A Study of the Safety and Efficacy of Ustekinumab in Pati... | NCT01077362 | Trialant
NCT01077362
Sponsor
Janssen Research & Development, LLC
Status
Completed
Last Update Posted
Feb 27, 2014Estimated
Enrollment
312Actual
Phase
Phase 3
Conditions
Arthritis, Psoriatic
Interventions
placebo
ustekinumab 45 mg
ustekinumab 90 mg
Countries
United States
Austria
Canada
France
Germany
Hungary
Poland
Russia
Sweden
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT01077362
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CR016483
Secondary IDs
ID
Type
Description
Link
CNTO1275PSA3002
Other Identifier
Janssen Research & Development, LLC
2009-012265-60
Other Identifier
Janssen Research & Development, LLC
Brief Title
A Study of the Safety and Efficacy of Ustekinumab in Patients With Psoriatic Arthritis With and Without Prior Exposure to Anti-TNF Agents
Official Title
A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Ustekinumab, a Fully Human Anti-IL-12/23p40 Monoclonal Antibody, Administered Subcutaneously, in Subjects With Active Psoriatic Arthritis Including Those Previously Treated With Biologic Anti-TNFalpha Agent(s)
Acronym
Not provided
Organization
Janssen Research & Development, LLCINDUSTRY
Status Module
Record Verification Date
Jan 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 2010
Primary Completion Date
Mar 2012Actual
Completion Date
Nov 2012Actual
First Submitted Date
Feb 25, 2010
First Submission Date that Met QC Criteria
Feb 26, 2010
First Posted Date
Mar 1, 2010Estimated
Results Waived
Not provided
Results First Submitted Date
Oct 11, 2013
Results First Submitted that Met QC Criteria
Jan 22, 2014
Results First Posted Date
Feb 27, 2014Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Mar 14, 2013
Certification/Extension First Submitted that Passed QC Review
Mar 14, 2013
Certification/Extension First Posted Date
Mar 21, 2013Estimated
Last Update Submitted Date
Jan 22, 2014
Last Update Posted Date
Feb 27, 2014Estimated
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 efficacy (improvement of signs and symptoms) and safety of ustekinumab in patients with psoriatic arthritis.
Detailed Description
This study is a randomized (patients are assigned different treatments based on chance), double-blind (neither the patient nor the physician knows whether drug or placebo is being taken, or at what dosage), parallel-group, multicenter study to evaluate the effectiveness and safety of ustekinumab compared to placebo in the treatment of patients with active psoriatic arthritis who have or are currently receiving treatment with a disease-modifying antirheumatic drug (DMARD) and/or a nonsteroidal anti-inflammatory drug (NSAID), including those who have previously received anti-tumor necrosis factor (anti-TNF) agents [(examples are infliximab (Remicade), etanercept (Enbrel), adalimumab (Humira)]. The primary effectiveness endpoint will be measured by the reduction in signs and symptoms of arthritis, as defined by 20% improvement from baseline in American College of Rheumatology (ACR) measurements of arthritis at Week 24. The study will additionally look at higher levels of joint improvement (ie, 50% or 70% improvement from baseline) and improvement in activity and quality of life, as well as the impact of ustekinumab on psoriatic skin lesions. Safety assessments will be performed throughout the study and include obtaining and evaluating laboratory tests, vital signs (eg, blood pressure) and the occurrence and severity of adverse events (side effects). Patients will be assigned to one of three treatment groups. Patients will receive either 45 mg ustekinumab, 90 mg ustekinumab, or placebo at Weeks 0, 4 and every 12 weeks until Week 40. Patients who do not have >=5% improvement in their disease (tender and swollen joints) at Week 16 may be eligible to receive an increase or change to their ustekinumab dosage. Ustekinumab 45 mg, 90 mg, or placebo subcutaneous injections at Weeks 0 and 4 followed by every-12-week dosing with the last dose at Week 40. Early escape possibility at Week 16. Patients randomized to placebo will crossover to receive ustekinumab at Weeks 24 and 28 followed by every-12-week dosing with the last dose at Week 40. Expected duration of exposure to study agent including follow up for safety is 60 weeks.
Conditions Module
Conditions
Arthritis, Psoriatic
Keywords
Ustekinumab
CNTO 1275
Stelara
Psoriatic Arthritis
Psoriasis
TNF alpha
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
312Actual
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 40. 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 40. 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 40. 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 40. 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 40. 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 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)
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 with at least 5 tender and 5 swollen joints at baseline
May have previously received at least 8 weeks of etanercept, adalimumab, golimumab or certolizumab pegol or at least 14 weeks of infliximab or proven inability to tolerate anti-TNF therapy for 8-14 weeks
If the patient is using methotrexate, they should have started treatment at a dose not to exceed 25 mg/week at least 3 months prior to the beginning of the study and should have no serious toxic side effects attributable to methotrexate
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 IL-12 or IL-23, including but not limited to ustekinumab and ABT-874
Have used infliximab, golimumab or certolizumab pegol within 12 weeks of first study drug injection, or etanercept or adalimumab within 8 weeks of first study drug injection
Have a medical history of latent or active granulomatous infection, including TB, histoplasmosis, or coccidioidomycosis, prior to screening
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
Participants received subcutaneous (SC) injections of placebo at Weeks 0, 4, 16, and 20. At Week 24 participants crossed 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 40. If early escape, SC injections of 45 mg ustekinumab were given at Weeks 16, 20, and 28 and every 12 weeks thereafter with the last dose at Week 40. For participants entering early escape, a SC placebo injection was given at Week 24 to maintain the blind.
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
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 scores and positive score changes indicate more radiographic damage and radiographic progression, respectively. As per protocol, the 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 the impact of ustekinumab on structural damage (SD) progression. The 2 studies, (which had similar study designs and dosing regimens and differed only with regards to prior exposure to anti-TNFα therapies), were intended to independently measure efficacy in terms of signs, symptoms and physical function, while effects on SD progression would be provided from an integrated analysis.
Day 1 (Baseline) and 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.
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.
FG001
Ustekinumab 45 mg
Participants received SC injections of ustekinumab 45 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 40. If early escape, SC injections of 90 mg ustekinumab were given at Week 16 and every 12 weeks thereafter with the last dose at Week 40. Participants received SC injections of placebo at Weeks 20 and 24 to maintain the blind.
FG002
Ustekinumab 90 mg
Participants received SC injections of ustekinumab 90 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 40. If early escape, the same dosage schedule continued. Participants received SC injections of placebo at Weeks 20 and 24 to maintain the blind.
FG000104 subjects
FG001103 subjects
FG002105 subjects
COMPLETED
FG00073 subjects
FG00184 subjects
FG00281 subjects
NOT COMPLETED
FG00031 subjects
FG00119 subjects
FG00224 subjects
Type
Comment
Reasons
Lack of Efficacy
FG00013 subjects
FG0018 subjects
FG00210 subjects
Lost to Follow-up
FG0001 subjects
FG0010 subjects
FG0023 subjects
Adverse Event
FG00012 subjects
FG0017 subjects
FG0024 subjects
Withdrawal by Subject
FG0005 subjects
FG0013 subjects
FG0025 subjects
Other
FG0000 subjects
FG0011 subjects
FG0022 subjects
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Placebo
Participants received subcutaneous (SC) injections of placebo at Weeks 0, 4, 16, and 20. At Week 24 participants crossed 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 40. If early escape, SC injections of 45 mg ustekinumab were given at Weeks 16, 20, and 28 and every 12 weeks thereafter with the last dose at Week 40. For participants entering early escape, a SC placebo injection was given at Week 24 to maintain the blind.
BG001
Ustekinumab 45 mg
Participants received SC injections of ustekinumab 45 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 40. If early escape, SC injections of 90 mg ustekinumab were given at Week 16 and every 12 weeks thereafter with the last dose at Week 40. Participants received SC injections of placebo at Weeks 20 and 24 to maintain the blind.
BG002
Ustekinumab 90 mg
Participants received SC injections of ustekinumab 90 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 40. If early escape, the same dosage schedule continued. Participants received SC injections of placebo at Weeks 20 and 24 to maintain the blind.
BG003
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000104
BG001103
BG002105
BG003312
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
BG00047.6± 11.19
BG00148± 11.21
BG00248.2± 12.36
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00053
BG00155
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 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 (SC) injections of placebo at Weeks 0, 4, 16, and 20. At Week 24 participants crossed 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 40. If early escape, SC injections of 45 mg ustekinumab were given at Weeks 16, 20, and 28 and every 12 weeks thereafter with the last dose at Week 40. For participants entering early escape, a SC placebo injection was given at Week 24 to maintain the blind.
OG001
Ustekinumab 45 mg
Participants received SC injections of ustekinumab 45 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 40. If early escape, SC injections of 90 mg ustekinumab were given at Week 16 and every 12 weeks thereafter with the last dose at Week 40. Participants received SC injections of placebo at Weeks 20 and 24 to maintain the blind.
OG002
Ustekinumab 90 mg
Participants received SC injections of ustekinumab 90 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 40. If early escape, the same dosage schedule continued. Participants received SC injections of placebo at Weeks 20 and 24 to maintain the blind.
OG003
All Ustekinumab Combined
Participants who received SC injections of ustekinumab at any dose (45 mg and 90 mg) through Week 40.
Units
Counts
Participants
OG000104
OG001103
OG002105
OG003
Title
Denominators
Categories
Title
Measurements
OG00020.2
OG00143.7
OG00243.8
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)
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 (SC) injections of placebo at Weeks 0, 4, 16, and 20. At Week 24 participants crossed 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 40. If early escape, SC injections of 45 mg ustekinumab were given at Weeks 16, 20, and 28 and every 12 weeks thereafter with the last dose at Week 40. For participants entering early escape, a SC placebo injection was given at Week 24 to maintain the blind.
OG001
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 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. 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 (SC) injections of placebo at Weeks 0, 4, 16, and 20. At Week 24 participants crossed 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 40. If early escape, SC injections of 45 mg ustekinumab were given at Weeks 16, 20, and 28 and every 12 weeks thereafter with the last dose at Week 40. For participants entering early escape, a SC 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 (SC) injections of placebo at Weeks 0, 4, 16, and 20. At Week 24 participants crossed 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 40. If early escape, SC injections of 45 mg ustekinumab were given at Weeks 16, 20, and 28 and every 12 weeks thereafter with the last dose at Week 40. For participants entering early escape, a SC placebo injection was given at Week 24 to maintain the blind.
OG001
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 scores and positive score changes indicate more radiographic damage and radiographic progression, respectively. As per protocol, the 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 the impact of ustekinumab on structural damage (SD) progression. The 2 studies, (which had similar study designs and dosing regimens and differed only with regards to prior exposure to anti-TNFα therapies), were intended to independently measure efficacy in terms of signs, symptoms and physical function, while effects on SD progression would be 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 (SC) injections of placebo at Weeks 0, 4, 16, and 20. At Week 24 participants crossed 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 40. If early escape, SC injections of 45 mg ustekinumab were given at Weeks 16, 20, and 28 and every 12 weeks thereafter with the last dose at Week 40. For participants entering early escape, a SC 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 escaped, 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 (SC) injections of placebo at Weeks 0, 4, 16, and 20. At Week 24 participants crossed 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 40. If early escape, SC injections of 45 mg ustekinumab were given at Weeks 16, 20, and 28 and every 12 weeks thereafter with the last dose at Week 40. For participants entering early escape, a SC placebo injection was given at Week 24 to maintain the blind.
OG001
Time Frame
Adverse event data were collected for the duration of the study (60 weeks).
Description
The safety analysis included all participants who were randomly assigned to a treatment group and received at least one dose of study agent, either placebo or ustekinumab. One participant, in the ustekinumab 90 mg group, did not receive treatment and is excluded from the safety analysis set.
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: Controlled Period
Adverse events which occurred during Weeks 0-16 (placebo-controlled period) in participants who were randomly assigned to placebo at Baseline.
5
104
19
104
EG001
Ustekinumab 45 mg: Controlled Period
Adverse events which occurred during Weeks 0-16 (placebo-controlled period) in participants who were randomly assigned to ustekinumab 45 mg at Baseline.
0
103
16
103
EG002
Ustekinumab 90 mg: Controlled Period
Adverse events which occurred during Weeks 0-16 (placebo-controlled period) in participants who were randomly assigned to ustekinumab 90 mg at Baseline.
1
104
19
104
EG003
Placebo: Weeks 16-24
Adverse events which occurred during Weeks 16-24 in participants who were randomly assigned to placebo at Baseline and did not early escape at Week 16.
0
60
5
60
EG004
Placebo -> Ustekinumab 45 mg: Weeks 16-60
Adverse events which occurred (1) during Weeks 16-60 in participants randomly assigned to placebo at Baseline and who early escaped to ustekinumab 45 mg at Week 16 and (2) during Weeks 24-60 in participants randomly assigned to placebo at Baseline and who crossed over to ustekinumab 45 mg at Week 24.
2
80
10
80
EG005
Ustekinumab 45 mg: Weeks 16-60
Adverse events which occurred during Weeks 16-60 in participants who were randomly assigned to ustekinumab 45 mg at Baseline.
6
100
16
100
EG006
Ustekinumab 90 mg: Weeks 16-60
Adverse events which occurred during Weeks 16-60 in participants who were randomly assigned to ustekinumab 90 mg at Baseline.
6
99
24
99
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA Version 15.1
Systematic Assessment
EG0000 affected104 at risk
EG0010 affected103 at risk
EG0020 affected104 at risk
EG0030 affected60 at risk
EG004
Acute Myocardial Infarction
Cardiac disorders
MedDRA Version 15.1
Systematic Assessment
EG0000 affected104 at risk
EG0010 affected103 at risk
EG0020 affected104 at risk
EG003
Angina Unstable
Cardiac disorders
MedDRA Version 15.1
Systematic Assessment
EG0000 affected104 at risk
EG0010 affected103 at risk
EG0020 affected104 at risk
EG003
Myocardial Infarction
Cardiac disorders
MedDRA Version 15.1
Systematic Assessment
EG0000 affected104 at risk
EG0010 affected103 at risk
EG0020 affected104 at risk
EG003
Gastric Ulcer Haemorrhage
Gastrointestinal disorders
MedDRA Version 15.1
Systematic Assessment
EG0000 affected104 at risk
EG0010 affected103 at risk
EG0020 affected104 at risk
EG003
Gastrointestinal Haemorrhage
Gastrointestinal disorders
MedDRA Version 15.1
Systematic Assessment
EG0000 affected104 at risk
EG0010 affected103 at risk
EG0020 affected104 at risk
EG003
Inguinal Hernia
Gastrointestinal disorders
MedDRA Version 15.1
Systematic Assessment
EG0000 affected104 at risk
EG0010 affected103 at risk
EG0020 affected104 at risk
EG003
Intestinal Haemorrhage
Gastrointestinal disorders
MedDRA Version 15.1
Systematic Assessment
EG0000 affected104 at risk
EG0010 affected103 at risk
EG0020 affected104 at risk
EG003
Umbilical Hernia
Gastrointestinal disorders
MedDRA Version 15.1
Systematic Assessment
EG0000 affected104 at risk
EG0010 affected103 at risk
EG0020 affected104 at risk
EG003
Upper Gastrointestinal Haemorrhage
Gastrointestinal disorders
MedDRA Version 15.1
Systematic Assessment
EG0000 affected104 at risk
EG0010 affected103 at risk
EG0020 affected104 at risk
EG003
Pyrexia
General disorders
MedDRA Version 15.1
Systematic Assessment
EG0001 affected104 at risk
EG0010 affected103 at risk
EG0020 affected104 at risk
EG003
Cholecystitis Chronic
Hepatobiliary disorders
MedDRA Version 15.1
Systematic Assessment
EG0001 affected104 at risk
EG0010 affected103 at risk
EG0020 affected104 at risk
EG003
Bacteraemia
Infections and infestations
MedDRA Version 15.1
Systematic Assessment
EG0000 affected104 at risk
EG0010 affected103 at risk
EG0020 affected104 at risk
EG003
Gastrointestinal Candidiasis
Infections and infestations
MedDRA Version 15.1
Systematic Assessment
EG0000 affected104 at risk
EG0010 affected103 at risk
EG0020 affected104 at risk
EG003
Septic Shock
Infections and infestations
MedDRA Version 15.1
Systematic Assessment
EG0000 affected104 at risk
EG0010 affected103 at risk
EG0020 affected104 at risk
EG003
Cervical Vertebral Fracture
Injury, poisoning and procedural complications
MedDRA Version 15.1
Systematic Assessment
EG0000 affected104 at risk
EG0010 affected103 at risk
EG0020 affected104 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA Version 15.1
Systematic Assessment
EG0001 affected104 at risk
EG0010 affected103 at risk
EG0020 affected104 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA Version 15.1
Systematic Assessment
EG0000 affected104 at risk
EG0010 affected103 at risk
EG0020 affected104 at risk
EG003
Bursitis
Musculoskeletal and connective tissue disorders
MedDRA Version 15.1
Systematic Assessment
EG0000 affected104 at risk
EG0010 affected103 at risk
EG0020 affected104 at risk
EG003
Joint Effusion
Musculoskeletal and connective tissue disorders
MedDRA Version 15.1
Systematic Assessment
EG0000 affected104 at risk
EG0010 affected103 at risk
EG0020 affected104 at risk
EG003
Tendonitis
Musculoskeletal and connective tissue disorders
MedDRA Version 15.1
Systematic Assessment
EG0000 affected104 at risk
EG0010 affected103 at risk
EG0020 affected104 at risk
EG003
Breast Cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 15.1
Systematic Assessment
EG0000 affected104 at risk
EG0010 affected103 at risk
EG0020 affected104 at risk
EG003
Cerebrovascular Insufficiency
Nervous system disorders
MedDRA Version 15.1
Systematic Assessment
EG0001 affected104 at risk
EG0010 affected103 at risk
EG0020 affected104 at risk
EG003
Syncope
Nervous system disorders
MedDRA Version 15.1
Systematic Assessment
EG0000 affected104 at risk
EG0010 affected103 at risk
EG0021 affected104 at risk
EG003
Depression
Psychiatric disorders
MedDRA Version 15.1
Systematic Assessment
EG0001 affected104 at risk
EG0010 affected103 at risk
EG0020 affected104 at risk
EG003
Suicide Attempt
Psychiatric disorders
MedDRA Version 15.1
Systematic Assessment
EG0000 affected104 at risk
EG0010 affected103 at risk
EG0020 affected104 at risk
EG003
Renal Failure Acute
Renal and urinary disorders
MedDRA Version 15.1
Systematic Assessment
EG0000 affected104 at risk
EG0010 affected103 at risk
EG0020 affected104 at risk
EG003
Renal Injury
Renal and urinary disorders
MedDRA Version 15.1
Systematic Assessment
EG0000 affected104 at risk
EG0010 affected103 at risk
EG0021 affected104 at risk
EG003
Interstitial Lung Disease
Respiratory, thoracic and mediastinal disorders
MedDRA Version 15.1
Systematic Assessment
EG0001 affected104 at risk
EG0010 affected103 at risk
EG0020 affected104 at risk
EG003
Psoriasis
Skin and subcutaneous tissue disorders
MedDRA Version 15.1
Systematic Assessment
EG0000 affected104 at risk
EG0010 affected103 at risk
EG0020 affected104 at risk
EG003
Scar
Skin and subcutaneous tissue disorders
MedDRA Version 15.1
Systematic Assessment
EG0000 affected104 at risk
EG0010 affected103 at risk
EG0020 affected104 at risk
EG003
Arteriosclerosis
Vascular disorders
MedDRA Version 15.1
Systematic Assessment
EG0000 affected104 at risk
EG0010 affected103 at risk
EG0020 affected104 at risk
EG003
Hypertension
Vascular disorders
MedDRA Version 15.1
Systematic Assessment
EG0001 affected104 at risk
EG0010 affected103 at risk
EG0020 affected104 at risk
EG003
Hypotension
Vascular disorders
MedDRA Version 15.1
Systematic Assessment
EG0000 affected104 at risk
EG0010 affected103 at risk
EG0020 affected104 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Bronchitis
Infections and infestations
MedDRA Version 15.1
Systematic Assessment
EG0003 affected104 at risk
EG0011 affected103 at risk
EG0020 affected104 at risk
EG0030 affected60 at risk
EG0042 affected80 at risk
EG0052 affected100 at risk
EG0068 affected99 at risk
Nasopharyngitis
Infections and infestations
MedDRA Version 15.1
Systematic Assessment
EG0005 affected104 at risk
EG0018 affected103 at risk
EG00210 affected104 at risk
EG003
Sinusitis
Infections and infestations
MedDRA Version 15.1
Systematic Assessment
EG0003 affected104 at risk
EG0011 affected103 at risk
EG0023 affected104 at risk
EG003
Psoriatic Arthropathy
Musculoskeletal and connective tissue disorders
MedDRA Version 15.1
Systematic Assessment
EG0005 affected104 at risk
EG0014 affected103 at risk
EG0021 affected104 at risk
EG003
Headache
Nervous system disorders
MedDRA Version 15.1
Systematic Assessment
EG0004 affected104 at risk
EG0015 affected103 at risk
EG0025 affected104 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
Senior 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
47.9
± 11.57
56
BG003164
Male
BG00051
BG00148
BG00249
BG003148
208
43.8
No
Superiority or Other
OG000
OG003
re-randomization test
<0.001
No
Superiority or Other
Ustekinumab 45 mg
Participants received SC injections of ustekinumab 45 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 40. If early escape, SC injections of 90 mg ustekinumab were given at Week 16 and every 12 weeks thereafter with the last dose at Week 40. Participants received SC injections of placebo at Weeks 20 and 24 to maintain the blind.
OG002
Ustekinumab 90 mg
Participants received SC injections of ustekinumab 90 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 40. If early escape, the same dosage schedule continued. Participants received SC injections of placebo at Weeks 20 and 24 to maintain the blind.
OG003
All Ustekinumab Combined
Participants who received SC injections of ustekinumab at any dose (45 mg and 90 mg) through Week 40.
Units
Counts
Participants
OG000104
OG001103
OG002105
OG003208
Title
Denominators
Categories
Title
Measurements
OG000-0.03± 0.380
OG001-0.21± 0.461
OG002-0.22± 0.436
OG003-0.21± 0.447
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
0.002
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 SC injections of ustekinumab 45 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 40. If early escape, SC injections of 90 mg ustekinumab were given at Week 16 and every 12 weeks thereafter with the last dose at Week 40. Participants received SC injections of placebo at Weeks 20 and 24 to maintain the blind.
OG002
Ustekinumab 90 mg
Participants received SC injections of ustekinumab 90 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 40. If early escape, the same dosage schedule continued. Participants received SC injections of placebo at Weeks 20 and 24 to maintain the blind.
OG003
All Ustekinumab Combined
Participants who received SC injections of ustekinumab at any dose (45 mg and 90 mg) through Week 40.
Units
Counts
Participants
OG00080
OG00180
OG00281
OG003161
Title
Denominators
Categories
Title
Measurements
OG0005.0
OG00151.3
OG00255.6
OG00353.4
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
Ustekinumab 45 mg
Participants received SC injections of ustekinumab 45 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 40. If early escape, SC injections of 90 mg ustekinumab were given at Week 16 and every 12 weeks thereafter with the last dose at Week 40. Participants received SC injections of placebo at Weeks 20 and 24 to maintain the blind.
OG002
Ustekinumab 90 mg
Participants received SC injections of ustekinumab 90 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 40. If early escape, the same dosage schedule continued. Participants received SC injections of placebo at Weeks 20 and 24 to maintain the blind.
OG003
All Ustekinumab Combined
Participants who received SC injections of ustekinumab at any dose (45 mg and 90 mg) through Week 40.
Units
Counts
Participants
OG000104
OG001103
OG002105
OG003208
Title
Denominators
Categories
Title
Measurements
OG0006.7
OG00117.5
OG00222.9
OG00320.2
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
0.018
No
Superiority or Other
OG000
OG002
re-randomization test
<0.001
No
Superiority or Other
OG000
OG003
re-randomization test
0.002
No
Superiority or Other
OG001
Ustekinumab 45 mg
Participants received SC injections of ustekinumab 45 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 40. If early escape, SC injections of 90 mg ustekinumab were given at Week 16 and every 12 weeks thereafter with the last dose at Week 40. Participants received SC injections of placebo at Weeks 20 and 24 to maintain the blind.
OG002
Ustekinumab 90 mg
Participants received SC injections of ustekinumab 90 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 40. If early escape, the same dosage schedule continued. Participants received SC injections of placebo at Weeks 20 and 24 to maintain the blind.
OG003
All Ustekinumab Combined
Participants who received SC injections of ustekinumab at any dose (45 mg and 90 mg) through Week 40.
Units
Counts
Participants
OG000310
OG001308
OG002309
OG003617
Title
Denominators
Categories
Title
Measurements
OG0000.97± 3.852
OG0010.40± 2.110
OG0020.39± 2.403
OG0030.40± 2.260
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
0.017
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
Ustekinumab 45 mg
Participants received SC injections of ustekinumab 45 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 40. If early escape, SC injections of 90 mg ustekinumab were given at Week 16 and every 12 weeks thereafter with the last dose at Week 40. Participants received SC injections of placebo at Weeks 20 and 24 to maintain the blind.
OG002
Ustekinumab 90 mg
Participants received SC injections of ustekinumab 90 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 40. If early escape, the same dosage schedule continued. Participants received SC injections of placebo at Weeks 20 and 24 to maintain the blind.
OG003
All Ustekinumab Combined
Participants who received SC injections of ustekinumab at any dose (45 mg and 90 mg) through Week 40.