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 |
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.
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
Cumberland, Maryland 21502
Principal Investigator: Steven J Klein
Phone: 301-724-4337
Click here to add this to my saved trials
7000 Fannin St
Houston, Texas 77030
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...
Click here to add this to my saved trials
3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
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...
Click here to add this to my saved trials
Aventura, Florida 33180
Principal Investigator: Norman B Gaylis
Phone: 305-932-4162
Click here to add this to my saved trials
Ciudad de Buenos Aires, Buenos Aires
Principal Investigator: Federico Javier Ariel
Phone: 541145445522
Click here to add this to my saved trials
Colorado Springs, Colorado 80920
Principal Investigator: Michael E Sayers
Phone: 719-475-9616
Click here to add this to my saved trials
Columbia, South Carolina 29204
Principal Investigator: Kathleen Flint
Phone: 803-779-0911
Click here to add this to my saved trials
Danbury, Connecticut 06810
Principal Investigator: Richard Roseff
Phone: 203-616-2710
Click here to add this to my saved trials
Duncansville, Pennsylvania 16635
Principal Investigator: Alan J. Kivitz
Phone: 814-693-0300
Click here to add this to my saved trials
Elizabethtown, Kentucky 42701
Principal Investigator: Daksha Mehta
Phone: 270-769-2535
Click here to add this to my saved trials
Hagerstown, Maryland 21740
Principal Investigator: Mary P Howell
Phone: 301-791-6680
Click here to add this to my saved trials
19582 Beach Boulevard
Huntington Beach, California 92648
Huntington Beach, California 92648
Principal Investigator: Christine Thai
Phone: 714-378-2440
Click here to add this to my saved trials
Idaho Falls, Idaho 83404
Principal Investigator: Craig D. Scoville
Phone: 208-542-9080
Click here to add this to my saved trials
Kalispell, Montana 59901
Principal Investigator: Roger Diegel
Phone: 406-755-1460
Click here to add this to my saved trials
Lincoln, Nebraska 68512
Principal Investigator: Melvin A Churchill
Phone: 402-420-1212
Click here to add this to my saved trials
Marietta, Georgia 30060
Principal Investigator: Roel N. Querubin
Phone: 770-590-8328
Click here to add this to my saved trials
Palm Desert, California 92260
Principal Investigator: Maria Greenwald
Phone: 760-341-6800
Click here to add this to my saved trials
Phoenix, Arizona 85037
Principal Investigator: Eric A Peters
Phone: 480-626-6653
Click here to add this to my saved trials
Raleigh, North Carolina 27617
Principal Investigator: Joseph Shanahan
Phone: 919-405-2040
Click here to add this to my saved trials
Saint Louis, Missouri 63141
Principal Investigator: Akgun Ince
Phone: 314-567-5100
Click here to add this to my saved trials
Sarasota, Florida 34239
Principal Investigator: Yoel Drucker
Phone: 941-485-8314
Click here to add this to my saved trials
Spokane, Washington 99204
Principal Investigator: Eric C Mueller
Phone: 509-838-6500
Click here to add this to my saved trials
Summerville, South Carolina 29486
Principal Investigator: Clarence Legerton
Phone: 843-572-1818
Click here to add this to my saved trials
Wilmington, North Carolina 28401
Principal Investigator: Mark D Harris
Phone: 910-762-1182
Click here to add this to my saved trials