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

Use our guide to learn which trials are right for you!

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
sites
Columbia, South Carolina 29204
Principal Investigator: Kathleen Flint
Phone: 803-779-0911
973
mi
from
Columbia, SC
Click here to add this to my saved trials
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...
563
mi
from
Houston, TX
Click here to add this to my saved trials
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...
1383
mi
from
Portland, OR
Click here to add this to my saved trials
Albany, New York 12206
Principal Investigator: Joel Kremer
Phone: 518-489-4471
1308
mi
from
Albany, NY
Click here to add this to my saved trials
Aventura, Florida 33180
Principal Investigator: Norman Gaylis
Phone: 305-652-6676
1314
mi
from
Aventura, FL
Click here to add this to my saved trials
Boise, Idaho 83702
Principal Investigator: James Loveless
Phone: 208-489-4326
1041
mi
from
Boise, ID
Click here to add this to my saved trials
Chesapeake, Virginia 23320
Principal Investigator: Roger Lidman
Phone: 757-461-3400
1186
mi
from
Chesapeake, VA
Click here to add this to my saved trials
Colorado Springs, Colorado 80920
Principal Investigator: MichaeL Sayers
Phone: 719-475-9616
386
mi
from
Colorado Springs, CO
Click here to add this to my saved trials
Cumberland, Maryland 21502
Principal Investigator: Steven Klein
Phone: 301-724-4337
1033
mi
from
Cumberland, MD
Click here to add this to my saved trials
Danbury, Connecticut 06810
Principal Investigator: Richard Roseff
Phone: 203-797-1500
1317
mi
from
Danbury, CT
Click here to add this to my saved trials
Denver, Colorado 80230
Principal Investigator: Ryan Antolini
Phone: 303-394-2828
404
mi
from
Denver, CO
Click here to add this to my saved trials
Duncansville, Pennsylvania 16635
Principal Investigator: Alan Kivitz
Phone: 814-693-0300
1053
mi
from
Duncansville, PA
Click here to add this to my saved trials
Elizabethtown, Kentucky 42701
Principal Investigator: Daksha Mehta
Phone: 270-769-2535
?
mi
from
Elizabethtown, KY
Click here to add this to my saved trials
215 South Hickory Street
Escondido, California 92025
Principal Investigator: Tania Rivera
Phone: 858-336-2810
1127
mi
from
Escondido, CA
Click here to add this to my saved trials
Franklin, Wisconsin 53132
Principal Investigator: Alvin Wells
Phone: 414-435-0025
625
mi
from
Franklin, WI
Click here to add this to my saved trials
Hagerstown, Maryland 21740
Principal Investigator: Mary Howell
Phone: 301-791-6680
1089
mi
from
Hagerstown, MD
Click here to add this to my saved trials
19582 Beach Boulevard
Huntington Beach, California 92648
Principal Investigator: Christine Thai
Phone: 949-385-0469
1163
mi
from
Huntington Beach, CA
Click here to add this to my saved trials
Idaho Falls, Idaho 83404
Principal Investigator: Craig Scoville
Phone: 208-542-9080
839
mi
from
Idaho Falls, ID
Click here to add this to my saved trials
Marietta, Georgia 30060
Principal Investigator: Roel Querubin
Phone: 678-984-9495
788
mi
from
Marietta, GA
Click here to add this to my saved trials
Mesquite, Texas 75150
Principal Investigator: Atul Singhal
Phone: 972-299-2600
346
mi
from
Mesquite, TX
Click here to add this to my saved trials
North Charleston, South Carolina 29406
Principal Investigator: Clarence Legerton
Phone: 843-572-1818
1054
mi
from
North Charleston, SC
Click here to add this to my saved trials
Palm Desert, California 92260
Principal Investigator: Maria Greenwald
Phone: 760-341-6800
1075
mi
from
Palm Desert, CA
Click here to add this to my saved trials
Phoenix, Arizona 85032
Principal Investigator: Eric Peters
Phone: 480-626-6656
844
mi
from
Phoenix, AZ
Click here to add this to my saved trials
Raleigh, North Carolina 27617
Principal Investigator: Joseph Shanahan
Phone: 919-405-2040
1068
mi
from
Raleigh, NC
Click here to add this to my saved trials
?
mi
from
Rosario,
Click here to add this to my saved trials
Saint Louis, Missouri 63141
Principal Investigator: Akgun Ince
Phone: 314-567-5100
403
mi
from
Saint Louis, MO
Click here to add this to my saved trials
Sarasota, Florida 34239
Principal Investigator: Jeffrey Kaine
Phone: 941-485-8314
1143
mi
from
Sarasota, FL
Click here to add this to my saved trials
Spokane, Washington 99204
Principal Investigator: Eric Mueller
Phone: 509-838-6500
1202
mi
from
Spokane, WA
Click here to add this to my saved trials