Back to results

A Study of Ixekizumab (LY2439821) in TNF Inhibitor Experienced Participants With Radiographic Axial Spondyloarthritis (COAST-W)

Primary Purpose

Spondyloarthritis

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Ixekizumab

Placebo

About this trial

This is an interventional treatment trial for Spondyloarthritis focused on measuring Ankylosing Spondylitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Are ambulatory.
Have an established 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.
Have had prior treatment with at least 1 and not more than 2 TNF inhibitors.
Must have had an inadequate response to 2 or more NSAIDs at the therapeutic dose range for a total duration of at least 4 weeks OR have a history of intolerance to NSAIDs.
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 never taken a TNF inhibitor medication or have taken more than 2.
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.

Sites / Locations

Arizona Arthritis Research, PLC
Rheumatology Center of San Diego
Care Access Research - Huntington Beach
Desert Medical Advances
Arthritis Assoc. & Osteoporosis Ctr of Colorado Springs, LLC
Denver Arthritis Center
Clinical Research Center of CT/NY
Arthritis Rheumatic Disease Specialties
Sarasota Arthritis Center
Marietta Rheumatology
St Luke's Clinic - Intermountain Orthopaedics
Institute of Arthritis Research
Center for Arthritis & Osteoporosis
Klein and Associates MD, PA
Osteoporosis And Clinical Trial Center
Arthritis Consultants
The Center for Rheumatology
Shanahan Rheumatology & Immunotherapy
Oregon Health and Science University
Altoona Center for Clinical Research
Articularis Healthcare Group, INC dba Columbia Arthritis Ctr
Low Country Research Center
Univ of Texas Health Science Center - Houston
Southwest Rheumatology, P.A.
Center for Arthritis and Rheumatic Diseases, PC
Arthritis Northwest Rheumatology
Rheumatology and Immunotherapy Center
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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.
Office: Perez-De Jesus, Amarilis
GCM Medical Group PSC
Mindful Medical Research
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

Q2W Ixekizumab

Q4W Ixekizumab

Placebo

Arm Description

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.

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.

Double Blind Period: Placebo given SC Q2W to week 14. Extended Treatment Period: Starting dose of 160 mg ixekizumab given SC at week 16 followed by 80 mg ixekizumab given SC Q2W or Q4W from week 16 to week 52.

Outcomes

Primary Outcome Measures

Percentage of Participants Achieving an Assessment of Spondyloarthritis International Society 40 (ASAS40) Response

ASAS40 is defined as improvement from baseline of greater than or equal to (>=) 40 % and absolute improvement from baseline of at least 2 units (range of 0 to 10) in at least 3 of the following 4 domains without any worsening in the remaining domain. Patient Global: How active was your spondylitis on average during the last week? score ranges 0 (not active) to 10 (very active). Spinal Pain: How much Pain of your spine due to Ankylosing spondylitis? score ranges 0 (no pain) to 10 (severe pain). Bath Ankylosing Spondylitis Functional Index (BASFI): Participant asked to rate the difficulty associated with 10 individual basic functional activities. Participant response was captured using Numeric Rating Scale (NRS) (range 0 to 10) with a higher score indicating worse function. Inflammation based on Q5 & Q6 mean of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) (mean of intensity & duration of stiffness): Score ranges from "0" (none) and "10" (very severe).

Secondary Outcome Measures

Percentage of Participants Achieving an ASAS20 Response

ASAS20 response is defined as a ≥20% improvement and an absolute improvement from baseline of ≥1 units (range 0 to 10) in ≥3 of 4 domains, and no worsening of ≥20% and ≥1 unit (range 0 to 10) in the remaining domain. Patient Global: How active was your spondylitis on average during the last week? score ranges 0 (not active) to 10 (very active). Spinal Pain: How much Pain of your spine due to Ankylosing spondylitis? score ranges 0 (no pain) to 10 (severe pain). Bath Ankylosing Spondylitis Functional Index (BASFI): Participant asked to rate the difficulty associated with 10 individual basic functional activities. Participant response was captured using Numeric Rating Scale (NRS) (range 0 to 10) with a higher score indicating worse function. Inflammation based on Q5 & Q6 mean of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) (mean of intensity & duration of stiffness): Score ranges from "0" (none) and "10" (very severe).

Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)

ASDAS is a composite index to assess disease activity in AS. The parameters used for the ASDAS (with CRP as acute phase reactant) are Total back pain Patient global Peripheral pain/swelling Duration of morning stiffness and CRP in mg/L. The ASDAScrp is calculated with the following equation: 0.121×total back pain+0.110×patient global+0.073×peripheral pain/swelling+0.058×duration of morning stiffness+0.579×Ln(CRP+1). (CRP is in mg/liter, the range of other variables is from 0(normal) to 10(very severe); Ln represents the natural logarithm). Data from five variables combined to yield a score (0.6361 to no defined upper limit), where higher scores indicated higher disease activity. Least Square (LS) mean was determined by mixed-model repeated measures (MMRM) with treatment, geographic region, baseline CRP status, number of prior tumor necrosis factor inhibitor (TNFi), baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.

Percentage of Participants Achieving Bath Ankylosing Spondylitis Disease Activity Index 50 (BASDAI50) Response

The BASDAI is a participant-reported assessment consisting of 6 questions that relate to 5 major symptoms relevant to radiographic axial spondyloarthritis (rad-axSpA): 1) Fatigue, 2) Spinal pain, 3) Peripheral arthritis, 4) Enthesitis, 5) Intensity, and 6) Duration of morning stiffness. Participants need to score each item with a score from 0 to 10 (NRS). Total score is obtained from the average of symptom scores ranging 0 (no problem) to 10 (worst problem), with a higher score indicating more severe AS symptom. BASDAI50 represents an improvement of ≥50% of the BASDAI score from baseline.

Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)

The BASDAI is a participant-reported assessment consisting of 6 questions that relate to 5 major symptoms relevant to radiographic axial spondyloarthritis (rad-axSpA): 1) Fatigue, 2) Spinal pain, 3) Peripheral arthritis, 4) Enthesitis, 5) Intensity, and 6) Duration of morning stiffness. Participants need to score each item with a score from 0 to 10 (NRS). Total score is obtained from the average of symptom scores ranging 0 (no problem) to 10 (worst problem), with a higher score indicating more severe AS symptom. LSmean was determined by MMRM with factors for treatment, geographic region, baseline CRP status, number of prior TNFi, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.

Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI)

The BASFI is a participant-reported assessment that establishes a participant's functional baseline and subsequent response to treatment. The BASFI is composed with 10 questions to assess the disease severity, including the first 8 questions regarding to functional anatomy related activities and the remaining 2 questions related to daily activities of AS participants. Participants respond to each question using an NRS scale (range 0 to 10). The BASFI score is the average of the 10 responses and has a possible minimum value of 0 and a possible maximum value of 10, with a higher score indicating worse function. LS mean was determined by MMRM with factors for treatment, geographic region, baseline CRP status, number of prior TNFi, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.

Percentage of Participants Achieving ASDAS Inactive Disease

ASDAS is a composite index to assess disease activity in AS. ASDAS Inactive Disease is defined as a score of <1.3. The parameters used for the ASDAS (with CRP as acute phase reactant) are Total back pain Patient global Peripheral pain/swelling Duration of morning stiffness and CRP in mg/L. The ASDAScrp is calculated with the following equation: 0.121×total back pain+0.110×patient global+0.073×peripheral pain/swelling+0.058×duration of morning stiffness+0.579×Ln(CRP+1). (CRP is in mg/liter, the range of other variables is from 0(normal) to 10(very severe); Ln represents the natural logarithm). Data from five variables combined to yield a score (0.6361 to no defined upper limit), where higher the score worse the disease activity.

Percentage of Participants Achieving ASDAS <2.1

ASDAS is a composite index to assess disease activity in AS. ASDAS <2.1 defines moderate disease activity. The parameters used for the ASDAS (with CRP as acute phase reactant) are Total back pain Patient global Peripheral pain/swelling Duration of morning stiffness and CRP in mg/L. The ASDAScrp is calculated with the following equation: 0.121×total back pain+0.110×patient global+0.073×peripheral pain/swelling+0.058×duration of morning stiffness+0.579×Ln(CRP+1). (CRP is in mg/liter, the range of other variables is from 0(normal) to 10(very severe); Ln represents the natural logarithm). Data from five variables combined to yield a score (0.6361 to no defined upper limit), where higher the score worse the disease activity.

Change From Baseline in 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores

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 determined by MMRM with factors for treatment, geographic region, baseline CRP status, number of prior TNFi, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.

Change From Baseline in ASAS Health Index (ASAS HI)

The ASAS Health Index (ASAS HI) is a disease specific health-index instrument designed to assess the impact of interventions for SpA, including axSpA. The 17 item instrument has scores ranging from 0 (good Health) to 17 (poor Health). Each item consists of 1 question that the patient needs to respond to with either "I agree" (score 1) or "I do not agree (score 0)." A score of "1" is given where the item is affirmed, indicating adverse health. All item scores are summed to give a total score or index. LS mean was determined by MMRM with treatment, geographic region, baseline CRP status, number of prior TNFi, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.

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

The study used MRI with fat-saturating techniques such as short tau inversion recovery (STIR) to look for the presence of bone marrow edema. The Berlin modification of Ankylosing Spondylitis spine MRI score for activity (ASspiMRI) scoring technique assesses inflammation in each of the 23 disco-vertebral units (DVU) of the spine (from C2 to S1), capturing 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.LS mean was determined by analysis of covariance (ANCOVA) with treatment, geographic region, baseline CRP status, number of prior TNF inhibitors used and baseline value as fixed factors.

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

MRI score of spine was assessed using SPARCC method. All 23 disco-vertebral units (DVU) of the spine (from C2 to S1) were scored for bone marrow edema. A single DVU has 18 scoring units, and each has score of 0 or 1, bringing the maximum total score to 414, the sum ranges from 0 to 414 with higher scores reflecting worse disease. Scoring was performed by central readers. LS mean was determined by ANCOVA with factors for treatment, geographic region, baseline CRP status, number of prior TNF inhibitors used and baseline value.

Change From Baseline in the Measure of High Sensitivity C-Reactive Protein (CRP)

High sensitivity CRP is the measure of acute phase reactant. It was measured with a high sensitivity assay at the central laboratory to help assess the effect of ixekizumab on disease activity. High sensitivity CRP is a sensitive laboratory assay for serum levels of C-Reactive Protein, which is a biomarker of inflammation. LS mean was determined by MMRM with treatment, geographic region, baseline CRP status, number of prior TNFi, visit, and treatment-by-visit interaction as fixed factors.

Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI)

BASMI is a combined index comprising of 5 clinical measurements of spinal mobility in patients with radiographic axial spondyloarthritis (rad-axSpA). Lateral Spinal Flexion Tragus-to-wall distance Lumbar Flexion (modified Schober) Maximal intermalleolar distance and Cervical rotation. The BASMI linear result is the average of the 5 assessments and ranges from 0 to 10. The higher the BASMI score the more severe the patient's limitation of movement due to their AS. LS mean was determined by MMRM with treatment, geographic region, baseline CRP status, number of prior TNFi, baseline value, visit, baseline value-by-visit and treatment-by-visit interaction as fixed factors.

Change From Baseline in Chest Expansion

Chest expansion is the difference, in centimeter (cm), between the circumference of the chest in maximal inspiration and maximal expiration. While patients have their hands resting on or behind the head, the assessor will measure the chest encircled length by centimeter (cm) at the fourth intercostal level anteriorly. Two tries were recorded. The better measurement (larger difference) of 2 tries (in centimeters) was used for analyses. LS mean was determined by MMRM with treatment, geographic region, baseline CRP status, number of prior TNFi, baseline value, visit, baseline value-by-visit and treatment-by-visit interaction as fixed factors.

Change From Baseline in Occiput to Wall Distance

The participant is to make a maximum effort to touch the head against the wall when standing with heels and back against the wall (occiput). Then the distance from occiput to wall is measured. Two tries will be recorded. The better (smaller) measurement of 2 tries (in centimeters) will be used for analyses. LS mean was determined by MMRM with factors for treatment, geographic region, baseline CRP status, number of prior TNFi, baseline value, visit, baseline value-by-visit and treatment-by-visit interaction as fixed factors.

Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES)

The MASES is an index used to measure the severity of enthesitis. The MASES assesses 13 sites for enthesitis using a score of "0" for no activity or "1" for activity. Sites assessed include costochondral 1 (right/left), costochondral 7 (right/left), spinal iliaca anterior superior (right/left), crista iliaca (right/left), spina iliaca posterior (right/left), processus spinosus L5, and Achilles tendon proximal insertion (right/left). The MASES is the sum of all site scores (range 0 to 13); higher scores indicate more severe enthesitis. LS mean was determined by MMRM with treatment, geographic region, baseline CRP status, number of prior TNFi, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.

Change From Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Score

The SPARCC enthesitis is an index used to measure the severity of enthesitis. The SPARCC assesses 16 sites for enthesitis using a score of "0" for no activity or "1" for activity. Sites assessed include Medial epicondyle (left/right [L/R]), Lateral epicondyle (L/R), Supraspinatus insertion into greater tuberosity of humerus (L/R), Greater trochanter (L/R), Quadriceps insertion into superior border of patella (L/R), Patellar ligament insertion into inferior pole of patella or tibial tubercle (L/R), Achilles tendon insertion into calcaneum (L/R), and Plantar fascia insertion into calcaneum (L/R). The SPARCC is the sum of all site scores (range 0 to 16). Higher scores indicate more severe enthesitis. LS mean was determined by MMRM with treatment, geographic region, baseline CRP status, number of prior TNFi, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.

Change From Baseline in Severity of Peripheral Arthritis by Tender Joint Count (TJC) Scores

The number of tender and painful joints was determined by examination of 46 joints (23 joints on each side of the body). The 46 joints were assessed and classified as tender or not tender. Sum of all joints checked to be tender/painful divided by number of evaluable joints which was multiplied by 46 to obtain TJC score. The scores ranges from 0 (no tender/painful joints) to 46 (all joints tender/painful). LS mean was determined by MMRM with treatment, geographic region, baseline CRP status, number of prior TNFi, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction.

Change From Baseline in Severity of Peripheral Arthritis by Swollen Joint Count (SJC) Scores

The number of swollen joints was determined by examination of 44 joints (22 joints on each side of the body). The 44 joints were assessed and classified as swollen or not swollen. Sum of all joints checked to be swollen divided by number of evaluable joints which was multiplied by 44 to obtain SJC score. The SJC score ranges from 0 (no swollen joints) to 44 (all joints swollen). LS mean was determined by MMRM with treatment, geographic region, baseline CRP status, number of prior TNFi, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction.

Percentage of Participants With Anterior Uveitis

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.

Change From Baseline in the Fatigue Numeric Rating Scale (NRS) Score

The fatigue severity NRS is a participant administered single-item 11-point horizontal scale anchored at 0 and 10, with 0 representing "no fatigue" and 10 representing "as bad as you can imagine". Participants rate their fatigue (feeling tired or worn out) by circling the 1 number that describes their worst level of fatigue during the previous 24 hours. LS mean was determined by MMRM with treatment, geographic region, baseline CRP status, number of prior TNFi, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.

Change From Baseline in the Jenkins Sleep Evaluation Questionnaire (JSEQ)

The Jenkins Sleep Evaluation Questionnaire (JSEQ) is a 4 item scale designed to estimate sleep problems in clinical research. The JSEQ assesses the frequency of sleep disturbance in 4 categories: 1) trouble falling asleep, 2) waking up several times during the night, 3) having trouble staying asleep (including waking up far too early), and 4) waking up after the usual amount of sleep feeling tired and worn out. Patients report the numbers of days they experience each of these problems in the past month on a 6 point Likert Scale ranging from 0 = "no days" to 5 = "22-30 days. The total JSEQ score ranges from 0 to 20, with higher scores indicating greater sleep disturbance. LS mean was determined by MMRM with treatment, geographic region, baseline CRP status, number of prior TNFi, baseline value, visit, baseline value-by-visit and treatment-by-visit interaction as fixed factors.

Change From Baseline in the Work Productivity Activity Impairment Spondyloarthritis (WPAI-SpA) Scores

The WPAI-SpA consists of 6 questions to determine employment status, hours missed from work because of SpA, hours missed from work for other reasons, hours actually worked, the degree to which SpA affected work productivity while at work, and the degree to which SpA affected activities outside of work. The WPAI-SpA has been validated in the rad-axSpA 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, with higher scores indicating greater impairment and less productivity. LS mean was determined by ANCOVA with treatment, geographic region, baseline CRP status, number of prior TNFi and baseline value as fixed factors.

Change From Baseline in ASAS-Nonsteroidal Anti-Inflammatory Drug (NSAID) Score

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). For NSAID equivalent scoring system, range is from 0 to 100, higher the score greated the NSAID intake. ASAS-NSAID score= (equivalent NSAID score) x (days of intake during PI) x (days per week)/(PI in days).

Percentage of Participants With Anti-Ixekizumab Antibodies

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. Percentage was calculated based on the number of evaluable participants and was calculated by number of participants with treatment-emergent positive anti-ixekizumab antibodies / number of evaluable participants * 100%.

Pharmacokinetics (PK): Trough Ixekizumab Concentration at Steady State (Ctrough ss)

Pharmacokinetics (PK): Steady-state trough serum concentration of Ixekizumab at week 16.

Full Information

NCT ID

NCT02696798

First Posted

February 26, 2016

Last Updated

June 10, 2020

Sponsor

Eli Lilly and Company

1. Study Identification

Unique Protocol Identification Number

NCT02696798

Brief Title

A Study of Ixekizumab (LY2439821) in TNF Inhibitor Experienced Participants With Radiographic Axial Spondyloarthritis

Acronym

COAST-W

Official Title

A Multicenter, Randomized, Double-Blind, Placebo- Controlled 16-Week Study Followed by Long-Term Evaluation of Efficacy and Safety of Ixekizumab (LY2439821) in TNFi-Experienced Patients With Radiographic Axial Spondyloarthritis

Study Type

Interventional

2. Study Status

Record Verification Date

June 2020

Overall Recruitment Status

Completed

Study Start Date

April 12, 2016 (Actual)

Primary Completion Date

May 18, 2018 (Actual)

Study Completion Date

May 3, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Eli Lilly and Company

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The main purpose of this study is to evaluate the efficacy and safety of ixekizumab in tumor necrosis factor (TNF) inhibitor-experienced participants with radiographic axial spondyloarthritis (rad-axSpA).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Spondyloarthritis

Keywords

Ankylosing Spondylitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

316 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Q2W Ixekizumab

Arm Type

Experimental

Arm Description

Arm Title

Q4W Ixekizumab

Arm Type

Experimental

Arm Description

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Ixekizumab

Other Intervention Name(s)

LY2439821

Intervention Description

Administered SC

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Administered SC

Primary Outcome Measure Information:

Title

Percentage of Participants Achieving an Assessment of Spondyloarthritis International Society 40 (ASAS40) Response

Description

Time Frame

Week 16

Secondary Outcome Measure Information:

Title

Percentage of Participants Achieving an ASAS20 Response

Description

Time Frame

Week 16

Title

Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)

Description

Time Frame

Baseline, Week 16

Title

Percentage of Participants Achieving Bath Ankylosing Spondylitis Disease Activity Index 50 (BASDAI50) Response

Description

Time Frame

Week 16

Title

Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)

Description

The BASDAI is a participant-reported assessment consisting of 6 questions that relate to 5 major symptoms relevant to radiographic axial spondyloarthritis (rad-axSpA): 1) Fatigue, 2) Spinal pain, 3) Peripheral arthritis, 4) Enthesitis, 5) Intensity, and 6) Duration of morning stiffness. Participants need to score each item with a score from 0 to 10 (NRS). Total score is obtained from the average of symptom scores ranging 0 (no problem) to 10 (worst problem), with a higher score indicating more severe AS symptom. LSmean was determined by MMRM with factors for treatment, geographic region, baseline CRP status, number of prior TNFi, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.

Time Frame

Baseline, Week 16

Title

Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI)

Description

Time Frame

Baseline, Week 16

Title

Percentage of Participants Achieving ASDAS Inactive Disease

Description

Time Frame

Week 16

Title

Percentage of Participants Achieving ASDAS <2.1

Description

Time Frame

Week 16

Title

Change From Baseline in 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores

Description

Time Frame

Baseline, Week 16

Title

Change From Baseline in ASAS Health Index (ASAS HI)

Description

Time Frame

Baseline, Week 16

Title

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

Description

Time Frame

Baseline, Week 16

Title

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

Description

Time Frame

Baseline, Week 16

Title

Change From Baseline in the Measure of High Sensitivity C-Reactive Protein (CRP)

Description

Time Frame

Baseline, Week 16

Title

Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI)

Description

Time Frame

Baseline, Week 16

Title

Change From Baseline in Chest Expansion

Description

Time Frame

Baseline, Week 16

Title

Change From Baseline in Occiput to Wall Distance

Description

Time Frame

Baseline, Week 16

Title

Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES)

Description

Time Frame

Baseline, Week 16

Title

Change From Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Score

Description

Time Frame

Baseline, Week 16

Title

Change From Baseline in Severity of Peripheral Arthritis by Tender Joint Count (TJC) Scores

Description

Time Frame

Baseline, Week 16

Title

Change From Baseline in Severity of Peripheral Arthritis by Swollen Joint Count (SJC) Scores

Description

Time Frame

Baseline, Week 16

Title

Percentage of Participants With Anterior Uveitis

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

Week 16

Title

Change From Baseline in the Fatigue Numeric Rating Scale (NRS) Score

Description

Time Frame

Baseline, Week 16

Title

Change From Baseline in the Jenkins Sleep Evaluation Questionnaire (JSEQ)

Description

Time Frame

Baseline, Week 16

Title

Change From Baseline in the Work Productivity Activity Impairment Spondyloarthritis (WPAI-SpA) Scores

Description

Time Frame

Baseline, Week 16

Title

Change From Baseline in ASAS-Nonsteroidal Anti-Inflammatory Drug (NSAID) Score

Description

Time Frame

Baseline, Week 52

Title

Percentage of Participants With Anti-Ixekizumab Antibodies

Description

Time Frame

Week 16

Title

Pharmacokinetics (PK): Trough Ixekizumab Concentration at Steady State (Ctrough ss)

Description

Pharmacokinetics (PK): Steady-state trough serum concentration of Ixekizumab at week 16.

Time Frame

Week 16

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Are ambulatory. Have an established 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. Have had prior treatment with at least 1 and not more than 2 TNF inhibitors. Must have had an inadequate response to 2 or more NSAIDs at the therapeutic dose range for a total duration of at least 4 weeks OR have a history of intolerance to NSAIDs. 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 never taken a TNF inhibitor medication or have taken more than 2. 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

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)

Organizational Affiliation

Eli Lilly and Company

Official's Role

Study Director

Facility Information:

Facility Name

Arizona Arthritis Research, PLC

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85032

Country

United States

Facility Name

Rheumatology Center of San Diego

City

Escondido

State/Province

California

ZIP/Postal Code

92025

Country

United States

Facility Name

Care Access Research - Huntington Beach

City

Huntington Beach

State/Province

California

ZIP/Postal Code

92648

Country

United States

Facility Name

Desert Medical Advances

City

Palm Desert

State/Province

California

ZIP/Postal Code

92260

Country

United States

Facility Name

Arthritis Assoc. & Osteoporosis Ctr of Colorado Springs, LLC

City

Colorado Springs

State/Province

Colorado

ZIP/Postal Code

80920

Country

United States

Facility Name

Denver Arthritis Center

City

Denver

State/Province

Colorado

ZIP/Postal Code

80230

Country

United States

Facility Name

Clinical Research Center of CT/NY

City

Danbury

State/Province

Connecticut

ZIP/Postal Code

06810

Country

United States

Facility Name

Arthritis Rheumatic Disease Specialties

City

Aventura

State/Province

Florida

ZIP/Postal Code

33180

Country

United States

Facility Name

Sarasota Arthritis Center

City

Sarasota

State/Province

Florida

ZIP/Postal Code

34239

Country

United States

Facility Name

Marietta Rheumatology

City

Marietta

State/Province

Georgia

ZIP/Postal Code

30060

Country

United States

Facility Name

St Luke's Clinic - Intermountain Orthopaedics

City

Boise

State/Province

Idaho

ZIP/Postal Code

83702

Country

United States

Facility Name

Institute of Arthritis Research

City

Idaho Falls

State/Province

Idaho

ZIP/Postal Code

83404

Country

United States

Facility Name

Center for Arthritis & Osteoporosis

City

Elizabethtown

State/Province

Kentucky

ZIP/Postal Code

42701

Country

United States

Facility Name

Klein and Associates MD, PA

City

Cumberland

State/Province

Maryland

ZIP/Postal Code

21502

Country

United States

Facility Name

Osteoporosis And Clinical Trial Center

City

Hagerstown

State/Province

Maryland

ZIP/Postal Code

21740

Country

United States

Facility Name

Arthritis Consultants

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63141

Country

United States

Facility Name

The Center for Rheumatology

City

Albany

State/Province

New York

ZIP/Postal Code

12203

Country

United States

Facility Name

Shanahan Rheumatology & Immunotherapy

City

Raleigh

State/Province

North Carolina

ZIP/Postal Code

27617

Country

United States

Facility Name

Oregon Health and Science University

City

Portland

State/Province

Oregon

ZIP/Postal Code

97239

Country

United States

Facility Name

Altoona Center for Clinical Research

City

Duncansville

State/Province

Pennsylvania

ZIP/Postal Code

16635

Country

United States

Facility Name

Articularis Healthcare Group, INC dba Columbia Arthritis Ctr

City

Columbia

State/Province

South Carolina

ZIP/Postal Code

29204

Country

United States

Facility Name

Low Country Research Center

City

North Charleston

State/Province

South Carolina

ZIP/Postal Code

29406

Country

United States

Facility Name

Univ of Texas Health Science Center - Houston

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

Southwest Rheumatology, P.A.

City

Mesquite

State/Province

Texas

ZIP/Postal Code

75150

Country

United States

Facility Name

Center for Arthritis and Rheumatic Diseases, PC

City

Chesapeake

State/Province

Virginia

ZIP/Postal Code

23320

Country

United States

Facility Name

Arthritis Northwest Rheumatology

City

Spokane

State/Province

Washington

ZIP/Postal Code

99204

Country

United States

Facility Name

Rheumatology and Immunotherapy Center

City

Franklin

State/Province

Wisconsin

ZIP/Postal Code

53132

Country

United States

Facility Name

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.

City

Rosario

ZIP/Postal Code

S2000CFJ

Country

Argentina

Facility Name

City

Rosario

ZIP/Postal Code

S2000DEJ

Country

Argentina

Facility Name

City

San Miguel de Tucuman

ZIP/Postal Code

T4000AXL

Country

Argentina

Facility Name

City

San Miguel de Tucuman

ZIP/Postal Code

T4000BRD

Country

Argentina

Facility Name

City

Curitiba

ZIP/Postal Code

80440-080

Country

Brazil

Facility Name

City

Goiás

ZIP/Postal Code

74043-110

Country

Brazil

Facility Name

City

Juiz de Fora

ZIP/Postal Code

36010-570

Country

Brazil

Facility Name

City

Porto Alegre

ZIP/Postal Code

90480-000

Country

Brazil

Facility Name

City

Sao Paulo

ZIP/Postal Code

01244-030

Country

Brazil

Facility Name

For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.

City

St. John's

ZIP/Postal Code

A1C 5B8

Country

Canada

Facility Name

City

Trois-Rivieres

ZIP/Postal Code

G8Z 1Y2

Country

Canada

Facility Name

City

Victoria

ZIP/Postal Code

V8V 3M9

Country

Canada

Facility Name

City

Helsinki

ZIP/Postal Code

00029

Country

Finland

Facility Name

City

Hyvinkaa

ZIP/Postal Code

05800

Country

Finland

Facility Name

City

Oulu

ZIP/Postal Code

90029

Country

Finland

Facility Name

City

Clermont

ZIP/Postal Code

63003

Country

France

Facility Name

City

Le Kremlin Bicetre

ZIP/Postal Code

94270

Country

France

Facility Name

City

Montpellier

ZIP/Postal Code

34295

Country

France

Facility Name

City

Orleans

ZIP/Postal Code

45100

Country

France

Facility Name

City

Paris CEDEX 14

ZIP/Postal Code

75679

Country

France

Facility Name

City

Tours

ZIP/Postal Code

37044

Country

France

Facility Name

City

Berlin

ZIP/Postal Code

10117

Country

Germany

Facility Name

City

Ashkelon

ZIP/Postal Code

7830604

Country

Israel

Facility Name

City

Haifa

ZIP/Postal Code

3525408

Country

Israel

Facility Name

City

Petach Tikva

ZIP/Postal Code

4941492

Country

Israel

Facility Name

City

Tel Aviv

ZIP/Postal Code

6423906

Country

Israel

Facility Name

City

Milano

ZIP/Postal Code

20157

Country

Italy

Facility Name

City

Reggio Emilia

ZIP/Postal Code

42123

Country

Italy

Facility Name

City

Roma

ZIP/Postal Code

00168

Country

Italy

Facility Name

City

Siena

ZIP/Postal Code

53100

Country

Italy

Facility Name

City

Hyogo

ZIP/Postal Code

663-8501

Country

Japan

Facility Name

City

Yamagata

ZIP/Postal Code

990-9585

Country

Japan

Facility Name

City

Daejeon

ZIP/Postal Code

35015

Country

Korea, Republic of

Facility Name

City

Seoul

ZIP/Postal Code

02447

Country

Korea, Republic of

Facility Name

City

Seoul

ZIP/Postal Code

03080

Country

Korea, Republic of

Facility Name

City

Seoul

ZIP/Postal Code

04763

Country

Korea, Republic of

Facility Name

City

Seoul

ZIP/Postal Code

05030

Country

Korea, Republic of

Facility Name

City

Seoul

ZIP/Postal Code

05278

Country

Korea, Republic of

Facility Name

City

Seoul

ZIP/Postal Code

05505

Country

Korea, Republic of

Facility Name

City

Seoul

ZIP/Postal Code

06273

Country

Korea, Republic of

Facility Name

City

Seoul

ZIP/Postal Code

06591

Country

Korea, Republic of

Facility Name

City

Seoul

ZIP/Postal Code

07061

Country

Korea, Republic of

Facility Name

City

Chihuahua

ZIP/Postal Code

31000

Country

Mexico

Facility Name

City

Guadalajara

ZIP/Postal Code

44650

Country

Mexico

Facility Name

City

Merida

ZIP/Postal Code

97070

Country

Mexico

Facility Name

City

Mexicali

ZIP/Postal Code

21200

Country

Mexico

Facility Name

City

Monterrey

ZIP/Postal Code

64020

Country

Mexico

Facility Name

City

San Luis Potosi

ZIP/Postal Code

78213

Country

Mexico

Facility Name

City

Amsterdam

ZIP/Postal Code

1105 AZ

Country

Netherlands

Facility Name

City

Sneek

ZIP/Postal Code

8601 ZK

Country

Netherlands

Facility Name

City

Bydgoszcz

ZIP/Postal Code

85-168

Country

Poland

Facility Name

City

Elblag

ZIP/Postal Code

82-300

Country

Poland

Facility Name

City

Lodz

ZIP/Postal Code

90-558

Country

Poland

Facility Name

City

Poznan

ZIP/Postal Code

61-397

Country

Poland

Facility Name

City

Swidnik

ZIP/Postal Code

21-040

Country

Poland

Facility Name

City

Warsaw

ZIP/Postal Code

01-518

Country

Poland

Facility Name

City

Warszawa

ZIP/Postal Code

02-691

Country

Poland

Facility Name

Office: Perez-De Jesus, Amarilis

City

Caguas

ZIP/Postal Code

00725

Country

Puerto Rico

Facility Name

GCM Medical Group PSC

City

San Juan

ZIP/Postal Code

00909

Country

Puerto Rico

Facility Name

Mindful Medical Research

City

San Juan

ZIP/Postal Code

00918

Country

Puerto Rico

Facility Name

City

Santurce

ZIP/Postal Code

00909

Country

Puerto Rico

Facility Name

City

Cordoba

ZIP/Postal Code

14004

Country

Spain

Facility Name

City

Elche

ZIP/Postal Code

03202

Country

Spain

Facility Name

City

Madrid

ZIP/Postal Code

28007

Country

Spain

Facility Name

City

Sabadell

ZIP/Postal Code

08208

Country

Spain

Facility Name

City

Sevilla

ZIP/Postal Code

41010

Country

Spain

Facility Name

City

Basingstoke

ZIP/Postal Code

RG24 9NA

Country

United Kingdom

Facility Name

City

Norwich

ZIP/Postal Code

NR4 7UY

Country

United Kingdom

Facility Name

City

Solihull

ZIP/Postal Code

B91 3JL

Country

United Kingdom

Facility Name

City

Stoke on Trent

ZIP/Postal Code

ST6 7AG

Country

United Kingdom

Facility Name

City

Wolverhampton

ZIP/Postal Code

WV10 0QP

Country

United Kingdom

Facility Name

City

Wythenshawe

ZIP/Postal Code

M23 9LT

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

IPD Sharing Time Frame

Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.

IPD Sharing Access Criteria

A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

IPD Sharing URL

https://vivli.org/

Citations:

PubMed Identifier

35429281

Citation

van der Horst-Bruinsma IE, de Vlam K, Walsh JA, Bolce R, Hunter T, Sandoval D, Zhu D, Geneus V, Soriano ER, Magrey M. Baseline Characteristics and Treatment Response to Ixekizumab Categorised by Sex in Radiographic and Non-radiographic Axial Spondylarthritis Through 52 Weeks: Data from Three Phase III Randomised Controlled Trials. Adv Ther. 2022 Jun;39(6):2806-2819. doi: 10.1007/s12325-022-02132-2. Epub 2022 Apr 16.

Results Reference

derived

PubMed Identifier

35188180

Citation

Maksymowych WP, Bolce R, Gallo G, Seem E, Geneus VJ, Sandoval DM, Ostergaard M, Tada K, Baraliakos X, Deodhar A, Gensler LS. Ixekizumab in radiographic axial spondyloarthritis with and without elevated C-reactive protein or positive magnetic resonance imaging. Rheumatology (Oxford). 2022 Nov 2;61(11):4324-4334. doi: 10.1093/rheumatology/keac104.

Results Reference

derived

PubMed Identifier

34853086

Citation

van der Heijde D, Ostergaard M, Reveille JD, Baraliakos X, Kronbergs A, Sandoval DM, Li X, Carlier H, Adams DH, Maksymowych WP. Spinal Radiographic Progression and Predictors of Progression in Patients With Radiographic Axial Spondyloarthritis Receiving Ixekizumab Over 2 Years. J Rheumatol. 2022 Mar;49(3):265-273. doi: 10.3899/jrheum.210471. Epub 2021 Dec 1.

Results Reference

derived

PubMed Identifier

34538257

Citation

Deodhar AA, Mease PJ, Rahman P, Navarro-Compan V, Strand V, Hunter T, Bolce R, Leon L, Lauzon S, Marzo-Ortega H. Ixekizumab improves spinal pain, function, fatigue, stiffness, and sleep in radiographic axial Spondyloarthritis: COAST-V/W 52-week results. BMC Rheumatol. 2021 Sep 20;5(1):35. doi: 10.1186/s41927-021-00205-3.

Results Reference

derived

PubMed Identifier

31685553

Citation

Dougados M, Wei JC, Landewe R, Sieper J, Baraliakos X, Van den Bosch F, Maksymowych WP, Ermann J, Walsh JA, Tomita T, Deodhar A, van der Heijde D, Li X, Zhao F, Bertram CC, Gallo G, Carlier H, Gensler LS; COAST-V and COAST-W Study Groups. Efficacy and safety of ixekizumab through 52 weeks in two phase 3, randomised, controlled clinical trials in patients with active radiographic axial spondyloarthritis (COAST-V and COAST-W). Ann Rheum Dis. 2020 Feb;79(2):176-185. doi: 10.1136/annrheumdis-2019-216118. Epub 2019 Nov 4. Erratum In: Ann Rheum Dis. 2020 Jun;79(6):e75.

Results Reference

derived

PubMed Identifier

31254223

Citation

Mease P, Walsh JA, Baraliakos X, Inman R, de Vlam K, Wei JC, Hunter T, Gallo G, Sandoval D, Zhao F, Dong Y, Bolce R, Marzo-Ortega H. Translating Improvements with Ixekizumab in Clinical Trial Outcomes into Clinical Practice: ASAS40, Pain, Fatigue, and Sleep in Ankylosing Spondylitis. Rheumatol Ther. 2019 Sep;6(3):435-450. doi: 10.1007/s40744-019-0165-3. Epub 2019 Jun 28.

Results Reference

derived

PubMed Identifier

30343531

Citation

Deodhar A, Poddubnyy D, Pacheco-Tena C, Salvarani C, Lespessailles E, Rahman P, Jarvinen P, Sanchez-Burson J, Gaffney K, Lee EB, Krishnan E, Santisteban S, Li X, Zhao F, Carlier H, Reveille JD; COAST-W Study Group. Efficacy and Safety of Ixekizumab in the Treatment of Radiographic Axial Spondyloarthritis: Sixteen-Week Results From a Phase III Randomized, Double-Blind, Placebo-Controlled Trial in Patients With Prior Inadequate Response to or Intolerance of Tumor Necrosis Factor Inhibitors. Arthritis Rheumatol. 2019 Apr;71(4):599-611. doi: 10.1002/art.40753. Epub 2019 Mar 8.

Results Reference

derived

Learn more about this trial

A Study of Ixekizumab (LY2439821) in TNF Inhibitor Experienced Participants With Radiographic Axial Spondyloarthritis

We'll reach out to this number within 24 hrs