receive Ustekinumab 90 mg injections starting Week 16 with the last dose at Week 88.
FG002
Group 3: USTEKINUMAB 90 MG
Ustekinumab Subcutaneous (SC) injections of 90 mg starting at Week 0 with the last dose at Week 88.
FG000206 subjects
FG001205 subjects
FG002204 subjects
COMPLETED
FG000162 subjects
FG001158 subjects
FG002170 subjects
NOT COMPLETED
FG00044 subjects
FG00147 subjects
FG00234 subjects
Type
Comment
Reasons
Lack of Efficacy
FG00016 subjects
FG00115 subjects
FG0029 subjects
Lost to Follow-up
FG0004 subjects
FG0015 subjects
FG0023 subjects
Adverse Event
FG00012 subjects
FG00111 subjects
FG0028 subjects
Withdrawal by Subject
FG0009 subjects
FG00111 subjects
FG00213 subjects
Other
FG0003 subjects
FG0015 subjects
FG0021 subjects
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Group 1: PLACEBO
Placebo Subcutaneous (SC) injections at Weeks 0, 4, 16 and 20. If Early Escape then participants would receive Ustekinumab 45 mg injections starting Week 16 with the last dose at Week 88. If Crossover then participants would receive Ustekinumab 45 milligram (mg) injections starting Week 24 with the last dose at Week 88.
BG001
Group 2: USTEKINUMAB 45 MG
Ustekinumab Subcutaneous (SC) injections of 45 mg starting at Week 0 with the last dose at Week 88. If Early Escape then participants would receive Ustekinumab 90 mg injections starting Week 16 with the last dose at Week 88.
BG002
Group 3: USTEKINUMAB 90 MG
Ustekinumab Subcutaneous (SC) injections of 90 mg starting at Week 0 with the last dose at Week 88.
BG003
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000206
BG001205
BG002204
BG003615
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
BG00047.4± 12.29
BG00147.1± 12.64
BG00246.8± 11.75
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00098
BG00199
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 American College of Rheumatology (ACR) 20 Response at Week 24.
An ACR 20 response is defined as a greater than or equal to 20 percent improvement from baseline in swollen (66 joints) and tender (68 joints) joint counts and greater than or equal to 20 percent improvement in 3 of the following 5 assessments: 1) Participant's assessment of pain by Visual Analog Scale (VAS) (0-10 cm), 2) Participant's global assessment of disease activity by VAS (0-10 cm), 3) Physician's global assessment of disease activity by VAS (0-10 centimeters [cm]) 4) Participant's assessment of physical function as measured by the "Disability Index of the Health Assessment Questionnaire" (HAQ-DI) (score of 0-3 in 8 functional areas) and 5) C reactive protein.
All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment. For early escape, data at or prior to Week 16 were carried forward through Week 24.
Posted
Number
Percentage of participants
Week 24
ID
Title
Description
OG000
Placebo
Participants received subcutaneous injections of placebo at Weeks 0, 4, 16, and 20. At Week 24 participants crossed over to receive subcutaneous injections of ustekinumab 45 milligram (mg) at Weeks 24 and 28 and every 12 weeks thereafter with the last dose at Week 88. If early escape, subcutaneous injections of 45 mg ustekinumab were given at Weeks 16, 20, and 28 and every 12 weeks thereafter with the last dose at Week 88. For participants entering early escape, a subcutaneous placebo injection was given at Week 24 to maintain the blind.
OG001
Ustekinumab 45 mg
Participants received subcutaneous injections of ustekinumab 45 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 88. If early escape, subcutaneous injections of 90 mg ustekinumab were given at Week 16 and every 12 weeks thereafter with the last dose at Week 88. Participants received subcutaneous injections of placebo at Weeks 20 and 24 to maintain the blind.
OG002
Ustekinumab 90 mg
Participants received subcutaneous injections of ustekinumab 90 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 88. Participants received subcutaneous injections of placebo at Weeks 20 and 24 to maintain the blind.
OG003
All Ustekinumab Combined
Participants who received subcutaneous injections of ustekinumab at any dose (45 mg and 90 mg) through Week 88.
Units
Counts
Participants
OG000206
OG001205
OG002204
OG003
Title
Denominators
Categories
Title
Measurements
OG00022.8
OG00142.4
OG00249.5
OG003
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
OG000
OG001
re-randomization test
<0.001
No
Superiority or Other
OG000
OG002
re-randomization test
<0.001
Secondary
Change From Baseline to Week 24 in the Disability Index Score as Measured With the "Disability Index of the Health Assessment Questionnaire" (HAQ-DI)
The HAQ-DI is 20-question instrument that assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area are scored from 0 (no difficulty), to 3 (inability to perform a task in that area). The average score across the functional areas yields an overall HAQ-DI score which ranges from 0 (no disability) to 3 (completely disabled). In psoriatic arthritis, a decrease in score of 0.30 indicates clinically meaningful improvement.
All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment. For early escape, data at or prior to Week 16 were carried forward through Week 24.
Posted
Mean
Standard Deviation
Score on a scale
Day 1 (Baseline) and Week 24
ID
Title
Description
OG000
Placebo
Participants received subcutaneous injections of placebo at Weeks 0, 4, 16, and 20. At Week 24 participants crossed over to receive subcutaneous injections of ustekinumab 45 milligram (mg) at Weeks 24 and 28 and every 12 weeks thereafter with the last dose at Week 88. If early escape, subcutaneous injections of 45 mg ustekinumab were given at Weeks 16, 20, and 28 and every 12 weeks thereafter with the last dose at Week 88. For participants entering early escape, a subcutaneous placebo injection was given at Week 24 to maintain the blind.
Secondary
Percentage of Participants (With >= 3% Baseline Body Surface Area (BSA) Psoriatic Involvement) Who Achieved a Psoriasis Area and Severity Index 75 (PASI 75) Response at Week 24
The PASI is a physician-administered assessment tool 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). A PASI 75 response is defined as greater than or equal to 75 percent improvement in PASI score from baseline.
All participants randomly assigned to a treatment group, regardless of whether they received the assigned treatment. For early escape, data at or prior to Week 16 were carried forward through Week 24. Only participants with >=3% baseline BSA psoriatic involvement were included in this analysis.
Posted
Number
Percentage of participants
Week 24
ID
Title
Description
OG000
Placebo
Participants received subcutaneous injections of placebo at Weeks 0, 4, 16, and 20. At Week 24 participants crossed over to receive subcutaneous injections of ustekinumab 45 milligram (mg) at Weeks 24 and 28 and every 12 weeks thereafter with the last dose at Week 88. If early escape, subcutaneous injections of 45 mg ustekinumab were given at Weeks 16, 20, and 28 and every 12 weeks thereafter with the last dose at Week 88. For participants entering early escape, a subcutaneous placebo injection was given at Week 24 to maintain the blind.
OG001
Ustekinumab 45 mg
Secondary
Percentage of Participants With American College of Rheumatology (ACR) 50 Response at Week 24
An ACR 50 response is defined as a greater than or equal to 50 percent improvement from baseline in swollen (66 joints) and tender (68 joints) joint counts and greater than or equal to 50 percent improvement in 3 of the following 5 assessments: 1) Participant's assessment of pain by Visual Analog Scale (VAS) (0-10 cm), 2) Participant's global assessment of disease activity by VAS (0-10 cm), 3) Physician's global assessment of disease activity by VAS (0-10 cm) 4)Participant's assessment of physical function as measured by the "Disability Index of the Health Assessment Questionnaire" (HAQ-DI) (score of 0-3 in 8 functional areas) and 5) C reactive protein.
All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment. For early escape, data at or prior to Week 16 were carried forward through Week 24.
Posted
Number
Percentage of participants
Week 24
ID
Title
Description
OG000
Placebo
Participants received subcutaneous injections of placebo at Weeks 0, 4, 16, and 20. At Week 24 participants crossed over to receive subcutaneous injections of ustekinumab 45 milligram (mg) at Weeks 24 and 28 and every 12 weeks thereafter with the last dose at Week 88. If early escape, subcutaneous injections of 45 mg ustekinumab were given at Weeks 16, 20, and 28 and every 12 weeks thereafter with the last dose at Week 88. For participants entering early escape, a subcutaneous placebo injection was given at Week 24 to maintain the blind.
Secondary
Percentage of Participants With American College of Rheumatology (ACR) 70 Response at Week 24
An ACR 70 response is defined as a greater than or equal to 70 percent improvement from baseline in swollen (66 joints) and tender (68 joints) joint counts and greater than or equal to 70 percent improvement in 3 of the following 5 assessments: 1) Participant's assessment of pain by Visual Analog Scale (VAS) (0-10 cm), 2) Participant's global assessment of disease activity by VAS (0-10 cm), 3) Physician's global assessment of disease activity by VAS (0-10 cm) 4) Participant's assessment of physical function as measured by the "Disability Index of the Health Assessment Questionnaire" (HAQ-DI) (score of 0-3 in 8 functional areas) and 5) C reactive protein.
All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment. For early escape, data at or prior to Week 16 were carried forward through Week 24.
Posted
Number
Percentage of participants
Week 24
ID
Title
Description
OG000
Placebo
Participants received subcutaneous injections of placebo at Weeks 0, 4, 16, and 20. At Week 24 participants crossed over to receive subcutaneous injections of ustekinumab 45 milligram (mg) at Weeks 24 and 28 and every 12 weeks thereafter with the last dose at Week 88. If early escape, subcutaneous injections of 45 mg ustekinumab were given at Weeks 16, 20, and 28 and every 12 weeks thereafter with the last dose at Week 88. For participants entering early escape, a subcutaneous placebo injection was given at Week 24 to maintain the blind.
Secondary
Change From Baseline to Week 24 in Total Modified Van Der Heijde-Sharp (vdH-S) Score for the Combined Radiographic Data From Studies CNTO1275PSA3001 and CNTO1275PSA3002
The modified vdH-S score is a radiographic evaluation of hand and feet erosions and joint space narrowing (JSN) for 20 joints per hand and 6 joints per foot with a total score ranging from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score and positive score changes indicate more radiographic damage and radiographic progression, respectively. As per protocol, analysis for this outcome measure used pooled data from 2 studies (CNTO1275PSA3001 and PSA3002) because initial power assumptions showed that 900 participants would be required to evaluate impact of ustekinumab on structural damage (SD) progression. The 2 studies, (which had similar study designs and dosing regimens with difference to prior exposure to anti-tumor necrosis factor alpha (TNFα) therapies), were intended to independently measure efficacy in terms of signs, symptoms and physical function, while effects on SD progression is provided from an integrated analysis.
Analysis included: (1) combined data from studies CNTO1275PSA3001 (NCT01009086) and CNTO1275PSA3002 (NCT01077362) and (2) all participants randomly assigned to a treatment group.
Posted
Mean
Standard Deviation
Score on a scale
Day 1 (Baseline) and Week 24
ID
Title
Description
OG000
Placebo
Participants received subcutaneous injections of placebo at Weeks 0, 4, 16, and 20. At Week 24 participants crossed over to receive subcutaneous injections of ustekinumab 45 milligram (mg) at Weeks 24 and 28 and every 12 weeks thereafter with the last dose at Week 88. If early escape, subcutaneous injections of 45 mg ustekinumab were given at Weeks 16, 20, and 28 and every 12 weeks thereafter with the last dose at Week 88. For participants entering early escape, a subcutaneous placebo injection was given at Week 24 to maintain the blind.
Time Frame
Baseline up to Week 108
Description
Safety population included all participants who received the investigational drug and had safety data.
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)
Controlled period (Week 0-16) - Placebo group. Placebo Subcutaneous (SC) injections will be received at Weeks 0, 4 and 16.
4
205
30
205
EG001
Ustekinumab 45 mg (CP)
Controlled period (Week 0-16) - Ustekinumab 45 mg group. Participants received SC injections of ustekinumab 45 mg at Weeks 0 and 4 and 16.
5
205
17
205
EG002
Ustekinumab 90 mg (CP)
Controlled period (Week 0-16) - Ustekinumab 90 mg group. Participants received SC injections of ustekinumab 90 mg at Weeks 0 and 4 and 16.
3
204
29
204
EG003
Placebo (After CP)
After Controlled period (Week 16-24) - participants receiving placebo at Weeks 0, 4, 16, and 20, then crossed over to ustekinumab 45 mg at Week 24.
2
140
7
140
EG004
Placebo -> Ustekinumab 45 mg (After CP)
After Controlled period (Week 16-108) - participants randomized to placebo who early escaped to ustekinumab 45 mg at Week 16 or who crossed over to ustekinumab 45 mg at Week 24.
14
189
50
189
EG005
Ustekinumab 45 mg (After CP)
After Controlled period (Week 16-108) - participants randomized to ustekinumab 45 mg at Week 0, irrespective of their early escape status.
20
203
42
203
EG006
Ustekinumab 90 mg (After CP)
After Controlled period (Week 16-108) - participants randomized to ustekinumab 90 mg at Week 0, irrespective of their early escape status.
13
199
57
199
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Idiopathic Thrombocytopenic Purpura
Blood and lymphatic system disorders
MedDRA Version 16.0
Systematic Assessment
EG0000 affected205 at risk
EG0010 affected205 at risk
EG0020 affected204 at risk
EG0030 affected140 at risk
EG004
Acute Coronary Syndrome
Cardiac disorders
MedDRA Version 16.0
Systematic Assessment
EG0000 affected205 at risk
EG0010 affected205 at risk
EG0020 affected204 at risk
EG003
Acute Myocardial Infarction
Cardiac disorders
MedDRA Version 16.0
Systematic Assessment
EG0000 affected205 at risk
EG0010 affected205 at risk
EG0020 affected204 at risk
EG003
Angina Pectoris
Cardiac disorders
MedDRA Version 16.0
Systematic Assessment
EG0001 affected205 at risk
EG0010 affected205 at risk
EG0020 affected204 at risk
EG003
Atrial Fibrillation
Cardiac disorders
MedDRA Version 16.0
Systematic Assessment
EG0000 affected205 at risk
EG0010 affected205 at risk
EG0020 affected204 at risk
EG003
Atrioventricular Block
Cardiac disorders
MedDRA Version 16.0
Systematic Assessment
EG0000 affected205 at risk
EG0010 affected205 at risk
EG0020 affected204 at risk
EG003
Cardiac Failure Congestive
Cardiac disorders
MedDRA Version 16.0
Systematic Assessment
EG0000 affected205 at risk
EG0010 affected205 at risk
EG0020 affected204 at risk
EG003
Ischaemic Cardiomyopathy
Cardiac disorders
MedDRA Version 16.0
Systematic Assessment
EG0000 affected205 at risk
EG0010 affected205 at risk
EG0020 affected204 at risk
EG003
Myocardial Infarction
Cardiac disorders
MedDRA Version 16.0
Systematic Assessment
EG0000 affected205 at risk
EG0010 affected205 at risk
EG0020 affected204 at risk
EG003
Retinal Detachment
Eye disorders
MedDRA Version 16.0
Systematic Assessment
EG0000 affected205 at risk
EG0010 affected205 at risk
EG0020 affected204 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA Version 16.0
Systematic Assessment
EG0000 affected205 at risk
EG0010 affected205 at risk
EG0020 affected204 at risk
EG003
Duodenitis
Gastrointestinal disorders
MedDRA Version 16.0
Systematic Assessment
EG0000 affected205 at risk
EG0011 affected205 at risk
EG0020 affected204 at risk
EG003
Gastritis Haemorrhagic
Gastrointestinal disorders
MedDRA Version 16.0
Systematic Assessment
EG0000 affected205 at risk
EG0010 affected205 at risk
EG0020 affected204 at risk
EG003
Gastroduodenitis
Gastrointestinal disorders
MedDRA Version 16.0
Systematic Assessment
EG0000 affected205 at risk
EG0010 affected205 at risk
EG0021 affected204 at risk
EG003
Gastrointestinal Haemorrhage
Gastrointestinal disorders
MedDRA Version 16.0
Systematic Assessment
EG0000 affected205 at risk
EG0010 affected205 at risk
EG0020 affected204 at risk
EG003
Inguinal Hernia
Gastrointestinal disorders
MedDRA Version 16.0
Systematic Assessment
EG0000 affected205 at risk
EG0011 affected205 at risk
EG0020 affected204 at risk
EG003
Pancreatitis Chronic
Gastrointestinal disorders
MedDRA Version 16.0
Systematic Assessment
EG0000 affected205 at risk
EG0010 affected205 at risk
EG0021 affected204 at risk
EG003
Rectal Haemorrhage
Gastrointestinal disorders
MedDRA Version 16.0
Systematic Assessment
EG0000 affected205 at risk
EG0010 affected205 at risk
EG0020 affected204 at risk
EG003
Chest Pain
General disorders
MedDRA Version 16.0
Systematic Assessment
EG0000 affected205 at risk
EG0010 affected205 at risk
EG0020 affected204 at risk
EG003
Cholecystitis
Hepatobiliary disorders
MedDRA Version 16.0
Systematic Assessment
EG0000 affected205 at risk
EG0010 affected205 at risk
EG0021 affected204 at risk
EG003
Cholecystitis Acute
Hepatobiliary disorders
MedDRA Version 16.0
Systematic Assessment
EG0000 affected205 at risk
EG0010 affected205 at risk
EG0020 affected204 at risk
EG003
Chronic Hepatitis
Hepatobiliary disorders
MedDRA Version 16.0
Systematic Assessment
EG0000 affected205 at risk
EG0010 affected205 at risk
EG0020 affected204 at risk
EG003
Device Related Infection
Infections and infestations
MedDRA Version 16.0
Systematic Assessment
EG0000 affected205 at risk
EG0010 affected205 at risk
EG0020 affected204 at risk
EG003
Erysipelas
Infections and infestations
MedDRA Version 16.0
Systematic Assessment
EG0000 affected205 at risk
EG0010 affected205 at risk
EG0020 affected204 at risk
EG003
Escherichia Sepsis
Infections and infestations
MedDRA Version 16.0
Systematic Assessment
EG0000 affected205 at risk
EG0010 affected205 at risk
EG0020 affected204 at risk
EG003
Lobar Pneumonia
Infections and infestations
MedDRA Version 16.0
Systematic Assessment
EG0000 affected205 at risk
EG0010 affected205 at risk
EG0020 affected204 at risk
EG003
Parotitis
Infections and infestations
MedDRA Version 16.0
Systematic Assessment
EG0000 affected205 at risk
EG0010 affected205 at risk
EG0020 affected204 at risk
EG003
Pharyngolaryngeal Abscess
Infections and infestations
MedDRA Version 16.0
Systematic Assessment
EG0000 affected205 at risk
EG0010 affected205 at risk
EG0020 affected204 at risk
EG003
Pneumonia
Infections and infestations
MedDRA Version 16.0
Systematic Assessment
EG0000 affected205 at risk
EG0010 affected205 at risk
EG0020 affected204 at risk
EG003
Pneumonia Mycoplasmal
Infections and infestations
MedDRA Version 16.0
Systematic Assessment
EG0000 affected205 at risk
EG0010 affected205 at risk
EG0020 affected204 at risk
EG003
Postoperative Wound Infection
Infections and infestations
MedDRA Version 16.0
Systematic Assessment
EG0000 affected205 at risk
EG0010 affected205 at risk
EG0020 affected204 at risk
EG003
Proteus Infection
Infections and infestations
MedDRA Version 16.0
Systematic Assessment
EG0000 affected205 at risk
EG0010 affected205 at risk
EG0020 affected204 at risk
EG003
Salpingitis
Infections and infestations
MedDRA Version 16.0
Systematic Assessment
EG0000 affected205 at risk
EG0010 affected205 at risk
EG0020 affected204 at risk
EG003
Joint Dislocation
Injury, poisoning and procedural complications
MedDRA Version 16.0
Systematic Assessment
EG0001 affected205 at risk
EG0010 affected205 at risk
EG0020 affected204 at risk
EG003
Radius Fracture
Injury, poisoning and procedural complications
MedDRA Version 16.0
Systematic Assessment
EG0001 affected205 at risk
EG0010 affected205 at risk
EG0020 affected204 at risk
EG003
Spinal Compression Fracture
Injury, poisoning and procedural complications
MedDRA Version 16.0
Systematic Assessment
EG0000 affected205 at risk
EG0011 affected205 at risk
EG0020 affected204 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA Version 16.0
Systematic Assessment
EG0000 affected205 at risk
EG0010 affected205 at risk
EG0020 affected204 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA Version 16.0
Systematic Assessment
EG0000 affected205 at risk
EG0010 affected205 at risk
EG0020 affected204 at risk
EG003
Finger Deformity
Musculoskeletal and connective tissue disorders
MedDRA Version 16.0
Systematic Assessment
EG0000 affected205 at risk
EG0010 affected205 at risk
EG0020 affected204 at risk
EG003
Foot Deformity
Musculoskeletal and connective tissue disorders
MedDRA Version 16.0
Systematic Assessment
EG0001 affected205 at risk
EG0010 affected205 at risk
EG0020 affected204 at risk
EG003
Lumbar Spinal Stenosis
Musculoskeletal and connective tissue disorders
MedDRA Version 16.0
Systematic Assessment
EG0000 affected205 at risk
EG0010 affected205 at risk
EG0020 affected204 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA Version 16.0
Systematic Assessment
EG0000 affected205 at risk
EG0010 affected205 at risk
EG0020 affected204 at risk
EG003
Osteoporotic Fracture
Musculoskeletal and connective tissue disorders
MedDRA Version 16.0
Systematic Assessment
EG0000 affected205 at risk
EG0010 affected205 at risk
EG0020 affected204 at risk
EG003
Psoriatic Arthropathy
Musculoskeletal and connective tissue disorders
MedDRA Version 16.0
Systematic Assessment
EG0000 affected205 at risk
EG0010 affected205 at risk
EG0020 affected204 at risk
EG003
Spinal Column Stenosis
Musculoskeletal and connective tissue disorders
MedDRA Version 16.0
Systematic Assessment
EG0000 affected205 at risk
EG0010 affected205 at risk
EG0020 affected204 at risk
EG003
Synovial Cyst
Musculoskeletal and connective tissue disorders
MedDRA Version 16.0
Systematic Assessment
EG0000 affected205 at risk
EG0010 affected205 at risk
EG0020 affected204 at risk
EG003
B-Cell Lymphoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 16.0
Systematic Assessment
EG0000 affected205 at risk
EG0010 affected205 at risk
EG0020 affected204 at risk
EG003
Renal Cell Carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 16.0
Systematic Assessment
EG0000 affected205 at risk
EG0010 affected205 at risk
EG0020 affected204 at risk
EG003
Squamous Cell Carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 16.0
Systematic Assessment
EG0000 affected205 at risk
EG0010 affected205 at risk
EG0020 affected204 at risk
EG003
Uterine Leiomyoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 16.0
Systematic Assessment
EG0000 affected205 at risk
EG0010 affected205 at risk
EG0020 affected204 at risk
EG003
Intracranial Aneurysm
Nervous system disorders
MedDRA Version 16.0
Systematic Assessment
EG0000 affected205 at risk
EG0010 affected205 at risk
EG0020 affected204 at risk
EG003
Ischaemic Stroke
Nervous system disorders
MedDRA Version 16.0
Systematic Assessment
EG0000 affected205 at risk
EG0010 affected205 at risk
EG0020 affected204 at risk
EG003
Presyncope
Nervous system disorders
MedDRA Version 16.0
Systematic Assessment
EG0000 affected205 at risk
EG0010 affected205 at risk
EG0020 affected204 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA Version 16.0
Systematic Assessment
EG0000 affected205 at risk
EG0010 affected205 at risk
EG0021 affected204 at risk
EG003
Depression
Psychiatric disorders
MedDRA Version 16.0
Systematic Assessment
EG0000 affected205 at risk
EG0010 affected205 at risk
EG0021 affected204 at risk
EG003
Suicidal Ideation
Psychiatric disorders
MedDRA Version 16.0
Systematic Assessment
EG0000 affected205 at risk
EG0010 affected205 at risk
EG0020 affected204 at risk
EG003
Renal Failure Acute
Renal and urinary disorders
MedDRA Version 16.0
Systematic Assessment
EG0000 affected205 at risk
EG0011 affected205 at risk
EG0020 affected204 at risk
EG003
Tubulointerstitial Nephritis
Renal and urinary disorders
MedDRA Version 16.0
Systematic Assessment
EG0000 affected205 at risk
EG0010 affected205 at risk
EG0020 affected204 at risk
EG003
Cervical Polyp
Reproductive system and breast disorders
MedDRA Version 16.0
Systematic Assessment
EG0000 affected205 at risk
EG0011 affected205 at risk
EG0020 affected204 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA Version 16.0
Systematic Assessment
EG0000 affected205 at risk
EG0010 affected205 at risk
EG0020 affected204 at risk
EG003
Erythrodermic Psoriasis
Skin and subcutaneous tissue disorders
MedDRA Version 16.0
Systematic Assessment
EG0000 affected205 at risk
EG0010 affected205 at risk
EG0021 affected204 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA Version 16.0
Systematic Assessment
EG0000 affected205 at risk
EG0010 affected205 at risk
EG0020 affected204 at risk
EG003
Aortic Aneurysm
Vascular disorders
MedDRA Version 16.0
Systematic Assessment
EG0000 affected205 at risk
EG0010 affected205 at risk
EG0020 affected204 at risk
EG003
Deep Vein Thrombosis
Vascular disorders
MedDRA Version 16.0
Systematic Assessment
EG0000 affected205 at risk
EG0010 affected205 at risk
EG0020 affected204 at risk
EG003
Hypertension
Vascular disorders
MedDRA Version 16.0
Systematic Assessment
EG0000 affected205 at risk
EG0010 affected205 at risk
EG0020 affected204 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Nasopharyngitis
Infections and infestations
MedDRA Version 16.0
Systematic Assessment
EG0008 affected205 at risk
EG0018 affected205 at risk
EG00211 affected204 at risk
EG0032 affected140 at risk
EG00415 affected189 at risk
EG00518 affected203 at risk
EG00620 affected199 at risk
Upper Respiratory Tract Infection
Infections and infestations
MedDRA Version 16.0
Systematic Assessment
EG00010 affected205 at risk
EG0015 affected205 at risk
EG0029 affected204 at risk
EG003
Urinary Tract Infection
Infections and infestations
MedDRA Version 16.0
Systematic Assessment
EG0002 affected205 at risk
EG0011 affected205 at risk
EG0022 affected204 at risk
EG003
Psoriatic Arthropathy
Musculoskeletal and connective tissue disorders
MedDRA Version 16.0
Systematic Assessment
EG0007 affected205 at risk
EG0010 affected205 at risk
EG0024 affected204 at risk
EG003
Hypertension
Vascular disorders
MedDRA Version 16.0
Systematic Assessment
EG0004 affected205 at risk
EG0013 affected205 at risk
EG0026 affected204 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
A copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested in writing, such publication will be withheld for up to an additional 60 days.
Point of Contact
Title
Organization
Phone
Extension
Email
Director, Clinical Research
Janssen Research & Development, LLC
1-800-526-7736
ID
Term
D015535
Arthritis, Psoriatic
D011565
Psoriasis
Ancestor Terms
ID
Term
D025242
Spondylarthropathies
D025241
Spondylarthritis
D013166
Spondylitis
D013122
Spinal Diseases
D001847
Bone Diseases
D009140
Musculoskeletal Diseases
D001168
Arthritis
D007592
Joint Diseases
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
47.1
± 12.21
88
BG003285
Male
BG000108
BG001106
BG002116
BG003330
409
46.0
No
Superiority or Other
OG000
OG003
re-randomization test
<0.001
No
Superiority or Other
OG001
Ustekinumab 45 mg
Participants received subcutaneous injections of ustekinumab 45 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 88. If early escape, subcutaneous injections of 90 mg ustekinumab were given at Week 16 and every 12 weeks thereafter with the last dose at Week 88. Participants received subcutaneous injections of placebo at Weeks 20 and 24 to maintain the blind.
OG002
Ustekinumab 90 mg
Participants received subcutaneous injections of ustekinumab 90 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 88. Participants received subcutaneous injections of placebo at Weeks 20 and 24 to maintain the blind.
OG003
All Ustekinumab Combined
Participants who received subcutaneous injections of ustekinumab at any dose (45 mg and 90 mg) through Week 88.
Units
Counts
Participants
OG000206
OG001205
OG002204
OG003409
Title
Denominators
Categories
Title
Measurements
OG000-0.10± 0.390
OG001-0.31± 0.521
OG002-0.40± 0.514
OG003-0.36± 0.518
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
OG000
OG001
re-randomization test
<0.001
No
Superiority or Other
OG000
OG002
re-randomization test
<0.001
No
Superiority or Other
OG000
OG003
re-randomization test
<0.001
No
Superiority or Other
Participants received subcutaneous injections of ustekinumab 45 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 88. If early escape, subcutaneous injections of 90 mg ustekinumab were given at Week 16 and every 12 weeks thereafter with the last dose at Week 88. Participants received subcutaneous injections of placebo at Weeks 20 and 24 to maintain the blind.
OG002
Ustekinumab 90 mg
Participants received subcutaneous injections of ustekinumab 90 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 88. Participants received subcutaneous injections of placebo at Weeks 20 and 24 to maintain the blind.
OG003
All Ustekinumab Combined
Participants who received subcutaneous injections of ustekinumab at any dose (45 mg and 90 mg) through Week 88.
Units
Counts
Participants
OG000146
OG001145
OG002149
OG003294
Title
Denominators
Categories
Title
Measurements
OG00011.0
OG00157.2
OG00262.4
OG00359.9
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
OG000
OG001
re-randomization test
<0.001
No
Superiority or Other
OG000
OG002
re-randomization test
<0.001
No
Superiority or Other
OG000
OG003
re-randomization test
<0.001
No
Superiority or Other
OG001
Ustekinumab 45 mg
Participants received subcutaneous injections of ustekinumab 45 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 88. If early escape, subcutaneous injections of 90 mg ustekinumab were given at Week 16 and every 12 weeks thereafter with the last dose at Week 88. Participants received subcutaneous injections of placebo at Weeks 20 and 24 to maintain the blind.
OG002
Ustekinumab 90 mg
Participants received subcutaneous injections of ustekinumab 90 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 88. Participants received subcutaneous injections of placebo at Weeks 20 and 24 to maintain the blind.
OG003
All Ustekinumab Combined
Participants who received subcutaneous injections of ustekinumab at any dose (45 mg and 90 mg) through Week 88.
Units
Counts
Participants
OG000206
OG001205
OG002204
OG003409
Title
Denominators
Categories
Title
Measurements
OG0008.7
OG00124.9
OG00227.9
OG00326.4
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
OG000
OG001
re-randomization test
<0.001
No
Superiority or Other
OG000
OG002
re-randomization test
<0.001
No
Superiority or Other
OG000
OG003
re-randomization test
<0.001
No
Superiority or Other
OG001
Ustekinumab 45 mg
Participants received subcutaneous injections of ustekinumab 45 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 88. If early escape, subcutaneous injections of 90 mg ustekinumab were given at Week 16 and every 12 weeks thereafter with the last dose at Week 88. Participants received subcutaneous injections of placebo at Weeks 20 and 24 to maintain the blind.
OG002
Ustekinumab 90 mg
Participants received subcutaneous injections of ustekinumab 90 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 88. Participants received subcutaneous injections of placebo at Weeks 20 and 24 to maintain the blind.
OG003
All Ustekinumab Combined
Participants who received subcutaneous injections of ustekinumab at any dose (45 mg and 90 mg) through Week 88.
Units
Counts
Participants
OG000206
OG001205
OG002204
OG003409
Title
Denominators
Categories
Title
Measurements
OG0002.4
OG00112.2
OG00214.2
OG00313.2
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
OG000
OG001
re-randomization test
<0.001
No
Superiority or Other
OG000
OG002
re-randomization test
<0.001
No
Superiority or Other
OG000
OG003
re-randomization test
<0.001
No
Superiority or Other
OG001
Ustekinumab 45 mg
Participants received subcutaneous injections of ustekinumab 45 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 88. If early escape, subcutaneous injections of 90 mg ustekinumab were given at Week 16 and every 12 weeks thereafter with the last dose at Week 88. Participants received subcutaneous injections of placebo at Weeks 20 and 24 to maintain the blind.
OG002
Ustekinumab 90 mg
Participants received subcutaneous injections of ustekinumab 90 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 88. Participants received subcutaneous injections of placebo at Weeks 20 and 24 to maintain the blind.
OG003
All Ustekinumab Combined
Participants who received subcutaneous injections of ustekinumab at any dose (45 mg and 90 mg) through Week 88.