A Long Term Extension Study of Ixekizumab (LY2439821) in... | NCT03129100 | Trialant
NCT03129100
Sponsor
Eli Lilly and Company
Status
Completed
Last Update Posted
Jun 13, 2022Actual
Enrollment
773Actual
Phase
Phase 3
Conditions
Axial Spondyloarthritis
Interventions
Ixekizumab
Placebo
Countries
United States
Argentina
Austria
Brazil
Canada
Czechia
Finland
France
Germany
Hungary
Israel
Italy
Japan
Mexico
Netherlands
Poland
Puerto Rico
Romania
Russia
South Korea
Spain
Taiwan
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT03129100
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
16181
Secondary IDs
ID
Type
Description
Link
I1F-MC-RHBY
Other Identifier
Eli Lilly and Company
2016-002634-69
EudraCT Number
Brief Title
A Long Term Extension Study of Ixekizumab (LY2439821) in Participants With Axial Spondyloarthritis
Official Title
A Multicenter, Long-Term Extension Study of 104 Weeks, Including a Double-Blind, Placebo-Controlled 40-Week Randomized Withdrawal-Retreatment Period, to Evaluate the Maintenance of Treatment Effect of Ixekizumab (LY2439821) in Patients With Axial Spondyloarthritis
Acronym
Not provided
Organization
Eli Lilly and CompanyINDUSTRY
Status Module
Record Verification Date
May 2022
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
May 9, 2017Actual
Primary Completion Date
May 26, 2020Actual
Completion Date
May 27, 2021Actual
First Submitted Date
Apr 3, 2017
First Submission Date that Met QC Criteria
Apr 21, 2017
First Posted Date
Apr 26, 2017Actual
Results Waived
Not provided
Results First Submitted Date
May 24, 2021
Results First Submitted that Met QC Criteria
May 24, 2021
Results First Posted Date
Jun 18, 2021Actual
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
May 12, 2022
Last Update Posted Date
Jun 13, 2022Actual
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
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of this study is to evaluate, in participants having achieved a state of sustained remission, if the ixekizumab treatment groups are superior to the placebo group in maintaining response during the randomized withdrawal-retreatment period in participants with axial spondyloarthritis.
Detailed Description
Not provided
Conditions Module
Conditions
Axial Spondyloarthritis
Keywords
Not provided
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
773Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Ixekizumab (IXE) 80Q4W
Experimental
Participants received 80 milligram (mg) of Ixekizumab subcutaneously (SC) every four weeks (Q4W).
Drug: Ixekizumab
Ixekizumab (IXE) 80Q2W
Experimental
Participants received 80 milligram (mg) of Ixekizumab subcutaneously (SC) every two weeks (Q2W).
Drug: Ixekizumab
Placebo
Placebo Comparator
Participants received subcutaneous dose of placebo.
Drug: Placebo
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Ixekizumab
Drug
Administered SC
Ixekizumab (IXE) 80Q2W
Ixekizumab (IXE) 80Q4W
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percentage of Participants Who do Not Experience a Flare (Combined Ixekizumab Treatment)
A flare is defined as Ankylosing Spondylitis Disease Activity Score (ASDAS ≥2.1) at 2 consecutive visits, or ASDAS >3.5 at any visit during Period 2.
ASDAS is a composite index to assess disease activity in AS. The parameters used for the ASDAS (with high sensitivity C-reactive protein (CRP) as acute phase reactant) are total back pain, patient global, peripheral pain/swelling, duration of morning stiffness and CRP in mg/L. The ASDAScrp is calculated with the following equation: 0.121×total back pain+0.110×patient global+0.073×peripheral pain/swelling+0.058×duration of morning stiffness+0.579×Ln(CRP+1). (CRP is in mg/liter, the range of other variables is from 0(normal) to 10(very severe); Ln represents the natural logarithm). Data from five variables combined to yield a score (0.6361 to no defined upper limit), where higher the score worse the disease activity.
Week 64
Secondary Outcomes
Measure
Description
Time Frame
Percentage of Participants Who do Not Experience a Flare
A flare is defined as Ankylosing Spondylitis Disease Activity Score (ASDAS ≥2.1) at 2 consecutive visits, or ASDAS >3.5 at any visit during Period 2.
ASDAS is a composite index to assess disease activity in AS. The parameters used for the ASDAS (with high sensitivity C-reactive protein (CRP) as acute phase reactant) are total back pain, patient global, peripheral pain/swelling, duration of morning stiffness and CRP in mg/L. The ASDAScrp is calculated with the following equation: 0.121×total back pain+0.110×patient global+0.073×peripheral pain/swelling+0.058×duration of morning stiffness+0.579×Ln(CRP+1). (CRP is in mg/liter, the range of other variables is from 0(normal) to 10(very severe); Ln represents the natural logarithm). Data from five variables combined to yield a score (0.6361 to no defined upper limit), where higher the score worse the disease activity.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Have completed the final study visit in Study RHBV (NCT02696785), RHBW (NCT02696798), or RHBX (NCT02757352).
(Note: Participants from Study RHBX are not eligible if they permanently discontinued ixekizumab and were receiving a tumor necrosis factor [TNF] inhibitor).
Must agree to use a reliable method of birth control.
Exclusion Criteria:
Have significant uncontrolled disorders or abnormal laboratory values that, in the opinion of the investigator, pose an unacceptable risk to the participant if investigational product continues to be administered.
Have a known hypersensitivity to ixekizumab or any component of this investigational product.
Had investigational product permanently discontinued during a previous ixekizumab study.
Had temporary investigational product interruption at any time during or at the final study visit of a previous ixekizumab study and, in the opinion of the investigator, restarting ixekizumab poses an unacceptable risk for the participant's participation in the study.
Have any other condition that, in the opinion of the investigator, renders the participant unable to understand the nature, scope, and possible consequences of the study or precludes the participant from following and completing the protocol.
Are currently enrolled in any other clinical trial involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study.
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
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 A, Poddubnyy D, Rahman P, Ermann J, Tomita T, Bolce R, Leage SL, Kronbergs A, Johnson C, Araujo J, Leung A, van der Heijde D. Long-Term Safety and Efficacy of Ixekizumab in Patients With Axial Spondyloarthritis: 3-year Data From the COAST Program. J Rheumatol. 2023 Aug;50(8):1020-1028. doi: 10.3899/jrheum.221022. Epub 2023 Feb 15.
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.
In Period 2, participants who did not achieve sustained remission were assigned to Group A and continued to receive the ixekizumab(IXE) dose regimen that they were receiving during Period 1. Participants who did achieve sustained remission were assigned to Group B (Randomized Withdrawal Extension(RWE) period) and were randomized 2:1 to either continue their IXE dose or to withdraw to placebo. Participants who experienced a flare in group B were retreated with IXE in Retreatment Extension Period.
Recruitment Details
Lead-In (Period 1): 24 weeks (Week 0 to Week 24)
Extension Period including Double-Blind, Placebo-Controlled, Randomized Withdrawal-Retreatment (RWR) (Period 2): 40 weeks (Week 24 to Week 64)
Long-Term Extension Period (Period 3): 40 weeks (Week 64 to Week 104)
Post-Treatment Follow-Up (Period 4): at least 12 weeks and up to 24 weeks after the date of the participant's ETV or last regularly scheduled visit.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
IXE 80Q4W-Lead-in Period
Participants received 80 milligram (mg) of Ixekizumab subcutaneously (SC) every four weeks (Q4W) for up to week 24.
FG001
IXE80Q2W-Lead-in Period
Participants received 80 mg of Ixekizumab subcutaneously every two weeks (Q2W) for up to week 24.
Periods
Title
Milestones
Reasons Not Completed
Lead-In Period (Period 1)
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Jun 27, 2017
Nov 18, 2020
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Cyprus
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
LY2439821
Placebo
Drug
Administered SC
Placebo
Week 64
Change From Baseline in Modified Stoke Ankylosing Spondylitis Spinal Score (mSASSS)
The mSASSS is a four-point scoring system for lateral radiographs of the lumbar and cervical spine and has been shown to reliably track disease progression over time, where: 0 = normal; 1 = sclerosis, squaring or erosion; 2 = syndesmophyte; 3 = bony bridge.
By the scoring system of mSASSS of the spinal x-rays, a total of 24 sites were scored on the lateral cervical and lumbar spine: the anterior corners of the vertebrae from lower border of C2 to upper border T1 (inclusive), and from lower border of T12 to upper border of S1 (inclusive). Each corner was scored from 0 to 3, resulting in a range from 0 [no change] to 72 [progression].
Baseline, 2 Years
Percentage of Participants Achieving an Assessment of Spondyloarthritis International Society (ASAS)20 Response
ASAS20 response is defined as a ≥20% improvement and an absolute improvement from baseline of ≥1 units (range 0 to 10) in ≥3 of 4 domains, and no worsening of ≥20% and ≥1 unit (range 0 to 10) in the remaining domain.
The following ASAS domains are used:
Patient Global: How active was your spondylitis on average during the last week? score ranges 0 (not active) to 10 (very active).
Spinal Pain: How much Pain of your spine due to Ankylosing spondylitis? score ranges 0 (no pain) to 10 (severe pain).
Bath Ankylosing Spondylitis Functional Index (BASFI): Participant asked to rate the difficulty associated with 10 individual basic functional activities. Participant response was captured using Numeric Rating Scale (NRS) (range 0 to 10) with a higher score indicating worse function.
Inflammation based on mean of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Q5 & Q6 (mean of intensity & duration of stiffness): Score ranges from "0" (none) and "10" (very severe).
Week 64
Percentage of Participants Achieving an ASAS40 Response
ASAS40 is defined as a ≥40% improvement and an absolute improvement from baseline of ≥2 units (range of 0 to 10) in at least 3 of the following 4 domains without any worsening in the remaining domain. The following ASAS domains are used:
Patient Global: How active was your spondylitis on average during the last week? score ranges 0 (not active) to 10 (very active).
Spinal Pain: How much Pain of your spine due to Ankylosing spondylitis? score ranges 0 (no pain) to 10 (severe pain).
Bath Ankylosing Spondylitis Functional Index (BASFI): Participant asked to rate the difficulty associated with 10 individual basic functional activities. Participant response was captured using Numeric Rating Scale (NRS) (range 0 to 10) with a higher score indicating worse function.
Inflammation based on mean of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Q5 & Q6 (mean of intensity & duration of stiffness): Score ranges from "0" (none) and "10" (very severe).
Week 64
Percentage of Participants With Change of Ankylosing Spondylitis Disease Activity Score (ASDAS) ≥1.1 Units
ASDAS is a composite index to assess disease activity in AS. The parameters used for the ASDAS (with CRP as acute phase reactant) are total back pain, patient global, peripheral pain/swelling, duration of morning stiffness and CRP in mg/L. The ASDAScrp is calculated with the following equation: 0.121×total back pain+0.110×patient global+0.073×peripheral pain/swelling+0.058×duration of morning stiffness
+0.579×Ln(CRP+1). (CRP is in mg/liter, the range of other variables is from 0(normal) to 10(very severe); Ln represents the natural logarithm). Data from five variables combined to yield a score (0.6361 to no defined upper limit), where higher the score worse the disease activity.
Week 64
Percentage of Participants With Inactive Disease on the ASDAS (<1.3 Units)
ASDAS is a composite index to assess disease activity in AS. The parameters used for the ASDAS (with CRP as acute phase reactant) are total back pain, patient global, peripheral pain/swelling, duration of morning stiffness and CRP in mg/L. The ASDAScrp is calculated with the following equation: 0.121×total back pain+0.110×patient global+0.073×peripheral pain/swelling+0.058×duration of morning stiffness+0.579×Ln(CRP+1). (CRP is in mg/liter, the range of other variables is from 0(normal) to 10(very severe); Ln represents the natural logarithm). Data from five variables combined to yield a score (0.6361 to no defined upper limit), where higher the score worse the disease activity.
Week 64
Change From Baseline in the Individual Components of the ASAS Criteria
Patient Global: How active was your spondylitis on average during the last week? score ranges 0 (not active) to 10 (very active).
Spinal Pain: How much Pain of your spine due to Ankylosing spondylitis? score ranges 0 (no pain) to 10 (severe pain).
Bath Ankylosing Spondylitis Functional Index (BASFI): Participant asked to rate the difficulty associated with 10 individual basic functional activities. Participant response was captured using Numeric Rating Scale (NRS) (range 0 to 10) with a higher score indicating worse function. Inflammation based on Q5 & Q6 mean of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) (mean of intensity & duration of stiffness): Score ranges from "0" (none) and "10" (very severe). LS mean was determined by ANCOVA with treatment, geographic region, originating study, baseline value and Week 24 value as fixed factors.
Baseline, Week 64
Percentage of Participants Achieving Bath Ankylosing Spondylitis Disease Activity Index 50 (BASDAI50) Response
The BASDAI is a participant-reported assessment consisting of 6 questions that relate to 5 major symptoms relevant to radiographic axial spondyloarthritis (rad-axSpA): 1) Fatigue, 2) Spinal pain, 3) Peripheral arthritis, 4) Enthesitis, 5) Intensity, and 6) Duration of morning stiffness. Participants need to score each item with a score from 0 to 10 (NRS). Total score is obtained from the average of symptom scores ranging 0 (no problem) to 10 (worst problem), with a higher score indicating more severe AS symptom. BASDAI50 represents an improvement of ≥50% of the BASDAI score from baseline.
Week 64
Change From Baseline in the Measure of High Sensitivity C-Reactive Protein (CRP)
High sensitivity CRP is the measure of acute phase reactant. It was measured with a high sensitivity assay at the central laboratory to help assess the effect of ixekizumab on disease activity. High sensitivity CRP is a sensitive laboratory assay for serum levels of C-Reactive Protein, which is a biomarker of inflammation. LS mean was determined by ANCOVA with treatment, geographic region, originating study, baseline value and Week 24 value as fixed factors.
Baseline, Week 64
Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI)
BASMI is a combined index comprising of the following 5 clinical measurements of spinal mobility in participants with radiographic axial spondyloarthritis (rad-axSpA).
Lateral Spinal Flexion
Tragus-to-wall distance
Lumbar Flexion (modified Schober)
Maximal intermalleolar distance and
Cervical rotation.
The BASMI linear result is the average of the 5 assessments and ranges from 0 to 10. The higher the BASMI score the more severe the participant's limitation of movement due to their AS. LS mean was determined by ANCOVA with treatment, geographic region, originating study, baseline value and Week 24 value as fixed factors.
Baseline, Week 64
Change From Baseline in Chest Expansion in Centimeters
Chest expansion is the difference, in centimeter (cm), between the circumference of the chest in maximal inspiration and maximal expiration. While participants have their hands resting on or behind the head, the assessor will measure the chest encircled length by centimeter (cm) at the fourth intercostal level anteriorly. Two tries were recorded. The better measurement (larger difference) of 2 tries (in centimeters) was used for analyses. LS mean was determined by ANCOVA with treatment, geographic region, originating study, baseline value and Week 24 value as fixed factors.
Baseline, Week 64
Change From Baseline in Occiput to Wall Distance
The participant is to make a maximum effort to touch the head against the wall when standing with heels and back against the wall (occiput). Then the distance from occiput to wall is measured. Two tries will be recorded. The better (smaller) measurement of 2 tries (in centimeters) will be used for analyses. LS mean was determined by ANCOVA with treatment, geographic region, originating study, baseline value and Week 24 value as fixed factors.
Baseline, Week 64
Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES)
The MASES is an index used to measure the severity of enthesitis. The MASES assesses 13 sites for enthesitis using a score of "0" for no activity or "1" for activity. Sites assessed include costochondral 1 (right/left), costochondral 7 (right/left), spinal iliaca anterior superior (right/left), crista iliaca (right/left), spina iliaca posterior (right/left), processus spinosus L5, and Achilles tendon proximal insertion (right/left). The MASES is the sum of all site scores (range 0 to 13); higher scores indicate more severe enthesitis. LS mean was determined by ANCOVA with treatment, geographic region, originating study, baseline value and Week 24 value as fixed factors.
Baseline, Week 64
Change From Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Score
The SPARCC enthesitis is an index used to measure the severity of enthesitis. The SPARCC assesses 16 sites for enthesitis using a score of "0" for no activity or "1" for activity. Sites assessed include Medial epicondyle (left/right [L/R]), Lateral epicondyle (L/R), Supraspinatus insertion into greater tuberosity of humerus (L/R), Greater trochanter (L/R), Quadriceps insertion into superior border of patella (L/R), Patellar ligament insertion into inferior pole of patella or tibial tubercle (L/R), Achilles tendon insertion into calcaneum (L/R), and Plantar fascia insertion into calcaneum (L/R). The SPARCC is the sum of all site scores (range 0 to 16). Higher scores indicate more severe enthesitis. LS mean was determined by ANCOVA with treatment, geographic region, originating study, baseline value and Week 24 value as fixed factors.
Baseline, Week 64
Change From Baseline in Severity of Peripheral Arthritis by Tender Joint Count (TJC) Score of 46 Joints
The number of tender and painful joints was determined by examination of 46 joints (23 joints on each side of the body). The 46 joints were assessed and classified as tender or not tender. Sum of all joints checked to be tender/painful divided by number of evaluable joints which was multiplied by 46 to obtain TJC score. The scores ranges from 0 (no tender/painful joints) to 46 (all joints tender/painful). LS mean was determined by ANCOVA with treatment, geographic region, originating study, baseline value and Week 24 value as fixed factors.
Baseline, Week 64
Change From Baseline in Severity of Peripheral Arthritis by Swollen Joint Count (SJC) Score of 44 Joints
The number of swollen joints was determined by examination of 44 joints (22 joints on each side of the body). The 44 joints were assessed and classified as swollen or not swollen. Sum of all joints checked to be swollen divided by number of evaluable joints which was multiplied by 44 to obtain SJC score. The SJC score ranges from 0 (no swollen joints) to 44 (all joints swollen). LS mean was determined by ANCOVA with treatment, geographic region, originating study, baseline value and Week 24 value as fixed factors.
Baseline, Week 64
Percentage of Participants With Anterior Uveitis or Uveitis Flares
Anterior uveitis is an inflammation of the middle layer of the eye. which includes the iris (colored part of the eye) and the adjacent tissue, known as the ciliary body.
Week 64
Change From Baseline in the Fatigue Numeric Rating Scale (NRS) Score
The fatigue severity NRS is a participant administered single-item 11-point horizontal scale anchored at 0 and 10, with 0 representing "no fatigue" and 10 representing "as bad as you can imagine". Participants rate their fatigue (feeling tired or worn out) by circling the 1 number that describes their worst level of fatigue during the previous 24 hours. LS mean was determined by ANCOVA with treatment, geographic region, originating study, baseline value and Week 24 value as fixed factors.
Baseline, Week 64
Change From Baseline on the Quick Inventory of Depressive Symptomatology Self-Report-16 (QIDS-SR16)
The 16-item QIDS-SR16 version is a widely used validated scale designed to assess the severity of depressive symptoms. The participant was asked to rate the severity and frequency of specific symptoms present over the last 7 days. The QIDS-SR16 total scores range from 0 to 27, where higher scores indicate higher severity of symptoms. LS mean was determined by ANCOVA with treatment, geographic region, originating study, baseline value and Week 24 value as fixed factors.
Baseline, Week 64
Change From Baseline in 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) Score
The SF-36 is a 36-item participant administered measure designed to be a short, multipurpose assessment of health in the areas of physical functioning, role - physical, role - emotional, bodily pain, vitality, social functioning, mental health, and general health. The 2 overarching domains of mental well- being and physical well-being are captured by the Mental Component Summary and Physical Component Summary scores. T-scores are used for analysis. The summary scores range from 0 to 100, with higher scores indicating better levels of function and/or better health. LS mean was determined by ANCOVA with treatment, geographic region, originating study, baseline value and Week 24 value as fixed factors.
Baseline, Week 64
Change From Baseline in SF-36 Mental Component Summary (MCS) Score
The SF-36 is a 36-item participant administered measure designed to be a short, multipurpose assessment of health in the areas of physical functioning, role - physical, role - emotional, bodily pain, vitality, social functioning, mental health, and general health. The 2 overarching domains of mental well- being and physical well-being are captured by the Mental Component Summary and Physical Component Summary scores. T-scores are used for analysis. The summary scores range from 0 to 100, with higher scores indicating better levels of function and/or better health. LS mean was determined by ANCOVA with treatment, geographic region, originating study, baseline value and Week 24 value as fixed factors.
Baseline, Week 64
Change From Baseline in ASAS Health Index (ASAS HI)
The ASAS Health Index (ASAS HI) is a disease specific health-index instrument designed to assess the impact of interventions for SpA, including axSpA. The 17 item instrument has scores ranging from 0 (good Health) to 17 (poor Health). Each item consists of 1 question that the participant needs to respond to with either "I agree" (score 1) or "I do not agree (score 0)." A score of "1" is given where the item is affirmed, indicating adverse health. All item scores are summed to give a total score or index. LS mean was determined by ANCOVA with treatment, geographic region, originating study, baseline value and Week 24 value as fixed factors.
Baseline, Week 64
Change From Baseline in the European Quality of Life - 5 Dimensions 5 Level (EQ-5D-5L) UK Population-based Index Score
The European Quality of Life - 5 Dimensions 5 Level (EQ-5D-5L) is a standardized measure of health status used to provide a simple, generic measure of health for clinical and economic appraisal. The EQ-5D-5L consists of 2 components: a descriptive system of the respondent's health and a rating of his/her current health state using a 0- to 100-mm visual analog scale (VAS). The descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. LS mean was determined by ANCOVA with treatment, geographic region, originating study, baseline value and Week 24 value as fixed factors.
Baseline, Week 64
Change From Baseline in the Work Productivity Activity Impairment Spondyloarthritis (WPAI-SpA) Scores
The WPAI-SpA consists of 6 questions to determine employment status, hours missed from work because of SpA, hours missed from work for other reasons, hours actually worked, the degree to which SpA affected work productivity while at work, and the degree to which SpA affected activities outside of work. The WPAI-SpA has been validated in the rad-axSpA participant population. Four scores are derived: percentage of absenteeism, percentage of presenteeism (reduced productivity while at work), an overall work impairment score that combines absenteeism and presenteeism, and percentage of impairment in activities performed outside of work. The computed percentage range for each sub-scale was from 0-100, with higher scores indicating greater impairment and less productivity. LS mean was determined by ANCOVA with treatment, geographic region, originating study, baseline value and Week 24 value as fixed factors.
Baseline, Week 64
Change From Baseline in the Jenkins Sleep Evaluation Questionnaire (JSEQ)
The Jenkins Sleep Evaluation Questionnaire (JSEQ) is a 4 item scale designed to estimate sleep problems in clinical research. The JSEQ assesses the frequency of sleep disturbance in 4 categories: 1) trouble falling asleep, 2) waking up several times during the night, 3) having trouble staying asleep (including waking up far too early), and 4) waking up after the usual amount of sleep feeling tired and worn out. Participants report the numbers of days they experience each of these problems in the past month on a 6 point Likert Scale ranging from 0 = "no days" to 5 = "22-30 days. The total JSEQ score ranges from 0 to 20, with higher scores indicating greater sleep disturbance. LS mean was determined by ANCOVA with treatment, geographic region, originating study, baseline value and Week 24 value as fixed factors.
Baseline, Week 64
Percentage of Participants With No New Syndesmophyte Formation
Percentage of participants with no new syndesmophyte formation was measured using the average of 2 selected readers of 3 readers.
Week 56
Percentage of Participants With Anti-Ixekizumab Antibodies
A treatment emergent - antidrug antibody (TE-ADA) positive participant is defined as: a) a participant with a >= 4-fold increase over a positive baseline antibody titer; or b) for a negative baseline titer, a participant with an increase from the baseline to a level of >= 1:10. Percentage was calculated based on the number of evaluable participants and was calculated by number of participants with treatment-emergent positive anti-ixekizumab antibodies / number of evaluable participants * 100%.
Baseline, Week 64
Huntington Beach
California
92648
United States
Desert Medical Advances
Palm Desert
California
92260
United States
Arthritis Assoc. & Osteoporosis Ctr of Colorado Springs, LLC
Colorado Springs
Colorado
80920
United States
Clinical Research Center of CT/NY
Danbury
Connecticut
06810
United States
Arthritis Rheumatic Disease Specialties
Aventura
Florida
33180
United States
Sarasota Arthritis Center
Sarasota
Florida
34239
United States
Marietta Rheumatology
Marietta
Georgia
30060
United States
Institute of Arthritis Research
Idaho Falls
Idaho
83404
United States
Center for Arthritis & Osteoporosis
Elizabethtown
Kentucky
42701
United States
Klein and Associates MD, PA
Cumberland
Maryland
21502
United States
Klein and Associates MD, PA
Hagerstown
Maryland
21740
United States
Arthritis Consultants Inc.
St Louis
Missouri
63141
United States
Glacier View Research Institute
Kalispell
Montana
59901
United States
Physician Research Collaboration, LLC
Lincoln
Nebraska
68516
United States
Shanahan Rheumatology & Immunotherapy, PLLC
Raleigh
North Carolina
27617
United States
Carolina Arthritis Associates
Wilmington
North Carolina
28401
United States
Oregon Health and Science University
Portland
Oregon
97239
United States
Altoona Center for Clinical Research
Duncansville
Pennsylvania
16635
United States
Articularis Healthcare Group, INC dba Columbia Arthritis Ctr
Columbia
South Carolina
29204
United States
Articularis Healthcare d/b/a/ Low Country Rheumatology, PA
Summerville
South Carolina
29486
United States
Univ of Texas Health Science Center - Houston
Houston
Texas
77030
United States
Arthritis Northwest PLLC
Spokane
Washington
99204
United States
Clinica Adventista de Belgrano
Ciudad de Buenos Aires
Buenos Aires
C1430EGF
Argentina
CER Instituto Medico
Quilmes
Buenos Aires
B1878DVC
Argentina
Centro de Enfermedades del Higado y Aparato Digestivo
Rosario
Santa Fe Province
S2000CFJ
Argentina
Centro Medico Privado de Reumatologia
San Miguel de Tucumán
Tucumán Province
T4000AXL
Argentina
Consultorios Reumatologicos Pampa
Ciudad Autonoma de Buenos Aire
C1428DZF
Argentina
CIR Centro de Investigacions Reumatologicas
San Miguel de Tucumán
4000
Argentina
KH der Barmherzigen Schwestern Wien BetriebsGesmbH
Vienna
1060
Austria
CMIP - Centro Mineiro de Pesquisa
Juiz de Fora
Minas Gerais
36010-570
Brazil
EDUMED - Educação em Saúde Ltda.
Curitiba
Paraná
80440-080
Brazil
CCBR Brasil Centro de Analises e Pesquisas ClÃnicas LTDA
Centrum Leczenia Osteoporozy Klinika Zdrowej Kosci
Lodz
90-558
Poland
Lecznica MAK-MED, NZOZ
Nadarzyn
05-830
Poland
Prywatna Praktyka Lekarska P. Hrycaj
Poznan
61-397
Poland
Lubelskie Centrum Diagnostyczne
Åšwidnik
21-040
Poland
Reumatika Centrum Reumatologii
Warsaw
02-691
Poland
Centrum Medyczne AMED
Warsaw
03-291
Poland
GCM Medical Group PSC
San Juan
PR
00909
Puerto Rico
Latin Clinical Trial Center
San Juan
PR
00909
Puerto Rico
Mindful Medical Research
San Juan
PR
00918
Puerto Rico
Spitalul Clinic Sf Maria Bucuresti
Bucharest
011172
Romania
Sp Clinic Judetean de Urgenta Sf.Apostol Andrei Constanta
Constanța
900591
Romania
V.A. Nasonova Research Institute of Rheumatology
Moscow
115522
Russia
City Clinical Hospital N1
Moscow
119049
Russia
Ryazan Regional Clinincal Cardiology Dispensary
Ryazan
390026
Russia
Clinical Rheumatology Hospital # 25
Saint Petersburg
190068
Russia
Saratov State Medical University
Saratov
410026
Russia
Clinical Hospital for Emergency Care
Yaroslavl
150003
Russia
Kyung Hee University Hospital
Seoul
Korea
02447
South Korea
Seoul St. Mary's Hospital
Seoul
Korea
06591
South Korea
Asan Medical Center
Songpa-gu
Seoul
05505
South Korea
Chungnam National University Hospital
Daejeon
35015
South Korea
Seoul National University Hospital
Seoul
03080
South Korea
Hanyang University Medical Center
Seoul
04763
South Korea
Konkuk University Hospital
Seoul
05030
South Korea
Kyunghee University Hospital at Gangdong
Seoul
05278
South Korea
Gangnam Severance Hospital
Seoul
06273
South Korea
Seoul Municipal Boramae Hospital
Seoul
07061
South Korea
Centro de Salud Mental Parc Tauli
Sabadell
Barcelona
08208
Spain
Hospital General Universitario Gregorio Marañon
Madrid
28007
Spain
Hospital Infanta Luisa
Seville
41010
Spain
Chang Gung Memorial Hospital - Kaohsiung
Kaohsiung City
83301
Taiwan
Chung Shan Medical University Hospital
Taichung
40201
Taiwan
China Medical University Hospital
Taichung
40447
Taiwan
National Taiwan University Hospital
Taipei
10002
Taiwan
Chi-Mei Medical Center
Yongkang District
71004
Taiwan
Wythenshawe Hospital
Wythenshawe
Manchester
M23 9LT
United Kingdom
Norfolk and Norwich Hospital
Norwich
Norfolk
NR4 7UY
United Kingdom
Haywood Hospital
Stoke-on-Trent
Staffordshire
ST6 7AG
United Kingdom
New Cross Hospital
Wolverhampton
West Midlands
WV10 0QP
United Kingdom
Solihull Hospital
Solihull
West Midland
B91 2JL
United Kingdom
Derived
Braun J, Kiltz U, Deodhar A, Tomita T, Dougados M, Bolce R, Sandoval D, Lin CY, Walsh J. Efficacy and safety of ixekizumab treatment in patients with axial spondyloarthritis: 2-year results from COAST. RMD Open. 2022 Jul;8(2):e002165. doi: 10.1136/rmdopen-2021-002165.
FG002
IXE80Q4W-Group A Extension Period
Participants continued to receive uninterrupted Ixekizumab 80 mg Q4W subcutaneous dose during the extension period.
FG003
IXE80Q2W-Group A Extension Period
Participants continued to receive uninterrupted Ixekizumab 80 mg Q2W subcutaneous dose during the extension period.
FG004
IXE80Q4W-Group B-Randomized Withdrawal Extension Period
Participants in the Ixekizumab 80 mg Q4W treatment group (Lead-in) were re randomized to receive Ixekizumab 80 mg Q4W subcutaneous dose at Week 24 in the randomized withdrawal extension period.
FG005
IXE80Q2W-Group B-Randomized Withdrawal Extension Period
Participants in the Ixekizumab 80 mg Q2W treatment group (Lead-in) were re randomized to receive subcutaneous dose of Ixekizumab 80 mg Q2W at Week 24 in the randomized withdrawal extension period.
FG006
Placebo-Group B-Randomized Withdrawal Extension Period
Participants were re-randomized to receive subcutaneous dose of placebo at Week 24 in the randomized withdrawal extension period.
FG007
IXE80Q2W/IXE80Q2W-Retreatment Extension Period
Participants in Group B who received Ixekizumab 80 mg Q2W in Period 2 and experienced a flare were retreated with subcutaneous dose of Ixekizumab 80 mg Q2W during the retreatment long-term extension period.
FG008
IXE80Q4W/IXE80Q4W-Retreatment Extension Period
Participants in Group B who received Ixekizumab 80 mg Q4W in Period 2 and experienced a flare were retreated with subcutaneous dose of Ixekizumab 80 mg Q4W during the retreatment long term extension period.
FG009
PBO/IXE80Q2W-Retreatment Extension Period
Participants in Group B who received placebo in Period 2 and experienced a flare were retreated with subcutaneous dose of Ixekizumab 80 mg Q2W during the retreatment long term extension period.
FG010
PBO/IXE80Q4W-Retreatment Extension Period
Participants in Group B who received placebo in Period 2 and experienced a flare were retreated with subcutaneous dose of Ixekizumab 80 mg Q4W during the retreatment long term extension period.
FG011
IXE80Q2W-group A Long-term Extension Period
Participants from "IXE80Q2W group A extension period" continued to receive same treatment that they were receiving at the end of Period 2.
FG012
IXE80Q4W-group A Long-term Extension Period
Participants from "IXE80Q4W group A extension period" continued to receive same treatment that they were receiving at the end of Period 2.
FG013
IXE80Q2W-Group B-Randomized Withdrawal Long-term Extension Period
Participants from "IXE80Q2W-Group B-Randomized Withdrawal Extension Period" continued to receive same treatment that they were receiving at the end of Period 2.
FG014
IXE80Q4W-Group B-Randomized Withdrawal Long-term Extension Period
Participants from "IXE80Q4W-Group B-Randomized Withdrawal Extension Period" continued to receive same treatment that they were receiving at the end of Period 2.
FG015
PBO-Group B-Randomized Withdrawal Long-term Extension Period
Participants from "Placebo-Group B-Randomized Withdrawal Extension Period" continued to receive same treatment that they were receiving at the end of Period 2.
FG016
IXE80Q2W/IXE80Q2W-Retreatment Long-term Extension Period
Participants in Group B who received Ixekizumab 80 mg Q2W in Period 3 and experienced a flare were retreated with subcutaneous dose of Ixekizumab 80 mg Q2W during the retreatment long-term extension period.
FG017
IXE80Q4W/IXE80Q4W-Retreatment Long-term Extension Period
Participants in Group B who received Ixekizumab 80 mg Q4W in Period 3 and experienced a flare were retreated with subcutaneous dose of Ixekizumab 80 mg Q4W during the retreatment long term extension period.
FG018
PBO/IXE80Q2W-Retreatment Long-term Extension Period
Participants in Group B who received placebo in Period 3 and experienced a flare were retreated with subcutaneous dose of Ixekizumab 80 mg Q2W during the retreatment long term extension period.
FG019
PBO/IXE80Q4W-Retreatment Long-term Extension Period
Participants in Group B who received placebo in Period 3 and experienced a flare were retreated with subcutaneous dose of Ixekizumab 80 mg Q4W during the retreatment long term extension period.
FG020
IXE80Q4W-Group A-Escalation Period
Participants in Group A receiving ixekizumab 80 mg Q4W escalated to ixekizumab 80 mg Q2W in Period 3.
FG021
IXE80Q4W-Randomized Withdrawal Escalation Period
Participants in Group B receiving Ixekizumab 80 mg Q4W escalated to ixekizumab 80 mg Q2W.
FG022
PBO-Randomized Withdrawal Escalation Period
Participants in Group B, who received PBO, experienced a flare and retreated with Ixekizumab 80 mg Q4W, escalated to ixekizumab 80 mg Q2W.
FG023
PBO-follow-up Period
Participants did not receive any intervention during Follow-up period.
FG024
IXE80Q4W-follow-up Period
Participants did not receive any intervention during Follow-up period.
FG025
IXE80Q2W-follow-up Period
Participants did not receive any intervention during Follow-up period.
FG000350 subjects
FG001423 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
FG0180 subjects
FG0190 subjects
FG0200 subjects
FG0210 subjects
FG0220 subjects
FG0230 subjects
FG0240 subjects
FG0250 subjects
Received at Least One Dose of Study Drug
FG000348 subjects
FG001423 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
FG0180 subjects
FG0190 subjects
FG0200 subjects
FG0210 subjects
FG0220 subjects
FG0230 subjects
FG0240 subjects
FG0250 subjects
COMPLETED
FG000335 subjects
FG001406 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
FG0180 subjects
FG0190 subjects
FG0200 subjects
FG0210 subjects
FG0220 subjects
FG0230 subjects
FG0240 subjects
FG0250 subjects
NOT COMPLETED
FG00015 subjects
FG00117 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
FG0180 subjects
FG0190 subjects
FG0200 subjects
FG0210 subjects
FG0220 subjects
FG0230 subjects
FG0240 subjects
FG0250 subjects
Type
Comment
Reasons
Adverse Event
FG0002 subjects
FG0016 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
FG0180 subjects
FG0190 subjects
FG0200 subjects
FG0210 subjects
FG0220 subjects
FG0230 subjects
FG0240 subjects
FG0250 subjects
Lost to Follow-up
FG0002 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0008 subjects
FG0018 subjects
FG0020 subjects
FG0030 subjects
FG004
Lack of Efficacy
FG0003 subjects
FG0012 subjects
FG0020 subjects
FG0030 subjects
FG004
Surgery Programmed
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Period2 Extension Period (Group A and B)
Type
Comment
Milestone Data
STARTED
FG0000 subjectsOnly Extension Period participants were included.
FG0010 subjectsOnly Extension Period participants were included.
FG002255 subjectsParticipants who entered extension period (Group A).
FG003318 subjectsParticipants who entered extension period (Group A).
FG00448 subjectsParticipants who entered extension period (Group B).
FG00554 subjectsParticipants who entered extension period (Group B).
FG00653 subjectsParticipants who entered extension period (Group B).
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
FG0180 subjects
FG0190 subjects
FG0200 subjects
FG0210 subjects
FG0220 subjects
FG0230 subjects
FG0240 subjects
FG0250 subjects
Received at Least One Dose of Study Drug
FG0000 subjects
FG0010 subjects
FG002255 subjects
FG003318 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG002234 subjects
FG003312 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG00221 subjects
FG0036 subjects
FG004
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0022 subjects
FG003
Period 2 (Retreatment Extension Period)
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0076 subjectsParticipants who experienced flare in Group B Extension period.
FG0085 subjectsParticipants who experienced flare in Group B Extension period.
FG0099 subjectsParticipants who experienced flare in Group B Extension period.
FG01010 subjectsParticipants who experienced flare in Group B Extension period.
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
FG0180 subjects
FG0190 subjects
FG0200 subjects
FG0210 subjects
FG0220 subjects
FG0230 subjects
FG0240 subjects
FG0250 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
Period3-Long-Term Extension Period A & B
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjectsThis period is to report Long-Term Extension Period participants
FG0080 subjectsThis period is to report Long-Term Extension Period participants
FG0090 subjectsThis period is to report Long-Term Extension Period participants
FG0100 subjectsThis period is to report Long-Term Extension Period participants
FG011306 subjectsThis period is to report Long-Term Extension Period participants
FG012177 subjectsThis period is to report Long-Term Extension Period participants
FG01345 subjectsThis period is to report Long-Term Extension Period participants
FG01442 subjectsThis period is to report Long-Term Extension Period participants
FG01530 subjectsThis period is to report Long-Term Extension Period participants
FG0160 subjects
FG0170 subjects
FG0180 subjects
FG0190 subjects
FG0200 subjects
FG0210 subjects
FG0220 subjects
FG0230 subjects
FG0240 subjects
FG0250 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
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Period 3 (Flare)
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjectsThis period is to report participants who experienced a flare in Period 3.
FG0120 subjectsThis period is to report participants who experienced a flare in Period 3.
FG0130 subjectsThis period is to report participants who experienced a flare in Period 3.
FG0140 subjectsThis period is to report participants who experienced a flare in Period 3.
FG0150 subjectsThis period is to report participants who experienced a flare in Period 3.
FG0166 subjectsThis period is to report participants who experienced a flare in Period 3.
FG0174 subjectsThis period is to report participants who experienced a flare in Period 3.
FG01811 subjectsThis period is to report participants who experienced a flare in Period 3.
FG01915 subjectsThis period is to report participants who experienced a flare in Period 3.
FG0200 subjects
FG0210 subjects
FG0220 subjects
FG0230 subjects
FG0240 subjects
FG0250 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
Escalated to IXE80Q2W
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Period 3 (Dose Escalation)
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjectsParticipants who are eligible for dose escalations.
FG0170 subjectsParticipants who are eligible for dose escalations.
FG0180 subjectsParticipants who are eligible for dose escalations.
FG0190 subjectsParticipants who are eligible for dose escalations.
FG02077 subjectsParticipants who are eligible for dose escalations.
FG0215 subjectsParticipants who are eligible for dose escalations.
FG0224 subjectsParticipants who are eligible for dose escalations.
FG0230 subjects
FG0240 subjects
FG0250 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
Period 4 (Post Treatment Follow-up)
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
FG0180 subjects
FG0190 subjects
FG0200 subjectsThis period is to report Follow-Up period participants.
FG0210 subjectsThis period is to report Follow-Up period participants.
FG0220 subjectsThis period is to report Follow-Up period participants.
FG02325 subjectsThis period is to report Follow-Up period participants.
FG024223 subjectsThis period is to report Follow-Up period participants.
FG025453 subjectsThis period is to report Follow-Up period participants.
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Death
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
All randomized participants from extension period (period 2).
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
IXE80Q4W-Group A Extension Period
Participants received 80 mg of Ixekizumab subcutaneously every four weeks (Q4W) for up to week 24.
BG001
IXE80Q2W-Group A Extension Period
Participants received 80 mg of Ixekizumab subcutaneously every two weeks (Q2W) for up to week 24.
BG002
IXE80Q4W-Group B-Randomized Withdrawal Extension Period
Participants in the Ixekizumab 80 mg Q4W treatment group (Lead-in) were re randomized to receive Ixekizumab 80 mg Q4W subcutaneous dose at Week 24 in the randomized withdrawal extension period.
BG003
IXE80Q2W-Group B-Randomized Withdrawal Extension Period
Participants in the Ixekizumab 80 mg Q2W treatment group (Lead-in) were re randomized to receive subcutaneous dose of Ixekizumab 80 mg Q2W at Week 24 in the randomized withdrawal extension period.
BG004
Placebo-Group B-Randomized Withdrawal Extension Period
Participants were re-randomized to receive subcutaneous dose of placebo at Week 24 in the randomized withdrawal extension period.
BG005
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000255
BG001318
BG00248
BG00354
BG00453
BG005728
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Categorical
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
<=18 years
BG0000
BG0010
BG0020
BG003
Sex: Female, Male
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
Female
BG00068
BG00195
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG00061
BG00186
BG002
Race (NIH/OMB)
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG00014
BG00111
BG002
Region of Enrollment
Count of Participants
Participants
No
Title
Denominators
Categories
Argentina
Title
Measurements
BG00011
BG00118
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Percentage of Participants Who do Not Experience a Flare (Combined Ixekizumab Treatment)
A flare is defined as Ankylosing Spondylitis Disease Activity Score (ASDAS ≥2.1) at 2 consecutive visits, or ASDAS >3.5 at any visit during Period 2.
ASDAS is a composite index to assess disease activity in AS. The parameters used for the ASDAS (with high sensitivity C-reactive protein (CRP) as acute phase reactant) are total back pain, patient global, peripheral pain/swelling, duration of morning stiffness and CRP in mg/L. The ASDAScrp is calculated with the following equation: 0.121×total back pain+0.110×patient global+0.073×peripheral pain/swelling+0.058×duration of morning stiffness+0.579×Ln(CRP+1). (CRP is in mg/liter, the range of other variables is from 0(normal) to 10(very severe); Ln represents the natural logarithm). Data from five variables combined to yield a score (0.6361 to no defined upper limit), where higher the score worse the disease activity.
Participants who achieved a state of sustained remission and were randomized to 40-week double-blind placebo controlled RWR period (Group B). Missing data was imputed using the nonresponder imputation (NRI) method.
Posted
Number
Percentage of participants
Week 64
ID
Title
Description
OG000
Combined IXE
Participants received 80 mg of Ixekizumab subcutaneously every four weeks (Q4W) and every two weeks (Q2W) during the randomized withdrawal extension period.
OG001
Placebo
Participants received placebo subcutaneously during the randomized withdrawal extension period.
Units
Counts
Participants
OG000102
OG00153
Title
Denominators
Categories
Title
Measurements
OG00083.3
OG00154.7
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Regression, Logistic
<0.001
Odds Ratio (OR)
4.35
2-Sided
95
2.03
9.35
Superiority
Secondary
Percentage of Participants Who do Not Experience a Flare
A flare is defined as Ankylosing Spondylitis Disease Activity Score (ASDAS ≥2.1) at 2 consecutive visits, or ASDAS >3.5 at any visit during Period 2.
ASDAS is a composite index to assess disease activity in AS. The parameters used for the ASDAS (with high sensitivity C-reactive protein (CRP) as acute phase reactant) are total back pain, patient global, peripheral pain/swelling, duration of morning stiffness and CRP in mg/L. The ASDAScrp is calculated with the following equation: 0.121×total back pain+0.110×patient global+0.073×peripheral pain/swelling+0.058×duration of morning stiffness+0.579×Ln(CRP+1). (CRP is in mg/liter, the range of other variables is from 0(normal) to 10(very severe); Ln represents the natural logarithm). Data from five variables combined to yield a score (0.6361 to no defined upper limit), where higher the score worse the disease activity.
Participants who achieved a state of sustained remission and were randomized to 40-week double-blind placebo controlled RWR period (Group B). Missing data was imputed using the nonresponder imputation (NRI) method.
Posted
Number
Percentage of participants
Week 64
ID
Title
Description
OG000
IXE80Q4W
Participants received 80 mg of Ixekizumab subcutaneously every four weeks (Q4W) during the randomized withdrawal extension period.
OG001
IXE80Q2W
Participants received 80 mg of Ixekizumab subcutaneously every two weeks (Q2W) during the randomized withdrawal extension period.
Secondary
Change From Baseline in Modified Stoke Ankylosing Spondylitis Spinal Score (mSASSS)
The mSASSS is a four-point scoring system for lateral radiographs of the lumbar and cervical spine and has been shown to reliably track disease progression over time, where: 0 = normal; 1 = sclerosis, squaring or erosion; 2 = syndesmophyte; 3 = bony bridge.
By the scoring system of mSASSS of the spinal x-rays, a total of 24 sites were scored on the lateral cervical and lumbar spine: the anterior corners of the vertebrae from lower border of C2 to upper border T1 (inclusive), and from lower border of T12 to upper border of S1 (inclusive). Each corner was scored from 0 to 3, resulting in a range from 0 [no change] to 72 [progression].
Ixekizumab structure population who have been treated with ixekizumab for at least 24 months.
Posted
Mean
Standard Deviation
Units on a Scale
Baseline, 2 Years
ID
Title
Description
OG000
IXE80Q4W
Participants received 80 mg of Ixekizumab subcutaneously every four weeks (Q4W).
OG001
IXE80Q2W
Participants received 80 mg of Ixekizumab subcutaneously every two weeks (Q2W).
OG002
Combined IXE
Participants received 80 mg of Ixekizumab subcutaneously every four weeks (Q4W) and two weeks (Q2W).
Secondary
Percentage of Participants Achieving an Assessment of Spondyloarthritis International Society (ASAS)20 Response
ASAS20 response is defined as a ≥20% improvement and an absolute improvement from baseline of ≥1 units (range 0 to 10) in ≥3 of 4 domains, and no worsening of ≥20% and ≥1 unit (range 0 to 10) in the remaining domain.
The following ASAS domains are used:
Patient Global: How active was your spondylitis on average during the last week? score ranges 0 (not active) to 10 (very active).
Spinal Pain: How much Pain of your spine due to Ankylosing spondylitis? score ranges 0 (no pain) to 10 (severe pain).
Bath Ankylosing Spondylitis Functional Index (BASFI): Participant asked to rate the difficulty associated with 10 individual basic functional activities. Participant response was captured using Numeric Rating Scale (NRS) (range 0 to 10) with a higher score indicating worse function.
Inflammation based on mean of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Q5 & Q6 (mean of intensity & duration of stiffness): Score ranges from "0" (none) and "10" (very severe).
Participants who achieved a state of sustained remission and were randomized to 40-week double-blind placebo controlled RWR period (Group B). Missing data was imputed using the nonresponder imputation (NRI) method.
Posted
Number
Percentage of participants
Week 64
ID
Title
Description
OG000
IXE80Q4W
Participants received 80 mg of Ixekizumab subcutaneously every four weeks (Q4W) during the randomized withdrawal extension period.
OG001
IXE80Q2W
Secondary
Percentage of Participants Achieving an ASAS40 Response
ASAS40 is defined as a ≥40% improvement and an absolute improvement from baseline of ≥2 units (range of 0 to 10) in at least 3 of the following 4 domains without any worsening in the remaining domain. The following ASAS domains are used:
Patient Global: How active was your spondylitis on average during the last week? score ranges 0 (not active) to 10 (very active).
Spinal Pain: How much Pain of your spine due to Ankylosing spondylitis? score ranges 0 (no pain) to 10 (severe pain).
Bath Ankylosing Spondylitis Functional Index (BASFI): Participant asked to rate the difficulty associated with 10 individual basic functional activities. Participant response was captured using Numeric Rating Scale (NRS) (range 0 to 10) with a higher score indicating worse function.
Inflammation based on mean of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Q5 & Q6 (mean of intensity & duration of stiffness): Score ranges from "0" (none) and "10" (very severe).
Participants who achieved a state of sustained remission and were randomized to 40-week double-blind placebo controlled RWR period (Group B). Missing data was imputed using the nonresponder imputation (NRI) method.
Posted
Number
Percentage of Participants
Week 64
ID
Title
Description
OG000
IXE80Q4W
Participants received 80 mg of Ixekizumab subcutaneously every four weeks (Q4W) during the randomized withdrawal extension period.
OG001
IXE80Q2W
Secondary
Percentage of Participants With Change of Ankylosing Spondylitis Disease Activity Score (ASDAS) ≥1.1 Units
ASDAS is a composite index to assess disease activity in AS. The parameters used for the ASDAS (with CRP as acute phase reactant) are total back pain, patient global, peripheral pain/swelling, duration of morning stiffness and CRP in mg/L. The ASDAScrp is calculated with the following equation: 0.121×total back pain+0.110×patient global+0.073×peripheral pain/swelling+0.058×duration of morning stiffness
+0.579×Ln(CRP+1). (CRP is in mg/liter, the range of other variables is from 0(normal) to 10(very severe); Ln represents the natural logarithm). Data from five variables combined to yield a score (0.6361 to no defined upper limit), where higher the score worse the disease activity.
Participants who achieved a state of sustained remission and were randomized to 40-week double-blind placebo controlled RWR period (Group B). Missing data was imputed using the nonresponder imputation (NRI) method.
Posted
Number
Percentage of participants
Week 64
ID
Title
Description
OG000
IXE80Q4W
Participants received 80 mg of Ixekizumab subcutaneously every four weeks (Q4W) during the randomized withdrawal extension period.
OG001
IXE80Q2W
Participants received 80 mg of Ixekizumab subcutaneously every two weeks (Q2W) during the randomized withdrawal extension period.
Secondary
Percentage of Participants With Inactive Disease on the ASDAS (<1.3 Units)
ASDAS is a composite index to assess disease activity in AS. The parameters used for the ASDAS (with CRP as acute phase reactant) are total back pain, patient global, peripheral pain/swelling, duration of morning stiffness and CRP in mg/L. The ASDAScrp is calculated with the following equation: 0.121×total back pain+0.110×patient global+0.073×peripheral pain/swelling+0.058×duration of morning stiffness+0.579×Ln(CRP+1). (CRP is in mg/liter, the range of other variables is from 0(normal) to 10(very severe); Ln represents the natural logarithm). Data from five variables combined to yield a score (0.6361 to no defined upper limit), where higher the score worse the disease activity.
Participants who achieved a state of sustained remission and were randomized to 40-week double-blind placebo controlled RWR period (Group B). Missing data was imputed using the nonresponder imputation (NRI) method.
Posted
Number
Percentage of participants
Week 64
ID
Title
Description
OG000
IXE80Q4W
Participants received 80 mg of Ixekizumab subcutaneously every four weeks (Q4W) during the randomized withdrawal extension period.
OG001
IXE80Q2W
Participants received 80 mg of Ixekizumab subcutaneously every two weeks (Q2W) during the randomized withdrawal extension period.
OG002
Secondary
Change From Baseline in the Individual Components of the ASAS Criteria
Patient Global: How active was your spondylitis on average during the last week? score ranges 0 (not active) to 10 (very active).
Spinal Pain: How much Pain of your spine due to Ankylosing spondylitis? score ranges 0 (no pain) to 10 (severe pain).
Bath Ankylosing Spondylitis Functional Index (BASFI): Participant asked to rate the difficulty associated with 10 individual basic functional activities. Participant response was captured using Numeric Rating Scale (NRS) (range 0 to 10) with a higher score indicating worse function. Inflammation based on Q5 & Q6 mean of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) (mean of intensity & duration of stiffness): Score ranges from "0" (none) and "10" (very severe). LS mean was determined by ANCOVA with treatment, geographic region, originating study, baseline value and Week 24 value as fixed factors.
Participants who achieved a state of sustained remission and were randomized to 40-week double-blind placebo controlled RWR period (Group B). Missing data was imputed using the modified baseline observation carried forward (mBOCF) method.
Posted
Least Squares Mean
Standard Error
Units on a scale
Baseline, Week 64
ID
Title
Description
OG000
IXE80Q4W
Participants received 80 mg of Ixekizumab subcutaneously every four weeks (Q4W) during the randomized withdrawal extension period.
OG001
IXE80Q2W
Participants received 80 mg of Ixekizumab subcutaneously every two weeks (Q2W) during the randomized withdrawal extension period.
Secondary
Percentage of Participants Achieving Bath Ankylosing Spondylitis Disease Activity Index 50 (BASDAI50) Response
The BASDAI is a participant-reported assessment consisting of 6 questions that relate to 5 major symptoms relevant to radiographic axial spondyloarthritis (rad-axSpA): 1) Fatigue, 2) Spinal pain, 3) Peripheral arthritis, 4) Enthesitis, 5) Intensity, and 6) Duration of morning stiffness. Participants need to score each item with a score from 0 to 10 (NRS). Total score is obtained from the average of symptom scores ranging 0 (no problem) to 10 (worst problem), with a higher score indicating more severe AS symptom. BASDAI50 represents an improvement of ≥50% of the BASDAI score from baseline.
Participants who achieved a state of sustained remission and were randomized to 40-week double-blind placebo controlled RWR period (Group B). Missing data was imputed using the nonresponder imputation (NRI) method.
Posted
Number
Percentage of participants
Week 64
ID
Title
Description
OG000
IXE80Q4W
Participants received 80 mg of Ixekizumab subcutaneously every four weeks (Q4W) during the randomized withdrawal extension period.
OG001
IXE80Q2W
Participants received 80 mg of Ixekizumab subcutaneously every two weeks (Q2W) during the randomized withdrawal extension period.
OG002
Placebo
Secondary
Change From Baseline in the Measure of High Sensitivity C-Reactive Protein (CRP)
High sensitivity CRP is the measure of acute phase reactant. It was measured with a high sensitivity assay at the central laboratory to help assess the effect of ixekizumab on disease activity. High sensitivity CRP is a sensitive laboratory assay for serum levels of C-Reactive Protein, which is a biomarker of inflammation. LS mean was determined by ANCOVA with treatment, geographic region, originating study, baseline value and Week 24 value as fixed factors.
Participants who achieved a state of sustained remission and were randomized to 40-week double-blind placebo controlled RWR period (Group B). Missing data was imputed using the modified baseline observation carried forward (mBOCF) method.
Posted
Least Squares Mean
Standard Error
milligram per liter (mg/L)
Baseline, Week 64
ID
Title
Description
OG000
IXE80Q4W
Participants received 80 mg of Ixekizumab subcutaneously every four weeks (Q4W) during the randomized withdrawal extension period.
OG001
IXE80Q2W
Participants received 80 mg of Ixekizumab subcutaneously every two weeks (Q2W) during the randomized withdrawal extension period.
OG002
Placebo
Secondary
Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI)
BASMI is a combined index comprising of the following 5 clinical measurements of spinal mobility in participants with radiographic axial spondyloarthritis (rad-axSpA).
Lateral Spinal Flexion
Tragus-to-wall distance
Lumbar Flexion (modified Schober)
Maximal intermalleolar distance and
Cervical rotation.
The BASMI linear result is the average of the 5 assessments and ranges from 0 to 10. The higher the BASMI score the more severe the participant's limitation of movement due to their AS. LS mean was determined by ANCOVA with treatment, geographic region, originating study, baseline value and Week 24 value as fixed factors.
Participants who achieved a state of sustained remission and were randomized to 40-week double-blind placebo controlled RWR period (Group B). Missing data was imputed using the modified baseline observation carried forward (mBOCF) method.
Posted
Least Squares Mean
Standard Error
Units on a scale
Baseline, Week 64
ID
Title
Description
OG000
IXE80Q4W
Participants received 80 mg of Ixekizumab subcutaneously every four weeks (Q4W) during the randomized withdrawal extension period.
OG001
IXE80Q2W
Participants received 80 mg of Ixekizumab subcutaneously every two weeks (Q2W) during the randomized withdrawal extension period.
Secondary
Change From Baseline in Chest Expansion in Centimeters
Chest expansion is the difference, in centimeter (cm), between the circumference of the chest in maximal inspiration and maximal expiration. While participants have their hands resting on or behind the head, the assessor will measure the chest encircled length by centimeter (cm) at the fourth intercostal level anteriorly. Two tries were recorded. The better measurement (larger difference) of 2 tries (in centimeters) was used for analyses. LS mean was determined by ANCOVA with treatment, geographic region, originating study, baseline value and Week 24 value as fixed factors.
Participants who achieved a state of sustained remission and were randomized to 40-week double-blind placebo controlled RWR period (Group B). Missing data was imputed using the modified baseline observation carried forward (mBOCF) method.
Posted
Least Squares Mean
Standard Error
centimeter (cm)
Baseline, Week 64
ID
Title
Description
OG000
IXE80Q4W
Participants received 80 mg of Ixekizumab subcutaneously every four weeks (Q4W) during the randomized withdrawal extension period.
OG001
IXE80Q2W
Participants received 80 mg of Ixekizumab subcutaneously every two weeks (Q2W) during the randomized withdrawal extension period.
OG002
Placebo
Secondary
Change From Baseline in Occiput to Wall Distance
The participant is to make a maximum effort to touch the head against the wall when standing with heels and back against the wall (occiput). Then the distance from occiput to wall is measured. Two tries will be recorded. The better (smaller) measurement of 2 tries (in centimeters) will be used for analyses. LS mean was determined by ANCOVA with treatment, geographic region, originating study, baseline value and Week 24 value as fixed factors.
Participants who achieved a state of sustained remission and were randomized to 40-week double-blind placebo controlled RWR period (Group B). Missing data was imputed using the modified baseline observation carried forward (mBOCF) method.
Posted
Least Squares Mean
Standard Error
cm
Baseline, Week 64
ID
Title
Description
OG000
IXE80Q4W
Participants received 80 mg of Ixekizumab subcutaneously every four weeks (Q4W) during the randomized withdrawal extension period.
OG001
IXE80Q2W
Participants received 80 mg of Ixekizumab subcutaneously every two weeks (Q2W) during the randomized withdrawal extension period.
OG002
Placebo
Participants received placebo subcutaneously during the randomized withdrawal extension period.
Secondary
Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES)
The MASES is an index used to measure the severity of enthesitis. The MASES assesses 13 sites for enthesitis using a score of "0" for no activity or "1" for activity. Sites assessed include costochondral 1 (right/left), costochondral 7 (right/left), spinal iliaca anterior superior (right/left), crista iliaca (right/left), spina iliaca posterior (right/left), processus spinosus L5, and Achilles tendon proximal insertion (right/left). The MASES is the sum of all site scores (range 0 to 13); higher scores indicate more severe enthesitis. LS mean was determined by ANCOVA with treatment, geographic region, originating study, baseline value and Week 24 value as fixed factors.
Participants who achieved a state of sustained remission and were randomized to 40-week double-blind placebo controlled RWR period (Group B), and with Baseline MASES score >0. Missing data was imputed using the modified baseline observation carried forward (mBOCF) method.
Posted
Least Squares Mean
Standard Error
Units on a scale
Baseline, Week 64
ID
Title
Description
OG000
IXE80Q4W
Participants received 80 mg of Ixekizumab subcutaneously every four weeks (Q4W) during the randomized withdrawal extension period.
OG001
IXE80Q2W
Participants received 80 mg of Ixekizumab subcutaneously every two weeks (Q2W) during the randomized withdrawal extension period.
Secondary
Change From Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Score
The SPARCC enthesitis is an index used to measure the severity of enthesitis. The SPARCC assesses 16 sites for enthesitis using a score of "0" for no activity or "1" for activity. Sites assessed include Medial epicondyle (left/right [L/R]), Lateral epicondyle (L/R), Supraspinatus insertion into greater tuberosity of humerus (L/R), Greater trochanter (L/R), Quadriceps insertion into superior border of patella (L/R), Patellar ligament insertion into inferior pole of patella or tibial tubercle (L/R), Achilles tendon insertion into calcaneum (L/R), and Plantar fascia insertion into calcaneum (L/R). The SPARCC is the sum of all site scores (range 0 to 16). Higher scores indicate more severe enthesitis. LS mean was determined by ANCOVA with treatment, geographic region, originating study, baseline value and Week 24 value as fixed factors.
Participants who achieved a state of sustained remission and were randomized to 40-week double-blind placebo controlled RWR period (Group B), and with baseline SPARCC score >0. Missing data was imputed using the modified baseline observation carried forward (mBOCF) method.
Posted
Least Squares Mean
Standard Error
Units on a scale
Baseline, Week 64
ID
Title
Description
OG000
IXE80Q4W
Participants received 80 mg of Ixekizumab subcutaneously every four weeks (Q4W) during the randomized withdrawal extension period.
OG001
IXE80Q2W
Secondary
Change From Baseline in Severity of Peripheral Arthritis by Tender Joint Count (TJC) Score of 46 Joints
The number of tender and painful joints was determined by examination of 46 joints (23 joints on each side of the body). The 46 joints were assessed and classified as tender or not tender. Sum of all joints checked to be tender/painful divided by number of evaluable joints which was multiplied by 46 to obtain TJC score. The scores ranges from 0 (no tender/painful joints) to 46 (all joints tender/painful). LS mean was determined by ANCOVA with treatment, geographic region, originating study, baseline value and Week 24 value as fixed factors.
Participants who achieved a state of sustained remission and were randomized to 40-week double-blind placebo controlled RWR period (Group B), and with baseline TJC >0. Missing data was imputed using the modified baseline observation carried forward (mBOCF) method.
Posted
Least Squares Mean
Standard Error
Units on a scale
Baseline, Week 64
ID
Title
Description
OG000
IXE80Q4W
Participants received 80 mg of Ixekizumab subcutaneously every four weeks (Q4W) during the randomized withdrawal extension period.
OG001
IXE80Q2W
Participants received 80 mg of Ixekizumab subcutaneously every two weeks (Q2W) during the randomized withdrawal extension period.
OG002
Secondary
Change From Baseline in Severity of Peripheral Arthritis by Swollen Joint Count (SJC) Score of 44 Joints
The number of swollen joints was determined by examination of 44 joints (22 joints on each side of the body). The 44 joints were assessed and classified as swollen or not swollen. Sum of all joints checked to be swollen divided by number of evaluable joints which was multiplied by 44 to obtain SJC score. The SJC score ranges from 0 (no swollen joints) to 44 (all joints swollen). LS mean was determined by ANCOVA with treatment, geographic region, originating study, baseline value and Week 24 value as fixed factors.
Participants who achieved a state of sustained remission and were randomized to 40-week double-blind placebo controlled RWR period (Group B), and with baseline SJC >0. Missing data was imputed using the modified baseline observation carried forward (mBOCF) method.
Posted
Least Squares Mean
Standard Error
Units on a scale
Baseline, Week 64
ID
Title
Description
OG000
IXE80Q4W
Participants received 80 mg of Ixekizumab subcutaneously every four weeks (Q4W) during the randomized withdrawal extension period.
OG001
IXE80Q2W
Participants received 80 mg of Ixekizumab subcutaneously every two weeks (Q2W) during the randomized withdrawal extension period.
OG002
Placebo
Secondary
Percentage of Participants With Anterior Uveitis or Uveitis Flares
Anterior uveitis is an inflammation of the middle layer of the eye. which includes the iris (colored part of the eye) and the adjacent tissue, known as the ciliary body.
Participants who achieved a state of sustained remission and were randomized to 40-week double-blind placebo controlled RWR period (Group B), and regardless of history of anterior uveitis.
Posted
Number
Percentage of Participants
Week 64
ID
Title
Description
OG000
IXE80Q4W
Participants received 80 mg of Ixekizumab subcutaneously every four weeks (Q4W) during the randomized withdrawal extension period.
OG001
IXE80Q2W
Participants received 80 mg of Ixekizumab subcutaneously every two weeks (Q2W) during the randomized withdrawal extension period.
OG002
Placebo
Participants received placebo subcutaneously during the randomized withdrawal extension period.
Units
Counts
Secondary
Change From Baseline in the Fatigue Numeric Rating Scale (NRS) Score
The fatigue severity NRS is a participant administered single-item 11-point horizontal scale anchored at 0 and 10, with 0 representing "no fatigue" and 10 representing "as bad as you can imagine". Participants rate their fatigue (feeling tired or worn out) by circling the 1 number that describes their worst level of fatigue during the previous 24 hours. LS mean was determined by ANCOVA with treatment, geographic region, originating study, baseline value and Week 24 value as fixed factors.
Participants who achieved a state of sustained remission and were randomized to 40-week double-blind placebo controlled RWR period (Group B). Missing data was imputed using the modified baseline observation carried forward (mBOCF) method.
Posted
Least Squares Mean
Standard Error
units on a scale
Baseline, Week 64
ID
Title
Description
OG000
IXE80Q4W
Participants received 80 mg of Ixekizumab subcutaneously every four weeks (Q4W) during the randomized withdrawal extension period.
OG001
IXE80Q2W
Participants received 80 mg of Ixekizumab subcutaneously every two weeks (Q2W) during the randomized withdrawal extension period.
OG002
Placebo
Secondary
Change From Baseline on the Quick Inventory of Depressive Symptomatology Self-Report-16 (QIDS-SR16)
The 16-item QIDS-SR16 version is a widely used validated scale designed to assess the severity of depressive symptoms. The participant was asked to rate the severity and frequency of specific symptoms present over the last 7 days. The QIDS-SR16 total scores range from 0 to 27, where higher scores indicate higher severity of symptoms. LS mean was determined by ANCOVA with treatment, geographic region, originating study, baseline value and Week 24 value as fixed factors.
Participants who achieved a state of sustained remission and were randomized to 40-week double-blind placebo controlled RWR period (Group B). Missing data was imputed using the modified baseline observation carried forward (mBOCF) method.
Posted
Least Squares Mean
Standard Error
units on a scale
Baseline, Week 64
ID
Title
Description
OG000
IXE80Q4W
Participants received 80 mg of Ixekizumab subcutaneously every four weeks (Q4W) during the randomized withdrawal extension period.
OG001
IXE80Q2W
Participants received 80 mg of Ixekizumab subcutaneously every two weeks (Q2W) during the randomized withdrawal extension period.
OG002
Placebo
Secondary
Change From Baseline in 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) Score
The SF-36 is a 36-item participant administered measure designed to be a short, multipurpose assessment of health in the areas of physical functioning, role - physical, role - emotional, bodily pain, vitality, social functioning, mental health, and general health. The 2 overarching domains of mental well- being and physical well-being are captured by the Mental Component Summary and Physical Component Summary scores. T-scores are used for analysis. The summary scores range from 0 to 100, with higher scores indicating better levels of function and/or better health. LS mean was determined by ANCOVA with treatment, geographic region, originating study, baseline value and Week 24 value as fixed factors.
Participants who achieved a state of sustained remission and were randomized to 40-week double-blind placebo controlled RWR period (Group B). Missing data was imputed using the modified baseline observation carried forward (mBOCF) method.
Posted
Least Squares Mean
Standard Error
units on a scale
Baseline, Week 64
ID
Title
Description
OG000
IXE80Q4W
Participants received 80 mg of Ixekizumab subcutaneously every four weeks (Q4W) during the randomized withdrawal extension period.
OG001
IXE80Q2W
Participants received 80 mg of Ixekizumab subcutaneously every two weeks (Q2W) during the randomized withdrawal extension period.
Secondary
Change From Baseline in SF-36 Mental Component Summary (MCS) Score
The SF-36 is a 36-item participant administered measure designed to be a short, multipurpose assessment of health in the areas of physical functioning, role - physical, role - emotional, bodily pain, vitality, social functioning, mental health, and general health. The 2 overarching domains of mental well- being and physical well-being are captured by the Mental Component Summary and Physical Component Summary scores. T-scores are used for analysis. The summary scores range from 0 to 100, with higher scores indicating better levels of function and/or better health. LS mean was determined by ANCOVA with treatment, geographic region, originating study, baseline value and Week 24 value as fixed factors.
Participants who achieved a state of sustained remission and were randomized to 40-week double-blind placebo controlled RWR period (Group B). Missing data was imputed using the modified baseline observation carried forward (mBOCF) method.
Posted
Least Squares Mean
Standard Error
units on a scale
Baseline, Week 64
ID
Title
Description
OG000
IXE80Q4W
Participants received 80 mg of Ixekizumab subcutaneously every four weeks (Q4W) during the randomized withdrawal extension period.
OG001
IXE80Q2W
Participants received 80 mg of Ixekizumab subcutaneously every two weeks (Q2W) during the randomized withdrawal extension period.
Secondary
Change From Baseline in ASAS Health Index (ASAS HI)
The ASAS Health Index (ASAS HI) is a disease specific health-index instrument designed to assess the impact of interventions for SpA, including axSpA. The 17 item instrument has scores ranging from 0 (good Health) to 17 (poor Health). Each item consists of 1 question that the participant needs to respond to with either "I agree" (score 1) or "I do not agree (score 0)." A score of "1" is given where the item is affirmed, indicating adverse health. All item scores are summed to give a total score or index. LS mean was determined by ANCOVA with treatment, geographic region, originating study, baseline value and Week 24 value as fixed factors.
Participants who achieved a state of sustained remission and were randomized to 40-week double-blind placebo controlled RWR period (Group B). Missing data was imputed using the modified baseline observation carried forward (mBOCF) method.
Posted
Least Squares Mean
Standard Error
units on a scale
Baseline, Week 64
ID
Title
Description
OG000
IXE80Q4W
Participants received 80 mg of Ixekizumab subcutaneously every four weeks (Q4W) during the randomized withdrawal extension period.
OG001
IXE80Q2W
Participants received 80 mg of Ixekizumab subcutaneously every two weeks (Q2W) during the randomized withdrawal extension period.
OG002
Secondary
Change From Baseline in the European Quality of Life - 5 Dimensions 5 Level (EQ-5D-5L) UK Population-based Index Score
The European Quality of Life - 5 Dimensions 5 Level (EQ-5D-5L) is a standardized measure of health status used to provide a simple, generic measure of health for clinical and economic appraisal. The EQ-5D-5L consists of 2 components: a descriptive system of the respondent's health and a rating of his/her current health state using a 0- to 100-mm visual analog scale (VAS). The descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. LS mean was determined by ANCOVA with treatment, geographic region, originating study, baseline value and Week 24 value as fixed factors.
Participants who achieved a state of sustained remission and were randomized to 40-week double-blind placebo controlled RWR period (Group B). Missing data was imputed using the modified baseline observation carried forward (mBOCF) method.
Posted
Least Squares Mean
Standard Error
units on a scale
Baseline, Week 64
ID
Title
Description
OG000
IXE80Q4W
Participants received 80 mg of Ixekizumab subcutaneously every four weeks (Q4W) during the randomized withdrawal extension period.
OG001
IXE80Q2W
Participants received 80 mg of Ixekizumab subcutaneously every two weeks (Q2W) during the randomized withdrawal extension period.
Secondary
Change From Baseline in the Work Productivity Activity Impairment Spondyloarthritis (WPAI-SpA) Scores
The WPAI-SpA consists of 6 questions to determine employment status, hours missed from work because of SpA, hours missed from work for other reasons, hours actually worked, the degree to which SpA affected work productivity while at work, and the degree to which SpA affected activities outside of work. The WPAI-SpA has been validated in the rad-axSpA participant population. Four scores are derived: percentage of absenteeism, percentage of presenteeism (reduced productivity while at work), an overall work impairment score that combines absenteeism and presenteeism, and percentage of impairment in activities performed outside of work. The computed percentage range for each sub-scale was from 0-100, with higher scores indicating greater impairment and less productivity. LS mean was determined by ANCOVA with treatment, geographic region, originating study, baseline value and Week 24 value as fixed factors.
Participants who achieved a state of sustained remission and were randomized to 40-week double-blind placebo controlled RWR period (Group B). Missing data was imputed using the modified baseline observation carried forward (mBOCF) method.
Posted
Least Squares Mean
Standard Error
units on a scale
Baseline, Week 64
ID
Title
Description
OG000
IXE80Q4W
Participants received 80 mg of Ixekizumab subcutaneously every four weeks (Q4W) during the randomized withdrawal extension period.
OG001
IXE80Q2W
Secondary
Change From Baseline in the Jenkins Sleep Evaluation Questionnaire (JSEQ)
The Jenkins Sleep Evaluation Questionnaire (JSEQ) is a 4 item scale designed to estimate sleep problems in clinical research. The JSEQ assesses the frequency of sleep disturbance in 4 categories: 1) trouble falling asleep, 2) waking up several times during the night, 3) having trouble staying asleep (including waking up far too early), and 4) waking up after the usual amount of sleep feeling tired and worn out. Participants report the numbers of days they experience each of these problems in the past month on a 6 point Likert Scale ranging from 0 = "no days" to 5 = "22-30 days. The total JSEQ score ranges from 0 to 20, with higher scores indicating greater sleep disturbance. LS mean was determined by ANCOVA with treatment, geographic region, originating study, baseline value and Week 24 value as fixed factors.
Participants who achieved a state of sustained remission and were randomized to 40-week double-blind placebo controlled RWR period (Group B). Missing data was imputed using the modified baseline observation carried forward (mBOCF) method.
Posted
Least Squares Mean
Standard Error
units on a scale
Baseline, Week 64
ID
Title
Description
OG000
IXE80Q4W
Participants received 80 mg of Ixekizumab subcutaneously every four weeks (Q4W) during the randomized withdrawal extension period.
OG001
IXE80Q2W
Participants received 80 mg of Ixekizumab subcutaneously every two weeks (Q2W) during the randomized withdrawal extension period.
Secondary
Percentage of Participants With No New Syndesmophyte Formation
Percentage of participants with no new syndesmophyte formation was measured using the average of 2 selected readers of 3 readers.
Ixekizumab structure population who have been treated with Ixekizumab for at least 24 months
Posted
Number
Percentage of participants
Week 56
ID
Title
Description
OG000
IXE80Q4W
Participants received 80 mg of Ixekizumab subcutaneously every four weeks (Q4W).
OG001
IXE80Q2W
Participants received 80 mg of Ixekizumab subcutaneously every two weeks (Q2W).
Units
Counts
Participants
OG000
Secondary
Percentage of Participants With Anti-Ixekizumab Antibodies
A treatment emergent - antidrug antibody (TE-ADA) positive participant is defined as: a) a participant with a >= 4-fold increase over a positive baseline antibody titer; or b) for a negative baseline titer, a participant with an increase from the baseline to a level of >= 1:10. Percentage was calculated based on the number of evaluable participants and was calculated by number of participants with treatment-emergent positive anti-ixekizumab antibodies / number of evaluable participants * 100%.
All randomized participants from Group B, who received at least one dose of study drug.
Posted
Number
Percentage of participants
Baseline, Week 64
ID
Title
Description
OG000
IXE80Q4W
Participants received 80 mg of Ixekizumab subcutaneously every four weeks (Q4W) during the randomized withdrawal extension period.
OG001
IXE80Q2W
Participants received 80 mg of Ixekizumab subcutaneously (SC) every two weeks (Q2W) during the randomized withdrawal extension period.
OG002
Placebo
Participants received placebo subcutaneously during the randomized withdrawal extension period.
Time Frame
Baseline, up to 128 weeks
Description
All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been 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
IXE 80Q4W-Lead-in Period
Participants received 80 milligram (mg) of Ixekizumab subcutaneously (SC) every four weeks (Q4W) for up to week 24.
0
348
10
348
79
348
EG001
IXE80Q2W-Lead-in Period
Participants received 80 mg of Ixekizumab subcutaneously every two weeks (Q2W) for up to week 24.
0
423
12
423
108
423
EG002
IXE80Q4W-Group A Extension Period
Participants continued to receive uninterrupted Ixekizumab 80 mg Q4W subcutaneous dose during the extension period.
2
255
12
255
62
255
EG003
IXE80Q2W-Group A Extension Period
Participants continued to receive uninterrupted Ixekizumab 80 mg Q2W subcutaneous dose during the extension period.
0
318
11
318
82
318
EG004
IXE80Q4W-Group B-Randomized Withdrawal Extension Period
Participants in the Ixekizumab 80 mg Q4W treatment group (Lead-in) were re randomized to receive Ixekizumab 80 mg Q4W subcutaneous dose at Week 24 in the randomized withdrawal extension period.
0
47
2
47
8
47
EG005
IXE80Q2W-Group B-Randomized Withdrawal Extension Period
Participants in the Ixekizumab 80 mg Q2W treatment group (Lead-in) were re randomized to receive subcutaneous dose of Ixekizumab 80 mg Q2W at Week 24 in the randomized withdrawal extension period.
0
54
2
54
17
54
EG006
Placebo-Group B-Randomized Withdrawal Extension Period
Participants were re-randomized to receive subcutaneous dose of placebo at Week 24 in the randomized withdrawal extension period.
0
53
1
53
16
53
EG007
IXE80Q2W/IXE80Q2W-Retreatment Extension Period
Participants in Group B who received Ixekizumab 80 mg Q2W in Period 2 and experienced a flare were retreated with subcutaneous dose of Ixekizumab 80 mg Q2W during the retreatment long-term extension period.
0
6
1
6
0
6
EG008
IXE80Q4W/IXE80Q4W-Retreatment Extension Period
Participants in Group B who received Ixekizumab 80 mg Q4W in Period 2 and experienced a flare were retreated with subcutaneous dose of Ixekizumab 80 mg Q4W during the retreatment long term extension period.
0
5
0
5
4
5
EG009
PBO/IXE80Q2W-Retreatment Extension Period
Participants in Group B who received placebo in Period 2 and experienced a flare were retreated with subcutaneous dose of Ixekizumab 80 mg Q2W during the retreatment long term extension period.
0
9
0
9
2
9
EG010
PBO/IXE80Q4W-Retreatment Extension Period
Participants in Group B who received placebo in Period 2 and experienced a flare were retreated with subcutaneous dose of Ixekizumab 80 mg Q4W during the retreatment long term extension period.
0
10
0
10
1
10
EG011
IXE80Q2W-group A Long-term Extension Period
Participants from "IXE80Q2W group A extension period" continued to receive same treatment that they were receiving at the end of Period 2.
0
306
15
306
52
306
EG012
IXE80Q4W-group A Long-term Extension Period
Participants from "IXE80Q4W group A extension period" continued to receive same treatment that they were receiving at the end of Period 2.
0
177
3
177
37
177
EG013
IXE80Q2W-Group B-Randomized Withdrawal Long-term Extension Period
Participants from "IXE80Q2W-Group B-Randomized Withdrawal Extension Period" continued to receive same treatment that they were receiving at the end of Period 2.
0
45
1
45
8
45
EG014
IXE80Q4W-Group B-Randomized Withdrawal Long-term Extension Period
Participants from "IXE80Q4W-Group B-Randomized Withdrawal Extension Period" continued to receive same treatment that they were receiving at the end of Period 2.
0
42
1
42
6
42
EG015
PBO-Group B-Randomized Withdrawal Long-term Extension Period
Participants from "Placebo-Group B-Randomized Withdrawal Extension Period" continued to receive same treatment that they were receiving at the end of Period 2.
0
30
0
30
9
30
EG016
IXE80Q2W/IXE80Q2W-Retreatment Long-term Extension Period
Participants in Group B who received Ixekizumab 80 mg Q2W in Period 3 and experienced a flare were retreated with subcutaneous dose of Ixekizumab 80 mg Q2W during the retreatment long-term extension period.
0
6
0
6
0
6
EG017
IXE80Q4W/IXE80Q4W-Retreatment Long-term Extension Period
Participants in Group B who received Ixekizumab 80 mg Q4W in Period 3 and experienced a flare were retreated with subcutaneous dose of Ixekizumab 80 mg Q4W during the retreatment long term extension period.
0
4
0
4
3
4
EG018
PBO/IXE80Q2W-Retreatment Long-term Extension Period
Participants in Group B who received placebo in Period 3 and experienced a flare were retreated with subcutaneous dose of Ixekizumab 80 mg Q2W during the retreatment long term extension period.
0
11
0
11
6
11
EG019
PBO/IXE80Q4W-Retreatment Long-term Extension Period
Participants in Group B who received placebo in Period 3 and experienced a flare were retreated with subcutaneous dose of Ixekizumab 80 mg Q4W during the retreatment long term extension period.
0
15
0
15
5
15
EG020
IXE80Q4W-Group A-Escalation Period
Participants in Group A receiving ixekizumab 80 mg Q4W escalated to ixekizumab 80 mg Q2W in Period 3.
0
77
1
77
6
77
EG021
IXE80Q4W-Randomized Withdrawal Escalation Period
Participants in Group B receiving ixekizumab 80 mg Q4W escalated to ixekizumab 80 mg Q2W.
0
5
0
5
2
5
EG022
PBO-randomized Withdrawal Escalation Period
Participants in Group B, who received PBO, experienced a flare and retreated with Ixekizumab 80 mg Q4W, escalated to ixekizumab 80 mg Q2W.
0
4
0
4
0
4
EG023
PBO-follow-up Period
Participants did not receive any intervention during Follow-up period.
0
25
0
25
0
25
EG024
IXE80Q4W-follow-up Period
Participants did not receive any intervention during Follow-up period.
1
223
3
223
14
223
EG025
IXE80Q2W-follow-up Period
Participants did not receive any intervention during Follow-up period.
0
453
2
453
27
453
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Neutropenia
Blood and lymphatic system disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected348 at risk
EG0010 events0 affected423 at risk
EG0020 events0 affected255 at risk
EG0030 events0 affected318 at risk
EG0040 events0 affected47 at risk
EG0050 events0 affected54 at risk
EG0060 events0 affected53 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected9 at risk
EG0100 events0 affected10 at risk
EG0110 events0 affected306 at risk
EG0120 events0 affected177 at risk
EG0130 events0 affected45 at risk
EG0140 events0 affected42 at risk
EG0150 events0 affected30 at risk
EG0160 events0 affected6 at risk
EG0170 events0 affected4 at risk
EG0180 events0 affected11 at risk
EG0190 events0 affected15 at risk
EG0200 events0 affected77 at risk
EG0210 events0 affected5 at risk
EG0220 events0 affected4 at risk
EG0230 events0 affected25 at risk
EG0241 events1 affected223 at risk
EG0250 events0 affected453 at risk
Acute myocardial infarction
Cardiac disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected348 at risk
EG0010 events0 affected423 at risk
EG0020 events0 affected255 at risk
EG003
Cardiac failure acute
Cardiac disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected348 at risk
EG0010 events0 affected423 at risk
EG0021 events1 affected255 at risk
EG003
Coronary artery stenosis
Cardiac disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected348 at risk
EG0010 events0 affected423 at risk
EG0020 events0 affected255 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected348 at risk
EG0010 events0 affected423 at risk
EG0021 events1 affected255 at risk
EG003
Myocardial ischaemia
Cardiac disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected348 at risk
EG0010 events0 affected423 at risk
EG0020 events0 affected255 at risk
EG003
Iridocyclitis
Eye disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected348 at risk
EG0010 events0 affected423 at risk
EG0021 events1 affected255 at risk
EG003
Colitis ulcerative
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected348 at risk
EG0012 events2 affected423 at risk
EG0022 events2 affected255 at risk
EG003
Crohn's disease
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected348 at risk
EG0010 events0 affected423 at risk
EG0020 events0 affected255 at risk
EG003
Inguinal hernia
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected348 at risk
EG0011 events1 affected423 at risk
EG0020 events0 affected255 at risk
EG003
Strangulated umbilical hernia
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected348 at risk
EG0010 events0 affected423 at risk
EG0020 events0 affected255 at risk
EG003
Death
General disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected348 at risk
EG0010 events0 affected423 at risk
EG0021 events1 affected255 at risk
EG003
Soft tissue inflammation
General disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected348 at risk
EG0010 events0 affected423 at risk
EG0020 events0 affected255 at risk
EG003
Cholecystitis acute
Hepatobiliary disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected348 at risk
EG0011 events1 affected423 at risk
EG0020 events0 affected255 at risk
EG003
Appendicitis
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected348 at risk
EG0010 events0 affected423 at risk
EG0020 events0 affected255 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected348 at risk
EG0010 events0 affected423 at risk
EG0020 events0 affected255 at risk
EG003
Chronic tonsillitis
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected348 at risk
EG0010 events0 affected423 at risk
EG0020 events0 affected255 at risk
EG003
Clostridium difficile colitis
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected348 at risk
EG0010 events0 affected423 at risk
EG0020 events0 affected255 at risk
EG003
Covid-19
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected348 at risk
EG0010 events0 affected423 at risk
EG0020 events0 affected255 at risk
EG003
Influenza
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected348 at risk
EG0010 events0 affected423 at risk
EG0020 events0 affected255 at risk
EG003
Orchitis
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected256 at risk
EG0010 events0 affected293 at risk
EG0020 events0 affected187 at risk
EG003
Respiratory tract infection viral
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected348 at risk
EG0010 events0 affected423 at risk
EG0021 events1 affected255 at risk
EG003
Sepsis
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected348 at risk
EG0010 events0 affected423 at risk
EG0021 events1 affected255 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected348 at risk
EG0010 events0 affected423 at risk
EG0020 events0 affected255 at risk
EG003
Clavicle fracture
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected348 at risk
EG0010 events0 affected423 at risk
EG0020 events0 affected255 at risk
EG003
Comminuted fracture
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected348 at risk
EG0010 events0 affected423 at risk
EG0020 events0 affected255 at risk
EG003
Compression fracture
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected348 at risk
EG0010 events0 affected423 at risk
EG0020 events0 affected255 at risk
EG003
Concussion
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected348 at risk
EG0010 events0 affected423 at risk
EG0020 events0 affected255 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected348 at risk
EG0010 events0 affected423 at risk
EG0020 events0 affected255 at risk
EG003
Femur fracture
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected348 at risk
EG0010 events0 affected423 at risk
EG0020 events0 affected255 at risk
EG003
Ilium fracture
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected348 at risk
EG0010 events0 affected423 at risk
EG0020 events0 affected255 at risk
EG003
Ligament sprain
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected348 at risk
EG0010 events0 affected423 at risk
EG0021 events1 affected255 at risk
EG003
Limb injury
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected348 at risk
EG0010 events0 affected423 at risk
EG0020 events0 affected255 at risk
EG003
Lumbar vertebral fracture
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected348 at risk
EG0010 events0 affected423 at risk
EG0020 events0 affected255 at risk
EG003
Meniscus injury
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected348 at risk
EG0010 events0 affected423 at risk
EG0020 events0 affected255 at risk
EG003
Pneumothorax traumatic
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected348 at risk
EG0010 events0 affected423 at risk
EG0020 events0 affected255 at risk
EG003
Rib fracture
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected348 at risk
EG0010 events0 affected423 at risk
EG0020 events0 affected255 at risk
EG003
Spinal column injury
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected348 at risk
EG0010 events0 affected423 at risk
EG0020 events0 affected255 at risk
EG003
Synovial rupture
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected348 at risk
EG0010 events0 affected423 at risk
EG0020 events0 affected255 at risk
EG003
Blood creatine phosphokinase increased
Investigations
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected348 at risk
EG0010 events0 affected423 at risk
EG0020 events0 affected255 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected348 at risk
EG0010 events0 affected423 at risk
EG0020 events0 affected255 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected348 at risk
EG0010 events0 affected423 at risk
EG0020 events0 affected255 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected348 at risk
EG0010 events0 affected423 at risk
EG0020 events0 affected255 at risk
EG003
Axial spondyloarthritis
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected348 at risk
EG0010 events0 affected423 at risk
EG0020 events0 affected255 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected348 at risk
EG0011 events1 affected423 at risk
EG0020 events0 affected255 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0002 events2 affected348 at risk
EG0011 events1 affected423 at risk
EG0022 events2 affected255 at risk
EG003
Pseudarthrosis
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected348 at risk
EG0010 events0 affected423 at risk
EG0020 events0 affected255 at risk
EG003
Spinal ligament ossification
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected348 at risk
EG0011 events1 affected423 at risk
EG0020 events0 affected255 at risk
EG003
Temporomandibular joint syndrome
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected348 at risk
EG0011 events1 affected423 at risk
EG0020 events0 affected255 at risk
EG003
Tenosynovitis
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected348 at risk
EG0011 events1 affected423 at risk
EG0020 events0 affected255 at risk
EG003
Abdominal neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected348 at risk
EG0010 events0 affected423 at risk
EG0020 events0 affected255 at risk
EG003
Adenocarcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected348 at risk
EG0010 events0 affected423 at risk
EG0020 events0 affected255 at risk
EG003
Anal cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected348 at risk
EG0011 events1 affected423 at risk
EG0020 events0 affected255 at risk
EG003
Benign lung neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected348 at risk
EG0010 events0 affected423 at risk
EG0020 events0 affected255 at risk
EG003
Breast cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected348 at risk
EG0011 events1 affected423 at risk
EG0020 events0 affected255 at risk
EG003
Chronic lymphocytic leukaemia
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected348 at risk
EG0010 events0 affected423 at risk
EG0020 events0 affected255 at risk
EG003
Ovarian cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected92 at risk
EG0011 events1 affected130 at risk
EG0020 events0 affected68 at risk
EG003
Ovarian germ cell teratoma benign
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected92 at risk
EG0010 events0 affected130 at risk
EG0020 events0 affected68 at risk
EG003
Papillary thyroid cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)