Abrilumab (AMG 181) in Adults With Moderate to Severe Cro... | NCT01696396 | Trialant
NCT01696396
Sponsor
Amgen
Status
Completed
Last Update Posted
Jun 27, 2019Actual
Enrollment
254Actual
Phase
Phase 2
Conditions
Crohn's Disease
Interventions
Abrilumab
Placebo
Countries
United States
Austria
Belgium
Canada
Czechia
Denmark
France
Germany
Hungary
Netherlands
Switzerland
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT01696396
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
20110232
Secondary IDs
ID
Type
Description
Link
2012-000529-31
EudraCT Number
Brief Title
Abrilumab (AMG 181) in Adults With Moderate to Severe Crohn's Disease
Official Title
A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 181 in Subjects With Moderate to Severe Crohn's Disease
Acronym
Not provided
Organization
AmgenINDUSTRY
Status Module
Record Verification Date
May 2019
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Dec 4, 2012Actual
Primary Completion Date
Dec 26, 2014Actual
Completion Date
Apr 10, 2018Actual
First Submitted Date
Sep 27, 2012
First Submission Date that Met QC Criteria
Sep 28, 2012
First Posted Date
Oct 1, 2012Estimated
Results Waived
Not provided
Results First Submitted Date
Apr 8, 2019
Results First Submitted that Met QC Criteria
May 24, 2019
Results First Posted Date
Jun 27, 2019Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Dec 19, 2015
Certification/Extension First Submitted that Passed QC Review
Dec 19, 2015
Certification/Extension First Posted Date
Jan 25, 2016Estimated
Last Update Submitted Date
May 24, 2019
Last Update Posted Date
Jun 27, 2019Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
AmgenINDUSTRY
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 primary objective of this study is to evaluate the efficacy of abrilumab as measured by the proportion of participants achieving Crohn's Disease Activity Index (CDAI) remission (CDAI < 150) after treatment for 8 weeks.
Detailed Description
The study consisted of a 24-week double-blind treatment period, a 108-week open-label treatment period, and a 2-year safety follow-up period.
Participants who did not reach minimal improvement, or experienced disease worsening after initial response, had the option to receive open-label abrilumab 210 mg every 3 months (Q3M) beginning at double-blind period week 12 or after. Not reaching minimal improvement was defined as not having an improvement in CDAI score of ≥ 70 points from baseline on 2 consecutive visits (at or after week 8) at least 2 weeks apart. Disease worsening after week 8 (or week 12) response was defined as having an increase in CDAI score of ≥ 70 points from the week 8 (or week 12) CDAI score on 2 consecutive visits at least 2 weeks apart, and a CDAI score of > 150.
Participants were planned to be randomized in a 2:1:2:1 ratio to SC placebo or abrilumab at 21 mg, 70 mg (on day 1, week 2, week 4, and every 4 weeks thereafter until week 24), or 210 mg (on day 1 followed by placebo in weeks 2 and 4 and every 4 weeks thereafter until week 24), respectively. Due to a consistent discrepancy between the investigational product (IP) instruction manual (IPIM) description of vial positions and the actual vial positions in the IP package participants were initially randomized to 3 arms (placebo, 70 mg, and 210 mg) with a randomization ratio of 3:2:1. The study was temporarily paused while this issue was investigated. Once the discrepancy was corrected, Protocol Amendment 3 implemented, and affected participants completed their double-blind treatment period, the study resumed enrollment and randomization per protocol. Neither the randomization nor study blind was compromised and therefore the intent-to-treat principle was maintained.
Conditions Module
Conditions
Crohn's Disease
Keywords
IBD, Crohn's Disease
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 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
254Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Placebo Q4W/Abrilumab 210 mg Q3M
Placebo Comparator
Participants received placebo by subcutaneous injection on day 1, week 2, week 4, and every 4 weeks thereafter until week 24.
During the open-label period, participants received abrilumab 210 mg once every 3 months (Q3M) for 108 weeks.
Drug: Abrilumab
Drug: Placebo
Abrilumab 21 mg Q4W/Abrilumab 210 mg Q3M
Experimental
Participants received 21 mg abrilumab by subcutaneous injection on day 1, week 2, week 4, and every 4 weeks (Q4W) thereafter until week 24.
During the open-label period, participants received abrilumab 210 mg once every 3 months (Q3M) for 108 weeks.
Drug: Abrilumab
Abrilumab 70 mg Q4W/Abrilumab 210 mg Q3M
Experimental
Participants received 70 mg abrilumab by subcutaneous injection on day 1, week 2, week 4, and every 4 weeks thereafter until week 24.
During the open-label period, participants received abrilumab 210 mg once every 3 months (Q3M) for 108 weeks.
Drug: Abrilumab
Abrilumab 210 mg/Abrilumab 210 mg Q3M
Experimental
Participants received a single dose of 210 mg abrilumab by subcutaneous injection on day 1, followed by placebo at week 2, week 4, and every 4 weeks thereafter until week 24.
During the open-label period, participants received abrilumab 210 mg once every 3 months (Q3M)for 108 weeks.
Drug: Abrilumab
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Abrilumab
Drug
Administered by subcutaneous injection.
Abrilumab 21 mg Q4W/Abrilumab 210 mg Q3M
Abrilumab 210 mg/Abrilumab 210 mg Q3M
Abrilumab 70 mg Q4W/Abrilumab 210 mg Q3M
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percentage of Participants With Remission at Week 8
Remission was defined as a Crohn's Disease Activity Index (CDAI) score < 150 at week 8.
The CDAI is a weighted, composite index of 8 disease variables (stool frequency, severity of abdominal pain, degree of general well-being, presence or absence of extra-intestinal manifestations or fistula, use or non-use of antidiarrheal agents, presence or absence of an abdominal mass, hematocrit, and body weight). Scores range from approximately 0 to 600, with a higher score indicating more-severe disease activity.
The remission rate (percentage of participants with remission) was calculated based on observed data (unadjusted remission rate) and also after applying a logistic regression model including the factors of treatment group, stratification factors (prior anti-TNF use and pre- versus post-Protocol Amendment 3) and baseline CDAI Score (adjusted remission rate).
Week 8
Secondary Outcomes
Measure
Description
Time Frame
Percentage of Participants With Remission at Week 12
Remission was defined as a Crohn's Disease Activity Index (CDAI) score < 150. The CDAI is a weighted, composite index of 8 disease variables (stool frequency, severity of abdominal pain, degree of general well-being, presence or absence of extra-intestinal manifestations or fistula, use or non-use of antidiarrheal agents, presence or absence of an abdominal mass, hematocrit, and body weight). Scores range from approximately 0 to 600, with a higher score indicating more-severe disease activity.
The remission rate (percentage of participants with remission) was calculated based on observed data (unadjusted remission rate) and also after applying a logistic regression model including the factors of treatment group, stratification factors (prior anti-TNF use and pre- versus post-Protocol Amendment 3) and baseline CDAI Score (adjusted remission rate).
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Diagnosed with ileal, ileo-colonic, or colonic Crohn's disease for a minimum of 6 months prior to baseline
Moderately to severely active Crohn's disease defined by a CDAI score ≥ 220 and ≤ 450 at baseline
Evidence of active inflammation within 12 weeks prior to baseline
Demonstrated an inadequate response to, loss of response to, or intolerance to at least one of the following agents: Immunomodulators and/or anti-tumor necrosis factor (TNF) agents or to corticosteroids (non-US sites only).
Neurological exam free of clinically significant, unexplained signs or symptoms during screening and no clinically significant change prior to randomization
Subject has no known history of active tuberculosis and has a negative test for tuberculosis during screening
Exclusion Criteria:
Short bowel syndrome
Stricture with obstructive symptoms within 3 months
Bowel surgery within 12 weeks prior baseline, or has planned bowel surgery within 24 weeks from baseline
Ileostomy and/or colostomy
Any gastric or intestinal pouch
Evidence of an infected abscess
Bowel perforation or evidence of non-inflammatory obstruction during the 6 months prior to baseline
Stool positive for C. difficile toxin at screening
Any uncontrolled or clinically significant systemic disease
Known to have tested positive for hepatitis B virus surface antigen, hepatitis C virus antibody, or human immunodeficiency virus (HIV)
Any underlying condition that predisposes subject to infections
Subject has malignancy (other than resected cutaneous basal or cutaneous squamous cell carcinoma, or treated in situ cervical cancer considered cured) within 5 years of baseline
Received an anti-TNF agent, cyclosporine, mycophenolate mofetil, sirolimus (rapamycin), thalidomide, tacrolimus, topical (rectal) aminosalicylic acid (eg, mesalamine) or topical (rectal) steroids, intravenous or intramuscular corticosteroids within protocol-specified time periods.
Any prior exposure to antagonists of integrins or integrin ligands (eg, natalizumab, efalizumab, or vedolizumab), rituximab, or TNF kinoid immunotherapies, AMG 181, or any form of cell-based transplantation
Received treatment of infection with intravenous (within 30 days of baseline) or oral (within 14 days prior to baseline) antibiotics, antivirals, or antifungals
Dummer R, Hoeller C, Gruter IP, Michielin O. Combining talimogene laherparepvec with immunotherapies in melanoma and other solid tumors. Cancer Immunol Immunother. 2017 Jun;66(6):683-695. doi: 10.1007/s00262-017-1967-1. Epub 2017 Feb 25.
Participants were to be randomly assigned in a 2:1:2:1 ratio to 1 of 4 treatment groups. Due to a misalignment error, some participants were erroneously assigned to incorrect treatment resulting in a final randomization ratio different from that originally stipulated in the protocol.
Recruitment Details
This study was conducted at 84 centers in Canada, European Union, and the United States. Participants were enrolled from 04 December 2012 to 30 September 2014.
The study consisted of a 24-week double-blind treatment period, a 108-week open-label treatment period, and a safety follow-up period.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Placebo/Abrilumab 210 mg Q3M
Participants randomized to receive placebo by subcutaneous injection on day 1, week 2, week 4, and every 4 weeks thereafter until week 24.
During the open-label period, participants received abrilumab 210 mg once every 3 months (Q3M) for 108 weeks.
FG001
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
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
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Triple
Masking Description
Not provided
Who Masked
ParticipantCare ProviderInvestigator
Drug: Placebo
Placebo Q4W/Abrilumab 210 mg Q3M
AMG 181
Placebo
Drug
Placebo matching to abrilumab administered by subcutaneous injection
Abrilumab 210 mg/Abrilumab 210 mg Q3M
Placebo Q4W/Abrilumab 210 mg Q3M
Week 12
Percentage of Participants With Response at Week 12
Response was defined as either remission (a CDAI score < 150) or a decrease from baseline in the CDAI score of ≥ 100 points.
The CDAI is a weighted, composite index of 8 disease variables (stool frequency, severity of abdominal pain, degree of general well-being, presence or absence of extra-intestinal manifestations or fistula, use or non-use of antidiarrheal agents, presence or absence of an abdominal mass, hematocrit, and body weight). Scores range from approximately 0 to 600, with a higher score indicating more-severe disease activity.
The response rate (percentage of participants with response) was calculated based on observed data (unadjusted response rate) and also after applying a logistic regression model including the factors of treatment group, stratification factors (prior anti-TNF use and pre- versus post-Protocol Amendment 3) and baseline CDAI score (adjusted response rate).
Baseline and week 12
Percentage of Participants With Response at Week 8
Response was defined as either remission (a CDAI score < 150) or a decrease from baseline in the CDAI score of ≥ 100 points.
The CDAI is a weighted, composite index of 8 disease variables (stool frequency, severity of abdominal pain, degree of general well-being, presence or absence of extra-intestinal manifestations or fistula, use or non-use of antidiarrheal agents, presence or absence of an abdominal mass, hematocrit, and body weight). Scores range from approximately 0 to 600, with a higher score indicating more-severe disease activity.
The response rate (percentage of participants with response) was calculated based on observed data (unadjusted response rate) and also after applying a logistic regression model including the factors of treatment group, stratification factors (prior anti-TNF use and pre- versus post-Protocol Amendment 3) and baseline CDAI score (adjusted response rate).
Baseline and week 8
Percentage of Participants With Sustained Remission at Both Week 12 and Week 24
Remission was defined as a Crohn's Disease Activity Index (CDAI) score < 150. Sustained remission was defined as achieving the criteria for remission at both week 12 and week 24.
The CDAI is a weighted, composite index of 8 disease variables (stool frequency, severity of abdominal pain, degree of general well-being, presence or absence of extra-intestinal manifestations or fistula, use or non-use of antidiarrheal agents, presence or absence of an abdominal mass, hematocrit, and body weight). Scores range from approximately 0 to 600, with a higher score indicating more-severe disease activity.
The remission rate (percentage of participants with sustained remission) was calculated based on observed data (unadjusted remission rate) and also after applying a logistic regression model including the factors of treatment group, stratification factors (prior anti-TNF use and pre- versus post-Protocol Amendment 3) and baseline CDAI Score (adjusted remission rate).
Week 12 and week 24
Percentage of Participants With Sustained Remission at Both Week 8 and Week 24
Remission was defined as a Crohn's Disease Activity Index (CDAI) score < 150. Sustained remission was defined as achieving the criteria for remission at both week 8 and week 24.
The CDAI is a weighted, composite index of 8 disease variables (stool frequency, severity of abdominal pain, degree of general well-being, presence or absence of extra-intestinal manifestations or fistula, use or non-use of antidiarrheal agents, presence or absence of an abdominal mass, hematocrit, and body weight). Scores range from approximately 0 to 600, with a higher score indicating more-severe disease activity.
The remission rate (percentage of participants with sustained remission) was calculated based on observed data (unadjusted remission rate) and also after applying a logistic regression model including the factors of treatment group, stratification factors (prior anti-TNF use and pre- versus post-Protocol Amendment 3) and baseline CDAI Score (adjusted remission rate).
Week 8 and week 24
Change From Baseline in CDAI Score at Week 12
The CDAI is a weighted, composite index of 8 disease variables (stool frequency, severity of abdominal pain, degree of general well-being, presence or absence of extra-intestinal manifestations or fistula, use or non-use of antidiarrheal agents, presence or absence of an abdominal mass, hematocrit, and body weight). Scores range from approximately 0 to 600, with a higher score indicating more-severe disease activity.
Baseline and week 12
Change From Baseline in CDAI Score at Week 8
The CDAI is a weighted, composite index of 8 disease variables (stool frequency, severity of abdominal pain, degree of general well-being, presence or absence of extra-intestinal manifestations or fistula, use or non-use of antidiarrheal agents, presence or absence of an abdominal mass, hematocrit, and body weight). Scores range from approximately 0 to 600, with a higher score indicating more-severe disease activity.
Participants randomized to receive 21 mg abrilumab by subcutaneous injection on day 1, week 2, week 4, and every 4 weeks (Q4W) thereafter until week 24.
During the open-label period, participants received abrilumab 210 mg once every 3 months for 108 weeks.
FG002
Abrilumab 70 mg Q4W/Abrilumab 210 mg Q3M
Participants randomized to receive 70 mg abrilumab by subcutaneous injection on day 1, week 2, week 4, and every 4 weeks thereafter until week 24.
During the open-label period, participants received abrilumab 210 mg once every 3 months for 108 weeks.
FG003
Abrilumab 210 mg/Abrilumab 210 mg Q3M
Participants randomized to receive a single dose of 210 mg abrilumab by subcutaneous injection on day 1, followed by placebo at week 2, week 4, and every 4 weeks thereafter until week 24.
During the open-label period, participants received abrilumab 210 mg once every 3 months for 108 weeks.
FG000100 subjects
FG00127 subjects
FG00285 subjects
FG00342 subjects
Received Study Drug
FG00098 subjects
FG00126 subjects
FG00284 subjects
FG00341 subjects
Entered Open-label Period
FG00084 subjects
FG00121 subjects
FG00275 subjects
FG00337 subjects
COMPLETED
Participants who completed the safety follow-up period
FG00069 subjects
FG00120 subjects
FG00259 subjects
FG00328 subjects
NOT COMPLETED
FG00031 subjects
FG0017 subjects
FG00226 subjects
FG00314 subjects
Type
Comment
Reasons
Withdrawal by Subject
FG00019 subjects
FG0015 subjects
FG00219 subjects
FG00311 subjects
Decision by Sponsor
FG0003 subjects
FG0011 subjects
FG0022 subjects
FG0032 subjects
Lost to Follow-up
FG0009 subjects
FG0011 subjects
FG0024 subjects
FG0031 subjects
Death
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Placebo
Participants randomized to receive placebo by subcutaneous injection on day 1, week 2, week 4, and every 4 weeks thereafter until week 24 during the double-blind treatment period.
BG001
Abrilumab 21 mg Q4W
Participants randomized to receive 21 mg abrilumab by subcutaneous injection on day 1, week 2, week 4, and every 4 weeks (Q4W) thereafter until week 24 during the double-blind treatment period.
BG002
Abrilumab 70 mg Q4W
Participants randomized to receive 70 mg abrilumab by subcutaneous injection on day 1, week 2, week 4, and every 4 weeks thereafter until week 24 during the double-blind treatment period.
BG003
Abrilumab 210 mg
Participants randomized to receive a single dose of 210 mg abrilumab by subcutaneous injection on day 1, followed by placebo at week 2, week 4, and every 4 weeks thereafter until week 24 during the double-blind treatment period.
BG004
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000100
BG00127
BG00285
BG00342
BG004254
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
ParticipantsBG000100
ParticipantsBG00127
ParticipantsBG00285
ParticipantsBG003
Age, Customized
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG000100
ParticipantsBG00127
ParticipantsBG002
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG000100
ParticipantsBG00127
ParticipantsBG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG000100
ParticipantsBG00127
ParticipantsBG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG000100
ParticipantsBG00127
ParticipantsBG002
Any Prior Anti-Tumor Necrosis Factor (TNF) Use
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG000100
ParticipantsBG00127
ParticipantsBG002
Enrollment Prior to Protocol Amendment 3
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG000100
ParticipantsBG00127
ParticipantsBG002
Duration of Crohn's Diease
Mean
Standard Deviation
years
Title
Denominators
Categories
ParticipantsBG000100
ParticipantsBG00127
ParticipantsBG002
Crohn's Disease Activity Index (CDAI) Score
The CDAI is a weighted, composite index of 8 disease variables (stool frequency, severity of abdominal pain, degree of general well-being, presence or absence of extra-intestinal manifestations or fistula, use or non-use of antidiarrheal agents, presence or absence of an abdominal mass, hematocrit, and body weight). Scores range from approximately 0 to 600, with a higher score indicating more-severe disease activity. Patients with scores of > 450 are considered to have very severe disease.
Participants with available data
Mean
Standard Deviation
units on a scale
Title
Denominators
Categories
ParticipantsBG00099
ParticipantsBG001
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 Remission at Week 8
Remission was defined as a Crohn's Disease Activity Index (CDAI) score < 150 at week 8.
The CDAI is a weighted, composite index of 8 disease variables (stool frequency, severity of abdominal pain, degree of general well-being, presence or absence of extra-intestinal manifestations or fistula, use or non-use of antidiarrheal agents, presence or absence of an abdominal mass, hematocrit, and body weight). Scores range from approximately 0 to 600, with a higher score indicating more-severe disease activity.
The remission rate (percentage of participants with remission) was calculated based on observed data (unadjusted remission rate) and also after applying a logistic regression model including the factors of treatment group, stratification factors (prior anti-TNF use and pre- versus post-Protocol Amendment 3) and baseline CDAI Score (adjusted remission rate).
The full analysis set includes all randomized participants who received at least 1 dose of study drug. Both unadjusted and adjusted remission rates were calculated using non-responder imputation, where participants with a missing CDAI Score at week 8 were counted as non-responders.
Posted
Number
percentage of participants
Week 8
ID
Title
Description
OG000
Placebo
Participants randomized to receive placebo by subcutaneous injection on day 1, week 2, week 4, and every 4 weeks thereafter until week 24 during the double-blind treatment period.
OG001
Abrilumab 21 mg Q4W
Participants randomized to receive 21 mg abrilumab by subcutaneous injection on day 1, week 2, week 4, and every 4 weeks (Q4W) thereafter until week 24 during the double-blind treatment period.
OG002
Abrilumab 70 mg Q4W
Participants randomized to receive 70 mg abrilumab by subcutaneous injection on day 1, week 2, week 4, and every 4 weeks thereafter until week 24 during the double-blind treatment period.
OG003
Abrilumab 210 mg
Participants randomized to receive a single dose of 210 mg abrilumab by subcutaneous injection on day 1, followed by placebo at week 2, week 4, and every 4 weeks thereafter until week 24 during the double-blind treatment period.
Units
Counts
Participants
OG00098
OG00126
OG00284
OG003
Title
Denominators
Categories
Unadjusted remission rate
Title
Measurements
OG00013.3
OG00123.1
OG00214.3
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
OG002
Comparisons between treatment groups were made using remission rates estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).
Regression, Logistic
Adjusted for baseline CDAI score and stratification factors.
0.76
Odds Ratio (OR)
1.15
2-Sided
90
0.54
2.44
An odds ratio > 1.0 indicates a higher remission rate for the abrilumab treatment group relative to placebo.
Superiority
Secondary
Percentage of Participants With Remission at Week 12
Remission was defined as a Crohn's Disease Activity Index (CDAI) score < 150. The CDAI is a weighted, composite index of 8 disease variables (stool frequency, severity of abdominal pain, degree of general well-being, presence or absence of extra-intestinal manifestations or fistula, use or non-use of antidiarrheal agents, presence or absence of an abdominal mass, hematocrit, and body weight). Scores range from approximately 0 to 600, with a higher score indicating more-severe disease activity.
The remission rate (percentage of participants with remission) was calculated based on observed data (unadjusted remission rate) and also after applying a logistic regression model including the factors of treatment group, stratification factors (prior anti-TNF use and pre- versus post-Protocol Amendment 3) and baseline CDAI Score (adjusted remission rate).
The full analysis set includes all randomized participants who received at least 1 dose of study drug. Both unadjusted and adjusted remission rates were calculated using non-responder imputation, where participants with a missing CDAI Score at week 12 were counted as non-responders.
Posted
Number
percentage of participants
Week 12
ID
Title
Description
OG000
Placebo
Participants randomized to receive placebo by subcutaneous injection on day 1, week 2, week 4, and every 4 weeks thereafter until week 24 during the double-blind treatment period.
OG001
Abrilumab 21 mg Q4W
Secondary
Percentage of Participants With Response at Week 12
Response was defined as either remission (a CDAI score < 150) or a decrease from baseline in the CDAI score of ≥ 100 points.
The CDAI is a weighted, composite index of 8 disease variables (stool frequency, severity of abdominal pain, degree of general well-being, presence or absence of extra-intestinal manifestations or fistula, use or non-use of antidiarrheal agents, presence or absence of an abdominal mass, hematocrit, and body weight). Scores range from approximately 0 to 600, with a higher score indicating more-severe disease activity.
The response rate (percentage of participants with response) was calculated based on observed data (unadjusted response rate) and also after applying a logistic regression model including the factors of treatment group, stratification factors (prior anti-TNF use and pre- versus post-Protocol Amendment 3) and baseline CDAI score (adjusted response rate).
The full analysis set includes all randomized participants who received at least 1 dose of study drug. Both unadjusted and adjusted response rates were calculated using non-responder imputation, where participants with a missing CDAI Score at week 12 were counted as non-responders.
Posted
Number
percentage of participants
Baseline and week 12
ID
Title
Description
OG000
Placebo
Participants randomized to receive placebo by subcutaneous injection on day 1, week 2, week 4, and every 4 weeks thereafter until week 24 during the double-blind treatment period.
OG001
Abrilumab 21 mg Q4W
Secondary
Percentage of Participants With Response at Week 8
Response was defined as either remission (a CDAI score < 150) or a decrease from baseline in the CDAI score of ≥ 100 points.
The CDAI is a weighted, composite index of 8 disease variables (stool frequency, severity of abdominal pain, degree of general well-being, presence or absence of extra-intestinal manifestations or fistula, use or non-use of antidiarrheal agents, presence or absence of an abdominal mass, hematocrit, and body weight). Scores range from approximately 0 to 600, with a higher score indicating more-severe disease activity.
The response rate (percentage of participants with response) was calculated based on observed data (unadjusted response rate) and also after applying a logistic regression model including the factors of treatment group, stratification factors (prior anti-TNF use and pre- versus post-Protocol Amendment 3) and baseline CDAI score (adjusted response rate).
The full analysis set includes all randomized participants who received at least 1 dose of study drug. Both unadjusted and adjusted response rates were calculated using non-responder imputation, where participants with a missing CDAI Score at week 8 were counted as non-responders.
Posted
Number
percentage of participants
Baseline and week 8
ID
Title
Description
OG000
Placebo
Participants randomized to receive placebo by subcutaneous injection on day 1, week 2, week 4, and every 4 weeks thereafter until week 24 during the double-blind treatment period.
OG001
Abrilumab 21 mg Q4W
Secondary
Percentage of Participants With Sustained Remission at Both Week 12 and Week 24
Remission was defined as a Crohn's Disease Activity Index (CDAI) score < 150. Sustained remission was defined as achieving the criteria for remission at both week 12 and week 24.
The CDAI is a weighted, composite index of 8 disease variables (stool frequency, severity of abdominal pain, degree of general well-being, presence or absence of extra-intestinal manifestations or fistula, use or non-use of antidiarrheal agents, presence or absence of an abdominal mass, hematocrit, and body weight). Scores range from approximately 0 to 600, with a higher score indicating more-severe disease activity.
The remission rate (percentage of participants with sustained remission) was calculated based on observed data (unadjusted remission rate) and also after applying a logistic regression model including the factors of treatment group, stratification factors (prior anti-TNF use and pre- versus post-Protocol Amendment 3) and baseline CDAI Score (adjusted remission rate).
The full analysis set includes all randomized participants who received at least 1 dose of study drug. Both unadjusted and adjusted sustained remission rates were calculated using non-responder imputation, where participants with missing CDAI scores at week 12 or week 24 were counted as non-responders.
Posted
Number
percentage of participants
Week 12 and week 24
ID
Title
Description
OG000
Placebo
Participants randomized to receive placebo by subcutaneous injection on day 1, week 2, week 4, and every 4 weeks thereafter until week 24 during the double-blind treatment period.
Secondary
Percentage of Participants With Sustained Remission at Both Week 8 and Week 24
Remission was defined as a Crohn's Disease Activity Index (CDAI) score < 150. Sustained remission was defined as achieving the criteria for remission at both week 8 and week 24.
The CDAI is a weighted, composite index of 8 disease variables (stool frequency, severity of abdominal pain, degree of general well-being, presence or absence of extra-intestinal manifestations or fistula, use or non-use of antidiarrheal agents, presence or absence of an abdominal mass, hematocrit, and body weight). Scores range from approximately 0 to 600, with a higher score indicating more-severe disease activity.
The remission rate (percentage of participants with sustained remission) was calculated based on observed data (unadjusted remission rate) and also after applying a logistic regression model including the factors of treatment group, stratification factors (prior anti-TNF use and pre- versus post-Protocol Amendment 3) and baseline CDAI Score (adjusted remission rate).
The full analysis set includes all randomized participants who received at least 1 dose of study drug. Both unadjusted and adjusted sustained remission rates were calculated using non-responder imputation, where participants with missing CDAI scores at week 8 or week 24 were counted as non-responders.
Posted
Number
percentage of participants
Week 8 and week 24
ID
Title
Description
OG000
Placebo
Participants randomized to receive placebo by subcutaneous injection on day 1, week 2, week 4, and every 4 weeks thereafter until week 24 during the double-blind treatment period.
Secondary
Change From Baseline in CDAI Score at Week 12
The CDAI is a weighted, composite index of 8 disease variables (stool frequency, severity of abdominal pain, degree of general well-being, presence or absence of extra-intestinal manifestations or fistula, use or non-use of antidiarrheal agents, presence or absence of an abdominal mass, hematocrit, and body weight). Scores range from approximately 0 to 600, with a higher score indicating more-severe disease activity.
The full analysis set includes all randomized participants who received at least 1 dose of study drug. Missing data were handled using the inverse probability weighting (IPW) method.
Posted
Least Squares Mean
Standard Error
units on a scale
Baseline and week 12
ID
Title
Description
OG000
Placebo
Participants randomized to receive placebo by subcutaneous injection on day 1, week 2, week 4, and every 4 weeks thereafter until week 24 during the double-blind treatment period.
OG001
Abrilumab 21 mg Q4W
Participants randomized to receive 21 mg abrilumab by subcutaneous injection on day 1, week 2, week 4, and every 4 weeks (Q4W) thereafter until week 24 during the double-blind treatment period.
OG002
Abrilumab 70 mg Q4W
Secondary
Change From Baseline in CDAI Score at Week 8
The CDAI is a weighted, composite index of 8 disease variables (stool frequency, severity of abdominal pain, degree of general well-being, presence or absence of extra-intestinal manifestations or fistula, use or non-use of antidiarrheal agents, presence or absence of an abdominal mass, hematocrit, and body weight). Scores range from approximately 0 to 600, with a higher score indicating more-severe disease activity.
The full analysis set includes all randomized participants who received at least 1 dose of study drug. Missing data were handled using the inverse probability weighting (IPW) method.
Posted
Least Squares Mean
Standard Error
units on a scale
Baseline and week 8
ID
Title
Description
OG000
Placebo
Participants randomized to receive placebo by subcutaneous injection on day 1, week 2, week 4, and every 4 weeks thereafter until week 24 during the double-blind treatment period.
OG001
Abrilumab 21 mg Q4W
Participants randomized to receive 21 mg abrilumab by subcutaneous injection on day 1, week 2, week 4, and every 4 weeks (Q4W) thereafter until week 24 during the double-blind treatment period.
OG002
Abrilumab 70 mg Q4W
Time Frame
From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
Description
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
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
DB Period: Placebo
Participants received placebo by subcutaneous injection on day 1, week 2, week 4, and every 4 weeks thereafter until week 24 during the double-blind (DB) treatment period.
14
98
61
98
EG001
DB Period: Abrilumab 21 mg Q4W
Participants received 21 mg abrilumab by subcutaneous injection on day 1, week 2, week 4, and every 4 weeks thereafter until week 24 during the double-blind treatment period.
7
25
14
25
EG002
DB Period: Abrilumab 70 mg Q4W
Participants received 70 mg abrilumab by subcutaneous injection on day 1, week 2, week 4, and every 4 weeks thereafter until week 24 during the double-blind treatment period.
13
85
48
85
EG003
DB Period: Abrilumab 210 mg
Participants received a single dose of 210 mg abrilumab by subcutaneous injection on day 1, followed by placebo at week 2, week 4, and every 4 weeks thereafter until week 24 during the double-blind treatment period.
6
41
27
41
EG004
OL Period: Placebo/Abrilumab 210 mg Q3M
Participants who received placebo during the double-blind treatment period received abrilumab 210 mg once every 3 months (Q3M) for 108 weeks during the open-label (OL) treatment period.
24
84
61
84
EG005
OL Period: Abrilumab 21 mg Q4W/210 mg Q3M
During the open-label period, participants who received 21 mg abrilumab Q4W during the DB treatment period received abrilumab 210 mg once every 3 months for 108 weeks.
3
20
16
20
EG006
OL Period: Abrilumab 70 mg Q4W/210 mg Q3M
Participants who received 70 mg abrilumab Q4W during the DB treatment period received abrilumab 210 mg once every 3 months for 108 weeks during the open-label period.
19
76
55
76
EG007
Period: Abrilumab 210 mg/210 mg Q3M
Participants who received 210 mg abrilumab during the DB treatment period received abrilumab 210 mg once every 3 months for 108 weeks during the open-label period.
12
37
28
37
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected98 at risk
EG0010 affected25 at risk
EG0020 affected85 at risk
EG0031 affected41 at risk
EG0040 affected84 at risk
EG0050 affected20 at risk
EG0060 affected76 at risk
EG0070 affected37 at risk
Acute myocardial infarction
Cardiac disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected98 at risk
EG0010 affected25 at risk
EG0020 affected85 at risk
EG003
Cardiac arrest
Cardiac disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected98 at risk
EG0010 affected25 at risk
EG0020 affected85 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected98 at risk
EG0010 affected25 at risk
EG0020 affected85 at risk
EG003
Myocardial ischaemia
Cardiac disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected98 at risk
EG0010 affected25 at risk
EG0020 affected85 at risk
EG003
Abdominal hernia
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected98 at risk
EG0010 affected25 at risk
EG0020 affected85 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected98 at risk
EG0011 affected25 at risk
EG0020 affected85 at risk
EG003
Abdominal pain lower
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected98 at risk
EG0010 affected25 at risk
EG0020 affected85 at risk
EG003
Anal fistula
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected98 at risk
EG0010 affected25 at risk
EG0021 affected85 at risk
EG003
Chronic gastritis
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected98 at risk
EG0010 affected25 at risk
EG0020 affected85 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected98 at risk
EG0010 affected25 at risk
EG0020 affected85 at risk
EG003
Crohn's disease
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0009 affected98 at risk
EG0014 affected25 at risk
EG0023 affected85 at risk
EG003
Enteritis
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected98 at risk
EG0010 affected25 at risk
EG0020 affected85 at risk
EG003
Enterocolonic fistula
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected98 at risk
EG0010 affected25 at risk
EG0020 affected85 at risk
EG003
Ileal stenosis
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected98 at risk
EG0010 affected25 at risk
EG0020 affected85 at risk
EG003
Ileus
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected98 at risk
EG0010 affected25 at risk
EG0021 affected85 at risk
EG003
Intestinal obstruction
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected98 at risk
EG0010 affected25 at risk
EG0021 affected85 at risk
EG003
Large intestine perforation
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected98 at risk
EG0010 affected25 at risk
EG0020 affected85 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0001 affected98 at risk
EG0010 affected25 at risk
EG0023 affected85 at risk
EG003
Adverse drug reaction
General disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected98 at risk
EG0010 affected25 at risk
EG0020 affected85 at risk
EG003
Chills
General disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected98 at risk
EG0010 affected25 at risk
EG0020 affected85 at risk
EG003
Influenza like illness
General disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected98 at risk
EG0010 affected25 at risk
EG0020 affected85 at risk
EG003
Multiple organ dysfunction syndrome
General disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected98 at risk
EG0010 affected25 at risk
EG0020 affected85 at risk
EG003
Pyrexia
General disorders
MedDRA 20.1
Systematic Assessment
EG0001 affected98 at risk
EG0010 affected25 at risk
EG0020 affected85 at risk
EG003
Bile duct stone
Hepatobiliary disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected98 at risk
EG0010 affected25 at risk
EG0020 affected85 at risk
EG003
Biliary colic
Hepatobiliary disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected98 at risk
EG0010 affected25 at risk
EG0020 affected85 at risk
EG003
Drug-induced liver injury
Hepatobiliary disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected98 at risk
EG0010 affected25 at risk
EG0020 affected85 at risk
EG003
Hepatic function abnormal
Hepatobiliary disorders
MedDRA 20.1
Systematic Assessment
EG0001 affected98 at risk
EG0010 affected25 at risk
EG0020 affected85 at risk
EG003
Abdominal abscess
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 affected98 at risk
EG0011 affected25 at risk
EG0020 affected85 at risk
EG003
Abdominal wall abscess
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0001 affected98 at risk
EG0010 affected25 at risk
EG0021 affected85 at risk
EG003
Abscess intestinal
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 affected98 at risk
EG0011 affected25 at risk
EG0020 affected85 at risk
EG003
Anal abscess
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 affected98 at risk
EG0010 affected25 at risk
EG0021 affected85 at risk
EG003
Appendicitis perforated
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 affected98 at risk
EG0010 affected25 at risk
EG0020 affected85 at risk
EG003
Clostridium difficile colitis
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0001 affected98 at risk
EG0010 affected25 at risk
EG0020 affected85 at risk
EG003
Clostridium difficile infection
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 affected98 at risk
EG0010 affected25 at risk
EG0020 affected85 at risk
EG003
Erysipelas
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 affected98 at risk
EG0010 affected25 at risk
EG0020 affected85 at risk
EG003
Escherichia sepsis
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0001 affected98 at risk
EG0010 affected25 at risk
EG0020 affected85 at risk
EG003
Escherichia urinary tract infection
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 affected98 at risk
EG0010 affected25 at risk
EG0020 affected85 at risk
EG003
External ear cellulitis
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 affected98 at risk
EG0010 affected25 at risk
EG0020 affected85 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 affected98 at risk
EG0010 affected25 at risk
EG0020 affected85 at risk
EG003
Gastroenteritis viral
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 affected98 at risk
EG0010 affected25 at risk
EG0021 affected85 at risk
EG003
Influenza
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 affected98 at risk
EG0010 affected25 at risk
EG0020 affected85 at risk
EG003
Intrauterine infection
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 affected98 at risk
EG0010 affected25 at risk
EG0020 affected85 at risk
EG003
Necrotising fasciitis
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 affected98 at risk
EG0010 affected25 at risk
EG0020 affected85 at risk
EG003
Pelvic abscess
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 affected98 at risk
EG0010 affected25 at risk
EG0020 affected85 at risk
EG003
Perineal abscess
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 affected98 at risk
EG0010 affected25 at risk
EG0021 affected85 at risk
EG003
Pneumonia parainfluenzae viral
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 affected98 at risk
EG0010 affected25 at risk
EG0021 affected85 at risk
EG003
Postoperative wound infection
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 affected98 at risk
EG0010 affected25 at risk
EG0021 affected85 at risk
EG003
Psoas abscess
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 affected98 at risk
EG0010 affected25 at risk
EG0020 affected85 at risk
EG003
Retroperitoneal abscess
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 affected98 at risk
EG0010 affected25 at risk
EG0020 affected85 at risk
EG003
Septic shock
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 affected98 at risk
EG0010 affected25 at risk
EG0020 affected85 at risk
EG003
Tubo-ovarian abscess
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 affected98 at risk
EG0010 affected25 at risk
EG0020 affected85 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0001 affected98 at risk
EG0010 affected25 at risk
EG0020 affected85 at risk
EG003
Vulval abscess
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 affected98 at risk
EG0010 affected25 at risk
EG0021 affected85 at risk
EG003
Anastomotic leak
Injury, poisoning and procedural complications
MedDRA 20.1
Systematic Assessment
EG0000 affected98 at risk
EG0010 affected25 at risk
EG0020 affected85 at risk
EG003
Clavicle fracture
Injury, poisoning and procedural complications
MedDRA 20.1
Systematic Assessment
EG0001 affected98 at risk
EG0010 affected25 at risk
EG0020 affected85 at risk
EG003
Intestinal anastomosis complication
Injury, poisoning and procedural complications
MedDRA 20.1
Systematic Assessment
EG0000 affected98 at risk
EG0010 affected25 at risk
EG0020 affected85 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected98 at risk
EG0010 affected25 at risk
EG0020 affected85 at risk
EG003
Chronic myeloid leukaemia
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 20.1
Systematic Assessment
EG0000 affected98 at risk
EG0010 affected25 at risk
EG0020 affected85 at risk
EG003
Cerebrovascular accident
Nervous system disorders
MedDRA 20.1
Systematic Assessment
EG0001 affected98 at risk
EG0010 affected25 at risk
EG0020 affected85 at risk
EG003
Transient ischaemic attack
Nervous system disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected98 at risk
EG0010 affected25 at risk
EG0020 affected85 at risk
EG003
Nephritis
Renal and urinary disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected98 at risk
EG0010 affected25 at risk
EG0020 affected85 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected98 at risk
EG0010 affected25 at risk
EG0020 affected85 at risk
EG003
Cervical dysplasia
Reproductive system and breast disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected98 at risk
EG0010 affected25 at risk
EG0020 affected85 at risk
EG003
Pleuritic pain
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected98 at risk
EG0011 affected25 at risk
EG0020 affected85 at risk
EG003
Aborted pregnancy
Social circumstances
MedDRA 20.1
Systematic Assessment
EG0000 affected98 at risk
EG0010 affected25 at risk
EG0021 affected85 at risk
EG003
Cholecystectomy
Surgical and medical procedures
MedDRA 20.1
Systematic Assessment
EG0000 affected98 at risk
EG0010 affected25 at risk
EG0020 affected85 at risk
EG003
Ileocolectomy
Surgical and medical procedures
MedDRA 20.1
Systematic Assessment
EG0000 affected98 at risk
EG0010 affected25 at risk
EG0020 affected85 at risk
EG003
Scoliosis surgery
Surgical and medical procedures
MedDRA 20.1
Systematic Assessment
EG0000 affected98 at risk
EG0010 affected25 at risk
EG0020 affected85 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 20.1
Systematic Assessment
EG0001 affected98 at risk
EG0010 affected25 at risk
EG0020 affected85 at risk
EG0030 affected41 at risk
EG0043 affected84 at risk
EG0052 affected20 at risk
EG0063 affected76 at risk
EG0071 affected37 at risk
Tinnitus
Ear and labyrinth disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected98 at risk
EG0010 affected25 at risk
EG0020 affected85 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0001 affected98 at risk
EG0010 affected25 at risk
EG0021 affected85 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0009 affected98 at risk
EG0011 affected25 at risk
EG0028 affected85 at risk
EG003
Anal fistula
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected98 at risk
EG0011 affected25 at risk
EG0021 affected85 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0002 affected98 at risk
EG0011 affected25 at risk
EG0021 affected85 at risk
EG003
Crohn's disease
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0008 affected98 at risk
EG0011 affected25 at risk
EG0022 affected85 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0002 affected98 at risk
EG0010 affected25 at risk
EG0024 affected85 at risk
EG003
Gastrointestinal fistula
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected98 at risk
EG0010 affected25 at risk
EG0020 affected85 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0008 affected98 at risk
EG0011 affected25 at risk
EG0022 affected85 at risk
EG003
Oral discomfort
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected98 at risk
EG0011 affected25 at risk
EG0020 affected85 at risk
EG003
Proctalgia
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0002 affected98 at risk
EG0011 affected25 at risk
EG0021 affected85 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0001 affected98 at risk
EG0010 affected25 at risk
EG0020 affected85 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0003 affected98 at risk
EG0010 affected25 at risk
EG0023 affected85 at risk
EG003
Asthenia
General disorders
MedDRA 20.1
Systematic Assessment
EG0002 affected98 at risk
EG0011 affected25 at risk
EG0021 affected85 at risk
EG003
Fatigue
General disorders
MedDRA 20.1
Systematic Assessment
EG0004 affected98 at risk
EG0011 affected25 at risk
EG0022 affected85 at risk
EG003
Influenza like illness
General disorders
MedDRA 20.1
Systematic Assessment
EG0004 affected98 at risk
EG0013 affected25 at risk
EG0024 affected85 at risk
EG003
Malaise
General disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected98 at risk
EG0010 affected25 at risk
EG0021 affected85 at risk
EG003
Oedema peripheral
General disorders
MedDRA 20.1
Systematic Assessment
EG0001 affected98 at risk
EG0010 affected25 at risk
EG0021 affected85 at risk
EG003
Pain
General disorders
MedDRA 20.1
Systematic Assessment
EG0002 affected98 at risk
EG0010 affected25 at risk
EG0020 affected85 at risk
EG003
Pyrexia
General disorders
MedDRA 20.1
Systematic Assessment
EG0002 affected98 at risk
EG0012 affected25 at risk
EG0024 affected85 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected98 at risk
EG0010 affected25 at risk
EG0020 affected85 at risk
EG003
Seasonal allergy
Immune system disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected98 at risk
EG0010 affected25 at risk
EG0020 affected85 at risk
EG003
Anal abscess
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0001 affected98 at risk
EG0011 affected25 at risk
EG0022 affected85 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0002 affected98 at risk
EG0011 affected25 at risk
EG0023 affected85 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 affected98 at risk
EG0010 affected25 at risk
EG0020 affected85 at risk
EG003
Clostridium difficile infection
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 affected98 at risk
EG0010 affected25 at risk
EG0021 affected85 at risk
EG003
Conjunctivitis
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0001 affected98 at risk
EG0010 affected25 at risk
EG0020 affected85 at risk
EG003
Fungal infection
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 affected98 at risk
EG0010 affected25 at risk
EG0020 affected85 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0006 affected98 at risk
EG0010 affected25 at risk
EG0023 affected85 at risk
EG003
Gastroenteritis viral
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 affected98 at risk
EG0010 affected25 at risk
EG0021 affected85 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 affected98 at risk
EG0010 affected25 at risk
EG0020 affected85 at risk
EG003
Influenza
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0001 affected98 at risk
EG0011 affected25 at risk
EG0021 affected85 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG00011 affected98 at risk
EG0012 affected25 at risk
EG0027 affected85 at risk
EG003
Psoas abscess
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 affected98 at risk
EG0010 affected25 at risk
EG0020 affected85 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 affected98 at risk
EG0010 affected25 at risk
EG0021 affected85 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 affected98 at risk
EG0010 affected25 at risk
EG0027 affected85 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0002 affected98 at risk
EG0010 affected25 at risk
EG0026 affected85 at risk
EG003
Viral infection
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0001 affected98 at risk
EG0010 affected25 at risk
EG0022 affected85 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 20.1
Systematic Assessment
EG0000 affected98 at risk
EG0010 affected25 at risk
EG0020 affected85 at risk
EG003
Blood iron decreased
Investigations
MedDRA 20.1
Systematic Assessment
EG0000 affected98 at risk
EG0010 affected25 at risk
EG0020 affected85 at risk
EG003
Blood urea increased
Investigations
MedDRA 20.1
Systematic Assessment
EG0000 affected98 at risk
EG0010 affected25 at risk
EG0020 affected85 at risk
EG003
Clostridium test positive
Investigations
MedDRA 20.1
Systematic Assessment
EG0000 affected98 at risk
EG0010 affected25 at risk
EG0020 affected85 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected98 at risk
EG0010 affected25 at risk
EG0021 affected85 at risk
EG003
Magnesium deficiency
Metabolism and nutrition disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected98 at risk
EG0010 affected25 at risk
EG0020 affected85 at risk
EG003
Vitamin B12 deficiency
Metabolism and nutrition disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected98 at risk
EG0010 affected25 at risk
EG0020 affected85 at risk
EG003
Vitamin D deficiency
Metabolism and nutrition disorders
MedDRA 20.1
Systematic Assessment
EG0001 affected98 at risk
EG0010 affected25 at risk
EG0020 affected85 at risk
EG003
Zinc deficiency
Metabolism and nutrition disorders
MedDRA 20.1
Systematic Assessment
EG0001 affected98 at risk
EG0010 affected25 at risk
EG0020 affected85 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 20.1
Systematic Assessment
EG00010 affected98 at risk
EG0011 affected25 at risk
EG0028 affected85 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA 20.1
Systematic Assessment
EG0001 affected98 at risk
EG0010 affected25 at risk
EG0021 affected85 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 20.1
Systematic Assessment
EG0004 affected98 at risk
EG0010 affected25 at risk
EG0021 affected85 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 20.1
Systematic Assessment
EG0001 affected98 at risk
EG0012 affected25 at risk
EG0020 affected85 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 20.1
Systematic Assessment
EG0002 affected98 at risk
EG0012 affected25 at risk
EG0021 affected85 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 20.1
Systematic Assessment
EG0007 affected98 at risk
EG0011 affected25 at risk
EG0024 affected85 at risk
EG003
Headache
Nervous system disorders
MedDRA 20.1
Systematic Assessment
EG00011 affected98 at risk
EG0014 affected25 at risk
EG00212 affected85 at risk
EG003
Memory impairment
Nervous system disorders
MedDRA 20.1
Systematic Assessment
EG0002 affected98 at risk
EG0010 affected25 at risk
EG0020 affected85 at risk
EG003
Nervous system disorder
Nervous system disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected98 at risk
EG0010 affected25 at risk
EG0020 affected85 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA 20.1
Systematic Assessment
EG0002 affected98 at risk
EG0012 affected25 at risk
EG0027 affected85 at risk
EG003
Depression
Psychiatric disorders
MedDRA 20.1
Systematic Assessment
EG0002 affected98 at risk
EG0010 affected25 at risk
EG0020 affected85 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 20.1
Systematic Assessment
EG0003 affected98 at risk
EG0011 affected25 at risk
EG0021 affected85 at risk
EG003
Restlessness
Psychiatric disorders
MedDRA 20.1
Systematic Assessment
EG0001 affected98 at risk
EG0010 affected25 at risk
EG0020 affected85 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA 20.1
Systematic Assessment
EG0001 affected98 at risk
EG0010 affected25 at risk
EG0020 affected85 at risk
EG003
Urinary incontinence
Renal and urinary disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected98 at risk
EG0010 affected25 at risk
EG0020 affected85 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1
Systematic Assessment
EG0001 affected98 at risk
EG0010 affected25 at risk
EG0021 affected85 at risk
EG003
Hiccups
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected98 at risk
EG0010 affected25 at risk
EG0020 affected85 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1
Systematic Assessment
EG0003 affected98 at risk
EG0010 affected25 at risk
EG0024 affected85 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected98 at risk
EG0010 affected25 at risk
EG0020 affected85 at risk
EG003
Acne
Skin and subcutaneous tissue disorders
MedDRA 20.1
Systematic Assessment
EG0002 affected98 at risk
EG0012 affected25 at risk
EG0020 affected85 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA 20.1
Systematic Assessment
EG0001 affected98 at risk
EG0011 affected25 at risk
EG0020 affected85 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 20.1
Systematic Assessment
EG0001 affected98 at risk
EG0010 affected25 at risk
EG0020 affected85 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 20.1
Systematic Assessment
EG0002 affected98 at risk
EG0011 affected25 at risk
EG0020 affected85 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA 20.1
Systematic Assessment
EG0001 affected98 at risk
EG0010 affected25 at risk
EG0020 affected85 at risk
EG003
Skin ulcer
Skin and subcutaneous tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected98 at risk
EG0010 affected25 at risk
EG0020 affected85 at risk
EG003
Female sterilisation
Surgical and medical procedures
MedDRA 20.1
Systematic Assessment
EG0000 affected98 at risk
EG0010 affected25 at risk
EG0020 affected85 at risk
EG003
Hypertension
Vascular disorders
MedDRA 20.1
Systematic Assessment
EG0002 affected98 at risk
EG0010 affected25 at risk
EG0020 affected85 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
Point of Contact
Title
Organization
Phone
Extension
Email
Study Director
Amgen Inc.
866-572-6436
medinfo@amgen.com
ID
Term
D003424
Crohn Disease
Ancestor Terms
ID
Term
D015212
Inflammatory Bowel Diseases
D005759
Gastroenteritis
D005767
Gastrointestinal Diseases
D004066
Digestive System Diseases
D007410
Intestinal Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C000591337
abrilumab
Ancestor Terms
Not provided
Browse Leaves
Not provided
Browse Branches
Not provided
42
ParticipantsBG004254
Title
Measurements
BG00036.2± 11.2
BG00138.9± 14.2
BG00235.6± 11.8
BG00336.5± 9.4
BG00436.4± 11.4
85
ParticipantsBG00342
ParticipantsBG004254
Title
Measurements
18 - 64 years
BG00099
BG00127
BG00285
BG00342
BG004253
≥ 65 years
BG0001
BG0010
BG0020
BG0030
BG004
85
ParticipantsBG00342
ParticipantsBG004254
Title
Measurements
Female
BG00058
BG00112
BG00251
BG00323
BG004144
Male
BG00042
BG00115
BG00234
BG00319
BG004
85
ParticipantsBG00342
ParticipantsBG004254
Title
Measurements
Hispanic or Latino
BG0000
BG0011
BG0020
BG0031
BG0042
Not Hispanic or Latino
BG000100
BG00126
BG00285
BG00341
BG004
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
BG004
85
ParticipantsBG00342
ParticipantsBG004254
Title
Measurements
Asian
BG0000
BG0010
BG0020
BG0031
BG0041
Black or African American
BG0002
BG0010
BG0020
BG0031
BG004
White
BG00097
BG00126
BG00282
BG00340
BG004
Other
BG0001
BG0011
BG0023
BG0030
BG004
85
ParticipantsBG00342
ParticipantsBG004254
Title
Measurements
Yes
BG00080
BG00121
BG00267
BG00333
BG004201
No
BG00020
BG0016
BG00218
BG0039
BG004
85
ParticipantsBG00342
ParticipantsBG004254
Title
Measurements
Yes
BG00044
BG0010
BG00229
BG00316
BG00489
No
BG00056
BG00127
BG00256
BG00326
BG004
85
ParticipantsBG00342
ParticipantsBG004254
Title
Measurements
BG00011.07± 8.33
BG00112.58± 9.55
BG00210.69± 7.75
BG00311.31± 7.54
BG00411.15± 8.12
27
ParticipantsBG00284
ParticipantsBG00342
ParticipantsBG004252
Title
Measurements
BG000303.8± 63.2
BG001310.0± 83.5
BG002314.0± 60.4
BG003319.3± 67.5
BG004310.5± 65.3
41
19.5
Adjusted remission rate
Title
Measurements
OG00012.8
OG00123.1
OG00214.4
OG00321.9
The study was powered for formal statistical testing of the abrilumab 70 mg group. The primary and key secondary endpoints were tested under a sequential framework of statistical hypotheses, each with 2-sided significance level of 0.10 for the treatment effect of abrilumab 70 mg compared with placebo.
OG000
OG002
The difference in remission rates, estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).
Difference in Adjusted Remission Rates
1.6
2-Sided
90
-7.9
8.9
Superiority
OG000
OG003
Comparisons between treatment groups were made using remission rates estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).
Regression, Logistic
Adjusted for baseline CDAI score and stratification factors.
0.22
Odds Ratio (OR)
1.91
2-Sided
90
0.80
4.57
An odds ratio > 1.0 indicates a higher remission rate for the abrilumab treatment group relative to placebo.
Superiority
Analysis was not part of the formal testing
OG000
OG003
The difference in remission rates, estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).
Difference in Adjusted Remission Rates
9.1
2-Sided
90
-4.6
19.4
Superiority
Analysis was not part of the formal testing
OG000
OG001
Comparisons between treatment groups were made using remission rates estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).
Regression, Logistic
Adjusted for baseline total CDAI score and stratification factors.
0.25
Odds Ratio (OR)
2.05
2-Sided
90
0.74
5.73
An odds ratio > 1.0 indicates a higher remission rate for the abrilumab treatment group relative to placebo.
Superiority
Analysis was not part of the formal testing
OG000
OG001
The difference in remission rates, estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).
Difference in Adjusted Remission Rates
10.3
2-Sided
90
-6.8
22.6
Superiority
Analysis was not part of the formal testing
Participants randomized to receive 21 mg abrilumab by subcutaneous injection on day 1, week 2, week 4, and every 4 weeks (Q4W) thereafter until week 24 during the double-blind treatment period.
OG002
Abrilumab 70 mg Q4W
Participants randomized to receive 70 mg abrilumab by subcutaneous injection on day 1, week 2, week 4, and every 4 weeks thereafter until week 24 during the double-blind treatment period.
OG003
Abrilumab 210 mg
Participants randomized to receive a single dose of 210 mg abrilumab by subcutaneous injection on day 1, followed by placebo at week 2, week 4, and every 4 weeks thereafter until week 24 during the double-blind treatment period.
Units
Counts
Participants
OG00098
OG00126
OG00284
OG00341
Title
Denominators
Categories
Unadjusted remission rate
Title
Measurements
OG00018.1
OG00133.3
OG00225.3
OG00327.0
Adjusted remission rate
Title
Measurements
OG00020.1
OG00143.8
OG00231.0
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
OG002
Comparisons between treatment groups were made using remission rates estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).
Regression, Logistic
Adjusted for baseline CDAI score and stratification factors.
0.16
Odds Ratio (OR)
1.78
2-Sided
90
0.90
3.53
An odds ratio > 1.0 indicates a higher remission rate for the abrilumab treatment group relative to placebo.
Superiority
OG000
OG002
The difference in remission rates, estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).
Difference in Adjusted Remission Rates
10.9
2-Sided
90
-1.8
21.0
Superiority
OG000
OG003
Comparisons between treatment groups were made using remission rates estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).
Regression, Logistic
Adjusted for baseline CDAI score and stratification factors.
0.13
Odds Ratio (OR)
2.12
2-Sided
90
0.93
4.84
An odds ratio > 1.0 indicates a higher remission rate for the abrilumab treatment group relative to placebo.
Superiority
Analysis was not part of the formal testing
OG000
OG003
The difference in remission rates, estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).
Difference in Adjusted Remission Rates
14.7
2-Sided
90
-2.1
27.5
Superiority
Analysis was not part of the formal testing
OG000
OG001
Comparisons between treatment groups were made using remission rates estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).
Regression, Logistic
Adjusted for baseline total CDAI score and stratification factors.
0.056
Odds Ratio (OR)
3.10
2-Sided
90
1.17
8.20
An odds ratio > 1.0 indicates a higher remission rate for the abrilumab treatment group relative to placebo.
Superiority
Analysis was not part of the formal testing
OG000
OG001
The difference in remission rates, estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).
Difference in Adjusted Remission Rates
23.7
2-Sided
90
2.8
39.2
Superiority
Analysis was not part of the formal testing
Participants randomized to receive 21 mg abrilumab by subcutaneous injection on day 1, week 2, week 4, and every 4 weeks (Q4W) thereafter until week 24 during the double-blind treatment period.
OG002
Abrilumab 70 mg Q4W
Participants randomized to receive 70 mg abrilumab by subcutaneous injection on day 1, week 2, week 4, and every 4 weeks thereafter until week 24 during the double-blind treatment period.
OG003
Abrilumab 210 mg
Participants randomized to receive a single dose of 210 mg abrilumab by subcutaneous injection on day 1, followed by placebo at week 2, week 4, and every 4 weeks thereafter until week 24 during the double-blind treatment period.
Units
Counts
Participants
OG00098
OG00126
OG00284
OG00341
Title
Denominators
Categories
Unadjusted response rate
Title
Measurements
OG00027.7
OG00141.7
OG00245.3
OG00343.2
Adjusted response rate
Title
Measurements
OG00035.3
OG00150.4
OG00255.1
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
OG002
Comparisons between treatment groups were made using response rates estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).
Regression, Logistic
Adjusted for baseline CDAI score and stratification factors.
0.021
Odds Ratio (OR)
2.25
2-Sided
90
1.27
4.01
An odds ratio > 1.0 indicates a higher response rate for the abrilumab treatment group relative to placebo.
Superiority
OG000
OG002
The difference in response rates, estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).
Difference in Adjusted Response Rates
19.8
2-Sided
90
5.8
31.3
Superiority
OG000
OG003
Comparisons between treatment groups were made using response rates estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).
Regression, Logistic
Adjusted for baseline CDAI score and stratification factors.
0.14
Odds Ratio (OR)
1.90
2-Sided
90
0.94
3.87
An odds ratio > 1.0 indicates a higher response rate for the abrilumab treatment group relative to placebo.
Superiority
Analysis was not part of the formal testing
OG000
OG003
The difference in response rates, estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).
Difference in Adjusted Response Rates
15.7
2-Sided
90
-2.3
29.7
Superiority
Analysis was not part of the formal testing
OG000
OG001
Comparisons between treatment groups were made using response rates estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).
Regression, Logistic
Adjusted for baseline total CDAI score and stratification factors.
0.23
Odds Ratio (OR)
1.87
2-Sided
90
0.79
4.39
An odds ratio > 1.0 indicates a higher response rate for the abrilumab treatment group relative to placebo.
Superiority
Analysis was not part of the formal testing
OG000
OG001
The difference in response rates, estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).
Difference in Adjusted Response Rates
15.1
2-Sided
90
-6.4
31.3
Superiority
Analysis was not part of the formal testing
Participants randomized to receive 21 mg abrilumab by subcutaneous injection on day 1, week 2, week 4, and every 4 weeks (Q4W) thereafter until week 24 during the double-blind treatment period.
OG002
Abrilumab 70 mg Q4W
Participants randomized to receive 70 mg abrilumab by subcutaneous injection on day 1, week 2, week 4, and every 4 weeks thereafter until week 24 during the double-blind treatment period.
OG003
Abrilumab 210 mg
Participants randomized to receive a single dose of 210 mg abrilumab by subcutaneous injection on day 1, followed by placebo at week 2, week 4, and every 4 weeks thereafter until week 24 during the double-blind treatment period.
Units
Counts
Participants
OG00098
OG00126
OG00284
OG00341
Title
Denominators
Categories
Unadjusted response rate
Title
Measurements
OG00026.4
OG00133.3
OG00242.9
OG00330.6
Adjusted response rate
Title
Measurements
OG00030.6
OG00133.8
OG00246.6
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
OG002
Comparisons between treatment groups were made using response rates estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).
Regression, Logistic
Adjusted for baseline CDAI score and stratification factors.
0.047
Odds Ratio (OR)
1.98
2-Sided
90
1.13
3.47
An odds ratio > 1.0 indicates a higher response rate for the abrilumab treatment group relative to placebo.
Superiority
OG000
OG002
The difference in response rates, estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).
Difference in Adjusted Response Rates
16.0
2-Sided
90
2.4
27.1
Superiority
OG000
OG003
Comparisons between treatment groups were made using response rates estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).
Regression, Logistic
Adjusted for baseline CDAI score and stratification factors.
0.84
Odds Ratio (OR)
1.09
2-Sided
90
0.52
2.29
An odds ratio > 1.0 indicates a higher response rate for the abrilumab treatment group relative to placebo.
Superiority
Analysis was not part of the formal testing
OG000
OG003
The difference in response rates, estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).
Difference in Adjusted Response Rates
1.9
2-Sided
90
-15.2
15.2
Superiority
Analysis was not part of the formal testing
OG000
OG001
Comparisons between treatment groups were made using response rates estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).
Regression, Logistic
Adjusted for baseline total CDAI score and stratification factors.
0.78
Odds Ratio (OR)
1.15
2-Sided
90
0.49
2.72
An odds ratio > 1.0 indicates a higher response rate for the abrilumab treatment group relative to placebo.
Superiority
Analysis was not part of the formal testing
OG000
OG001
The difference in response rates, estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).
Difference in Adjusted Response Rates
3.1
2-Sided
90
-17.4
18.3
Superiority
Analysis was not part of the formal testing
OG001
Abrilumab 21 mg Q4W
Participants randomized to receive 21 mg abrilumab by subcutaneous injection on day 1, week 2, week 4, and every 4 weeks (Q4W) thereafter until week 24 during the double-blind treatment period.
OG002
Abrilumab 70 mg Q4W
Participants randomized to receive 70 mg abrilumab by subcutaneous injection on day 1, week 2, week 4, and every 4 weeks thereafter until week 24 during the double-blind treatment period.
OG003
Abrilumab 210 mg
Participants randomized to receive a single dose of 210 mg abrilumab by subcutaneous injection on day 1, followed by placebo at week 2, week 4, and every 4 weeks thereafter until week 24 during the double-blind treatment period.
Units
Counts
Participants
OG00098
OG00126
OG00284
OG00341
Title
Denominators
Categories
Unadjusted remission rate
Title
Measurements
OG0008.2
OG00119.2
OG00211.9
OG00317.1
Adjusted remission rate
Title
Measurements
OG0009.0
OG00125.0
OG00214.0
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
OG002
Comparisons between treatment groups were made using sustained remission rates estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).
Regression, Logistic
Adjusted for baseline CDAI score and stratification factors.
0.34
Odds Ratio (OR)
1.65
2-Sided
90
0.69
3.91
An odds ratio > 1.0 indicates a higher sustained remission rate for the abrilumab treatment group relative to placebo.
Superiority
OG000
OG002
The difference in sustained remission rates, estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).
Difference in Adjusted Remission Rates
5.0
2-Sided
90
-3.9
11.7
Superiority
OG000
OG003
Comparisons between treatment groups were made using sustained remission rates estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).
Regression, Logistic
Adjusted for baseline CDAI score and stratification factors.
0.078
Odds Ratio (OR)
2.82
2-Sided
90
1.07
7.41
An odds ratio > 1.0 indicates a higher sustained remission rate for the abrilumab treatment group relative to placebo.
Superiority
Analysis was not part of the formal testing
OG000
OG003
The difference in sustained remission rates, estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).
Difference in Adjusted Remission Rates
12.8
2-Sided
90
-0.6
22.6
Superiority
Analysis was not part of the formal testing
OG000
OG001
Comparisons between treatment groups were made using sustained remission rates estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).
Regression, Logistic
Adjusted for baseline total CDAI score and stratification factors.
0.083
Odds Ratio (OR)
3.37
2-Sided
90
1.07
10.66
An odds ratio > 1.0 indicates a higher sustained remission rate for the abrilumab treatment group relative to placebo.
Superiority
Analysis was not part of the formal testing
OG000
OG001
The difference in sustained remission rates, estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).
Difference in Adjusted Remission Rates
16.0
2-Sided
90
-1.2
28.3
Superiority
Analysis was not part of the formal testing
OG001
Abrilumab 21 mg Q4W
Participants randomized to receive 21 mg abrilumab by subcutaneous injection on day 1, week 2, week 4, and every 4 weeks (Q4W) thereafter until week 24 during the double-blind treatment period.
OG002
Abrilumab 70 mg Q4W
Participants randomized to receive 70 mg abrilumab by subcutaneous injection on day 1, week 2, week 4, and every 4 weeks thereafter until week 24 during the double-blind treatment period.
OG003
Abrilumab 210 mg
Participants randomized to receive a single dose of 210 mg abrilumab by subcutaneous injection on day 1, followed by placebo at week 2, week 4, and every 4 weeks thereafter until week 24 during the double-blind treatment period.
Units
Counts
Participants
OG00098
OG00126
OG00284
OG00341
Title
Denominators
Categories
Unadjusted remission rate
Title
Measurements
OG0007.1
OG00115.4
OG0029.5
OG00312.2
Adjusted remission rate
Title
Measurements
OG0005.9
OG00114.3
OG0028.7
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
OG002
Comparisons between treatment groups were made using sustained remission rates estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).
Regression, Logistic
Adjusted for baseline CDAI score and stratification factors.
0.47
Odds Ratio (OR)
1.52
2-Sided
90
0.59
3.93
An odds ratio > 1.0 indicates a higher sustained remission rate for the abrilumab treatment group relative to placebo.
Superiority
OG000
OG002
The difference in sustained remission rates, estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).
Difference in Adjusted Remission Rates
2.8
2-Sided
90
-4.7
8.1
Superiority
OG000
OG003
Comparisons between treatment groups were made using sustained remission rates estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).
Regression, Logistic
Adjusted for baseline CDAI score and stratification factors.
0.21
Odds Ratio (OR)
2.32
2-Sided
90
0.77
6.98
An odds ratio > 1.0 indicates a higher sustained remission rate for the abrilumab treatment group relative to placebo.
Superiority
Analysis was not part of the formal testing
OG000
OG003
The difference in sustained remission rates, estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).
Difference in Adjusted Remission Rates
6.8
2-Sided
90
-4.3
14.5
Superiority
Analysis was not part of the formal testing
OG000
OG001
Comparisons between treatment groups were made using sustained remission rates estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).
Regression, Logistic
Adjusted for baseline total CDAI score and stratification factors.
0.21
Odds Ratio (OR)
2.66
2-Sided
90
0.75
9.45
An odds ratio > 1.0 indicates a higher sustained remission rate for the abrilumab treatment group relative to placebo.
Superiority
Analysis was not part of the formal testing
OG000
OG001
The difference in sustained remission rates, estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).
Difference in Adjusted Remission Rates
8.4
2-Sided
90
-6.0
17.9
Superiority
Analysis was not part of the formal testing
Participants randomized to receive 70 mg abrilumab by subcutaneous injection on day 1, week 2, week 4, and every 4 weeks thereafter until week 24 during the double-blind treatment period.
OG003
Abrilumab 210 mg
Participants randomized to receive a single dose of 210 mg abrilumab by subcutaneous injection on day 1, followed by placebo at week 2, week 4, and every 4 weeks thereafter until week 24 during the double-blind treatment period.
Units
Counts
Participants
OG00098
OG00126
OG00284
OG00341
Title
Denominators
Categories
Title
Measurements
OG000-55.32± 11.41
OG001-92.16± 21.85
OG002-97.41± 12.92
OG003-96.11± 22.78
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
OG002
Comparisons between treatment arms was conducted using an inverse probability weighting (IPW) generalized estimating equations (GEE) model adjusted for prior anti-TNF use, pre-versus post-protocol amendment 3 and baseline CDAI score.
IPW GEE Model
Adjusted for prior anti-TNF use, pre-versus post-protocol amendment 3 and baseline CDAI score.
0.006
LS Mean Treatment Difference
-42.09
2-Sided
90
-67.3
-16.9
Superiority
OG000
OG003
Comparisons between treatment arms was conducted using an inverse probability weighting (IPW) generalized estimating equations (GEE) model adjusted for prior anti-TNF use, pre-versus post-protocol amendment 3 and baseline CDAI score.
IPW GEE Model
Adjusted for prior anti-TNF use, pre-versus post-protocol amendment 3 and baseline CDAI score.
0.095
LS Mean Treatment Difference
-40.79
2-Sided
90
-81.5
-0.5
Superiority
Analysis was not part of the formal testing
OG000
OG001
Comparisons between treatment arms was conducted using an inverse probability weighting (IPW) generalized estimating equations (GEE) model adjusted for prior anti-TNF use, pre-versus post-protocol amendment 3 and baseline CDAI score.
IPW GEE Model
Adjusted for prior anti-TNF use, pre-versus post-protocol amendment 3 and baseline CDAI score.
0.11
LS Mean Treatment Difference
-36.84
2-Sided
90
-74.3
0.7
Superiority
Analysis was not part of the formal testing
Participants randomized to receive 70 mg abrilumab by subcutaneous injection on day 1, week 2, week 4, and every 4 weeks thereafter until week 24 during the double-blind treatment period.
OG003
Abrilumab 210 mg
Participants randomized to receive a single dose of 210 mg abrilumab by subcutaneous injection on day 1, followed by placebo at week 2, week 4, and every 4 weeks thereafter until week 24 during the double-blind treatment period.
Units
Counts
Participants
OG00098
OG00126
OG00284
OG00341
Title
Denominators
Categories
Title
Measurements
OG000-64.05± 9.62
OG001-80.42± 20.86
OG002-91.52± 11.78
OG003-87.64± 19.89
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
OG002
Comparisons between treatment arms was conducted using an inverse probability weighting (IPW) generalized estimating equations (GEE) model adjusted for prior anti-TNF use, pre-versus post-protocol amendment 3 and baseline CDAI score.
IPW GEE Model
Adjusted for prior anti-TNF use, pre-versus post-protocol amendment 3 and baseline CDAI score.
0.045
LS Mean Treatment Difference
-27.47
2-Sided
90
-50.0
-4.9
Superiority
OG000
OG003
Comparisons between treatment arms was conducted using an inverse probability weighting (IPW) generalized estimating equations (GEE) model adjusted for prior anti-TNF use, pre-versus post-protocol amendment 3 and baseline CDAI score.
IPW GEE Model
Adjusted for prior anti-TNF use, pre-versus post-protocol amendment 3 and baseline CDAI score.
0.27
LS Mean Treatment Difference
-23.59
2-Sided
90
-58.7
11.5
Superiority
Analysis was not part of the formal testing
OG000
OG001
Comparisons between treatment arms was conducted using an inverse probability weighting (IPW) generalized estimating equations (GEE) model adjusted for prior anti-TNF use, pre-versus post-protocol amendment 3 and baseline CDAI score.
IPW GEE Model
Adjusted for prior anti-TNF use, pre-versus post-protocol amendment 3 and baseline CDAI score.