A Long-Term Efficacy and Safety Study of Ixekizumab (LY24... | NCT02584855 | Trialant
NCT02584855
Sponsor
Eli Lilly and Company
Status
Completed
Last Update Posted
Nov 15, 2019Actual
Enrollment
394Actual
Phase
Phase 3
Conditions
Psoriatic Arthritis
Interventions
Ixekizumab
Placebo
Countries
United States
Bulgaria
Czechia
Estonia
Mexico
Poland
Russia
Slovakia
South Africa
Spain
Ukraine
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT02584855
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
14518
Secondary IDs
ID
Type
Description
Link
I1F-MC-RHBF
Other Identifier
Eli Lilly and Company
2015-002433-22
EudraCT Number
Brief Title
A Long-Term Efficacy and Safety Study of Ixekizumab (LY2439821) in Participants With Active Psoriatic Arthritis
Official Title
A Phase 3, Multicenter Study With a 36-Week Open-Label Period Followed by a Randomized Double-Blind Withdrawal Period From Week 36 to Week 104 to Evaluate the Long-Term Efficacy and Safety of Ixekizumab (LY2439821) 80 mg Every 2 Weeks in Biologic Disease-Modifying Antirheumatic Drug-Naive Patients With Active Psoriatic Arthritis
Acronym
SPIRIT P3
Organization
Eli Lilly and CompanyINDUSTRY
Status Module
Record Verification Date
Nov 2018
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
Sep 14, 2015Actual
Primary Completion Date
Oct 30, 2018Actual
Completion Date
Oct 30, 2018Actual
First Submitted Date
Oct 16, 2015
First Submission Date that Met QC Criteria
Oct 22, 2015
First Posted Date
Oct 23, 2015Estimated
Results Waived
Not provided
Results First Submitted Date
Oct 25, 2019
Results First Submitted that Met QC Criteria
Oct 25, 2019
Results First Posted Date
Nov 15, 2019Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Oct 25, 2019
Last Update Posted Date
Nov 15, 2019Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Eli Lilly and CompanyINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The main purpose of this study is to evaluate the safety and long-term efficacy of ixekizumab compared to placebo in participants with active psoriatic arthritis.
Detailed Description
Not provided
Conditions Module
Conditions
Psoriatic Arthritis
Keywords
Spondyloarthritis
Spondylarthropathy
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
394Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Ixekizumab Open Label
Experimental
Open-Label Treatment Period: Starting dose of 160 milligrams (mg) ixekizumab given as two subcutaneous (SC) injections at baseline (week 0) followed by 80 mg given as one SC injection every two weeks (Q2W) from week 2 to randomization (week 36 to 64).
Drug: Ixekizumab
Ixekizumab
Experimental
Participants completed open label and met criteria for randomization to the double-blind Withdrawal Period.
Double-Blind Withdrawal Period: 80 mg ixekizumab given as one SC injection Q2W from randomization to week 104 (or, early termination or relapse).
Drug: Ixekizumab
Placebo
Placebo Comparator
Participants completed open label and met criteria for randomization to the double-blind Withdrawal Period.
Double-Blind Withdrawal Period: Placebo given as one SC injection Q2W any time from randomization to week 104 (or, early termination or relapse)
Drug: Ixekizumab
Drug: Placebo
IXE80Q2W Non-randomized
Experimental
Participants completed open label but did not meet criteria for randomization to the double-blind Withdrawal Period.
Participants continued to receive 80 mg given as one SC injection every two weeks during the double-blind withdrawal period.
Drug: Ixekizumab
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Ixekizumab
Drug
Administered SC
IXE80Q2W Non-randomized
Ixekizumab
Ixekizumab Open Label
Placebo
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Double-Blind Withdrawal Period: Time to Relapse (No Longer Meeting Coates Criteria for Minimal Disease Activity [MDA])
Relapse is loss of MDA response. MDA is achieved if 5 of 7 outcome measures are fulfilled:TJC ≤1;SJC ≤1;psoriasis activity & severity index(PASI total score) ≤1 or body surface area(BSA) ≤3;participant pain VAS score of ≤15;participant global disease activity VAS score of ≤20;HAQ-DI score ≤0.5;and tender entheseal points ≤1.Participants met the randomization criteria if they had MDA for 3 consecutive months over 4 consecutive visits.Time-to relapse was calculated in weeks as follows:((Date of Relapse) - Date of first injection of randomized study treatment in period 3)+1) divided by 7.If the date of first dose is missing,the date of randomization will be used.Participants completing Period 3 will be censored at date of completion(the date of the last scheduled visit in the period).Participants without a date of completion or discontinuation for Period 3 will be censored at latest non-missing date out of the following dates:date of last dose & date of last attended visit in Period 3.
Double Blind Randomization through Week 104 (or Early Termination or Relapse)
Secondary Outcomes
Measure
Description
Time Frame
Double-Blind Withdrawal Period: Percentage of Participants Who Relapse in MDA
Relapsed participants are defined as participants no longer meeting Coates criteria for MDA. MDA is achieved if 5 of 7 outcome measures are fulfilled: TJC ≤1; SJC ≤1; psoriasis activity and severity index (PASI total score) ≤1 or body surface area (BSA) ≤3; participant pain VAS score of ≤15; participant global disease activity VAS score of ≤20; HAQ-DI score ≤0.5; and tender entheseal points ≤1.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Presents with established diagnosis of active psoriatic arthritis (PsA) for at least 6 months, and currently meets Classification for Psoriatic Arthritis (CASPAR) criteria
Active PsA defined as the presence of at least 3 tender and at least 3 swollen joints
Presence of active psoriatic skin lesion or a history of plaque psoriasis (Ps)
Men must agree to use a reliable method of birth control or remain abstinent during the study
Women must agree to use reliable birth control or remain abstinent during the study and for at least 12 weeks after stopping treatment
Have been treated with 1 or more conventional disease-modifying antirheumatic drugs (cDMARDs)
Exclusion Criteria:
Current or prior use of biologic agents for treatment of Ps or PsA
Inadequate response to greater than or equal to 4 conventional disease-modifying antirheumatic drugs (DMARDS)
Current use of more than one cDMARDs
Diagnosis of active inflammatory arthritic syndromes or spondyloarthropathies other than PsA
Have received treatment with interleukin (IL) -17 or IL12/23 targeted monoclonal antibody (MAb) therapy
Serious disorder or illness other than psoriatic arthritis
Serious infection within the last 3 months
Breastfeeding or nursing (lactating) women
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Deodhar AA, Combe B, Accioly AP, Bolce R, Zhu D, Gellett AM, Sprabery AT, Burmester GR. Safety of ixekizumab in patients with psoriatic arthritis: data from four clinical trials with over 2000 patient-years of exposure. Ann Rheum Dis. 2022 Jul;81(7):944-950. doi: 10.1136/annrheumdis-2021-222027. Epub 2022 Apr 7.
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Types
Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame
Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
Access Criteria
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Participants were randomized during week 36 to week 64. The criteria for randomization in period 3 was having received ixekizumab (IXE) 80 mg Q2W for at least 6 months and meeting Coates criteria for minimal disease activity (MDA) for 3 consecutive months over 4 consecutive visits.The criteria was met anytime from 36 to 64 weeks.
Recruitment Details
This study had four periods: Period 1: Screening period lasting from 4 to 30 days before Week 0, Period 2: Initial open-label treatment period from Week 0 up to Week 36, Period 3: randomized double-blind withdrawal period from Week 36 to week 104 (or, early termination or relapse) and Period 4: post treatment follow-up.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Ixekizumab Open Label
Open-Label Treatment Period (OLTP): Starting dose of 160 milligrams (mg) ixekizumab given as two subcutaneous (SC) injections at baseline (Week 0) followed by 80 mg given as one SC injection every two weeks (Q2W) from week 2 to randomization (week 36 to 64).
FG001
Periods
Title
Milestones
Reasons Not Completed
Open-Label Treatment Period
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
SAP
No
Yes
No
Statistical Analysis Plan: Statistical Analysis Plan V3
Oct 25, 2018
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Argentina
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Double
Masking Description
Not provided
Who Masked
ParticipantInvestigator
LY2439821
Placebo
Drug
Administered SC
Placebo
Double Blind Randomization through Week 104 (or Early Termination or Relapse)
Double-Blind Withdrawal Period: Time to Loss of Response in Each Individual Component of MDA: Tender Joint Count 68 (TJC)
TJC is the number of tender and painful joints determined for each participant by examination of 68 joints.TJC possible values range from 0 to 68. A lower TJC indicated less number of joints with tenderness. A higher TJC indicated more joint tenderness. Joints were assessed by pressure and joint manipulation on physical examination. Participants were asked for pain sensations on these manipulations and watched for spontaneous pain reactions. Any positive response on pressure, movement, or both was translated into a single tender-versus-nontender dichotomy.
Loss of Response = Not Meeting less than or equal to 1 TJC. Time to loss of response (in weeks) = (date of loss of response - date of first injection of randomized dose of study treatment in the Randomized Double-Blind Withdrawal Period + 1)/7.
Double Blind Randomization through Week 104 (or Early Termination or Relapse)
Double-Blind Withdrawal Period: Time to Loss of Response in Each Individual Component of MDA: Swollen Joint Count 66 (SJC)
SJC is the number of swollen joints determined for each participant by examination of 66 joints. SJC possible values range from 0 to 66. A lower SJC indicated less joints with swelling. A higher SJC indicated more joints with swelling. Swelling was defined as palpable fluctuating synovitis of the joint.
Loss of Response = Not Meeting less than or equal to 1 SJC. Time to loss of response (in weeks) = (date of loss of response - date of first injection of randomized dose of study treatment in the Randomized Double-Blind Withdrawal Period + 1)/7.
Double Blind Randomization through Week 104 (or Early Termination or Relapse)
Double-Blind Withdrawal Period: Time to Loss of Response in Each Individual Component of MDA: Psoriasis Area and Severity Index (PASI)
The PASI is an index that combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation, erythema, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis to 72 for the most severe disease.
Loss of Response = Not Meeting less than or equal to 1 PASI total score. Time to loss of response (in weeks) = (date of loss of response - date of first injection of randomized dose of study treatment in the Randomized Double-Blind Withdrawal Period + 1)/7.
Double Blind Randomization through Week 104 (or Early Termination or Relapse)
Double-Blind Withdrawal Period: Time to Loss of Response in Each Individual Component of MDA: BSA
BSA is an investigator evaluated measure, where the percentage of involvement of psoriasis on each participant's BSA is assessed. BSA was measured on a continuous scale from 0% = no involvement to 100% = full involvement, where 1% corresponded to the size of the participant's handprint including the palm, fingers, and thumb. Loss of Response = Not meeting less than or equal to 3% BSA.
Time to loss of response (in weeks) = (date of loss of response - date of first injection of randomized dose of study treatment in the Randomized Double-Blind Withdrawal Period + 1)/7.
Double Blind Randomization through Week 104 (or Early Termination or Relapse)
Double-Blind Withdrawal Period: Time to Loss of Response in Each Individual Component of MDA: Pain Visual Analog Scale (VAS) Score
The pain VAS is an instrument used to measure a person's subjective quantitative evaluation of an item such as pain intensity. The VAS contains a continuous line between two endpoints whereby the respondent places a mark on the line to indicate his or her response The scale ranges from 0 (no pain) to 100 (unbearable pain). The scores were measured to the nearest millimeter from the left. Loss of Response = Not Meeting less than or equal to 15 Pain VAS. Time to loss of response (in weeks) = (date of loss of response - date of first injection of randomized dose of study treatment in the Randomized Double-Blind Withdrawal Period + 1)/7.
Double Blind Randomization through Week 104 (or Early Termination or Relapse)
Double-Blind Withdrawal Period: Time to Loss of Response in Each Individual Component of MDA: Patients Global Assessment of Disease Activity (PatGA) Visual Analog Scale (VAS) Score
Participants scored their overall assessment of their psoriatic arthritis (PsA) activity on a 0 to 100 mm horizontal VAS. The scale ranged from 0 (no disease activity) to 100 (extremely active disease activity). The scores were measured to the nearest millimeter from the left.
Loss of Response = Not Meeting less than or equal to 20 PatGA. Time to loss of response (in weeks) = (date of loss of response - date of first injection of randomized dose of study treatment in the Randomized Double-Blind Withdrawal Period + 1)/7.
Double Blind Randomization through Week 104 (or Early Termination or Relapse)
Double-Blind Withdrawal Period: Time to Loss of Response in Each Individual Component of MDA: Health Assessment Questionnaire-Disability Index (HAQ-DI)
The HAQ-DI questionnaire assesses the participant's self-perception on the degree of difficulty [0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), and 3 (unable to do)] when dressing and grooming, arising, eating, walking, hygiene, reaching, gripping, and performing other daily activities. Scores for each functional area were averaged to calculate HAQ-DI scores, which ranged from 0 (no disability) to 3 (severe disability). A decrease in HAQ-DI score indicated an improvement in the participant's condition.
Loss of Response = Not Meeting less than or equal to 0.5 HAQ-DI. Time to loss of response (in weeks) = (date of loss of response - date of first injection of randomized dose of study treatment in the Randomized Double-Blind Withdrawal Period + 1)/7.
Double Blind Randomization through Week 104 (or Early Termination or Relapse)
Double-Blind Withdrawal Period: Time to Loss of Response in Each Individual Component of MDA: Tender Entheseal Points
Tender entheseal points was based on the assessment of the 18 entheseal points. Loss of Response = Not Meeting less than or equal to 1 Tender Entheseal Point. Time to loss of response (in weeks) = (date of loss of response - date of first injection of randomized dose of study treatment in the Randomized Double-Blind Withdrawal Period + 1)/7.
Double Blind Randomization through Week 104 (or Early Termination or Relapse)
Open-Label Treatment Period: Time to Achieve Randomization Criteria (Meeting MDA for 3 Consecutive Months Over 4 Consecutive Visits)
Time to meeting MDA for 3 Consecutive Months Over 4 Consecutive Visits. Time to first response (in weeks) = [(date of first response - date of first injection of study treatment in the Open-Label Treatment Period)+1]/7.
Open-Label Treatment Period ended at the time when a participant was randomized so the end time was not the same for all participants. Participants were randomized only if they met randomization criteria which was at anytime from week 36 to week 64.
Open Label Baseline through Double-Blind Randomization (Week 36 to 64)
Double-Blind Withdrawal Period: Time to Re-Gain MDA Following Relapse in MDA
MDA is achieved if 5 of 7 outcome measures are fulfilled: TJC ≤1; SJC ≤1; psoriasis activity and severity index (PASI total score) ≤1 or BSA ≤3; participant pain VAS score of ≤15; participant global disease activity VAS score of ≤20; HAQ-DI score ≤0.5; and tender entheseal points ≤1. Time to first response (in weeks) = (date of first response - date of first injection of study treatment in the Relapse Period + 1)/7.
Relapse in MDA After Double Blind Randomization through Week 104 (or Early Termination)
Double-Blind Withdrawal Period: Change From Baseline in Physical Functioning Assessed by the Health Assessment Questionnaire-Disability Index (HAQ-DI)
The HAQ-DI questionnaire assesses the participant's self-perception on the degree of difficulty [0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), and 3 (unable to do)] when dressing and grooming, arising, eating, walking, hygiene, reaching, gripping, and performing other daily activities. Scores for each functional area were averaged to calculate HAQ-DI scores, which ranged from 0 (no disability) to 3 (severe disability). A decrease in HAQ-DI score indicated an improvement in the participant's condition.Least Square (LS) mean calculated using Mixed Model Repeated Measurements (MMRM) analysis with treatment group, baseline measure, geographic region, cDMARD use, treatment week, baseline measure-by-treatment week interaction term, and treatment week-by-treatment interaction term as fixed factors.
Participants were randomized only if they met randomization criteria which was at anytime from week 36 to week 64.
Baseline, 40 Weeks from Double Blind Randomization (Week 36 to 64)
Mesa
Arizona
85202
United States
Arizona Arthritis Research, PLC
Phoenix
Arizona
85032
United States
University of California, Davis - Health Systems
Sacramento
California
95817
United States
East Bay Rheumatology Medical Group
San Leandro
California
94578
United States
Arthritis & Osteoporosis Treatment Center, PA
Orange Park
Florida
32073
United States
Florida Medical Clinic PA
Zephyrhills
Florida
33542
United States
Physicians Clinic of Iowa
Cedar Rapids
Iowa
54203
United States
Heartland Research Associates
Wichita
Kansas
67207
United States
Klein and Associates MD, PA
Cumberland
Maryland
21502
United States
Klein and Associates MD, PA
Hagerstown
Maryland
21740
United States
University of Massachusetts Medical Center
Worcester
Massachusetts
01605
United States
Glacier View Research Institute
Kalispell
Montana
59901
United States
Arthritis, Rheumatic & Back Disease Associates
Voorhees Township
New Jersey
08043
United States
Weill Cornell Physicians at Brooklyn Heights
Brooklyn
New York
11201
United States
Robert A. Harrell, III, MD
Durham
North Carolina
27704
United States
Pennsylvania Regional Center for Arthritis & Osteoarthritis
Wyomissing
Pennsylvania
19610
United States
Pioneer Research Solutions
Cypress
Texas
77429
United States
Arthritis Care & Diagnostic Center P.A.
Dallas
Texas
75231
United States
Kadlec Clinic Rheumatology
Kennewick
Washington
99336
United States
Seattle Rheumatology Associates, P.L.L.C.
Seattle
Washington
98122
United States
Arthritis Northwest Rheumatology
Spokane
Washington
99204
United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Plovdiv
4000
Bulgaria
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Plovdiv
4002
Bulgaria
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Rousse
7002
Bulgaria
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Sofia
1784
Bulgaria
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Brno
60200
Czechia
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Brno
638 00
Czechia
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
ÄŒeská LÃpa
470 01
Czechia
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Ostrava
722 00
Czechia
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Pardubice
53002
Czechia
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Prague
128 50
Czechia
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Prague
13000
Czechia
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Prague
15800
Czechia
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Praha 4 Nusle
140 00
Czechia
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
ZlÃn
760 01
Czechia
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Tallinn
10117
Estonia
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Tallinn
10128
Estonia
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Tallinn
10138
Estonia
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Tallinn
13419
Estonia
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Tartu
50107
Estonia
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Chihuahua City
03100
Mexico
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Cuautitlán Izcalli
54769
Mexico
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Durango
34000
Mexico
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Guadalajara
45040
Mexico
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Monterrey
64610
Mexico
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Morelia
58260
Mexico
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
San Luis Potosà City
78213
Mexico
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Bialystok
15879
Poland
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Krakow
30-510
Poland
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Krakow
31-023
Poland
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Krakow
31-501
Poland
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Lublin
20-582
Poland
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Nowa Sól
67100
Poland
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Nowy Duninów
09505
Poland
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Poznan
61-113
Poland
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Sochaczew
96500
Poland
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Torun
87-100
Poland
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Warsaw
00-465
Poland
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Warsaw
00660
Poland
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Warsaw
01-868
Poland
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Warsaw
02-118
Poland
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Wroclaw
51-124
Poland
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Chelyabinsk
454076
Russia
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Kazan'
420012
Russia
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Moscow
119333
Russia
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Novosibirsk
630061
Russia
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Saint Petersburg
190068
Russia
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Saint Petersburg
191186
Russia
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Saint Petersburg
194291
Russia
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Yekaterinburg
620043
Russia
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Bratislava
83103
Slovakia
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Bratislava
84231
Slovakia
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Košice
040 15
Slovakia
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Považská Bystrica
01701
Slovakia
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Senica
90501
Slovakia
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Stará Ľubovňa
06401
Slovakia
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
SvidnÃk
08901
Slovakia
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Trnava
91701
Slovakia
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Zvolen
96001
Slovakia
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Cape Town
7405
South Africa
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Kempton Park
1619
South Africa
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Port Elizabeth
6057
South Africa
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Pretoria
0002
South Africa
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Pretoria
0084
South Africa
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Stellenbosch
7600
South Africa
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
A Coruña
15006
Spain
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Málaga
29009
Spain
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Sabadell
08208
Spain
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Santander
39008
Spain
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Seville
41010
Spain
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Kharkiv
61039
Ukraine
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Kharkiv
61176
Ukraine
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Kyiv
03151
Ukraine
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Lviv
79011
Ukraine
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Odesa
65026
Ukraine
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Vinnytsia
21018
Ukraine
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Vinnytsia
21029
Ukraine
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Vinnytsia
21030
Ukraine
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Zaporizhzhia
69600
Ukraine
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Goodmayes
IG7 4DY
United Kingdom
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Harlow
CM20 1QX
United Kingdom
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
London
E11 1NR
United Kingdom
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Truro
TR1 3LJ
United Kingdom
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Wolverhampton
WV10 0QP
United Kingdom
Coates LC, Pillai SG, Tahir H, Valter I, Chandran V, Kameda H, Okada M, Kerr L, Alves D, Park SY, Adams DH, Gallo G, Hufford MM, Hojnik M, Mease PJ, Kavanaugh A; SPIRIT-P3 Study Group. Withdrawing Ixekizumab in Patients With Psoriatic Arthritis Who Achieved Minimal Disease Activity: Results From a Randomized, Double-Blind Withdrawal Study. Arthritis Rheumatol. 2021 Sep;73(9):1663-1672. doi: 10.1002/art.41716. Epub 2021 Aug 6.
Combe B, Rahman P, Kameda H, Canete JD, Gallo G, Agada N, Xu W, Genovese MC. Safety results of ixekizumab with 1822.2 patient-years of exposure: an integrated analysis of 3 clinical trials in adult patients with psoriatic arthritis. Arthritis Res Ther. 2020 Jan 21;22(1):14. doi: 10.1186/s13075-020-2099-0.
IXE80Q2W Non-randomized
Participants completed open label but did not meet criteria for randomization to the double-blind Withdrawal Period.
Participants continued to receive 80 mg given as one SC injection every two weeks during the double-blind withdrawal period.
FG002
Ixekizumab
Participants completed open label and met criteria for randomization to the double-blind Withdrawal Period.
Double-Blind Withdrawal Period: 80 mg ixekizumab given as one SC injection Q2W from randomization to week 104 (or, early termination or relapse).
FG003
Placebo
Participants completed open label and met criteria for randomization to the double-blind Withdrawal Period.
Double-Blind Withdrawal Period: Placebo given as one SC injection Q2W any time from randomization to week 104 (or, early termination or relapse)
FG004
IXE80Q2W Post-Treatment Follow-up Period
Participants did not receive any study treatment during post treatment follow-up period. Post-Treatment Follow-up Period was summarized by last treatment assigned to a participant prior to entering the post-treatment follow up period.
FG005
Placebo Post-Treatment Follow-up Period
Participants did not receive any study treatment during post treatment follow-up period. Placebo Post-Treatment Follow-up Period was summarized by last treatment assigned to a participant prior to entering the post-treatment follow up period.
FG0020 subjectsParticipants were randomized to this arm during double-blind withdrawal period.
FG0030 subjectsParticipants were randomized to this arm during double-blind withdrawal period.
FG0040 subjects
FG0050 subjects
Received at Least One Dose of Study Drug
FG000394 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
Met Randomization Criteria
FG000158 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
Non-randomized
FG000133 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
COMPLETED
FG000291 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
NOT COMPLETED
FG000103 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
Type
Comment
Reasons
Lack of Efficacy
FG00061 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
Withdrawal by Subject
FG00021 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Adverse Event
FG00014 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Death
FG0002 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Lost to Follow-up
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Protocol Violation
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
No PI Available
FG0002 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Sponsor Decision
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Double-Blind Withdrawal Period
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG001133 subjectsParticipants completed open label but did not meet criteria for double-blind withdrawal period.
FG00279 subjectsParticipants completed open label and met criteria for double-blind withdrawal period.
FG00379 subjectsParticipants completed open label and met criteria for double-blind withdrawal period.
FG0040 subjects
FG0050 subjects
Relapsed
FG0000 subjects
FG0010 subjects
FG00267 subjects
FG00330 subjects
FG004
COMPLETED
FG0000 subjects
FG001118 subjects
FG00277 subjects
FG00378 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG00115 subjects
FG0022 subjects
FG0031 subjects
FG004
Type
Comment
Reasons
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0022 subjects
FG003
Post Treatment Follow-up Period
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004355 subjects
FG00512 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
All participants who received at least one dose of study drug.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Ixekizumab Open Label
Open-Label Treatment Period: Starting dose of 160 milligrams (mg) ixekizumab given as two subcutaneous (SC) injections at baseline (week 0) followed by 80 mg given as one SC injection every two weeks (Q2W) from week 2 to randomization (week 36 to 64).
Denominators
Units
Counts
Participants
BG000394
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00047.4± 11.40
Sex: Female, Male
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
Female
BG000212
Male
BG000182
Ethnicity (NIH/OMB)
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG00016
Not Hispanic or Latino
BG000330
Race (NIH/OMB)
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
Asian
BG0006
Region of Enrollment
Number
participants
Title
Denominators
Categories
United States
Title
Measurements
BG00032
Czechia
Title
Measurements
BG000
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
Double-Blind Withdrawal Period: Time to Relapse (No Longer Meeting Coates Criteria for Minimal Disease Activity [MDA])
Relapse is loss of MDA response. MDA is achieved if 5 of 7 outcome measures are fulfilled:TJC ≤1;SJC ≤1;psoriasis activity & severity index(PASI total score) ≤1 or body surface area(BSA) ≤3;participant pain VAS score of ≤15;participant global disease activity VAS score of ≤20;HAQ-DI score ≤0.5;and tender entheseal points ≤1.Participants met the randomization criteria if they had MDA for 3 consecutive months over 4 consecutive visits.Time-to relapse was calculated in weeks as follows:((Date of Relapse) - Date of first injection of randomized study treatment in period 3)+1) divided by 7.If the date of first dose is missing,the date of randomization will be used.Participants completing Period 3 will be censored at date of completion(the date of the last scheduled visit in the period).Participants without a date of completion or discontinuation for Period 3 will be censored at latest non-missing date out of the following dates:date of last dose & date of last attended visit in Period 3.
All participants who received at least one dose of study drug in randomized withdrawal Intent-to-Treat population. Censored participants were Ixekizumab = 49 and Placebo =12.
Posted
Median
95% Confidence Interval
Weeks
Double Blind Randomization through Week 104 (or Early Termination or Relapse)
ID
Title
Description
OG000
Ixekizumab
Participants completed open label and met criteria for randomization to the double-blind Withdrawal Period.
Double-Blind Withdrawal Period: 80 mg ixekizumab given as one SC injection Q2W from randomization to week 104 (or, early termination or relapse).
OG001
Placebo
Participants completed open label and met criteria for randomization to the double-blind Withdrawal Period.
Double-Blind Withdrawal Period: Placebo given as one SC injection Q2W any time from randomization to week 104 (or, early termination or relapse)
Units
Counts
Participants
OG00079
OG00179
Title
Denominators
Categories
Title
Measurements
OG000NA(64.29 to NA)Median and upper confidence interval could not be estimated due to insufficient events in analysis duration.
OG00122.29(16.14 to 28.29)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Log Rank Test adjusting for geographic region and conventional disease-modifying antirheumatic drug (cDMARD) use at the time of double blind randomization.
Log Rank
<0.001
Superiority
Secondary
Double-Blind Withdrawal Period: Percentage of Participants Who Relapse in MDA
Relapsed participants are defined as participants no longer meeting Coates criteria for MDA. MDA is achieved if 5 of 7 outcome measures are fulfilled: TJC ≤1; SJC ≤1; psoriasis activity and severity index (PASI total score) ≤1 or body surface area (BSA) ≤3; participant pain VAS score of ≤15; participant global disease activity VAS score of ≤20; HAQ-DI score ≤0.5; and tender entheseal points ≤1.
All participants who received at least one dose of study drug in randomized withdrawal Intent-to-Treat population.
Posted
Number
95% Confidence Interval
percentage of participants
Double Blind Randomization through Week 104 (or Early Termination or Relapse)
ID
Title
Description
OG000
Ixekizumab
Participants completed open label and met criteria for randomization to the double-blind Withdrawal Period.
Double-Blind Withdrawal Period: 80 mg ixekizumab given as one SC injection Q2W from randomization to week 104 (or, early termination or relapse).
OG001
Placebo
Participants completed open label and met criteria for randomization to the double-blind Withdrawal Period.
Double-Blind Withdrawal Period: Placebo given as one SC injection Q2W any time from randomization to week 104 (or, early termination or relapse)
Secondary
Double-Blind Withdrawal Period: Time to Loss of Response in Each Individual Component of MDA: Tender Joint Count 68 (TJC)
TJC is the number of tender and painful joints determined for each participant by examination of 68 joints.TJC possible values range from 0 to 68. A lower TJC indicated less number of joints with tenderness. A higher TJC indicated more joint tenderness. Joints were assessed by pressure and joint manipulation on physical examination. Participants were asked for pain sensations on these manipulations and watched for spontaneous pain reactions. Any positive response on pressure, movement, or both was translated into a single tender-versus-nontender dichotomy.
Loss of Response = Not Meeting less than or equal to 1 TJC. Time to loss of response (in weeks) = (date of loss of response - date of first injection of randomized dose of study treatment in the Randomized Double-Blind Withdrawal Period + 1)/7.
All participants who received at least one dose of study drug in the randomized withdrawal Intent-to-Treat Population who had tender joint counts <= 1 at time of randomization. Censored participants: Ixekizumab= 29 and Placebo= 16.
Posted
Median
95% Confidence Interval
weeks
Double Blind Randomization through Week 104 (or Early Termination or Relapse)
ID
Title
Description
OG000
Ixekizumab
Participants completed open label and met criteria for randomization to the double-blind Withdrawal Period.
Double-Blind Withdrawal Period: 80 mg ixekizumab given as one SC injection Q2W from randomization to week 104 (or, early termination or relapse).
OG001
Secondary
Double-Blind Withdrawal Period: Time to Loss of Response in Each Individual Component of MDA: Swollen Joint Count 66 (SJC)
SJC is the number of swollen joints determined for each participant by examination of 66 joints. SJC possible values range from 0 to 66. A lower SJC indicated less joints with swelling. A higher SJC indicated more joints with swelling. Swelling was defined as palpable fluctuating synovitis of the joint.
Loss of Response = Not Meeting less than or equal to 1 SJC. Time to loss of response (in weeks) = (date of loss of response - date of first injection of randomized dose of study treatment in the Randomized Double-Blind Withdrawal Period + 1)/7.
All participants who received at least one dose of study drug in the randomized withdrawal Intent-to-Treat population who had swollen joint counts <= 1 at time of randomization. Censored participants: Ixekizumab= 61 and Placebo = 40.
Posted
Median
95% Confidence Interval
weeks
Double Blind Randomization through Week 104 (or Early Termination or Relapse)
ID
Title
Description
OG000
Ixekizumab
Participants completed open label and met criteria for randomization to the double-blind Withdrawal Period.
Double-Blind Withdrawal Period: 80 mg ixekizumab given as one SC injection Q2W from randomization to week 104 (or, early termination or relapse).
OG001
Placebo
Participants completed open label and met criteria for randomization to the double-blind Withdrawal Period.
Double-Blind Withdrawal Period: Placebo given as one SC injection Q2W any time from randomization to week 104 (or, early termination or relapse)
Secondary
Double-Blind Withdrawal Period: Time to Loss of Response in Each Individual Component of MDA: Psoriasis Area and Severity Index (PASI)
The PASI is an index that combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation, erythema, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis to 72 for the most severe disease.
Loss of Response = Not Meeting less than or equal to 1 PASI total score. Time to loss of response (in weeks) = (date of loss of response - date of first injection of randomized dose of study treatment in the Randomized Double-Blind Withdrawal Period + 1)/7.
All participants who received at least one dose of study drug in the randomized withdrawal intent-to-treat population Who had PASI <= 1 at time of randomization. Censored participants: Ixekizumab = 64 and Placebo = 43.
Posted
Median
95% Confidence Interval
weeks
Double Blind Randomization through Week 104 (or Early Termination or Relapse)
ID
Title
Description
OG000
Ixekizumab
Participants completed open label and met criteria for randomization to the double-blind Withdrawal Period.
Double-Blind Withdrawal Period: 80 mg ixekizumab given as one SC injection Q2W from randomization to week 104 (or, early termination or relapse).
OG001
Placebo
Participants completed open label and met criteria for randomization to the double-blind Withdrawal Period.
Double-Blind Withdrawal Period: Placebo given as one SC injection Q2W any time from randomization to week 104 (or, early termination or relapse)
Secondary
Double-Blind Withdrawal Period: Time to Loss of Response in Each Individual Component of MDA: BSA
BSA is an investigator evaluated measure, where the percentage of involvement of psoriasis on each participant's BSA is assessed. BSA was measured on a continuous scale from 0% = no involvement to 100% = full involvement, where 1% corresponded to the size of the participant's handprint including the palm, fingers, and thumb. Loss of Response = Not meeting less than or equal to 3% BSA.
Time to loss of response (in weeks) = (date of loss of response - date of first injection of randomized dose of study treatment in the Randomized Double-Blind Withdrawal Period + 1)/7.
All participants who received at least one dose of study drug in the randomized Withdrawal Intent-to-Treat Population who had BSA <= 3% at time of randomization. Censored participants: Ixekizumab=70 and Placebo= 59.
Posted
Median
95% Confidence Interval
weeks
Double Blind Randomization through Week 104 (or Early Termination or Relapse)
ID
Title
Description
OG000
Ixekizumab
Participants completed open label and met criteria for randomization to the double-blind Withdrawal Period.
Double-Blind Withdrawal Period: 80 mg ixekizumab given as one SC injection Q2W from randomization to week 104 (or, early termination or relapse).
OG001
Placebo
Participants completed open label and met criteria for randomization to the double-blind Withdrawal Period.
Double-Blind Withdrawal Period: Placebo given as one SC injection Q2W any time from randomization to week 104 (or, early termination or relapse)
Secondary
Double-Blind Withdrawal Period: Time to Loss of Response in Each Individual Component of MDA: Pain Visual Analog Scale (VAS) Score
The pain VAS is an instrument used to measure a person's subjective quantitative evaluation of an item such as pain intensity. The VAS contains a continuous line between two endpoints whereby the respondent places a mark on the line to indicate his or her response The scale ranges from 0 (no pain) to 100 (unbearable pain). The scores were measured to the nearest millimeter from the left. Loss of Response = Not Meeting less than or equal to 15 Pain VAS. Time to loss of response (in weeks) = (date of loss of response - date of first injection of randomized dose of study treatment in the Randomized Double-Blind Withdrawal Period + 1)/7.
All participants who received at least one dose of study drug in the randomized withdrawal Intent-to-Treat Population who had Pain VAS <= 15 at time of randomization. Censored participants: Ixekizumab=42 and Placebo= 7.
Posted
Median
95% Confidence Interval
weeks
Double Blind Randomization through Week 104 (or Early Termination or Relapse)
ID
Title
Description
OG000
Ixekizumab
Participants completed open label and met criteria for randomization to the double-blind Withdrawal Period.
Double-Blind Withdrawal Period: 80 mg ixekizumab given as one SC injection Q2W from randomization to week 104 (or, early termination or relapse).
OG001
Placebo
Participants completed open label and met criteria for randomization to the double-blind Withdrawal Period.
Double-Blind Withdrawal Period: Placebo given as one SC injection Q2W any time from randomization to week 104 (or, early termination or relapse)
Secondary
Double-Blind Withdrawal Period: Time to Loss of Response in Each Individual Component of MDA: Patients Global Assessment of Disease Activity (PatGA) Visual Analog Scale (VAS) Score
Participants scored their overall assessment of their psoriatic arthritis (PsA) activity on a 0 to 100 mm horizontal VAS. The scale ranged from 0 (no disease activity) to 100 (extremely active disease activity). The scores were measured to the nearest millimeter from the left.
Loss of Response = Not Meeting less than or equal to 20 PatGA. Time to loss of response (in weeks) = (date of loss of response - date of first injection of randomized dose of study treatment in the Randomized Double-Blind Withdrawal Period + 1)/7.
All participants who received at least one dose of study drug in the randomized withdrawal Intent-to-Treat population Who had PatGA VAS <= 20 at time of randomization. Censored participants: Ixekizumab= 57 and Placebo=18.
Posted
Median
95% Confidence Interval
weeks
Double Blind Randomization through Week 104 (or Early Termination or Relapse)
ID
Title
Description
OG000
Ixekizumab
Participants completed open label and met criteria for randomization to the double-blind Withdrawal Period.
Double-Blind Withdrawal Period: 80 mg ixekizumab given as one SC injection Q2W from randomization to week 104 (or, early termination or relapse).
OG001
Placebo
Participants completed open label and met criteria for randomization to the double-blind Withdrawal Period.
Double-Blind Withdrawal Period: Placebo given as one SC injection Q2W any time from randomization to week 104 (or, early termination or relapse)
Secondary
Double-Blind Withdrawal Period: Time to Loss of Response in Each Individual Component of MDA: Health Assessment Questionnaire-Disability Index (HAQ-DI)
The HAQ-DI questionnaire assesses the participant's self-perception on the degree of difficulty [0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), and 3 (unable to do)] when dressing and grooming, arising, eating, walking, hygiene, reaching, gripping, and performing other daily activities. Scores for each functional area were averaged to calculate HAQ-DI scores, which ranged from 0 (no disability) to 3 (severe disability). A decrease in HAQ-DI score indicated an improvement in the participant's condition.
Loss of Response = Not Meeting less than or equal to 0.5 HAQ-DI. Time to loss of response (in weeks) = (date of loss of response - date of first injection of randomized dose of study treatment in the Randomized Double-Blind Withdrawal Period + 1)/7.
All participants who received at least one dose of study drug in the randomized withdrawal Intent-to-Treat population Who had HAQ-DI <= 0.5 at Time of randomization. Censored participants: Ixekizumab= 55 and Placebo=53.
Posted
Median
95% Confidence Interval
weeks
Double Blind Randomization through Week 104 (or Early Termination or Relapse)
ID
Title
Description
OG000
Ixekizumab
Participants completed open label and met criteria for randomization to the double-blind Withdrawal Period.
Double-Blind Withdrawal Period: 80 mg ixekizumab given as one SC injection Q2W from randomization to week 104 (or, early termination or relapse).
OG001
Secondary
Double-Blind Withdrawal Period: Time to Loss of Response in Each Individual Component of MDA: Tender Entheseal Points
Tender entheseal points was based on the assessment of the 18 entheseal points. Loss of Response = Not Meeting less than or equal to 1 Tender Entheseal Point. Time to loss of response (in weeks) = (date of loss of response - date of first injection of randomized dose of study treatment in the Randomized Double-Blind Withdrawal Period + 1)/7.
All participants who received at least one dose of study drug in the randomized withdrawal Intent-to-Treat Population who had tender Entheseal Point <= 1 at time of randomization. Censored participants: Ixekizumab= 58 and Placebo= 58.
Posted
Median
95% Confidence Interval
weeks
Double Blind Randomization through Week 104 (or Early Termination or Relapse)
ID
Title
Description
OG000
Ixekizumab
Participants completed open label and met criteria for randomization to the double-blind Withdrawal Period.
Double-Blind Withdrawal Period: 80 mg ixekizumab given as one SC injection Q2W from randomization to week 104 (or, early termination or relapse).
OG001
Placebo
Double-Blind Withdrawal Period: Placebo given as one SC injection Q2W any time from randomization to week 104 (or, early termination or relapse).
Secondary
Open-Label Treatment Period: Time to Achieve Randomization Criteria (Meeting MDA for 3 Consecutive Months Over 4 Consecutive Visits)
Time to meeting MDA for 3 Consecutive Months Over 4 Consecutive Visits. Time to first response (in weeks) = [(date of first response - date of first injection of study treatment in the Open-Label Treatment Period)+1]/7.
Open-Label Treatment Period ended at the time when a participant was randomized so the end time was not the same for all participants. Participants were randomized only if they met randomization criteria which was at anytime from week 36 to week 64.
All participants who received at least one dose of study drug in initial open-label treatment period. Censored participants were 239.
Posted
Median
95% Confidence Interval
weeks
Open Label Baseline through Double-Blind Randomization (Week 36 to 64)
ID
Title
Description
OG000
Ixekizumab Open Label
Open-Label Treatment Period: Starting dose of 160 milligrams (mg) ixekizumab given as two subcutaneous (SC) injections at baseline (week 0) followed by 80 mg given as one SC injection every two weeks (Q2W) from week 2 to randomization (week 36 to 64).
Units
Counts
Participants
Secondary
Double-Blind Withdrawal Period: Time to Re-Gain MDA Following Relapse in MDA
MDA is achieved if 5 of 7 outcome measures are fulfilled: TJC ≤1; SJC ≤1; psoriasis activity and severity index (PASI total score) ≤1 or BSA ≤3; participant pain VAS score of ≤15; participant global disease activity VAS score of ≤20; HAQ-DI score ≤0.5; and tender entheseal points ≤1. Time to first response (in weeks) = (date of first response - date of first injection of study treatment in the Relapse Period + 1)/7.
All participants who received at least one dose of study drug and relapsed in MDA After Double Blind Randomization Until Re-Gain MDA. Censored participants were: Ixekizumab= 3 and Placebo= 3.
Posted
Median
95% Confidence Interval
weeks
Relapse in MDA After Double Blind Randomization through Week 104 (or Early Termination)
ID
Title
Description
OG000
Ixekizumab
Participants completed open label and met criteria for randomization to the double-blind Withdrawal Period.
Double-Blind Withdrawal Period: 80 mg ixekizumab given as one SC injection Q2W from randomization to week 104 (or, early termination or relapse).
OG001
Placebo
Participants completed open label and met criteria for randomization to the double-blind Withdrawal Period.
Double-Blind Withdrawal Period: Placebo given as one SC injection Q2W any time from randomization to week 104 (or, early termination or relapse)
Secondary
Double-Blind Withdrawal Period: Change From Baseline in Physical Functioning Assessed by the Health Assessment Questionnaire-Disability Index (HAQ-DI)
The HAQ-DI questionnaire assesses the participant's self-perception on the degree of difficulty [0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), and 3 (unable to do)] when dressing and grooming, arising, eating, walking, hygiene, reaching, gripping, and performing other daily activities. Scores for each functional area were averaged to calculate HAQ-DI scores, which ranged from 0 (no disability) to 3 (severe disability). A decrease in HAQ-DI score indicated an improvement in the participant's condition.Least Square (LS) mean calculated using Mixed Model Repeated Measurements (MMRM) analysis with treatment group, baseline measure, geographic region, cDMARD use, treatment week, baseline measure-by-treatment week interaction term, and treatment week-by-treatment interaction term as fixed factors.
Participants were randomized only if they met randomization criteria which was at anytime from week 36 to week 64.
All participants who received at least one dose of study drug had a baseline and post baseline measure in the Double-Blind Withdrawal Period.
Posted
Least Squares Mean
Standard Error
score on a scale
Baseline, 40 Weeks from Double Blind Randomization (Week 36 to 64)
ID
Title
Description
OG000
Ixekizumab
Participants completed open label and met criteria for randomization to the double-blind Withdrawal Period.
Double-Blind Withdrawal Period: 80 mg ixekizumab given as one SC injection Q2W from randomization to week 104 (or, early termination or relapse).
Time Frame
Up To 3 Years
Description
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
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
Ixekizumab Open Label
Open-Label Treatment Period: Starting dose of 160 milligrams (mg) ixekizumab given as two subcutaneous (SC) injections at baseline (week 0) followed by 80 mg given as one SC injection every two weeks (Q2W) from week 2 to randomization (week 36 to 64).
2
394
20
394
143
394
EG001
Ixekizumab
Participants completed open label and met criteria for randomization to the double-blind Withdrawal Period.
Double-Blind Withdrawal Period: 80 mg ixekizumab given as one SC injection Q2W from randomization to week 104 (or, early termination or relapse).
0
79
1
79
25
79
EG002
Placebo
Participants completed open label and met criteria for randomization to the double-blind Withdrawal Period.
Double-Blind Withdrawal Period: Placebo given as one SC injection Q2W any time from randomization to week 104 (or, early termination or relapse).
0
79
2
79
14
79
EG003
IXE80Q2W Non-randomized Population to Withdrawal Period
Participants completed open label but did not meet criteria for randomization to the double-blind Withdrawal Period.
Participants continued to receive 80 mg given as one SC injection every two weeks during the double-blind withdrawal period.
0
133
6
133
37
133
EG004
IXE80Q2W Relapse Period
IXE80Q2W Relapse Period
Double Blind Period: 80 mg ixekizumab given as one SC injection Q2W from randomization to week 104 (or, early termination or relapse).
Double Blind Period: Placebo given as one SC injection Q2W any time from randomization to week 104 (or, early termination or relapse).
0
97
1
97
30
97
EG005
IXE80Q2W Post-Treatment Follow-up Period
Participants did not receive any study treatment during post treatment follow-up period. Post-Treatment Follow-up Period was summarized by last treatment assigned to a participant prior to entering the post-treatment follow up period.
0
355
4
355
19
355
EG006
Placebo Post-Treatment Follow-up Period
Participants did not receive any study treatment during post treatment follow-up period. Placebo Post-Treatment Follow-up Period was summarized by last treatment assigned to a participant prior to entering the post-treatment follow up period.
0
12
0
12
0
12
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Acute myocardial infarction
Cardiac disorders
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected394 at risk
EG0010 events0 affected79 at risk
EG0020 events0 affected79 at risk
EG0030 events0 affected133 at risk
EG0040 events0 affected97 at risk
EG0050 events0 affected355 at risk
EG0060 events0 affected12 at risk
Angina unstable
Cardiac disorders
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected394 at risk
EG0010 events0 affected79 at risk
EG0020 events0 affected79 at risk
EG003
Coronary artery disease
Cardiac disorders
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected394 at risk
EG0010 events0 affected79 at risk
EG0020 events0 affected79 at risk
EG003
Crohn's disease
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected394 at risk
EG0010 events0 affected79 at risk
EG0020 events0 affected79 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected394 at risk
EG0010 events0 affected79 at risk
EG0020 events0 affected79 at risk
EG003
Gastrointestinal necrosis
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected394 at risk
EG0010 events0 affected79 at risk
EG0020 events0 affected79 at risk
EG003
Intestinal obstruction
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected394 at risk
EG0010 events0 affected79 at risk
EG0020 events0 affected79 at risk
EG003
Large intestine polyp
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected394 at risk
EG0010 events0 affected79 at risk
EG0021 events1 affected79 at risk
EG003
Drowning
General disorders
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected394 at risk
EG0010 events0 affected79 at risk
EG0020 events0 affected79 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected394 at risk
EG0010 events0 affected79 at risk
EG0020 events0 affected79 at risk
EG003
Cholecystitis acute
Hepatobiliary disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected394 at risk
EG0010 events0 affected79 at risk
EG0020 events0 affected79 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA 21.1
Systematic Assessment
EG0002 events2 affected394 at risk
EG0010 events0 affected79 at risk
EG0020 events0 affected79 at risk
EG003
Hepatic steatosis
Hepatobiliary disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected394 at risk
EG0010 events0 affected79 at risk
EG0020 events0 affected79 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0002 events2 affected394 at risk
EG0010 events0 affected79 at risk
EG0020 events0 affected79 at risk
EG003
Erysipelas
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected394 at risk
EG0010 events0 affected79 at risk
EG0020 events0 affected79 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected394 at risk
EG0010 events0 affected79 at risk
EG0020 events0 affected79 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected394 at risk
EG0010 events0 affected79 at risk
EG0020 events0 affected79 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected394 at risk
EG0010 events0 affected79 at risk
EG0021 events1 affected79 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected394 at risk
EG0010 events0 affected79 at risk
EG0020 events0 affected79 at risk
EG003
Foreign body in eye
Injury, poisoning and procedural complications
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected394 at risk
EG0010 events0 affected79 at risk
EG0020 events0 affected79 at risk
EG003
Humerus fracture
Injury, poisoning and procedural complications
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected394 at risk
EG0010 events0 affected79 at risk
EG0020 events0 affected79 at risk
EG003
Meniscus injury
Injury, poisoning and procedural complications
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected394 at risk
EG0010 events0 affected79 at risk
EG0020 events0 affected79 at risk
EG003
Radius fracture
Injury, poisoning and procedural complications
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected394 at risk
EG0010 events0 affected79 at risk
EG0020 events0 affected79 at risk
EG003
Road traffic accident
Injury, poisoning and procedural complications
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected394 at risk
EG0010 events0 affected79 at risk
EG0020 events0 affected79 at risk
EG003
Thermal burn
Injury, poisoning and procedural complications
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected394 at risk
EG0010 events0 affected79 at risk
EG0020 events0 affected79 at risk
EG003
Upper limb fracture
Injury, poisoning and procedural complications
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected394 at risk
EG0010 events0 affected79 at risk
EG0020 events0 affected79 at risk
EG003
Troponin increased
Investigations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected394 at risk
EG0010 events0 affected79 at risk
EG0020 events0 affected79 at risk
EG003
Foot deformity
Musculoskeletal and connective tissue disorders
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected394 at risk
EG0010 events0 affected79 at risk
EG0020 events0 affected79 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected394 at risk
EG0010 events0 affected79 at risk
EG0020 events0 affected79 at risk
EG003
Uterine leiomyoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected212 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected39 at risk
EG003
Embolic stroke
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected394 at risk
EG0010 events0 affected79 at risk
EG0020 events0 affected79 at risk
EG003
Transient ischaemic attack
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected394 at risk
EG0010 events0 affected79 at risk
EG0020 events0 affected79 at risk
EG003
Vascular headache
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected394 at risk
EG0010 events0 affected79 at risk
EG0020 events0 affected79 at risk
EG003
Endometriosis
Reproductive system and breast disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected212 at risk
EG0011 events1 affected32 at risk
EG0020 events0 affected39 at risk
EG003
Ovarian cyst
Reproductive system and breast disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected212 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected39 at risk
EG003
Acute respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected394 at risk
EG0010 events0 affected79 at risk
EG0020 events0 affected79 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected394 at risk
EG0010 events0 affected79 at risk
EG0020 events0 affected79 at risk
EG003
Angioedema
Skin and subcutaneous tissue disorders
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected394 at risk
EG0010 events0 affected79 at risk
EG0020 events0 affected79 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Injection site reaction
General disorders
MedDRA 21.1
Systematic Assessment
EG000270 events59 affected394 at risk
EG0018 events1 affected79 at risk
EG0020 events0 affected79 at risk
EG00320 events2 affected133 at risk
EG00427 events7 affected97 at risk
EG0050 events0 affected355 at risk
EG0060 events0 affected12 at risk
Bronchitis
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG00023 events18 affected394 at risk
EG0014 events4 affected79 at risk
EG0021 events1 affected79 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG00037 events34 affected394 at risk
EG00113 events11 affected79 at risk
EG0024 events4 affected79 at risk
EG003
Oral herpes
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG00010 events9 affected394 at risk
EG0019 events4 affected79 at risk
EG0023 events1 affected79 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG00066 events49 affected394 at risk
EG00114 events9 affected79 at risk
EG0025 events4 affected79 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 21.1
Systematic Assessment
EG00014 events11 affected394 at risk
EG0014 events4 affected79 at risk
EG0022 events1 affected79 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 21.1
Systematic Assessment
EG0008 events6 affected394 at risk
EG0014 events4 affected79 at risk
EG0022 events1 affected79 at risk
EG003
Uterine leiomyoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)