BI 655066/ABBV-066 (Risankizumab) Compared to Active Comp... | NCT02694523 | Trialant
NCT02694523
Sponsor
AbbVie
Status
Completed
Last Update Posted
Jul 30, 2021Actual
Enrollment
684Actual
Phase
Phase 3
Conditions
Psoriasis
Interventions
risankizumab
adalimumab
placebo for risankizumab
placebo for adalimumab
Countries
Not provided
Protocol Section
Identification Module
NCT ID
NCT02694523
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
M16-010
Secondary IDs
ID
Type
Description
Link
2015-003623-65
EudraCT Number
1311.30
Other Identifier
Boehringer Ingelheim
Brief Title
BI 655066/ABBV-066 (Risankizumab) Compared to Active Comparator (Adalimumab) in Patients With Moderate to Severe Chronic Plaque Psoriasis
Official Title
BI 655066/ABBV-066 (Risankizumab) Versus Adalimumab in a Randomized, Double Blind, Parallel Group Trial in Moderate to Severe Plaque Psoriasis to Assess Safety and Efficacy After 16 Weeks of Treatment and After Inadequate Adalimumab Treatment Response (IMMvent)
Acronym
Not provided
Organization
AbbVieINDUSTRY
Status Module
Record Verification Date
Jul 2021
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 2016Actual
Primary Completion Date
Aug 2017Actual
Completion Date
Aug 2017Actual
First Submitted Date
Feb 24, 2016
First Submission Date that Met QC Criteria
Feb 24, 2016
First Posted Date
Feb 29, 2016Estimated
Results Waived
Not provided
Results First Submitted Date
May 3, 2019
Results First Submitted that Met QC Criteria
May 3, 2019
Results First Posted Date
May 28, 2019Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Jan 9, 2018
Certification/Extension First Submitted that Passed QC Review
Jan 9, 2018
Certification/Extension First Posted Date
Jan 12, 2018Actual
Last Update Submitted Date
Jul 28, 2021
Last Update Posted Date
Jul 30, 2021Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
AbbVieINDUSTRY
Collaborators
Name
Class
Boehringer Ingelheim
INDUSTRY
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
This is a randomized double blind, double dummy, active comparator controlled, parallel design study that is performed to assess the safety and efficacy of BI 655066/ABBV-066 (risankizumab) compared to adalimumab to support registration for the treatment of moderate to severe chronic plaque psoriasis in adult patients.
Detailed Description
This study consists of 2 parts (Part A and Part B).
Part A:
Participants were randomized to receive either risankizumab or adalimumab.
Part B:
Participants who received risankizumab in Part A continued to receive risankizumab in Part B
Adalimumab nonresponders (\
Conditions Module
Conditions
Psoriasis
Keywords
Psoriasis
Skin Diseases
Skin Diseases, Papulosquamous
Adalimumab
Anti-Inflammatory Agents
ABBV-066
BI 655066
Risankizumab
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
684Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Adalimumab (Part A)
Active Comparator
Participants randomized to receive double-blind (DB) adalimumab 80 mg by subcutaneous (SC) injection at Week 0, then 40 mg at Week 1 and every 2 weeks for 15 weeks (Part A).
Biological: adalimumab
Drug: placebo for risankizumab
Risankizumab (Part A)
Experimental
Participants randomized to receive risankizumab at Weeks 0 and 4 (Part A).
Drug: risankizumab
Biological: placebo for adalimumab
Interventions
Name
Type
Description
Arm Group Labels
Other Names
risankizumab
Drug
Risankizumab administered by subcutaneous (SC) injection
Risankizumab (Part A)
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percentage of Participants Achieving 90% Improvement in Psoriasis Area and Severity Index (PASI) Score (PASI90) at Week 16 (Part A)
PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. Nonresponder imputation (NRI) was used for missing data.
Week 16
Percentage of Participants Achieving Static Physician Global Assessment (sPGA) Score of Clear or Almost Clear at Week 16 (Part A)
The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean >0, <1.5; Mild (2) = mean ≥1.5, <2.5; Moderate (3) = mean ≥2.5, <3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.
Week 16
Percentage of Participants Who Were Re-Randomized to Receive Either Adalimumab or Risankizumab in Part B Achieving PASI90 at Week 44 (Part B)
PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.
Secondary Outcomes
Measure
Description
Time Frame
Percentage of Participants Achieving PASI75 at Week 16 (Part A)
PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI75 is defined as at least a 75% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.
Other Outcomes
Measure
Description
Time Frame
Percentage of Participants Who Were Rerandomized to Receive Either Adalimumab or Risankizumab in Part B Achieving sPGA Score of Clear or Almost Clear at Week 44 (Part B)
The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean >0, <1.5; Mild (2) = mean ≥1.5, <2.5; Moderate (3) = mean ≥2.5, <3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.
Eligibility Module
Eligibility Criteria
Inclusion criteria:
Male or female patients. Women of childbearing potential* must be ready and able to use highly effective methods of birth control per ICH M3(R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria is provided in the patient information.
*Women of childbearing potential are defined as:
having experienced menarche and
not postmenopausal (12 months with no menses without an alternative medical cause) and
not permanently sterilized (e.g., tubal occlusion, hysterectomy, bilateral oophorectomy or bilateral salpingectomy).
Age ≥ 18 years at screening
Have a diagnosis of chronic plaque psoriasis (with or without psoriatic arthritis) for at least 6 months before the first administration of study drug. Duration of diagnosis may be reported by the patient.
Have stable moderate to severe chronic plaque psoriasis with or without psoriatic arthritis at both Screening and Baseline (Randomization):
Have an involved body surface area (BSA) ≥ 10% and
Have a Psoriasis Area and Severity Index (PASI) score ≥ 12 and
Have a static Physician Global Assessment (sPGA) score of ≥ 3.
Must be candidates for systemic therapy or phototherapy for psoriasis treatment, as assessed by the investigator
Must be candidates for treatment with adalimumab (Humira®) according to local label as confirmed by the investigator.
Signed and dated written informed consent prior to admission to the study in accordance with GCP and local legislation
Exclusion criteria:
Patients with
non-plaque forms of psoriasis (including guttate, erythrodermic, or pustular)
current drug-induced psoriasis (including an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium)
active ongoing inflammatory diseases other than psoriasis that might confound trial evaluations according to investigator's judgment
Previous exposure to ABBV-066
Previous exposure to adalimumab (Humira®)
Currently enrolled in another investigational study or less than 30 days or more from screening since completing another investigational drug or device study.
Use of any restricted medication or any drug considered likely to interfere with the safe conduct of the study.
Major surgery performed within 12 weeks prior to randomization or planned within 12 months after screening (e.g. hip replacement, removal aneurysm, stomach ligation).
Known chronic or relevant acute infections, such as active tuberculosis (TB), human immunodeficiency virus (HIV) or viral hepatitis; QuantiFERON® TB test or purified protein derivative (PPD) skin test will be performed according to local labelling for Humira®. If the result is positive, patients may participate in the study if further work up (according to local practice/guidelines) establishes conclusively that the patient has no evidence of active TB. If presence of latent TB is established, then treatment should have been initiated and maintained according to local country guidelines.
Any documented active or suspected malignancy or history of malignancy within 5 years prior to screening, except appropriately treated basal cell or squamous cell carcinoma of the skin or in situ carcinoma of uterine cervix.
Evidence of a current or previous disease, medical condition (including chronic alcohol or drug abuse) other than psoriasis, surgical procedure (i.e., organ transplant), medical examination finding (including vital signs and electrocardiogram [ECG]), or laboratory value at the Screening Visit outside the reference range that in the opinion of the investigator is clinically significant and would make the study participant unreliable to adhere to the protocol or to complete the trial, compromise the safety of the patient, or compromise the quality of the data.
History of allergy/hypersensitivity to a systemically administered biologic agent or its excipients
Women who are pregnant, nursing, or who plan to become pregnant while in the trial
Reich K, Gooderham M, Thaci D, Crowley JJ, Ryan C, Krueger JG, Tsai TF, Flack M, Gu Y, Williams DA, Thompson EHZ, Paul C. Risankizumab compared with adalimumab in patients with moderate-to-severe plaque psoriasis (IMMvent): a randomised, double-blind, active-comparator-controlled phase 3 trial. Lancet. 2019 Aug 17;394(10198):576-586. doi: 10.1016/S0140-6736(19)30952-3. Epub 2019 Jul 4.
A total of 684 subjects were enrolled; 79 subjects failed screening and are excluded from the analyses.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Adalimumab (Part A)
Participants randomized to receive double-blind (DB) adalimumab 80 mg by subcutaneous (SC) injection at Week 0, then 40 mg at Week 1 and every 2 weeks for 15 weeks (Part A).
FG001
Risankizumab (Part A)
Periods
Title
Milestones
Reasons Not Completed
Part A
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Oct 17, 2016
Dec 19, 2018
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Canada
Czechia
Finland
France
Germany
Italy
Mexico
Poland
Portugal
Sweden
Taiwan
United Kingdom
United States
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Double
Masking Description
Not provided
Who Masked
ParticipantInvestigator
BI 655066
ABBV-066
SKYRIZI
adalimumab
Biological
Adalimumab pre-filled syringe, administered by subcutaneous (SC) injection
Adalimumab (Part A)
Humira
ABT-D2E7
placebo for risankizumab
Drug
Placebo risankizumab administered by subcutaneous (SC) injection
Adalimumab (Part A)
placebo for adalimumab
Biological
Placebo for adalimumab pre-filled syringe, administered by subcutaneous (SC) injection
Risankizumab (Part A)
Week 44
Week 16
Percentage of Participants Achieving PASI100 at Week 16 (Part A)
PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI100 is defined as a 100% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.
Week 16
Percentage of Participants Who Were Rerandomized to Receive Either Adalimumab or Risankizumab in Part B Achieving PASI100 at Week 44 (Part B)
PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI100 is defined as a 100% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.
Week 44
Percentage of Participants Who Were ReRandomized to Receive Either Adalimumab or Risankizumab in Part B Achieving sPGA Score of Clear at Week 44 (Part B)
The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean >0, <1.5; Mild (2) = mean ≥1.5, <2.5; Moderate (3) = mean ≥2.5, <3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.
Week 44
Week 44
Derived
Hsieh CY, Hsu FL, Tsai TF. Comparison of Drug-Free Remission after the End of Phase III Trials of Three Different Anti-IL-23 Inhibitors in Psoriasis. Dermatol Ther (Heidelb). 2024 Sep;14(9):2607-2620. doi: 10.1007/s13555-024-01229-6. Epub 2024 Jul 29.
Lebwohl MG, Soliman AM, Yang H, Wang J, Hagan K, Padilla B, Pinter A. Impact of Risankizumab on PASI90 and DLQI0/1 Duration in Moderate-to-Severe Psoriasis: A Post Hoc Analysis of Four Phase 3 Clinical Trials. Dermatol Ther (Heidelb). 2022 Feb;12(2):407-418. doi: 10.1007/s13555-021-00660-3. Epub 2021 Dec 18.
Suleiman AA, Khatri A, Oberoi RK, Othman AA. Exposure-Response Relationships for the Efficacy and Safety of Risankizumab in Japanese Subjects with Psoriasis. Clin Pharmacokinet. 2020 May;59(5):575-589. doi: 10.1007/s40262-019-00829-2.
Suleiman AA, Minocha M, Khatri A, Pang Y, Othman AA. Population Pharmacokinetics of Risankizumab in Healthy Volunteers and Subjects with Moderate to Severe Plaque Psoriasis: Integrated Analyses of Phase I-III Clinical Trials. Clin Pharmacokinet. 2019 Oct;58(10):1309-1321. doi: 10.1007/s40262-019-00759-z.
Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
FG002
Risankizumab/Risankizumab (Part B)
Participants randomized to receive double-blind (DB) risankizumab in Part A continued to receive risankizumab 150 mg by subcutaneous (SC) injection at Weeks 16, and 28 (Part B).
FG003
Adalimumab/Adalimumab (Part B)
Participants who were responders after receiving adalimumab in Part A continued to receive adalimumab 40 mg by subcutaneous (SC) injection every other week through Week 41 (Part B).
FG004
Adalimumab/Risankizumab (Part B)
Participants who were nonresponders after receiving adalimumab in Part A switched to risankizumab 150 mg by subcutaneous (SC) injection at Weeks 16, 20, and 32 (Part B).
FG005
Adalimumab/Rerandomized to Adalimumab (Part B)
Participants who were inadequate responders after receiving adalimumab in Part A and rerandomized to continue to receive adalimumab 40 mg by subcutaneous (SC) injection every 2 weeks through Week 41 (Part B).
FG006
Adalimumab/Rerandomized to Risankizumab (Part B)
Participants who were inadequate responders after receiving adalimumab in Part A and rerandomized to receive risankizumab 150 mg by subcutaneous (SC) injection at Weeks 16, 20, and 32 (Part B).
FG000304 subjects
FG001301 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
COMPLETED
FG000291 subjects
FG001294 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
NOT COMPLETED
FG00013 subjects
FG0017 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
Type
Comment
Reasons
Adverse Event
FG0007 subjects
FG0013 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
Protocol Violation
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Lost to Follow-up
FG0001 subjects
FG0012 subjects
FG0020 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0003 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Other
FG0001 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Part B
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG002294 subjectsParticipants who received risankizumab in Part A continued to received risankizumab in Part B
FG003144 subjectsAdalimumab responders in Part A continued to received adalimumab in Part B
FG00438 subjectsAdalimumab nonresponders in Part A switched to risankizumab in Part B
FG00556 subjectsAdalimumab inadequate responders in Part A, rerandomized to adalimumab in Part B
FG00653 subjectsAdalimumab inadequate responders in Part A, rerandomized to risankizumab in Part B
COMPLETED
FG0000 subjects
FG0010 subjects
FG002274 subjects
FG003140 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG00220 subjects
FG0034 subjects
FG004
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0027 subjects
FG003
Intent-to-treat population in Part A (ITT_A): All subjects randomized at Baseline.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Adalimumab (Part A)
Participants randomized to receive double blind (DB) adalimumab 80 mg by subcutaneous (SC) injection at Weeks 0, 1, and every other week for 15 weeks (Part A).
BG001
Risankizumab (Part A)
Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0, 4 (Part A).
BG002
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000304
BG001301
BG002605
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
BG00047.0± 13.09
BG00145.3± 13.79
BG00246.2± 13.46
Sex: Female, Male
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
Female
BG00092
BG00191
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG00059
BG00144
BG002
Race (NIH/OMB)
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0012
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 Achieving 90% Improvement in Psoriasis Area and Severity Index (PASI) Score (PASI90) at Week 16 (Part A)
PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. Nonresponder imputation (NRI) was used for missing data.
Intent-to-treat population in Part A (ITT_A): All subjects randomized at Baseline.
Posted
Number
percentage of participants
Week 16
ID
Title
Description
OG000
Adalimumab (Part A)
Participants randomized to receive double-blind (DB) adalimumab 80 mg by subcutaneous (SC) injection at Week 0, then 40 mg at Week 1 and every 2 weeks for 15 weeks (Part A).
OG001
Risankizumab (Part A)
Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
Units
Counts
Participants
OG000304
OG001301
Title
Denominators
Categories
Title
Measurements
OG00047.4
OG00172.4
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
P-value calculated according to the Cochran-Mantel-Haenszel test adjusted for baseline weight (≤100 kg vs >100 kg) and prior exposure to tumor necrosis factor (TNF) antagonists (0 vs ≥1).
Cochran-Mantel-Haenszel
<0.001
difference in percentage of participants
24.9
2-Sided
95
17.5
32.4
Other
Primary
Percentage of Participants Achieving Static Physician Global Assessment (sPGA) Score of Clear or Almost Clear at Week 16 (Part A)
The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean >0, <1.5; Mild (2) = mean ≥1.5, <2.5; Moderate (3) = mean ≥2.5, <3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.
ITT_A population.
Posted
Number
percentage of participants
Week 16
ID
Title
Description
OG000
Adalimumab (Part A)
Participants randomized to receive double-blind (DB) adalimumab 80 mg by subcutaneous (SC) injection at Week 0, then 40 mg at Week 1 and every 2 weeks for 15 weeks (Part A).
OG001
Risankizumab (Part A)
Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
Units
Counts
Participants
Primary
Percentage of Participants Who Were Re-Randomized to Receive Either Adalimumab or Risankizumab in Part B Achieving PASI90 at Week 44 (Part B)
PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.
Intent-to-treat population in Part B who were re-randomized (ITT_B_RR): All subjects who started with adalimumab at Baseline and were re-randomized at Week 16
Posted
Number
percentage of participants
Week 44
ID
Title
Description
OG000
Adalimumab/Rerandomized to Adalimumab (Part B)
Participants who were inadequate responders after receiving adalimumab in Part A, and rerandomized to continue to receive adalimumab 40 mg by subcutaneous (SC) injection every 2 weeks through Week 41 (Part B).
OG001
Adalimumab/Rerandomized to Risankizumab (Part B)
Participants who were inadequate responders after receiving adalimumab in Part A, and rerandomized to receive risankizumab 150 mg by subcutaneous (SC) injection at Weeks 16, 20, and 32 (Part B).
Secondary
Percentage of Participants Achieving PASI75 at Week 16 (Part A)
PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI75 is defined as at least a 75% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.
ITT_A population
Posted
Number
percentage of participants
Week 16
ID
Title
Description
OG000
Adalimumab (Part A)
Participants randomized to receive double-blind (DB) adalimumab 80 mg by subcutaneous (SC) injection at Week 0, then 40 mg at Week 1 and every 2 weeks for 15 weeks (Part A).
OG001
Risankizumab (Part A)
Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
Secondary
Percentage of Participants Achieving PASI100 at Week 16 (Part A)
PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI100 is defined as a 100% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.
ITT_A population
Posted
Number
percentage of participants
Week 16
ID
Title
Description
OG000
Adalimumab (Part A)
Participants randomized to receive double-blind (DB) adalimumab 80 mg by subcutaneous (SC) injection at Week 0, then 40 mg at Week 1 and every 2 weeks for 15 weeks (Part A).
OG001
Risankizumab (Part A)
Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
Secondary
Percentage of Participants Who Were Rerandomized to Receive Either Adalimumab or Risankizumab in Part B Achieving PASI100 at Week 44 (Part B)
PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI100 is defined as a 100% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.
ITT_B_RR population
Posted
Number
percentage of participants
Week 44
ID
Title
Description
OG000
Adalimumab/Rerandomized to Adalimumab (Part B)
Participants who were inadequate responders after receiving adalimumab in Part A, and rerandomized to continue to receive adalimumab 40 mg by subcutaneous (SC) injection every 2 weeks through Week 41 (Part B).
OG001
Adalimumab/Rerandomized to Risankizumab (Part B)
Participants who were inadequate responders after receiving adalimumab in Part A, and rerandomized to receive risankizumab 150 mg by subcutaneous (SC) injection at Weeks 16, 20, and 32 (Part B).
Secondary
Percentage of Participants Who Were ReRandomized to Receive Either Adalimumab or Risankizumab in Part B Achieving sPGA Score of Clear at Week 44 (Part B)
The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean >0, <1.5; Mild (2) = mean ≥1.5, <2.5; Moderate (3) = mean ≥2.5, <3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.
ITT_B_RR population
Posted
Number
percentage of participants
Week 44
ID
Title
Description
OG000
Adalimumab/Rerandomized to Adalimumab (Part B)
Participants who were inadequate responders after receiving adalimumab in Part A, and rerandomized to continue to receive adalimumab 40 mg by subcutaneous (SC) injection every 2 weeks through Week 41 (Part B).
OG001
Adalimumab/Rerandomized to Risankizumab (Part B)
Participants who were inadequate responders after receiving adalimumab in Part A, and rerandomized to receive risankizumab 150 mg by subcutaneous (SC) injection at Weeks 16, 20, and 32 (Part B).
Other Pre-specified
Percentage of Participants Who Were Rerandomized to Receive Either Adalimumab or Risankizumab in Part B Achieving sPGA Score of Clear or Almost Clear at Week 44 (Part B)
The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean >0, <1.5; Mild (2) = mean ≥1.5, <2.5; Moderate (3) = mean ≥2.5, <3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.
ITT_B_RR population
Posted
Number
percentage of participants
Week 44
ID
Title
Description
OG000
Adalimumab/Rerandomized to Adalimumab (Part B)
Participants who were inadequate responders after receiving adalimumab in Part A, and rerandomized to continue to receive adalimumab 40 mg by subcutaneous (SC) injection every 2 weeks through Week 41 (Part B).
OG001
Adalimumab/Rerandomized to Risankizumab (Part B)
Participants who were inadequate responders after receiving adalimumab in Part A, and rerandomized to receive risankizumab 150 mg by subcutaneous (SC) injection at Weeks 16, 20, and 32 (Part B).
Time Frame
Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).
Description
AEs in Part A are defined as events from the first dose of study drug in Part A until prior to the first dose in Part B (Week 16) or up to 15 weeks after the last dose of study drug if the participant discontinued in Part A; AEs in Part B are defined as events from the first dose of study drug in Part B (Week 16) until up to 15 weeks after the last dose of study drug.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Adalimumab (Part A)
Participants randomized to receive double-blind (DB) adalimumab 80 mg by subcutaneous (SC) injection at Week 0, then 40 mg at Week 1 and every 2 weeks for 15 weeks (Part A).
2
304
9
304
71
304
EG001
Risankizumab (Part A)
Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
1
301
10
301
76
301
EG002
Risankizumab/Risankizumab (Part B)
Participants randomized to receive double-blind (DB) risankizumab in Part A continued to receive risankizumab 150 mg by subcutaneous (SC) injection at Weeks 16, and 28 (Part B).
0
294
12
294
95
294
EG003
Adalimumab/Risankizumab (Part B)
Participants who were nonresponders after receiving adalimumab in Part A switched to risankizumab 150 mg by subcutaneous (SC) injection at Weeks 16, 20, and 32 (Part B).
0
38
4
38
16
38
EG004
Adalimumab/Rerandomized to Adalimumab (Part B)
Participants who were inadequate responders after receiving adalimumab in Part A and re-randomized to continue to receive adalimumab 40 mg by subcutaneous (SC) injection every 2 weeks through Week 41 (Part B).
0
56
2
56
21
56
EG005
Adalimumab/Rerandomized to Risankizumab (Part B)
Participants who were inadequate responders after receiving adalimumab in Part A and re-randomized to receive risankizumab 150 mg by subcutaneous (SC) injection at Weeks 16, 20, and 32 (Part B).
0
53
3
53
24
53
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Lymphadenopathy mediastinal
Blood and lymphatic system disorders
MedDRA (20.0)
Systematic Assessment
EG0000 events0 affected304 at risk
EG0010 events0 affected301 at risk
EG0021 events1 affected294 at risk
EG0030 events0 affected38 at risk
EG004
Acute myocardial infarction
Cardiac disorders
MedDRA (20.0)
Systematic Assessment
EG0000 events0 affected304 at risk
EG0011 events1 affected301 at risk
EG0020 events0 affected294 at risk
EG003
Cardiac failure congestive
Cardiac disorders
MedDRA (20.0)
Systematic Assessment
EG0001 events1 affected304 at risk
EG0010 events0 affected301 at risk
EG0020 events0 affected294 at risk
EG003
Coronary artery occlusion
Cardiac disorders
MedDRA (20.0)
Systematic Assessment
EG0000 events0 affected304 at risk
EG0010 events0 affected301 at risk
EG0020 events0 affected294 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA (20.0)
Systematic Assessment
EG0000 events0 affected304 at risk
EG0010 events0 affected301 at risk
EG0021 events1 affected294 at risk
EG003
Palpitations
Cardiac disorders
MedDRA (20.0)
Systematic Assessment
EG0000 events0 affected304 at risk
EG0010 events0 affected301 at risk
EG0020 events0 affected294 at risk
EG003
Macrocornea
Congenital, familial and genetic disorders
MedDRA (20.0)
Systematic Assessment
EG0000 events0 affected304 at risk
EG0011 events1 affected301 at risk
EG0020 events0 affected294 at risk
EG003
Macular hole
Eye disorders
MedDRA (20.0)
Systematic Assessment
EG0000 events0 affected304 at risk
EG0010 events0 affected301 at risk
EG0021 events1 affected294 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA (20.0)
Systematic Assessment
EG0001 events1 affected304 at risk
EG0010 events0 affected301 at risk
EG0020 events0 affected294 at risk
EG003
Gastric perforation
Gastrointestinal disorders
MedDRA (20.0)
Systematic Assessment
EG0001 events1 affected304 at risk
EG0010 events0 affected301 at risk
EG0020 events0 affected294 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA (20.0)
Systematic Assessment
EG0000 events0 affected304 at risk
EG0010 events0 affected301 at risk
EG0021 events1 affected294 at risk
EG003
Pancreatitis
Gastrointestinal disorders
MedDRA (20.0)
Systematic Assessment
EG0001 events1 affected304 at risk
EG0010 events0 affected301 at risk
EG0020 events0 affected294 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA (20.0)
Systematic Assessment
EG0001 events1 affected304 at risk
EG0010 events0 affected301 at risk
EG0020 events0 affected294 at risk
EG003
Liver injury
Hepatobiliary disorders
MedDRA (20.0)
Systematic Assessment
EG0000 events0 affected304 at risk
EG0011 events1 affected301 at risk
EG0020 events0 affected294 at risk
EG003
Abdominal abscess
Infections and infestations
MedDRA (20.0)
Systematic Assessment
EG0001 events1 affected304 at risk
EG0010 events0 affected301 at risk
EG0020 events0 affected294 at risk
EG003
Erysipelas
Infections and infestations
MedDRA (20.0)
Systematic Assessment
EG0000 events0 affected304 at risk
EG0010 events0 affected301 at risk
EG0020 events0 affected294 at risk
EG003
Influenza
Infections and infestations
MedDRA (20.0)
Systematic Assessment
EG0000 events0 affected304 at risk
EG0010 events0 affected301 at risk
EG0020 events0 affected294 at risk
EG003
Perirectal abscess
Infections and infestations
MedDRA (20.0)
Systematic Assessment
EG0000 events0 affected304 at risk
EG0011 events1 affected301 at risk
EG0020 events0 affected294 at risk
EG003
Pneumonia
Infections and infestations
MedDRA (20.0)
Systematic Assessment
EG0000 events0 affected304 at risk
EG0010 events0 affected301 at risk
EG0021 events1 affected294 at risk
EG003
Sepsis
Infections and infestations
MedDRA (20.0)
Systematic Assessment
EG0001 events1 affected304 at risk
EG0010 events0 affected301 at risk
EG0021 events1 affected294 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA (20.0)
Systematic Assessment
EG0000 events0 affected304 at risk
EG0010 events0 affected301 at risk
EG0021 events1 affected294 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA (20.0)
Systematic Assessment
EG0000 events0 affected304 at risk
EG0010 events0 affected301 at risk
EG0021 events1 affected294 at risk
EG003
Joint dislocation
Injury, poisoning and procedural complications
MedDRA (20.0)
Systematic Assessment
EG0000 events0 affected304 at risk
EG0010 events0 affected301 at risk
EG0020 events0 affected294 at risk
EG003
Radius fracture
Injury, poisoning and procedural complications
MedDRA (20.0)
Systematic Assessment
EG0000 events0 affected304 at risk
EG0011 events1 affected301 at risk
EG0020 events0 affected294 at risk
EG003
Respiratory fume inhalation disorder
Injury, poisoning and procedural complications
MedDRA (20.0)
Systematic Assessment
EG0000 events0 affected304 at risk
EG0011 events1 affected301 at risk
EG0020 events0 affected294 at risk
EG003
Upper limb fracture
Injury, poisoning and procedural complications
MedDRA (20.0)
Systematic Assessment
EG0000 events0 affected304 at risk
EG0010 events0 affected301 at risk
EG0021 events1 affected294 at risk
EG003
Anticoagulation drug level above therapeutic
Investigations
MedDRA (20.0)
Systematic Assessment
EG0000 events0 affected304 at risk
EG0010 events0 affected301 at risk
EG0020 events0 affected294 at risk
EG003
Diabetes mellitus
Metabolism and nutrition disorders
MedDRA (20.0)
Systematic Assessment
EG0001 events1 affected304 at risk
EG0010 events0 affected301 at risk
EG0020 events0 affected294 at risk
EG003
Diabetes mellitus inadequate control
Metabolism and nutrition disorders
MedDRA (20.0)
Systematic Assessment
EG0000 events0 affected304 at risk
EG0010 events0 affected301 at risk
EG0020 events0 affected294 at risk
EG003
Diabetic ketoacidosis
Metabolism and nutrition disorders
MedDRA (20.0)
Systematic Assessment
EG0001 events1 affected304 at risk
EG0010 events0 affected301 at risk
EG0020 events0 affected294 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA (20.0)
Systematic Assessment
EG0000 events0 affected304 at risk
EG0010 events0 affected301 at risk
EG0021 events1 affected294 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA (20.0)
Systematic Assessment
EG0000 events0 affected304 at risk
EG0010 events0 affected301 at risk
EG0021 events1 affected294 at risk
EG003
Basal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (20.0)
Systematic Assessment
EG0000 events0 affected304 at risk
EG0010 events0 affected301 at risk
EG0021 events1 affected294 at risk
EG003
Gallbladder cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (20.0)
Systematic Assessment
EG0001 events1 affected304 at risk
EG0010 events0 affected301 at risk
EG0020 events0 affected294 at risk
EG003
Invasive lobular breast carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (20.0)
Systematic Assessment
EG0000 events0 affected304 at risk
EG0011 events1 affected301 at risk
EG0020 events0 affected294 at risk
EG003
Prostate cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (20.0)
Systematic Assessment
EG0000 events0 affected304 at risk
EG0010 events0 affected301 at risk
EG0021 events1 affected294 at risk
EG003
Syncope
Nervous system disorders
MedDRA (20.0)
Systematic Assessment
EG0001 events1 affected304 at risk
EG0010 events0 affected301 at risk
EG0020 events0 affected294 at risk
EG003
Alcohol withdrawal syndrome
Psychiatric disorders
MedDRA (20.0)
Systematic Assessment
EG0000 events0 affected304 at risk
EG0010 events0 affected301 at risk
EG0020 events0 affected294 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA (20.0)
Systematic Assessment
EG0000 events0 affected304 at risk
EG0010 events0 affected301 at risk
EG0021 events1 affected294 at risk
EG003
Depression
Psychiatric disorders
MedDRA (20.0)
Systematic Assessment
EG0000 events0 affected304 at risk
EG0011 events1 affected301 at risk
EG0021 events1 affected294 at risk
EG003
Suicide attempt
Psychiatric disorders
MedDRA (20.0)
Systematic Assessment
EG0001 events1 affected304 at risk
EG0011 events1 affected301 at risk
EG0020 events0 affected294 at risk
EG003
Haemorrhagic ovarian cyst
Reproductive system and breast disorders
MedDRA (20.0)
Systematic Assessment
EG0001 events1 affected304 at risk
EG0010 events0 affected301 at risk
EG0020 events0 affected294 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA (20.0)
Systematic Assessment
EG0000 events0 affected304 at risk
EG0011 events1 affected301 at risk
EG0020 events0 affected294 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA (20.0)
Systematic Assessment
EG0000 events0 affected304 at risk
EG0011 events1 affected301 at risk
EG0020 events0 affected294 at risk
EG003
Abortion induced
Surgical and medical procedures
MedDRA (20.0)
Systematic Assessment
EG0000 events0 affected304 at risk
EG0010 events0 affected301 at risk
EG0021 events1 affected294 at risk
EG003
Hypertensive crisis
Vascular disorders
MedDRA (20.0)
Systematic Assessment
EG0001 events1 affected304 at risk
EG0010 events0 affected301 at risk
EG0020 events0 affected294 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Bronchitis
Infections and infestations
MedDRA (20.0)
Systematic Assessment
EG0003 events3 affected304 at risk
EG0014 events4 affected301 at risk
EG0028 events7 affected294 at risk
EG0032 events2 affected38 at risk
EG0043 events3 affected56 at risk
EG0052 events2 affected53 at risk
Upper respiratory tract infection
Infections and infestations
MedDRA (20.0)
Systematic Assessment
EG00015 events12 affected304 at risk
EG00126 events21 affected301 at risk
EG00244 events34 affected294 at risk
EG003
Viral upper respiratory tract infection
Infections and infestations
MedDRA (20.0)
Systematic Assessment
EG00029 events24 affected304 at risk
EG00131 events26 affected301 at risk
EG00248 events39 affected294 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA (20.0)
Systematic Assessment
EG00012 events9 affected304 at risk
EG00112 events11 affected301 at risk
EG0024 events4 affected294 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA (20.0)
Systematic Assessment
EG0006 events6 affected304 at risk
EG0019 events9 affected301 at risk
EG0026 events6 affected294 at risk
EG003
Seborrhoeic keratosis
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (20.0)
Systematic Assessment
EG0000 events0 affected304 at risk
EG0010 events0 affected301 at risk
EG0022 events2 affected294 at risk
EG003
Headache
Nervous system disorders
MedDRA (20.0)
Systematic Assessment
EG00029 events20 affected304 at risk
EG00113 events12 affected301 at risk
EG0027 events6 affected294 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA (20.0)
Systematic Assessment
EG0003 events3 affected304 at risk
EG0016 events6 affected301 at risk
EG0024 events3 affected294 at risk
EG003
Hypertension
Vascular disorders
MedDRA (20.0)
Systematic Assessment
EG00012 events8 affected304 at risk
EG0011 events1 affected301 at risk
EG0029 events9 affected294 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
AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
P-value calculated according to the Cochran-Mantel-Haenszel test adjusted for baseline weight (≤100 kg vs >100 kg) and prior exposure to TNF antagonists (0 vs ≥1).
Cochran-Mantel-Haenszel
<0.001
difference in percentage of participants
23.3
2-Sided
95
16.6
30.1
Other
Units
Counts
Participants
OG00056
OG00153
Title
Denominators
Categories
Title
Measurements
OG00021.4
OG00166.0
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
P-value calculated according to the Cochran-Mantel-Haenszel test adjusted for baseline weight (≤100 kg vs >100 kg) and prior exposure to TNF antagonists (0 vs ≥1).
Cochran-Mantel-Haenszel
<0.001
difference in percentage of participants
45.0
2-Sided
95
28.9
61.1
Other
Units
Counts
Participants
OG000304
OG001301
Title
Denominators
Categories
Title
Measurements
OG00071.7
OG00190.7
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
P-value calculated according to the Cochran-Mantel-Haenszel test adjusted for baseline weight (≤100 kg vs >100 kg) and prior exposure to TNF antagonists (0 vs ≥1).
Cochran-Mantel-Haenszel
<0.001
difference in percentage of participants
18.9
2-Sided
95
13.0
24.9
Other
Units
Counts
Participants
OG000304
OG001301
Title
Denominators
Categories
Title
Measurements
OG00023.0
OG00139.9
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
P-value calculated according to the Cochran-Mantel-Haenszel test adjusted for baseline weight (≤100 kg vs >100 kg) and prior exposure to TNF antagonists (0 vs ≥1).
Cochran-Mantel-Haenszel
<0.001
difference in percentage of participants
16.7
2-Sided
95
9.5
23.9
Other
Units
Counts
Participants
OG00056
OG00153
Title
Denominators
Categories
Title
Measurements
OG0007.1
OG00139.6
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
P-value calculated according to the Cochran-Mantel-Haenszel test adjusted for baseline weight (≤100 kg vs >100 kg) and prior exposure to TNF antagonists (0 vs ≥1).
Cochran-Mantel-Haenszel
<0.001
difference in percentage of participants
32.8
2-Sided
95
18.8
46.9
Other
Units
Counts
Participants
OG00056
OG00153
Title
Denominators
Categories
Title
Measurements
OG0007.1
OG00139.6
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
P-value calculated according to the Cochran-Mantel-Haenszel test adjusted for baseline weight (≤100 kg vs >100 kg) and prior exposure to TNF antagonists (0 vs ≥1).
Cochran-Mantel-Haenszel
<0.001
difference in percentage of participants
32.8
2-Sided
95
18.8
46.9
Other
Units
Counts
Participants
OG00056
OG00153
Title
Denominators
Categories
Title
Measurements
OG00033.9
OG00173.6
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
P-value calculated according to the Cochran-Mantel-Haenszel test adjusted for baseline weight (≤100 kg vs >100 kg) and prior exposure to TNF antagonists (0 vs ≥1).