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



Status:Active, not recruiting
Conditions:Arthritis, Arthritis, Neurology, Orthopedic
Therapuetic Areas:Neurology, Rheumatology, Orthopedics / Podiatry
Healthy:No
Age Range:18 - Any
Updated:2/17/2019
Start Date:April 12, 2016
End Date:July 15, 2019

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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

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).


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.
We found this trial at
28
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7000 Fannin St
Houston, Texas 77030
(713) 500-4472
Principal Investigator: John Reveille
Phone: 713-486-2550
University of Texas Health Science Center at Houston The University of Texas Health Science Center...
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Principal Investigator: Atulya Deodhar
Phone: 503-494-5571
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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Albany, New York 12206
Principal Investigator: Joel Kremer
Phone: 518-489-4471
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Aventura, Florida 33180
Principal Investigator: Norman Gaylis
Phone: 305-652-6676
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Boise, Idaho 83702
Principal Investigator: James Loveless
Phone: 208-489-4326
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Chesapeake, Virginia 23320
Principal Investigator: Roger Lidman
Phone: 757-461-3400
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Colorado Springs, Colorado 80920
Principal Investigator: MichaeL Sayers
Phone: 719-475-9616
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Columbia, South Carolina 29204
Principal Investigator: Kathleen Flint
Phone: 803-779-0911
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Cumberland, Maryland 21502
Principal Investigator: Steven Klein
Phone: 301-724-4337
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Danbury, Connecticut 06810
Principal Investigator: Richard Roseff
Phone: 203-797-1500
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Denver, Colorado 80230
Principal Investigator: Ryan Antolini
Phone: 303-394-2828
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Duncansville, Pennsylvania 16635
Principal Investigator: Alan Kivitz
Phone: 814-693-0300
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Elizabethtown, Kentucky 42701
Principal Investigator: Daksha Mehta
Phone: 270-769-2535
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215 South Hickory Street
Escondido, California 92025
Principal Investigator: Tania Rivera
Phone: 858-336-2810
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Franklin, Wisconsin 53132
Principal Investigator: Alvin Wells
Phone: 414-435-0025
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Hagerstown, Maryland 21740
Principal Investigator: Mary Howell
Phone: 301-791-6680
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19582 Beach Boulevard
Huntington Beach, California 92648
Principal Investigator: Christine Thai
Phone: 949-385-0469
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Idaho Falls, Idaho 83404
Principal Investigator: Craig Scoville
Phone: 208-542-9080
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Marietta, Georgia 30060
Principal Investigator: Roel Querubin
Phone: 678-984-9495
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Mesquite, Texas 75150
Principal Investigator: Atul Singhal
Phone: 972-299-2600
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North Charleston, South Carolina 29406
Principal Investigator: Clarence Legerton
Phone: 843-572-1818
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Palm Desert, California 92260
Principal Investigator: Maria Greenwald
Phone: 760-341-6800
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Phoenix, Arizona 85032
Principal Investigator: Eric Peters
Phone: 480-626-6656
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Raleigh, North Carolina 27617
Principal Investigator: Joseph Shanahan
Phone: 919-405-2040
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Saint Louis, Missouri 63141
Principal Investigator: Akgun Ince
Phone: 314-567-5100
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Sarasota, Florida 34239
Principal Investigator: Jeffrey Kaine
Phone: 941-485-8314
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Spokane, Washington 99204
Principal Investigator: Eric Mueller
Phone: 509-838-6500
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