A Long Term Extension Study of Ixekizumab (LY2439821) in Participants With Axial Spondyloarthritis



Status:Recruiting
Conditions:Arthritis, Arthritis, Orthopedic
Therapuetic Areas:Rheumatology, Orthopedics / Podiatry
Healthy:No
Age Range:18 - Any
Updated:4/5/2019
Start Date:May 9, 2017
End Date:March 1, 2021
Contact:There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
Email:ClinicalTrials.gov@lilly.com
Phone:1-317-615-4559

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A Multicenter, Long-Term Extension Study of 104 Weeks, Including a Double-Blind, Placebo-Controlled 40-Week Randomized Withdrawal-Retreatment Period, to Evaluate the Maintenance of Treatment Effect of Ixekizumab (LY2439821) in Patients With Axial Spondyloarthritis

The purpose of this study is to evaluate, in participants having achieved a state of
sustained remission, if the ixekizumab treatment groups are superior to the placebo group in
maintaining response during the randomized withdrawal-retreatment period in participants with
axial spondyloarthritis.


Inclusion Criteria:

- Have completed the final study visit in Study RHBV (NCT02696785), RHBW (NCT02696798),
or RHBX (NCT02757352).

(Note: Participants from Study RHBX are not eligible if they permanently discontinued
ixekizumab and were receiving a tumor necrosis factor [TNF] inhibitor).

- Must agree to use a reliable method of birth control.

Exclusion Criteria:

- Have significant uncontrolled disorders or abnormal laboratory values that, in the
opinion of the investigator, pose an unacceptable risk to the participant if
investigational product continues to be administered.

- Have a known hypersensitivity to ixekizumab or any component of this investigational
product.

- Had investigational product permanently discontinued during a previous ixekizumab
study.

- Had temporary investigational product interruption at any time during or at the final
study visit of a previous ixekizumab study and, in the opinion of the investigator,
restarting ixekizumab poses an unacceptable risk for the participant's participation
in the study.

- Have any other condition that, in the opinion of the investigator, renders the
participant unable to understand the nature, scope, and possible consequences of the
study or precludes the participant from following and completing the protocol.

- Are currently enrolled in any other clinical trial involving an investigational
product or any other type of medical research judged not to be scientifically or
medically compatible with this study.
We found this trial at
24
sites
7000 Fannin St
Houston, Texas 77030
(713) 500-4472
Principal Investigator: John Reveille
Phone: 713-500-6900
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 A Deodhar
Phone: 503-494-5571
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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Aventura, Florida 33180
Principal Investigator: Norman B Gaylis
Phone: 305-932-4162
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Ciudad de Buenos Aires, Buenos Aires
Principal Investigator: Federico Javier Ariel
Phone: 541145445522
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Colorado Springs, Colorado 80920
Principal Investigator: Michael E 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 J Klein
Phone: 301-724-4337
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Danbury, Connecticut 06810
Principal Investigator: Richard Roseff
Phone: 203-616-2710
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Duncansville, Pennsylvania 16635
Principal Investigator: Alan J. Kivitz
Phone: 814-693-0300
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Elizabethtown, Kentucky 42701
Principal Investigator: Daksha Mehta
Phone: 270-769-2535
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Hagerstown, Maryland 21740
Principal Investigator: Mary P Howell
Phone: 301-791-6680
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19582 Beach Boulevard
Huntington Beach, California 92648
Principal Investigator: Christine Thai
Phone: 714-378-2440
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Idaho Falls, Idaho 83404
Principal Investigator: Craig D. Scoville
Phone: 208-542-9080
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Kalispell, Montana 59901
Principal Investigator: Roger Diegel
Phone: 406-755-1460
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Lincoln, Nebraska 68512
Principal Investigator: Melvin A Churchill
Phone: 402-420-1212
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Marietta, Georgia 30060
Principal Investigator: Roel N. Querubin
Phone: 770-590-8328
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Palm Desert, California 92260
Principal Investigator: Maria Greenwald
Phone: 760-341-6800
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Phoenix, Arizona 85037
Principal Investigator: Eric A Peters
Phone: 480-626-6653
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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: Yoel Drucker
Phone: 941-485-8314
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Spokane, Washington 99204
Principal Investigator: Eric C Mueller
Phone: 509-838-6500
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Summerville, South Carolina 29486
Principal Investigator: Clarence Legerton
Phone: 843-572-1818
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Wilmington, North Carolina 28401
Principal Investigator: Mark D Harris
Phone: 910-762-1182
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