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COAST-V: A Study of Ixekizumab (LY2439821) in bDMARD-Naive Participants With Radiographic Axial Spondyloarthritis

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Completed
CT.gov ID
NCT02696785
Collaborator
(none)
341
Enrollment
28
Locations
4
Arms
29.5
Actual Duration (Months)
12.2
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The main purpose of this study is to evaluate the safety and efficacy of the study drug known as ixekizumab in biological disease-modifying anti-rheumatic drugs (bDMARDs)-naive participants with radiographic axial spondyloarthritis (rad-axSpA).

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
341 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Multicenter, Randomized, Double-Blind, Active and Placebo-Controlled 16-Week Study Followed by Long-Term Evaluation of Efficacy and Safety of Ixekizumab (LY2439821) in bDMARD-Naive Patients With Radiographic Axial Spondyloarthritis
Actual Study Start Date :
May 2, 2016
Actual Primary Completion Date :
Dec 8, 2017
Actual Study Completion Date :
Oct 17, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: Q2W Ixekizumab

Double Blind Period: Starting dose of 80 or 160 milligrams (mg) ixekizumab given subcutaneously (SC) at baseline followed by 80 mg ixekizumab given SC every two weeks (Q2W) to week 14. Extended Treatment Period: 80 mg ixekizumab given SC Q2W from week 16 to week 52.

Drug: Ixekizumab
Administered SC
Other Names:
  • LY2439821

    		•
    Experimental: Q4W Ixekizumab

    Double Blind Period: Starting dose of 80 or 160 mg ixekizumab given SC at baseline followed by 80 mg ixekizumab given SC every four weeks (Q4W) to week 14. Extended Treatment Period: 80 mg ixekizumab given SC Q4W from week 16 to week 52.

    Drug: Ixekizumab
    Administered SC
    Other Names:
  • LY2439821

    		•
    Placebo Comparator: Placebo

    Double Blind Period: Placebo given SC Q2W to week 14. Extended Treatment Period: 80 mg ixekizumab given SC Q2W or Q4W from week 16 to week 52.

    Drug: Ixekizumab
    Administered SC
    Other Names:
  • LY2439821

    • Drug: Placebo
    Administered SC
    Active Comparator: Adalimumab

    Double Blind Period: 40 mg Adalimumab given SC Q2W to week 14. Extended Treatment Period: 80 mg ixekizumab given SC Q2W or Q4W from week 20 to week 52.

    Drug: Ixekizumab
    Administered SC
    Other Names:
  • LY2439821

    • Drug: Adalimumab
    Administered SC

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of Participants Achieving an Assessment of Spondyloarthritis International Society 40 (ASAS40) Response [Week 16]

      ASAS40 is defined as improvement from baseline of greater than or equal to (>=) 40% and absolute improvement from baseline of at least 2 units in at least 3 of the following 4 domains without any worsening in the remaining domains. Patient Global: How active was your spondylitis on average during the last week? score range 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: Participant is asked to rate the difficulty associated with 10 individual basic functional activities. Participants response is captured using numeric rating scale (NRS) scale (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).

    Secondary Outcome Measures

    1. Percentage of Participants Achieving an ASAS20 Response [Week 16]

      ASAS20 response is defined as a ≥20% improvement and an absolute improvement from baseline of ≥1 units in ≥3 of 4 following domains and no worsening of ≥20% and ≥1 unit (range 0 to 10) in the remaining domain. Patient Global: How active was your spondylitis on average during the last week? score range 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: Participant is asked to rate the difficulty associated with 10 individual basic functional activities. Participants response is captured using NRS scale (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).

    2. Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) [Baseline, Week 16]

      ASDAS is a composite index to assess disease activity in AS. The parameters used for the ASDAS (with CRP as acute phase reactant) are the following: Total back pain Patient global Peripheral pain/swelling Duration of morning stiffness 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 to 10.Data from five variables combined to yield a score (0.6361 to no defined upper limit), where higher scores indicated higher disease activity. Ln represents the natural logarithm. Least Square (LS) Mean was calculated using mixed model repeated measures (MMRM) model with treatment, geographic region, baseline CRP status, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.

    3. Percentage of Participants Achieving Bath Ankylosing Spondylitis Disease Activity Index 50 (BASDAI50) Response [Week 16]

      The BASDAI is a participant-reported assessment consisting of 6 questions that relate to 5 major symptoms relevant to radiographic axial spondyloarthritis measuring discomfort, pain, and fatigue. 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). BASDAI50 represents an improvement of ≥50% of the BASDAI score from baseline.

    4. Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) [Baseline, Week 16]

      The BASFI is a participant-reported assessment that establishes a participants functional baseline and subsequent response to treatment. To complete the BASFI, a participant is asked to rate the difficulty associated with 10 individual basic functional activities. Participants respond to each question using an NRS scale (range 0 to 10) with a higher score indicating worse function. The participants final BASFI score is the mean of the 10 item scores has a possible minimum value of 0 and a possible maximum value of 10, with a higher score indicating worse function. LSMean was calculated using MMRM model with treatment, geographic region, baseline CRP status, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.

    5. Percentage of Participants Achieving ASDAS Inactive Disease [Week 16]

      ASDAS is a composite index to assess disease activity in AS. The parameters used for the ASDAS (with CRP as acute phase reactant) are the following: Total back pain Patient global Peripheral pain/swelling Duration of morning stiffness 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 to 10.Data from five variables combined to yield a score (0.6361 to no defined upper limit), where higher scores indicated higher disease activity. Ln represents the natural logarithm. ASDAS Inactive Disease is defined as a score of <1.3.

    6. Change From Baseline in Magnetic Resonance Imaging (MRI) of the Spine (Ankylosing Spondylitis Spinal Magnetic Resonance Imaging [ASSpiMRI] - Berlin Score) [Baseline, Week 16]

      The Berlin modification of Ankylosing Spondylitis spine MRI score for activity (ASspiMRI) scoring technique assesses inflammation in each of 23 disco-vertebral units (DVU). All 23 disco-vertebral units (DVU) of the spine (from C2 to S1) are scored for bone marrow edema. Scores for each DVU range from 0-3 (0=normal; 1=minor bone marrow edema [less than or equal to 25% of DVU; 3=severe bone marrow edema (more that 50% of DVU)]. The composite score ranges from 0 to 69, with higher scores reflecting worse disease. Least Squares (LS) Mean was calculated using ANCOVA model with treatment, geographic region, baseline CRP status and baseline value as fixed factors.

    7. Change From Baseline in 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores [Baseline, Week 16]

      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. LSMean was calculated using MMRM model with treatment, geographic region, baseline CRP status, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.

    8. Change From Baseline in ASAS Health Index (ASAS HI) [Baseline, Week 16]

      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 one question that the participant needs to respond to with either "I agree" (score of 1) or "I do not agree" (score of 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. LSMean was calculated using MMRM model with treatment, geographic region, baseline CRP status, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors

    9. Change From Baseline in the Measure of High Sensitivity C-Reactive Protein (CRP) [Baseline, Week 16]

      High sensitivity CRP is the measure of acute phase reactant. It will be measured with a high sensitivity assay at the central laboratory to help assess the effect of Ixekizumab on disease activity. LSMean was calculated using MMRM model with treatment, geographic region, baseline CRP status, visit and treatment-by-visit interaction as fixed factors.

    10. Change From Baseline in Mobility on the Bath Ankylosing Spondylitis Metrology Index (BASMI) [Baseline, Week 16]

      The BASMI is a combined index comprising the following 5 clinical measurements of spinal mobility in participants with rad-axSpA. Lateral spinal flexion Tragus-to-wall distance Lumbar flexion (modified Schrober) Maximal intermalleolar distance Cervical rotation. The BASMI includes these 5 measurements that are each scaled to a score of 0 to 10 depending on the result of the assessment (BASMI linear function). The average score of the 5 assessments gives the BASMI linear result. The higher the BASMI score the more severe the participants limitation of movement due to their AS. LSMean was calculated using MMRM model with treatment, geographic region, baseline CRP status, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.

    11. Change From Baseline in Chest Expansion [Baseline, Week 16]

      While participants have their hands resting on or behind the head, the assessor has measured the chest's encircled length by centimeter at the fourth intercostal level anteriorly. The difference between maximal inspiration and expiration in centimeters was recorded. Two tries were recorded. The better measurement (larger difference) of 2 tries (in centimeters) was used for analyses. LSMean was calculated using MMRM model with treatment, geographic region, baseline CRP status, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.

    12. Change From Baseline in Occiput to Wall Distance [Baseline, Week 16]

      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. LSMean was calculated using MMRM model with treatment, geographic region, baseline CRP status, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.

    13. Change From Baseline in MRI Sacroiliac Joint(s) (SIJ) Spondyloarthritis Research Consortium of Canada (SPARCC) Score [Baseline, Week 16]

      Both left and right SIJ are scored for bone marrow edema.Each side has 6 slices and each slice has 6 scoring units, and each scoring unit has a score of 0 or 1. Total SIJ SPARCC scores can range from 0 to 72 with higher scores reflecting worse disease. LSMean was calculated using ANCOVA model with treatment, geographic region, baseline CRP status and baseline value as fixed factors.

    14. Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) [Baseline, Week 16]

      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. LSMean was calculated using MMRM model with treatment, geographic region, baseline CRP status, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.

    15. Change From Baseline in SPARCC Enthesitis Score [Baseline, Week 16]

      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. LSMean was calculated using MMRM model with treatment, geographic region, baseline CRP status, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.

    16. Change From Baseline in Severity of Peripheral Arthritis by Tender (TJC) [Baseline, Week 16]

      The number of tender and painful joints was determined by examination of 46 joints (23 joints on each side of the participants body. The 46 joints are assessed and classified as tender or not tender. sum of all joints checked to be tender/painful divided by number of evaluable joints which is multiplied by 46 to obtain TJC score. The scores ranges from 0 (no tender/painful joints) to 46 (all joints tender/painful). LSMean was calculated using MMRM model with treatment, geographic region, baseline CRP status, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.

    17. Number of Participants With Anterior Uveitis or Uveitis Flares [Baseline through Week 16]

      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.

    18. Change From Baseline in the Fatigue Numeric Rating Scale (NRS) Score [Baseline, Week 16]

      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 one number that describes their worst level of fatigue during the previous 24 hours. LSMean was calculated using MMRM model with treatment, geographic region, baseline CRP status, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.

    19. Change From Baseline in the Jenkins Sleep Evaluation Questionnaire (JSEQ) [Baseline, Week 16]

      The 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 number 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. LSMean was calculated using MMRM model with treatment, geographic region, baseline CRP status, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.

    20. Change From Baseline in the Work Productivity Activity Impairment Spondyloarthritis (WPAI-SpA) Scores [Baseline, Week 16]

      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 patient 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. Greater scores indicate greater impairment and less productivity. LSMean was calculated using ANCOVA model with treatment, geographic region, baseline CRP status and baseline value as fixed factors.

    21. Change From Baseline in ASAS-Nonsteroidal Anti-Inflammatory Drug (NSAID) Score [Baseline, Week 52]

      ASAS-NSAID score is used to present the NSAID intake by considering the type of NSAID, the total dose, & the number of days taking NSAID during a period of interest (PI).. ASAS-NSAID score=(equivalent NSAID score)x(days of intake during PI)x(days per week)/(PI in days). Higher scores indicate greater NSAIDs intake. 0= no intake, 100 = equivalent NSAID intake.

    22. Number of Participants With Anti Ixekizumab Antibodies [Week 16]

      A treatment emergent - antidrug antibody (TE-ADA) positive patient is defined as: a) a patient with a >= 4-fold increase over a positive baseline antibody titer; or b) for a negative baseline titer, a patient with an increase from the baseline to a level of >= 1:10.

    23. Pharmacokinetics: Trough Ixekizumab Concentration at Steady State (Ctrough ss) [Week 16]

    24. Change From Baseline in Severity of Peripheral Arthritis by Swollen Joint Count (SJC) [Baseline, Week 16]

      The number of swollen joints was determined by examination of 44 joints (22 joints on each side of the participants body. The 44 joints are assessed and classified as swollen or not swollen. "sum of all joints checked to be swollen" divided by "number of evaluable joints" and then multiplied by 44 to obtain SJC score. The SJC score ranges from 0 (no swollen joints) to 44 (all joints swollen). LSMean was calculated using MMRM model with treatment, geographic region, baseline CRP status, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.

    25. Change From Baseline in Magnetic Resonance Imaging (MRI) of the Spine (Spondyloarthritis Research Consortium of Canada [SPARCC] Score) [Baseline, Week 16]

      MRI score of spine was assessed using SPARCC method. All 23 disco-vertebral units (DVUs) of the spine (from C2 to S1) are scored for bone marrow edema. A single DVU has a scoring range of 0 to 18, bringing the maximum total score to 414, with higher scores reflecting worse disease. Scoring was performed by central readers. LSMean was calculated using ANCOVA model with treatment, geographic region, baseline CRP status and baseline value as fixed factors

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Are ambulatory.

    • Diagnosis of radiographic axial spondyloarthritis (rad-xSpA) with sacroiliitis defined radiographically according to the modified New York criteria.

    • Participants have a history of back pain ≥3 months with age at onset <45 years.

    • In the past had an inadequate response to at least 2 non-steroidal anti-inflammatory drugs (for duration 4 weeks) or cannot tolerate NSAIDS.

    • If taking NSAIDS be on a stable dose for at least 2 weeks prior to randomization.

    • Have a history of prior therapy for axSpa for at least 12 weeks prior to screening.

    Exclusion Criteria:

    • Have total ankylosis of the spine.

    • Have received any prior, or are currently receiving, treatment with biologics, tumor necrosis factor inhibitors or other immunomodulatory agents.

    • Have recently received a live vaccine within 12 weeks or have had a vaccination with Bacillus Calmette-Guerin (BCG) within the past year.

    • Have an ongoing or serious infection within the last 12 weeks or evidence of active tuberculosis.

    • Have a compromised immune system.

    • Have any other serious and/or uncontrolled diseases.

    • Have either a current diagnosis or a recent history of malignant disease.

    • Have had major surgery within 8 weeks of baseline, or will require surgery during the study.

    • Are pregnant or breastfeeding.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Arizona Arthritis Research, PLC Phoenix Arizona United States 85032
    2 Care Access Research - Huntington Beach Huntington Beach California United States 92648
    3 Desert Medical Advances Palm Desert California United States 92260
    4 Arthritis Assoc. & Osteoporosis Ctr of Colorado Springs, LLC Colorado Springs Colorado United States 80920
    5 Denver Arthritis Center Denver Colorado United States 80230
    6 New England Research Associates Trumbull Connecticut United States 06611
    7 Sarasota Arthritis Center Sarasota Florida United States 34239
    8 Marietta Rheumatology Marietta Georgia United States 30060
    9 Center for Arthritis & Osteoporosis Elizabethtown Kentucky United States 42701
    10 Klein and Associates MD, PA Cumberland Maryland United States 21502
    11 Klein and Associates MD, PA Hagerstown Maryland United States 21740
    12 Arthritis Consultants Saint Louis Missouri United States 63141
    13 Glacier View Research Institute Kalispell Montana United States 59901
    14 Physician Research Collaboration, LLC Lincoln Nebraska United States 68516
    15 Shanahan Rheumatology & Immunotherapy Raleigh North Carolina United States 27617
    16 Articularis Healthcare Group, INC dba Columbia Arthritis Ctr Columbia South Carolina United States 29204
    17 Low Country Research Center North Charleston South Carolina United States 29406
    18 Univ of Texas Health Science Center - Houston Houston Texas United States 77030
    19 Arthritis Northwest Rheumatology Spokane Washington United States 99204
    20 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Brno Czechia 611 41
    21 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Berlin Germany 12203
    22 "For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician Hyōgo Japan 366 8501
    23 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Gwangjin-gu Korea, Republic of 05080
    24 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Seoul Korea, Republic of 04763
    25 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Warszawa Netherlands 02-691
    26 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Taichung City Taiwan 40201
    27 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Taichung Taiwan 40447
    28 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Taipei Taiwan 10048

    Sponsors and Collaborators

    • Eli Lilly and Company

    Investigators

    • Study Director: 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), Eli Lilly and Company

    Study Documents (Full-Text)

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Eli Lilly and Company
    ClinicalTrials.gov Identifier:
    NCT02696785
    Other Study ID Numbers:
    • 16178
    • I1F-MC-RHBV
    • 2015-003932-11
    First Posted:
    Mar 2, 2016
    Last Update Posted:
    Nov 19, 2019
    Last Verified:
    Nov 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Keywords provided by Eli Lilly and Company
    Ankylosing Spondylitis
    Additional relevant MeSH terms:
    Spondylitis
    Spondylarthritis
    Adalimumab
    Ixekizumab

    Study Results

    Participant Flow

    Recruitment Details Blinded treatment period (Week 0 to Week 16), followed by extended treatment period (Week 16 to Week 52), followed by post treatment period for a maximum of 24 weeks. Washout period occurred for only Adalimumab group for 6 weeks (Week 14 to Week 20).
    Pre-assignment Detail Participants who completed study were eligible to enroll into a long-term study (Study I1F-MC-RHBY [RHBY]) for up to 2 additional years. Participants that do not enroll into study RHBY will complete the Post-Treatment Follow-Up Period.
    Arm/Group Title PBO/IXE ADA/PBO/IXE IXE80Q2W/IXE80Q2W IXE80Q4W/IXE80Q4W
    Arm/Group Description Blinded Treatment Period: Participants received placebo every two weeks by subcutaneous injection. Extended Treatment Period: Participants received starting dose of 160mg Ixekizumab at week 16 followed by 80mg Ixekizumab either every two weeks (Q2W) or every four weeks (Q4W) by subcutaneous (SC) injection during extended treatment period. Participants did not receive any intervention during Follow-up period. Blinded Treatment Period:Participants received 40mg Adalimumab every two weeks by SC injection. Washout Period: Participants received placebo for 6 weeks. Extended Treatment Period:Participants received 80mg Ixekizumab either Q2W or Q4W by SC injection during extension treatment period. Participants did not receive any intervention during Follow-up period. Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every two weeks by subcutaneous injection during blinded & extension treatment period. Participants did not receive any intervention during Follow-up period. Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every four weeks by subcutaneous injection during blinded & extension treatment period. Participants did not receive any intervention during Follow-up period.
    Period Title: Blinded Treatment Period
    STARTED 87 90 83 81
    Received at Least One Dose of Study Drug 86 90 83 81
    COMPLETED 86 88 79 78
    NOT COMPLETED 1 2 4 3
    Period Title: Blinded Treatment Period
    STARTED 0 88 0 0
    COMPLETED 0 86 0 0
    NOT COMPLETED 0 2 0 0
    Period Title: Blinded Treatment Period
    STARTED 86 86 79 78
    COMPLETED 83 80 74 72
    NOT COMPLETED 3 6 5 6
    Period Title: Blinded Treatment Period
    STARTED 1 0 24 16
    COMPLETED 0 0 11 8
    NOT COMPLETED 1 0 13 8

    Baseline Characteristics

    Arm/Group Title PBO/IXE ADA/IXE IXE80Q2W/IXE80Q2W IXE80Q4W/IXE80Q4W Total
    Arm/Group Description Participants received placebo every two weeks by subcutaneous injection during blinded treatment period and 80mg Ixekizumab either Q2W or Q4W by subcutaneous injection during extension treatment period. Participants received 40mg Adalimumab every two weeks by SC injection during blinded treatment period and 80mg Ixekizumab either Q2W or Q4W by SC injection during extension treatment period. Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every two weeks by subcutaneous injection during blinded & extension treatment period. Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every four weeks by subcutaneous injection during blinded & extension treatment period. Total of all reporting groups
    Overall Participants 86 90 83 81 340
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    42.7
    (12.01)
    41.8
    (11.44)
    41.3
    (11.17)
    41.0
    (12.13)
    41.7
    (11.66)
    Sex: Female, Male (Count of Participants)
    Female
    15
    17.4%
    17
    18.9%
    19
    22.9%
    13
    16%
    64
    18.8%
    Male
    71
    82.6%
    73
    81.1%
    64
    77.1%
    68
    84%
    276
    81.2%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    11
    12.8%
    7
    7.8%
    8
    9.6%
    8
    9.9%
    34
    10%
    Not Hispanic or Latino
    67
    77.9%
    74
    82.2%
    68
    81.9%
    66
    81.5%
    275
    80.9%
    Unknown or Not Reported
    8
    9.3%
    9
    10%
    7
    8.4%
    7
    8.6%
    31
    9.1%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    4
    4.7%
    2
    2.2%
    4
    4.8%
    4
    4.9%
    14
    4.1%
    Asian
    28
    32.6%
    29
    32.2%
    25
    30.1%
    25
    30.9%
    107
    31.5%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Black or African American
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    White
    52
    60.5%
    57
    63.3%
    52
    62.7%
    52
    64.2%
    213
    62.6%
    More than one race
    2
    2.3%
    2
    2.2%
    2
    2.4%
    0
    0%
    6
    1.8%
    Unknown or Not Reported
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Region of Enrollment (Count of Participants)
    South Korea
    10
    11.6%
    14
    15.6%
    12
    14.5%
    11
    13.6%
    47
    13.8%
    Netherlands
    0
    0%
    2
    2.2%
    2
    2.4%
    0
    0%
    4
    1.2%
    United States
    5
    5.8%
    3
    3.3%
    4
    4.8%
    3
    3.7%
    15
    4.4%
    Czechia
    14
    16.3%
    14
    15.6%
    13
    15.7%
    13
    16%
    54
    15.9%
    Japan
    3
    3.5%
    3
    3.3%
    0
    0%
    1
    1.2%
    7
    2.1%
    Taiwan
    13
    15.1%
    12
    13.3%
    13
    15.7%
    13
    16%
    51
    15%
    Germany
    0
    0%
    2
    2.2%
    1
    1.2%
    0
    0%
    3
    0.9%
    Canada
    2
    2.3%
    3
    3.3%
    2
    2.4%
    2
    2.5%
    9
    2.6%
    Hungary
    3
    3.5%
    2
    2.2%
    2
    2.4%
    3
    3.7%
    10
    2.9%
    Mexico
    8
    9.3%
    7
    7.8%
    8
    9.6%
    7
    8.6%
    30
    8.8%
    Poland
    16
    18.6%
    15
    16.7%
    15
    18.1%
    16
    19.8%
    62
    18.2%
    Russia
    12
    14%
    13
    14.4%
    11
    13.3%
    12
    14.8%
    48
    14.1%

    Outcome Measures

    1. Primary Outcome
    Title Percentage of Participants Achieving an Assessment of Spondyloarthritis International Society 40 (ASAS40) Response
    Description ASAS40 is defined as improvement from baseline of greater than or equal to (>=) 40% and absolute improvement from baseline of at least 2 units in at least 3 of the following 4 domains without any worsening in the remaining domains. Patient Global: How active was your spondylitis on average during the last week? score range 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: Participant is asked to rate the difficulty associated with 10 individual basic functional activities. Participants response is captured using numeric rating scale (NRS) scale (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).
    Time Frame Week 16

    Outcome Measure Data

    Analysis Population Description
    All Randomized participants.
    Arm/Group Title Placebo Adalimumab IXE80Q4W IXE80Q2W
    Arm/Group Description Participants received placebo every two weeks by subcutaneous injection. Participants received 40mg Adalimumab every two weeks by SC injection. Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every four weeks by subcutaneous injection. Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every two weeks by subcutaneous injection.
    Measure Participants 87 90 81 83
    Number [percentage of participants]
    18.4
    21.4%
    35.6
    39.6%
    48.1
    58%
    51.8
    64%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Adalimumab
    Comments Overall Work Impairment Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.005
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.73
    Confidence Interval (2-Sided) 95%
    1.35 to 5.52
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, IXE80Q4W
    Comments Overall Work Impairment Score.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 4.45
    Confidence Interval (2-Sided) 95%
    2.20 to 9.03
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Placebo, IXE80Q2W
    Comments Overall Work Impairment Score.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 5.09
    Confidence Interval (2-Sided) 95%
    2.52 to 10.28
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Placebo, Adalimumab
    Comments Percentage of Activity Impairment
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter LSMean Difference
    Estimated Value -7.0
    Confidence Interval (2-Sided) 95%
    -13.2 to -0.7
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 3.16
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Placebo, IXE80Q2W
    Comments Percentage of Activity Impairment
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter LSMean Difference
    Estimated Value -9.3
    Confidence Interval (2-Sided) 95%
    -15.5 to -3.0
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 3.19
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Placebo, IXE80Q4W
    Comments Percentage of Activity Impairment
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter LSMean Difference
    Estimated Value -8.9
    Confidence Interval (2-Sided) 95%
    -15.2 to -2.5
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 3.22
    Estimation Comments
    2. Secondary Outcome
    Title Percentage of Participants Achieving an ASAS20 Response
    Description ASAS20 response is defined as a ≥20% improvement and an absolute improvement from baseline of ≥1 units in ≥3 of 4 following domains and no worsening of ≥20% and ≥1 unit (range 0 to 10) in the remaining domain. Patient Global: How active was your spondylitis on average during the last week? score range 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: Participant is asked to rate the difficulty associated with 10 individual basic functional activities. Participants response is captured using NRS scale (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).
    Time Frame Week 16

    Outcome Measure Data

    Analysis Population Description
    All randomized participants.
    Arm/Group Title Placebo Adalimumab 40mg IXE80Q4W IXE80Q2W
    Arm/Group Description Participants received placebo every two weeks by subcutaneous injection. Participants received 40mg Adalimumab every two weeks by SC injection. Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every four weeks by subcutaneous injection. Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every two weeks by subcutaneous injection.
    Measure Participants 87 90 81 83
    Number [percentage of participants]
    40.2
    46.7%
    58.9
    65.4%
    64.2
    77.3%
    68.7
    84.8%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Adalimumab
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.007
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.30
    Confidence Interval (2-Sided) 95%
    1.25 to 4.23
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, IXE80Q4W
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.001
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.78
    Confidence Interval (2-Sided) 95%
    1.48 to 5.24
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Placebo, IXE80Q2W
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.39
    Confidence Interval (2-Sided) 95%
    1.79 to 6.41
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    3. Secondary Outcome
    Title Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)
    Description ASDAS is a composite index to assess disease activity in AS. The parameters used for the ASDAS (with CRP as acute phase reactant) are the following: Total back pain Patient global Peripheral pain/swelling Duration of morning stiffness 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 to 10.Data from five variables combined to yield a score (0.6361 to no defined upper limit), where higher scores indicated higher disease activity. Ln represents the natural logarithm. Least Square (LS) Mean was calculated using mixed model repeated measures (MMRM) model with treatment, geographic region, baseline CRP status, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.
    Time Frame Baseline, Week 16

    Outcome Measure Data

    Analysis Population Description
    All randomized participants.
    Arm/Group Title Placebo Adalimumab 40mg IXE80Q4W IXE80Q2W
    Arm/Group Description Participants received placebo every two weeks by subcutaneous injection. Participants received 40mg Adalimumab every two weeks by SC injection. Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every four weeks by subcutaneous injection. Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every two weeks by subcutaneous injection.
    Measure Participants 87 90 81 83
    Least Squares Mean (Standard Error) [score on a scale]
    -0.46
    (0.099)
    -1.30
    (0.096)
    -1.43
    (0.102)
    -1.37
    (0.101)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Adalimumab
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter LSMean Difference
    Estimated Value -0.84
    Confidence Interval (2-Sided) 95%
    -1.11 to -0.57
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.137
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, IXE80Q4W
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter LSMean Difference
    Estimated Value -0.97
    Confidence Interval (2-Sided) 95%
    -1.25 to -0.70
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.141
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Placebo, IXE80Q2W
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter LSMean Difference
    Estimated Value -0.91
    Confidence Interval (2-Sided) 95%
    -1.18 to -0.63
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.140
    Estimation Comments
    4. Secondary Outcome
    Title Percentage of Participants Achieving Bath Ankylosing Spondylitis Disease Activity Index 50 (BASDAI50) Response
    Description The BASDAI is a participant-reported assessment consisting of 6 questions that relate to 5 major symptoms relevant to radiographic axial spondyloarthritis measuring discomfort, pain, and fatigue. 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). BASDAI50 represents an improvement of ≥50% of the BASDAI score from baseline.
    Time Frame Week 16

    Outcome Measure Data

    Analysis Population Description
    All randomized participants.
    Arm/Group Title Placebo Adalimumab 40mg IXE80Q4W IXE80Q2W
    Arm/Group Description Participants received placebo every two weeks by subcutaneous injection. Participants received 40mg Adalimumab every two weeks by SC injection. Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every four weeks by subcutaneous injection. Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every two weeks by subcutaneous injection.
    Measure Participants 87 90 81 83
    Number [percentage of participants]
    17.2
    20%
    32.2
    35.8%
    42.0
    50.6%
    43.4
    53.6%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Adalimumab
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.012
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.53
    Confidence Interval (2-Sided) 95%
    1.23 to 5.21
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, IXE80Q4W
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.74
    Confidence Interval (2-Sided) 95%
    1.82 to 7.70
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Placebo, IXE80Q2W
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.90
    Confidence Interval (2-Sided) 95%
    1.91 to 7.98
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    5. Secondary Outcome
    Title Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI)
    Description The BASFI is a participant-reported assessment that establishes a participants functional baseline and subsequent response to treatment. To complete the BASFI, a participant is asked to rate the difficulty associated with 10 individual basic functional activities. Participants respond to each question using an NRS scale (range 0 to 10) with a higher score indicating worse function. The participants final BASFI score is the mean of the 10 item scores has a possible minimum value of 0 and a possible maximum value of 10, with a higher score indicating worse function. LSMean was calculated using MMRM model with treatment, geographic region, baseline CRP status, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.
    Time Frame Baseline, Week 16

    Outcome Measure Data

    Analysis Population Description
    All randomized participants.
    Arm/Group Title Placebo Adalimumab 40mg IXE80Q4W IXE80Q2W
    Arm/Group Description Participants received placebo every two weeks by subcutaneous injection. Participants received 40mg Adalimumab every two weeks by SC injection. Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every four weeks by subcutaneous injection. Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every two weeks by subcutaneous injection.
    Measure Participants 87 90 81 83
    Least Squares Mean (Standard Error) [score on a scale]
    -1.16
    (0.215)
    -2.14
    (0.209)
    -2.39
    (0.222)
    -2.43
    (0.219)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Adalimumab
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter LSMean Difference
    Estimated Value -0.97
    Confidence Interval (2-Sided) 95%
    -1.56 to -0.39
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.299
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, IXE80Q4W
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter LSMean Difference
    Estimated Value -1.22
    Confidence Interval (2-Sided) 95%
    -1.83 to -0.62
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.307
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Placebo, IXE80Q2W
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter LSMean Difference
    Estimated Value -1.27
    Confidence Interval (2-Sided) 95%
    -1.86 to -0.67
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.304
    Estimation Comments
    6. Secondary Outcome
    Title Percentage of Participants Achieving ASDAS Inactive Disease
    Description ASDAS is a composite index to assess disease activity in AS. The parameters used for the ASDAS (with CRP as acute phase reactant) are the following: Total back pain Patient global Peripheral pain/swelling Duration of morning stiffness 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 to 10.Data from five variables combined to yield a score (0.6361 to no defined upper limit), where higher scores indicated higher disease activity. Ln represents the natural logarithm. ASDAS Inactive Disease is defined as a score of <1.3.
    Time Frame Week 16

    Outcome Measure Data

    Analysis Population Description
    All randomized participants.
    Arm/Group Title Placebo Adalimumab 40mg IXE80Q4W IXE80Q2W
    Arm/Group Description Participants received placebo every two weeks by subcutaneous injection. Participants received 40mg Adalimumab every two weeks by SC injection. Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every four weeks by subcutaneous injection. Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every two weeks by subcutaneous injection.
    Measure Participants 87 90 81 83
    Number [percentage of Participants]
    2.3
    2.7%
    15.6
    17.3%
    16.0
    19.3%
    10.8
    13.3%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Adalimumab
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.009
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter LSMean Difference
    Estimated Value 7.62
    Confidence Interval (2-Sided) 95%
    1.67 to 34.68
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, IXE80Q4W
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.007
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 8.03
    Confidence Interval (2-Sided) 95%
    1.75 to 36.83
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Placebo, IXE80Q2W
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.041
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 5.13
    Confidence Interval (2-Sided) 95%
    1.07 to 24.49
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    7. Secondary Outcome
    Title Change From Baseline in Magnetic Resonance Imaging (MRI) of the Spine (Ankylosing Spondylitis Spinal Magnetic Resonance Imaging [ASSpiMRI] - Berlin Score)
    Description The Berlin modification of Ankylosing Spondylitis spine MRI score for activity (ASspiMRI) scoring technique assesses inflammation in each of 23 disco-vertebral units (DVU). All 23 disco-vertebral units (DVU) of the spine (from C2 to S1) are scored for bone marrow edema. Scores for each DVU range from 0-3 (0=normal; 1=minor bone marrow edema [less than or equal to 25% of DVU; 3=severe bone marrow edema (more that 50% of DVU)]. The composite score ranges from 0 to 69, with higher scores reflecting worse disease. Least Squares (LS) Mean was calculated using ANCOVA model with treatment, geographic region, baseline CRP status and baseline value as fixed factors.
    Time Frame Baseline, Week 16

    Outcome Measure Data

    Analysis Population Description
    All randomized participants with baseline and week 16 Berlin score.
    Arm/Group Title Placebo Adalimumab 40mg IXE80Q4W IXE80Q2W
    Arm/Group Description Participants received placebo every two weeks by subcutaneous injection. Participants received 40mg Adalimumab every two weeks by SC injection. Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every four weeks by subcutaneous injection. Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every two weeks by subcutaneous injection.
    Measure Participants 81 82 78 76
    Least Squares Mean (Standard Error) [score on a scale]
    -0.15
    (0.323)
    -2.92
    (0.314)
    -2.77
    (0.328)
    -2.54
    (0.330)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Adalimumab
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter LSMean Difference
    Estimated Value -2.78
    Confidence Interval (2-Sided) 95%
    -3.7 to -1.9
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.447
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, IXE80Q4W
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter LSMean Difference
    Estimated Value -2.62
    Confidence Interval (2-Sided) 95%
    -3.5 to -1.7
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.450
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Placebo, IXE80Q2W
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter LSMean Difference
    Estimated Value -2.39
    Confidence Interval (2-Sided) 95%
    -3.3 to -1.5
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.452
    Estimation Comments
    8. Secondary Outcome
    Title Change From Baseline in 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores
    Description 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. LSMean was calculated using MMRM model with treatment, geographic region, baseline CRP status, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.
    Time Frame Baseline, Week 16

    Outcome Measure Data

    Analysis Population Description
    All randomized participants.
    Arm/Group Title Placebo Adalimumab 40mg IXE80Q4W IXE80Q2W
    Arm/Group Description Participants received placebo every two weeks by subcutaneous injection. Participants received 40mg Adalimumab every two weeks by SC injection. Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every four weeks by subcutaneous injection. Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every two weeks by subcutaneous injection.
    Measure Participants 87 90 81 83
    PCS
    3.6432
    (0.7530)
    6.9005
    (0.7310)
    7.6952
    (0.7768)
    7.9686
    (0.7665)
    MCS
    2.1229
    (0.8431)
    2.5550
    (0.8225)
    2.7502
    (0.8763)
    2.5696
    (0.8650)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Adalimumab
    Comments PCS
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.002
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter LSMean Difference
    Estimated Value 3.2574
    Confidence Interval (2-Sided) 95%
    1.2041 to 5.3106
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.0437
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, IXE80Q4W
    Comments PCS
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter LSMean Difference
    Estimated Value 4.0520
    Confidence Interval (2-Sided) 95%
    1.9432 to 6.1608
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.0720
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Placebo, IXE80Q2W
    Comments PCS
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter LSMean Difference
    Estimated Value 4.3254
    Confidence Interval (2-Sided) 95%
    2.2321 to 6.4186
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.0641
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Placebo, Adalimumab
    Comments MCS
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.713
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter LSMean Difference
    Estimated Value 0.4321
    Confidence Interval (2-Sided) 95%
    -1.8732 to 2.7373
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.1718
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Placebo, IXE80Q4W
    Comments MCS
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.602
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter LSMean Difference
    Estimated Value 0.6273
    Confidence Interval (2-Sided) 95%
    -1.7387 to 2.9934
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.2028
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Placebo, IXE80Q2W
    Comments MCS
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.709
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter LSMean Difference
    Estimated Value 0.4467
    Confidence Interval (2-Sided) 95%
    -1.9097 to 2.8030
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.1978
    Estimation Comments
    9. Secondary Outcome
    Title Change From Baseline in ASAS Health Index (ASAS HI)
    Description 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 one question that the participant needs to respond to with either "I agree" (score of 1) or "I do not agree" (score of 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. LSMean was calculated using MMRM model with treatment, geographic region, baseline CRP status, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors
    Time Frame Baseline, Week 16

    Outcome Measure Data

    Analysis Population Description
    All randomized participants.
    Arm/Group Title Placebo Adalimumab 40mg IXE80Q4W IXE80Q2W
    Arm/Group Description Participants received placebo every two weeks by subcutaneous injection. Participants received 40mg Adalimumab every two weeks by SC injection. Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every four weeks by subcutaneous injection. Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every two weeks by subcutaneous injection.
    Measure Participants 87 90 81 83
    Least Squares Mean (Standard Error) [score on a scale]
    -1.25
    (0.300)
    -2.30
    (0.292)
    -2.36
    (0.311)
    -2.74
    (0.306)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Adalimumab
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.012
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter LSMean Difference
    Estimated Value -1.05
    Confidence Interval (2-Sided) 95%
    -1.87 to -0.23
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.416
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, IXE80Q4W
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.010
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter LSMean Difference
    Estimated Value -1.11
    Confidence Interval (2-Sided) 95%
    -1.95 to -0.27
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.428
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Placebo, IXE80Q2W
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter LSMean Difference
    Estimated Value -1.49
    Confidence Interval (2-Sided) 95%
    -2.32 to -0.66
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.423
    Estimation Comments
    10. Secondary Outcome
    Title Change From Baseline in the Measure of High Sensitivity C-Reactive Protein (CRP)
    Description High sensitivity CRP is the measure of acute phase reactant. It will be measured with a high sensitivity assay at the central laboratory to help assess the effect of Ixekizumab on disease activity. LSMean was calculated using MMRM model with treatment, geographic region, baseline CRP status, visit and treatment-by-visit interaction as fixed factors.
    Time Frame Baseline, Week 16

    Outcome Measure Data

    Analysis Population Description
    All randomized participants.
    Arm/Group Title Placebo Adalimumab 40mg IXE80Q4W IXE80Q2W
    Arm/Group Description Participants received placebo every two weeks by subcutaneous injection. Participants received 40mg Adalimumab every two weeks by SC injection. Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every four weeks by subcutaneous injection. Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every two weeks by subcutaneous injection.
    Measure Participants 87 90 81 83
    Least Squares Mean (Standard Error) [Milliragm per Litre (mg/mL)]
    1.426
    (1.9244)
    -7.202
    (1.8688)
    -5.209
    (1.9803)
    -6.565
    (1.9582)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Adalimumab
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter LSMean Difference
    Estimated Value -8.628
    Confidence Interval (2-Sided) 95%
    -13.885 to -3.371
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.6724
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, IXE80Q4W
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.016
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter LSMean Difference
    Estimated Value -6.635
    Confidence Interval (2-Sided) 95%
    -12.033 to -1.238
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.7438
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Placebo, IXE80Q2W
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.004
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter LSMean Difference
    Estimated Value -7.991
    Confidence Interval (2-Sided) 95%
    -13.351 to -2.631
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.7248
    Estimation Comments
    11. Secondary Outcome
    Title Change From Baseline in Mobility on the Bath Ankylosing Spondylitis Metrology Index (BASMI)
    Description The BASMI is a combined index comprising the following 5 clinical measurements of spinal mobility in participants with rad-axSpA. Lateral spinal flexion Tragus-to-wall distance Lumbar flexion (modified Schrober) Maximal intermalleolar distance Cervical rotation. The BASMI includes these 5 measurements that are each scaled to a score of 0 to 10 depending on the result of the assessment (BASMI linear function). The average score of the 5 assessments gives the BASMI linear result. The higher the BASMI score the more severe the participants limitation of movement due to their AS. LSMean was calculated using MMRM model with treatment, geographic region, baseline CRP status, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.
    Time Frame Baseline, Week 16

    Outcome Measure Data

    Analysis Population Description
    All randomized participants.
    Arm/Group Title Placebo Adalimumab 40mg IXE80Q4W IXE80Q2W
    Arm/Group Description Participants received placebo every two weeks by subcutaneous injection. Participants received 40mg Adalimumab every two weeks by SC injection. Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every four weeks by subcutaneous injection. Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every two weeks by subcutaneous injection.
    Measure Participants 87 90 81 83
    Least Squares Mean (Standard Error) [score on a scale]
    -0.080
    (0.0826)
    -0.447
    (0.0800)
    -0.502
    (0.0858)
    -0.408
    (0.0840)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Adalimumab
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter LSMean Difference
    Estimated Value -0.367
    Confidence Interval (2-Sided) 95%
    -0.592 to -0.142
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.1143
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, IXE80Q4W
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter LSMean Difference
    Estimated Value -0.422
    Confidence Interval (2-Sided) 95%
    -0.655 to -0.189
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.1184
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Placebo, IXE80Q2W
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.005
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter LSMean Difference
    Estimated Value -0.329
    Confidence Interval (2-Sided) 95%
    -0.558 to -0.099
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.1167
    Estimation Comments
    12. Secondary Outcome
    Title Change From Baseline in Chest Expansion
    Description While participants have their hands resting on or behind the head, the assessor has measured the chest's encircled length by centimeter at the fourth intercostal level anteriorly. The difference between maximal inspiration and expiration in centimeters was recorded. Two tries were recorded. The better measurement (larger difference) of 2 tries (in centimeters) was used for analyses. LSMean was calculated using MMRM model with treatment, geographic region, baseline CRP status, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.
    Time Frame Baseline, Week 16

    Outcome Measure Data

    Analysis Population Description
    All Randomized Participants.
    Arm/Group Title Placebo Adalimumab 40mg IXE80Q4W IXE80Q2W
    Arm/Group Description Participants received placebo every two weeks by subcutaneous injection. Participants received 40mg Adalimumab every two weeks by SC injection. Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every four weeks by subcutaneous injection. Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every two weeks by subcutaneous injection.
    Measure Participants 87 90 81 83
    Least Squares Mean (Standard Error) [Centimeters (cm)]
    0.06
    (0.152)
    0.70
    (0.148)
    0.49
    (0.158)
    0.67
    (0.155)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Adalimumab
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.003
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter LSMean Difference
    Estimated Value 0.63
    Confidence Interval (2-Sided) 95%
    0.22 to 1.05
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.211
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, IXE80Q4W
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.051
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter LSMean Difference
    Estimated Value 0.43
    Confidence Interval (2-Sided) 95%
    -0.00 to 0.86
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.219
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Placebo, IXE80Q2W
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.005
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter LSMean Difference
    Estimated Value 0.60
    Confidence Interval (2-Sided) 95%
    0.18 to 1.03
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.215
    Estimation Comments
    13. Secondary Outcome
    Title Change From Baseline in Occiput to Wall Distance
    Description 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. LSMean was calculated using MMRM model with treatment, geographic region, baseline CRP status, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.
    Time Frame Baseline, Week 16

    Outcome Measure Data

    Analysis Population Description
    All randomized participants.
    Arm/Group Title Placebo Adalimumab 40mg IXE80Q4W IXE80Q2W
    Arm/Group Description Participants received placebo every two weeks by subcutaneous injection. Participants received 40mg Adalimumab every two weeks by SC injection. Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every four weeks by subcutaneous injection. Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every two weeks by subcutaneous injection.
    Measure Participants 87 90 81 83
    Least Squares Mean (Standard Error) [cm]
    -0.06
    (0.232)
    -0.72
    (0.225)
    -0.69
    (0.240)
    -0.73
    (0.236)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Adalimumab
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.039
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter LSMean Difference
    Estimated Value -0.67
    Confidence Interval (2-Sided) 95%
    -1.30 to -0.03
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.321
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, IXE80Q4W
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.057
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter LSMean Difference
    Estimated Value -0.63
    Confidence Interval (2-Sided) 95%
    -1.28 to 0.02
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.330
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Placebo, IXE80Q2W
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.042
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter LSMean Difference
    Estimated Value -0.67
    Confidence Interval (2-Sided) 95%
    -1.31 to -0.03
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.327
    Estimation Comments
    14. Secondary Outcome
    Title Change From Baseline in MRI Sacroiliac Joint(s) (SIJ) Spondyloarthritis Research Consortium of Canada (SPARCC) Score
    Description Both left and right SIJ are scored for bone marrow edema.Each side has 6 slices and each slice has 6 scoring units, and each scoring unit has a score of 0 or 1. Total SIJ SPARCC scores can range from 0 to 72 with higher scores reflecting worse disease. LSMean was calculated using ANCOVA model with treatment, geographic region, baseline CRP status and baseline value as fixed factors.
    Time Frame Baseline, Week 16

    Outcome Measure Data

    Analysis Population Description
    All randomized participants with baseline and week 16 SPARCC score.
    Arm/Group Title Placebo Adalimumab 40mg IXE80Q4W IXE80Q2W
    Arm/Group Description Participants received placebo every two weeks by subcutaneous injection. Participants received 40mg Adalimumab every two weeks by SC injection. Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every four weeks by subcutaneous injection. Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every two weeks by subcutaneous injection.
    Measure Participants 81 82 78 77
    Least Squares Mean (Standard Error) [score on a scale]
    0.92
    (0.582)
    -4.21
    (0.568)
    -3.97
    (0.590)
    -4.25
    (0.591)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Adalimumab
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter LSMean Difference
    Estimated Value -5.13
    Confidence Interval (2-Sided) 95%
    -6.7 to -3.5
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.806
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, IXE80Q4W
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter LSMean Difference
    Estimated Value -4.89
    Confidence Interval (2-Sided) 95%
    -6.5 to -3.3
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.812
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Placebo, IXE80Q2W
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter LSMean Difference
    Estimated Value -5.17
    Confidence Interval (2-Sided) 95%
    -6.8 to -3.6
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.816
    Estimation Comments
    15. Secondary Outcome
    Title Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES)
    Description 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. LSMean was calculated using MMRM model with treatment, geographic region, baseline CRP status, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.
    Time Frame Baseline, Week 16

    Outcome Measure Data

    Analysis Population Description
    All randomized participants with baseline MASES score > 0.
    Arm/Group Title Placebo Adalimumab 40mg IXE80Q4W IXE80Q2W
    Arm/Group Description Participants received placebo every two weeks by subcutaneous injection. Participants received 40mg Adalimumab every two weeks by SC injection. Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every four weeks by subcutaneous injection. Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every two weeks by subcutaneous injection.
    Measure Participants 56 51 49 50
    Least Squares Mean (Standard Error) [score on a scale]
    -2.1
    (0.34)
    -2.6
    (0.34)
    -2.3
    (0.36)
    -2.4
    (0.35)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Adalimumab
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.317
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter LSMean Difference
    Estimated Value -0.5
    Confidence Interval (2-Sided) 95%
    -1.4 to 0.5
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.48
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, IXE80Q4W
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.683
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter LSMean Difference
    Estimated Value -0.2
    Confidence Interval (2-Sided) 95%
    -1.1 to 0.8
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.48
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Placebo, IXE80Q2W
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.500
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter LSMean Difference
    Estimated Value -0.3
    Confidence Interval (2-Sided) 95%
    -1.3 to 0.6
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.48
    Estimation Comments
    16. Secondary Outcome
    Title Change From Baseline in SPARCC Enthesitis Score
    Description 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. LSMean was calculated using MMRM model with treatment, geographic region, baseline CRP status, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.
    Time Frame Baseline, Week 16

    Outcome Measure Data

    Analysis Population Description
    All randomized participants with baseline SPARCC score > 0.
    Arm/Group Title Placebo Adalimumab 40mg IXE80Q4W IXE80Q2W
    Arm/Group Description Participants received placebo every two weeks by subcutaneous injection. Participants received 40mg Adalimumab every two weeks by SC injection. Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every four weeks by subcutaneous injection. Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every two weeks by subcutaneous injection.
    Measure Participants 41 40 40 35
    Least Squares Mean (Standard Error) [score on a scale]
    -2.1
    (0.40)
    -2.9
    (0.40)
    -2.7
    (0.40)
    -2.6
    (0.43)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Adalimumab
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.154
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter LSMean Difference
    Estimated Value -0.8
    Confidence Interval (2-Sided) 95%
    -1.9 to 0.3
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.56
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, IXE80Q4W
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value -0.6
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter LSMean Difference
    Estimated Value 0.255
    Confidence Interval (2-Sided) 95%
    -1.8 to 0.5
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.56
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Placebo, IXE80Q2W
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.398
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter LSMean Difference
    Estimated Value -0.5
    Confidence Interval (2-Sided) 95%
    -1.6 to 0.7
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.58
    Estimation Comments
    17. Secondary Outcome
    Title Change From Baseline in Severity of Peripheral Arthritis by Tender (TJC)
    Description The number of tender and painful joints was determined by examination of 46 joints (23 joints on each side of the participants body. The 46 joints are assessed and classified as tender or not tender. sum of all joints checked to be tender/painful divided by number of evaluable joints which is multiplied by 46 to obtain TJC score. The scores ranges from 0 (no tender/painful joints) to 46 (all joints tender/painful). LSMean was calculated using MMRM model with treatment, geographic region, baseline CRP status, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.
    Time Frame Baseline, Week 16

    Outcome Measure Data

    Analysis Population Description
    All randomized participants with baseline TJC > 0.
    Arm/Group Title Placebo Adalimumab 40mg IXE80Q4W IXE80Q2W
    Arm/Group Description Participants received placebo every two weeks by subcutaneous injection. Participants received 40mg Adalimumab every two weeks by SC injection. Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every four weeks by subcutaneous injection. Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every two weeks by subcutaneous injection.
    Measure Participants 51 49 44 45
    Least Squares Mean (Standard Error) [score on a scale]
    -2.0
    (0.53)
    -2.2
    (0.55)
    -2.5
    (0.58)
    -3.3
    (0.58)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Adalimumab
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.783
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter LSMean Difference
    Estimated Value -0.2
    Confidence Interval (2-Sided) 95%
    -1.7 to 1.3
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.76
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, IXE80Q4W
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.550
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter LSMean Difference
    Estimated Value -0.5
    Confidence Interval (2-Sided) 95%
    -2.0 to 1.1
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.78
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Placebo, IXE80Q2W
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.091
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter LSMean Difference
    Estimated Value -1.3
    Confidence Interval (2-Sided) 95%
    -2.8 to 0.2
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.77
    Estimation Comments
    18. Secondary Outcome
    Title Number of Participants With Anterior Uveitis or Uveitis Flares
    Description 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.
    Time Frame Baseline through Week 16

    Outcome Measure Data

    Analysis Population Description
    All randomized participants.
    Arm/Group Title Placebo Adalimumab 40mg IXE80Q4W IXE80Q2W
    Arm/Group Description Participants received placebo every two weeks by subcutaneous injection. Participants received 40mg Adalimumab every two weeks by SC injection. Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every four weeks by subcutaneous injection. Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every two weeks by subcutaneous injection.
    Measure Participants 87 90 81 83
    Number [Count of Participants]
    0
    0%
    0
    0%
    1
    1.2%
    0
    0%
    19. Secondary Outcome
    Title Change From Baseline in the Fatigue Numeric Rating Scale (NRS) Score
    Description 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 one number that describes their worst level of fatigue during the previous 24 hours. LSMean was calculated using MMRM model with treatment, geographic region, baseline CRP status, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.
    Time Frame Baseline, Week 16

    Outcome Measure Data

    Analysis Population Description
    All randomized participants.
    Arm/Group Title Placebo Adalimumab 40mg IXE80Q4W IXE80Q2W
    Arm/Group Description Participants placebo every two weeks by subcutaneous injection. Participants received 40mg Adalimumab every two weeks by SC injection. Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every four weeks by subcutaneous injection. Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every two weeks by subcutaneous injection.
    Measure Participants 87 90 81 83
    Least Squares Mean (Standard Error) [score on a scale]
    -1.4
    (0.23)
    -2.2
    (0.23)
    -2.5
    (0.24)
    -2.1
    (0.24)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Adalimumab
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.027
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter LSMean Difference
    Estimated Value -0.7
    Confidence Interval (2-Sided) 95%
    -1.3 to -0.1
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.32
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, Adalimumab
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.002
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter LSMean Difference
    Estimated Value -1.0
    Confidence Interval (2-Sided) 95%
    -1.7 to -0.4
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.33
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Placebo, IXE80Q2W
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.035
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter LSMean Difference
    Estimated Value -0.7
    Confidence Interval (2-Sided) 95%
    -1.3 to -0.0
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.33
    Estimation Comments
    20. Secondary Outcome
    Title Change From Baseline in the Jenkins Sleep Evaluation Questionnaire (JSEQ)
    Description The 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 number 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. LSMean was calculated using MMRM model with treatment, geographic region, baseline CRP status, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.
    Time Frame Baseline, Week 16

    Outcome Measure Data

    Analysis Population Description
    All randomized participants.
    Arm/Group Title Placebo Adalimumab 40mg IXE80Q4W IXE80Q2W
    Arm/Group Description Participants received placebo every two weeks by subcutaneous injection. Participants received 40mg Adalimumab every two weeks by SC injection. Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every four weeks by subcutaneous injection. Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every two weeks by subcutaneous injection.
    Measure Participants 87 90 81 83
    Least Squares Mean (Standard Error) [score on a scale]
    -1.5
    (0.41)
    -2.7
    (0.40)
    -2.5
    (0.43)
    -3.0
    (0.42)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Adalimumab
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.041
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter LSMean Difference
    Estimated Value -1.2
    Confidence Interval (2-Sided) 95%
    -2.3 to -0.0
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.57
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, IXE80Q4W
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.125
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter LSMean Difference
    Estimated Value -0.9
    Confidence Interval (2-Sided) 95%
    -2.1 to 0.3
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.59
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Placebo, IXE80Q2W
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.013
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter LSMean Difference
    Estimated Value -1.4
    Confidence Interval (2-Sided) 95%
    -2.6 to -0.3
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.58
    Estimation Comments
    21. Secondary Outcome
    Title Change From Baseline in the Work Productivity Activity Impairment Spondyloarthritis (WPAI-SpA) Scores
    Description 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 patient 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. Greater scores indicate greater impairment and less productivity. LSMean was calculated using ANCOVA model with treatment, geographic region, baseline CRP status and baseline value as fixed factors.
    Time Frame Baseline, Week 16

    Outcome Measure Data

    Analysis Population Description
    All randomized participants.
    Arm/Group Title Placebo Adalimumab 40mg IXE80Q4W IXE80Q2W
    Arm/Group Description Participants received placebo every two weeks by subcutaneous injection. Participants received 40mg Adalimumab every two weeks by SC injection. Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every four weeks by subcutaneous injection. Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every two weeks by subcutaneous injection.
    Measure Participants 87 90 81 83
    Overall Work Impairment Score
    -17.82
    (3.254)
    -21.44
    (2.921)
    -21.36
    (3.061)
    -24.06
    (3.299)
    Percentage of Activity Impairment
    -14.1
    (2.28)
    -21.1
    (2.22)
    -23.0
    (2.35)
    -23.4
    (2.30)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Adalimumab
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.989
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter LSMean Difference
    Estimated Value 0.04
    Confidence Interval (2-Sided) 95%
    -6.03 to 6.12
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 3.082
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, IXE80Q4W
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.429
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter LSMean Difference
    Estimated Value 2.50
    Confidence Interval (2-Sided) 95%
    -3.71 to 8.70
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 3.146
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Placebo, IXE80Q2W
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.096
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter LSMean Difference
    Estimated Value -5.47
    Confidence Interval (2-Sided) 95%
    -11.92 to 0.98
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 3.270
    Estimation Comments
    22. Secondary Outcome
    Title Change From Baseline in ASAS-Nonsteroidal Anti-Inflammatory Drug (NSAID) Score
    Description ASAS-NSAID score is used to present the NSAID intake by considering the type of NSAID, the total dose, & the number of days taking NSAID during a period of interest (PI).. ASAS-NSAID score=(equivalent NSAID score)x(days of intake during PI)x(days per week)/(PI in days). Higher scores indicate greater NSAIDs intake. 0= no intake, 100 = equivalent NSAID intake.
    Time Frame Baseline, Week 52

    Outcome Measure Data

    Analysis Population Description
    Participants in Extended Treatment Period Population Who had NSAID Intake at Baseline.
    Arm/Group Title Placebo/Ixekizumab Adalimumab/Ixekizumab Ixekizumab Q4W/Ixekizumab Q4W Ixekizumab 80mg Q2W/Ixekizumab 80mg Q2W
    Arm/Group Description Participants received placebo every two weeks during blinded treatment period and starting dose of 160mg Ixekizumab at week 16 followed by 80mg Ixekizumab either Q2W or Q4W extended treatment period by subcutaneous injection. Participants received 40mg Adalimumab every two weeks during blinded treatment period and 80mg Ixekizumab either Q2W or Q4W during extended treatment period by subcutaneous injection. Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every four weeks during blinded treatment and extension period by subcutaneous injection. Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every four weeks during blinded treatment and extension period by subcutaneous injection.
    Measure Participants 78 80 71 76
    Mean (Standard Deviation) [score on a scale]
    -10.28
    (27.472)
    -5.91
    (20.861)
    -7.62
    (25.430)
    -9.91
    (27.940)
    23. Secondary Outcome
    Title Number of Participants With Anti Ixekizumab Antibodies
    Description A treatment emergent - antidrug antibody (TE-ADA) positive patient is defined as: a) a patient with a >= 4-fold increase over a positive baseline antibody titer; or b) for a negative baseline titer, a patient with an increase from the baseline to a level of >= 1:10.
    Time Frame Week 16

    Outcome Measure Data

    Analysis Population Description
    All randomized participants.
    Arm/Group Title Placebo Adalimumab 40mg IXE80Q4W IXE80Q2W
    Arm/Group Description Participants received placebo every two weeks by subcutaneous injection. Participants received 40mg Adalimumab every two weeks by SC injection. Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every four weeks by subcutaneous injection. Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every two weeks by subcutaneous injection.
    Measure Participants 87 90 81 83
    Count of Participants [Participants]
    2
    2.3%
    5
    5.6%
    2
    2.4%
    2
    2.5%
    24. Secondary Outcome
    Title Pharmacokinetics: Trough Ixekizumab Concentration at Steady State (Ctrough ss)
    Description
    Time Frame Week 16

    Outcome Measure Data

    Analysis Population Description
    All randomized participants who received at least one dose of Ixekizumab.
    Arm/Group Title IXE80Q4W IXE160/80Q4W IXE80Q2W IXE160/80Q2W
    Arm/Group Description Participants received 80mg Ixekizumab every four weeks by subcutaneous injection. Participants received starting dose of 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every four weeks by subcutaneous injection. Participants received 80mg Ixekizumab every two weeks by subcutaneous injection. Participants received starting dose of 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every two weeks by subcutaneous injection.
    Measure Participants 42 39 45 38
    Geometric Mean (Geometric Coefficient of Variation) [microgram per millilitre (μg/mL)]
    3.56
    (56)
    3.88
    (55)
    11.6
    (54)
    11.3
    (43)
    25. Secondary Outcome
    Title Change From Baseline in Severity of Peripheral Arthritis by Swollen Joint Count (SJC)
    Description The number of swollen joints was determined by examination of 44 joints (22 joints on each side of the participants body. The 44 joints are assessed and classified as swollen or not swollen. "sum of all joints checked to be swollen" divided by "number of evaluable joints" and then multiplied by 44 to obtain SJC score. The SJC score ranges from 0 (no swollen joints) to 44 (all joints swollen). LSMean was calculated using MMRM model with treatment, geographic region, baseline CRP status, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.
    Time Frame Baseline, Week 16

    Outcome Measure Data

    Analysis Population Description
    All randomized participants with baseline SJC > 0.
    Arm/Group Title Placebo Adalimumab 40mg IXE80Q4W IXE80Q2W
    Arm/Group Description Participants received placebo every two weeks by subcutaneous injection. Participants received 40mg Adalimumab every two weeks by SC injection. Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every four weeks by subcutaneous injection. Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every two weeks by subcutaneous injection.
    Measure Participants 22 23 24 22
    Least Squares Mean (Standard Error) [score on a scale]
    -1.7
    (0.55)
    -2.7
    (0.53)
    -3.6
    (0.53)
    -2.7
    (0.57)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Adalimumab
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.166
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter LSMean Difference
    Estimated Value -1.1
    Confidence Interval (2-Sided) 95%
    -2.6 to 0.4
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.76
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, IXE80Q4W
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.011
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter LSMean Difference
    Estimated Value -1.9
    Confidence Interval (2-Sided) 95%
    -3.4 to -0.4
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.73
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Placebo, IXE80Q2W
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.182
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter LSMean Difference
    Estimated Value -1.0
    Confidence Interval (2-Sided) 95%
    -2.6 to 0.5
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.77
    Estimation Comments
    26. Secondary Outcome
    Title Change From Baseline in Magnetic Resonance Imaging (MRI) of the Spine (Spondyloarthritis Research Consortium of Canada [SPARCC] Score)
    Description MRI score of spine was assessed using SPARCC method. All 23 disco-vertebral units (DVUs) of the spine (from C2 to S1) are scored for bone marrow edema. A single DVU has a scoring range of 0 to 18, bringing the maximum total score to 414, with higher scores reflecting worse disease. Scoring was performed by central readers. LSMean was calculated using ANCOVA model with treatment, geographic region, baseline CRP status and baseline value as fixed factors
    Time Frame Baseline, Week 16

    Outcome Measure Data

    Analysis Population Description
    All randomized participants with baseline and week 16 SPARCC MRI score for spine.
    Arm/Group Title Placebo Adalimumab IXE80Q4W IXE80Q2W
    Arm/Group Description Participants received placebo every two weeks by subcutaneous injection. Participants received 40mg Adalimumab every two weeks by SC injection. Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every four weeks by subcutaneous injection. Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every two weeks by subcutaneous injection.
    Measure Participants 81 82 78 76
    Least Squares Mean (Standard Error) [score on a scale]
    -1.51
    (1.147)
    -11.57
    (1.113)
    -11.02
    (1.160)
    -9.58
    (1.168)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Adalimumab
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter LSMean Difference
    Estimated Value -10.07
    Confidence Interval (2-Sided) 95%
    -13.2 to -6.9
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.588
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, IXE80Q4W
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter LSMean Difference
    Estimated Value -9.51
    Confidence Interval (2-Sided) 95%
    -12.6 to -6.4
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.591
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Placebo, IXE80Q2W
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter LSMean Difference
    Estimated Value -8.08
    Confidence Interval (2-Sided) 95%
    -11.2 to -4.9
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.603
    Estimation Comments

    Adverse Events

    Time Frame Upto 76 Weeks
    Adverse Event Reporting Description All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
    Arm/Group Title Placebo - Blinded Treatment Adalimumab 40mg - Blinded Treatment IXE80Q2W - Blinded Treatment IXE80Q4W - Blinded Treatment ADA/PBO - Washout Treatment Period PBO/IXE - Extended Treatment Period ADA/PBO/IXE - Extended Treatment Period IXE80Q2W/IXE80Q2W - Extended Treatment IXE80Q4W/IXE80Q4W - Extended Treatment PBO-follow-up Period IXE80Q2W-follow-up Period IXE80Q4W-follow-up Period
    Arm/Group Description Participants received placebo every two weeks by subcutaneous injection. Participants received 40mg Adalimumab every two weeks by SC injection. Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every two weeks by subcutaneous injection. Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every four weeks by subcutaneous injection. Participants received placebo by subcutaneous injection Participants received starting dose of 160mg Ixekizumab at week 16 followed by 80mg Q2W or 80mg Q4W by subcutaneous injection. Participants received 80mg Ixekizumab Q2W or 80mg Q4W by subcutaneous injection. Participants received 80mg Ixekizumab every two weeks by subcutaneous injection. Participants received 80mg Ixekizumab every four weeks by subcutaneous injection. Participants did not receive any intervention. Participants did not receive any intervention. Participants did not receive any intervention.
    All Cause Mortality
    Placebo - Blinded Treatment Adalimumab 40mg - Blinded Treatment IXE80Q2W - Blinded Treatment IXE80Q4W - Blinded Treatment ADA/PBO - Washout Treatment Period PBO/IXE - Extended Treatment Period ADA/PBO/IXE - Extended Treatment Period IXE80Q2W/IXE80Q2W - Extended Treatment IXE80Q4W/IXE80Q4W - Extended Treatment PBO-follow-up Period IXE80Q2W-follow-up Period IXE80Q4W-follow-up Period
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/86 (0%) 0/90 (0%) 0/83 (0%) 0/81 (0%) 0/88 (0%) 0/86 (0%) 0/86 (0%) 0/79 (0%) 0/78 (0%) 0/1 (0%) 0/24 (0%) 0/16 (0%)
    Serious Adverse Events
    Placebo - Blinded Treatment Adalimumab 40mg - Blinded Treatment IXE80Q2W - Blinded Treatment IXE80Q4W - Blinded Treatment ADA/PBO - Washout Treatment Period PBO/IXE - Extended Treatment Period ADA/PBO/IXE - Extended Treatment Period IXE80Q2W/IXE80Q2W - Extended Treatment IXE80Q4W/IXE80Q4W - Extended Treatment PBO-follow-up Period IXE80Q2W-follow-up Period IXE80Q4W-follow-up Period
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/86 (0%) 3/90 (3.3%) 1/83 (1.2%) 1/81 (1.2%) 0/88 (0%) 4/86 (4.7%) 7/86 (8.1%) 3/79 (3.8%) 4/78 (5.1%) 0/1 (0%) 0/24 (0%) 0/16 (0%)
    Blood and lymphatic system disorders
    Lymphadenitis 0/86 (0%) 0 0/90 (0%) 0 0/83 (0%) 0 0/81 (0%) 0 0/88 (0%) 0 1/86 (1.2%) 1 0/86 (0%) 0 0/79 (0%) 0 0/78 (0%) 0 0/1 (0%) 0 0/24 (0%) 0 0/16 (0%) 0
    Cardiac disorders
    Atrioventricular block complete 0/86 (0%) 0 0/90 (0%) 0 0/83 (0%) 0 0/81 (0%) 0 0/88 (0%) 0 1/86 (1.2%) 1 0/86 (0%) 0 0/79 (0%) 0 0/78 (0%) 0 0/1 (0%) 0 0/24 (0%) 0 0/16 (0%) 0
    Gastrointestinal disorders
    Crohn's disease 0/86 (0%) 0 0/90 (0%) 0 1/83 (1.2%) 1 0/81 (0%) 0 0/88 (0%) 0 0/86 (0%) 0 1/86 (1.2%) 1 0/79 (0%) 0 0/78 (0%) 0 0/1 (0%) 0 0/24 (0%) 0 0/16 (0%) 0
    Dyspepsia 0/86 (0%) 0 0/90 (0%) 0 1/83 (1.2%) 1 0/81 (0%) 0 0/88 (0%) 0 0/86 (0%) 0 0/86 (0%) 0 0/79 (0%) 0 0/78 (0%) 0 0/1 (0%) 0 0/24 (0%) 0 0/16 (0%) 0
    Infections and infestations
    Appendicitis 0/86 (0%) 0 1/90 (1.1%) 1 0/83 (0%) 0 0/81 (0%) 0 0/88 (0%) 0 0/86 (0%) 0 0/86 (0%) 0 0/79 (0%) 0 0/78 (0%) 0 0/1 (0%) 0 0/24 (0%) 0 0/16 (0%) 0
    Cellulitis 0/86 (0%) 0 0/90 (0%) 0 0/83 (0%) 0 0/81 (0%) 0 0/88 (0%) 0 1/86 (1.2%) 2 0/86 (0%) 0 0/79 (0%) 0 0/78 (0%) 0 0/1 (0%) 0 0/24 (0%) 0 0/16 (0%) 0
    Gastroenteritis 0/86 (0%) 0 0/90 (0%) 0 1/83 (1.2%) 1 0/81 (0%) 0 0/88 (0%) 0 0/86 (0%) 0 0/86 (0%) 0 0/79 (0%) 0 0/78 (0%) 0 0/1 (0%) 0 0/24 (0%) 0 0/16 (0%) 0
    Pneumonia haemophilus 0/86 (0%) 0 0/90 (0%) 0 0/83 (0%) 0 0/81 (0%) 0 0/88 (0%) 0 0/86 (0%) 0 1/86 (1.2%) 1 0/79 (0%) 0 0/78 (0%) 0 0/1 (0%) 0 0/24 (0%) 0 0/16 (0%) 0
    Tonsillitis 0/86 (0%) 0 0/90 (0%) 0 0/83 (0%) 0 0/81 (0%) 0 0/88 (0%) 0 0/86 (0%) 0 0/86 (0%) 0 1/79 (1.3%) 1 0/78 (0%) 0 0/1 (0%) 0 0/24 (0%) 0 0/16 (0%) 0
    Urinary tract infection 0/86 (0%) 0 0/90 (0%) 0 0/83 (0%) 0 1/81 (1.2%) 1 0/88 (0%) 0 0/86 (0%) 0 0/86 (0%) 0 0/79 (0%) 0 0/78 (0%) 0 0/1 (0%) 0 0/24 (0%) 0 0/16 (0%) 0
    Injury, poisoning and procedural complications
    Ankle fracture 0/86 (0%) 0 1/90 (1.1%) 1 0/83 (0%) 0 0/81 (0%) 0 0/88 (0%) 0 0/86 (0%) 0 0/86 (0%) 0 0/79 (0%) 0 0/78 (0%) 0 0/1 (0%) 0 0/24 (0%) 0 0/16 (0%) 0
    Avulsion fracture 0/86 (0%) 0 0/90 (0%) 0 0/83 (0%) 0 0/81 (0%) 0 0/88 (0%) 0 0/86 (0%) 0 0/86 (0%) 0 1/79 (1.3%) 1 0/78 (0%) 0 0/1 (0%) 0 0/24 (0%) 0 0/16 (0%) 0
    Cervical vertebral fracture 0/86 (0%) 0 0/90 (0%) 0 0/83 (0%) 0 0/81 (0%) 0 0/88 (0%) 0 1/86 (1.2%) 1 0/86 (0%) 0 0/79 (0%) 0 0/78 (0%) 0 0/1 (0%) 0 0/24 (0%) 0 0/16 (0%) 0
    Post procedural haematoma 0/86 (0%) 0 0/90 (0%) 0 0/83 (0%) 0 0/81 (0%) 0 0/88 (0%) 0 0/86 (0%) 0 1/86 (1.2%) 1 0/79 (0%) 0 0/78 (0%) 0 0/1 (0%) 0 0/24 (0%) 0 0/16 (0%) 0
    Radius fracture 0/86 (0%) 0 0/90 (0%) 0 0/83 (0%) 0 0/81 (0%) 0 0/88 (0%) 0 0/86 (0%) 0 0/86 (0%) 0 0/79 (0%) 0 1/78 (1.3%) 1 0/1 (0%) 0 0/24 (0%) 0 0/16 (0%) 0
    Road traffic accident 0/86 (0%) 0 0/90 (0%) 0 0/83 (0%) 0 0/81 (0%) 0 0/88 (0%) 0 0/86 (0%) 0 0/86 (0%) 0 0/79 (0%) 0 1/78 (1.3%) 1 0/1 (0%) 0 0/24 (0%) 0 0/16 (0%) 0
    Investigations
    Blood creatine phosphokinase increased 0/86 (0%) 0 0/90 (0%) 0 0/83 (0%) 0 0/81 (0%) 0 0/88 (0%) 0 0/86 (0%) 0 0/86 (0%) 0 0/79 (0%) 0 1/78 (1.3%) 1 0/1 (0%) 0 0/24 (0%) 0 0/16 (0%) 0
    Musculoskeletal and connective tissue disorders
    Arthritis 0/86 (0%) 0 0/90 (0%) 0 0/83 (0%) 0 0/81 (0%) 0 0/88 (0%) 0 0/86 (0%) 0 0/86 (0%) 0 0/79 (0%) 0 1/78 (1.3%) 1 0/1 (0%) 0 0/24 (0%) 0 0/16 (0%) 0
    Osteoarthritis 0/86 (0%) 0 0/90 (0%) 0 0/83 (0%) 0 0/81 (0%) 0 0/88 (0%) 0 1/86 (1.2%) 1 0/86 (0%) 0 0/79 (0%) 0 0/78 (0%) 0 0/1 (0%) 0 0/24 (0%) 0 0/16 (0%) 0
    Plica syndrome 0/86 (0%) 0 0/90 (0%) 0 0/83 (0%) 0 0/81 (0%) 0 0/88 (0%) 0 0/86 (0%) 0 0/86 (0%) 0 1/79 (1.3%) 1 0/78 (0%) 0 0/1 (0%) 0 0/24 (0%) 0 0/16 (0%) 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Bladder cancer 0/86 (0%) 0 0/90 (0%) 0 0/83 (0%) 0 0/81 (0%) 0 0/88 (0%) 0 0/86 (0%) 0 1/86 (1.2%) 1 0/79 (0%) 0 0/78 (0%) 0 0/1 (0%) 0 0/24 (0%) 0 0/16 (0%) 0
    Parathyroid tumour benign 0/86 (0%) 0 0/90 (0%) 0 0/83 (0%) 0 0/81 (0%) 0 0/88 (0%) 0 0/86 (0%) 0 1/86 (1.2%) 1 0/79 (0%) 0 0/78 (0%) 0 0/1 (0%) 0 0/24 (0%) 0 0/16 (0%) 0
    Skin papilloma 0/86 (0%) 0 0/90 (0%) 0 0/83 (0%) 0 0/81 (0%) 0 0/88 (0%) 0 0/86 (0%) 0 0/86 (0%) 0 1/79 (1.3%) 1 0/78 (0%) 0 0/1 (0%) 0 0/24 (0%) 0 0/16 (0%) 0
    Nervous system disorders
    Cerebral haemorrhage 0/86 (0%) 0 0/90 (0%) 0 0/83 (0%) 0 0/81 (0%) 0 0/88 (0%) 0 0/86 (0%) 0 1/86 (1.2%) 1 0/79 (0%) 0 0/78 (0%) 0 0/1 (0%) 0 0/24 (0%) 0 0/16 (0%) 0
    Subarachnoid haemorrhage 0/86 (0%) 0 0/90 (0%) 0 0/83 (0%) 0 0/81 (0%) 0 0/88 (0%) 0 0/86 (0%) 0 1/86 (1.2%) 1 0/79 (0%) 0 0/78 (0%) 0 0/1 (0%) 0 0/24 (0%) 0 0/16 (0%) 0
    Renal and urinary disorders
    Nephrolithiasis 0/86 (0%) 0 0/90 (0%) 0 0/83 (0%) 0 0/81 (0%) 0 0/88 (0%) 0 0/86 (0%) 0 1/86 (1.2%) 1 0/79 (0%) 0 0/78 (0%) 0 0/1 (0%) 0 0/24 (0%) 0 0/16 (0%) 0
    Reproductive system and breast disorders
    Adnexal torsion 0/15 (0%) 0 1/17 (5.9%) 1 0/19 (0%) 0 0/13 (0%) 0 0/17 (0%) 0 0/15 (0%) 0 0/16 (0%) 0 0/18 (0%) 0 0/13 (0%) 0 0/1 (0%) 0 0/9 (0%) 0 0/3 (0%) 0
    Skin and subcutaneous tissue disorders
    Erythema multiforme 0/86 (0%) 0 0/90 (0%) 0 1/83 (1.2%) 1 0/81 (0%) 0 0/88 (0%) 0 0/86 (0%) 0 0/86 (0%) 0 0/79 (0%) 0 0/78 (0%) 0 0/1 (0%) 0 0/24 (0%) 0 0/16 (0%) 0
    Other (Not Including Serious) Adverse Events
    Placebo - Blinded Treatment Adalimumab 40mg - Blinded Treatment IXE80Q2W - Blinded Treatment IXE80Q4W - Blinded Treatment ADA/PBO - Washout Treatment Period PBO/IXE - Extended Treatment Period ADA/PBO/IXE - Extended Treatment Period IXE80Q2W/IXE80Q2W - Extended Treatment IXE80Q4W/IXE80Q4W - Extended Treatment PBO-follow-up Period IXE80Q2W-follow-up Period IXE80Q4W-follow-up Period
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 12/86 (14%) 16/90 (17.8%) 18/83 (21.7%) 11/81 (13.6%) 8/88 (9.1%) 26/86 (30.2%) 20/86 (23.3%) 21/79 (26.6%) 14/78 (17.9%) 1/1 (100%) 2/24 (8.3%) 2/16 (12.5%)
    Eye disorders
    Ocular discomfort 0/86 (0%) 0 0/90 (0%) 0 0/83 (0%) 0 0/81 (0%) 0 0/88 (0%) 0 0/86 (0%) 0 0/86 (0%) 0 0/79 (0%) 0 0/78 (0%) 0 1/1 (100%) 1 0/24 (0%) 0 0/16 (0%) 0
    Gastrointestinal disorders
    Diarrhoea 2/86 (2.3%) 2 4/90 (4.4%) 4 2/83 (2.4%) 2 0/81 (0%) 0 0/88 (0%) 0 0/86 (0%) 0 1/86 (1.2%) 4 4/79 (5.1%) 4 2/78 (2.6%) 2 0/1 (0%) 0 1/24 (4.2%) 1 0/16 (0%) 0
    General disorders
    Injection site reaction 2/86 (2.3%) 33 3/90 (3.3%) 6 7/83 (8.4%) 37 0/81 (0%) 0 0/88 (0%) 0 8/86 (9.3%) 53 8/86 (9.3%) 24 6/79 (7.6%) 34 3/78 (3.8%) 4 0/1 (0%) 0 0/24 (0%) 0 0/16 (0%) 0
    Infections and infestations
    Nasopharyngitis 6/86 (7%) 6 6/90 (6.7%) 7 5/83 (6%) 6 6/81 (7.4%) 6 6/88 (6.8%) 6 17/86 (19.8%) 22 7/86 (8.1%) 8 7/79 (8.9%) 9 8/78 (10.3%) 8 0/1 (0%) 0 0/24 (0%) 0 0/16 (0%) 0
    Upper respiratory tract infection 4/86 (4.7%) 5 2/90 (2.2%) 3 4/83 (4.8%) 4 7/81 (8.6%) 8 2/88 (2.3%) 2 4/86 (4.7%) 4 4/86 (4.7%) 5 8/79 (10.1%) 9 4/78 (5.1%) 4 0/1 (0%) 0 1/24 (4.2%) 1 0/16 (0%) 0
    Vaginal infection 0/15 (0%) 0 1/17 (5.9%) 1 0/19 (0%) 0 0/13 (0%) 0 0/17 (0%) 0 0/15 (0%) 0 0/16 (0%) 0 0/18 (0%) 0 0/13 (0%) 0 0/1 (0%) 0 0/9 (0%) 0 0/3 (0%) 0
    Musculoskeletal and connective tissue disorders
    Back pain 1/86 (1.2%) 1 1/90 (1.1%) 1 1/83 (1.2%) 1 0/81 (0%) 0 0/88 (0%) 0 0/86 (0%) 0 1/86 (1.2%) 1 1/79 (1.3%) 1 3/78 (3.8%) 3 0/1 (0%) 0 0/24 (0%) 0 2/16 (12.5%) 2
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Uterine leiomyoma 0/15 (0%) 0 1/17 (5.9%) 1 0/19 (0%) 0 0/13 (0%) 0 0/17 (0%) 0 0/15 (0%) 0 0/16 (0%) 0 0/18 (0%) 0 0/13 (0%) 0 0/1 (0%) 0 0/9 (0%) 0 0/3 (0%) 0
    Reproductive system and breast disorders
    Adnexal torsion 0/15 (0%) 0 1/17 (5.9%) 1 0/19 (0%) 0 0/13 (0%) 0 0/17 (0%) 0 0/15 (0%) 0 0/16 (0%) 0 0/18 (0%) 0 0/13 (0%) 0 0/1 (0%) 0 0/9 (0%) 0 0/3 (0%) 0
    Menopausal symptoms 0/15 (0%) 0 0/17 (0%) 0 0/19 (0%) 0 0/13 (0%) 0 0/17 (0%) 0 0/15 (0%) 0 0/16 (0%) 0 0/18 (0%) 0 0/13 (0%) 0 1/1 (100%) 1 0/9 (0%) 0 0/3 (0%) 0
    Menstruation irregular 1/15 (6.7%) 1 0/17 (0%) 0 0/19 (0%) 0 0/13 (0%) 0 0/17 (0%) 0 0/15 (0%) 0 0/16 (0%) 0 0/18 (0%) 0 0/13 (0%) 0 0/1 (0%) 0 0/9 (0%) 0 0/3 (0%) 0

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.

    Results Point of Contact

    Name/Title Chief Medical Officer
    Organization Eli Lilly and Company
    Phone 800-545-5979
    Email ClinicalTrials.gov@lilly.com
    Responsible Party:
    Eli Lilly and Company
    ClinicalTrials.gov Identifier:
    NCT02696785
    Other Study ID Numbers:
    • 16178
    • I1F-MC-RHBV
    • 2015-003932-11
    First Posted:
    Mar 2, 2016
    Last Update Posted:
    Nov 19, 2019
    Last Verified:
    Nov 1, 2018