Secukinumab Efficacy and Safety Study in Patients With Rheumatoid Arthritis and Inadequate Response to Anti-TNFα Agents.



Status:Completed
Conditions:Arthritis, Rheumatoid Arthritis
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:October 2012
End Date:May 2015

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A Phase III Randomized, Double-blind, Placebo-controlled Multicenter Study of Subcutaneous Secukinumab in Prefilled Syringes to Demonstrate the Efficacy at 24 Weeks and to Assess the Long Term Efficacy, Safety, Tolerability and Usability up to 5 Years in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Anti-TNFα Agents

This study will provide efficacy and safety data of the secukinumab pre-filled syringe (PFS)
for subcutaneous self-administration in patients with active rheumatoid arthritis who are
intolerant to or have had an inadequate response to anti-TNF-α agents.


Inclusion Criteria: • Presence of Rheumatoid Arthritis classified by ACR 2010 revised
criteria for at least 3 months •Disease activity defined by ≥6 tender joints out of 68 and
≥ 6 swollen joints out of 66 at baseline and with: Either Anti-CCP antibodies positive OR
Rheumatoid Factor positive AND WITH Either hsCRP ≥ 10 mg/L OR ESR ≥28 mm/1st hr •Intake of
at least one anti-TNF-α agent such as etanercept, adalimumab, infliximab, certolizumab or
golimumab for at least 3 months before entering the study and to have experienced an
inadequate response to treatment or to have been intolerant to at least one administration
Exclusion Criteria:

- Current RA functional status class IV according to the ACR 1991 revised criteria
•Previous use of secukinumab or other biologic drug directly targeting IL-17 or IL-17
receptor and/or any history of hypersensitivity to secukinumab or its excipient or to
drugs of similar chemical classes. Other protocol-defined inclusion/exclusion
criteria may apply
We found this trial at
26
sites
Rapid City, South Dakota 57701
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Rapid City, SD
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Albuquerque, New Mexico 87108
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Albuquerque, NM
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Amarillo, Texas 79106
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Amarillo, TX
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Benbrook, Texas 76126
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Benbrook, TX
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Cumberland, Maryland 21502
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Cumberland, MD
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Edina, Minnesota 55435
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Edina, MN
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Houston, Texas 77030
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Houston, TX
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Houston, Texas 77030
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Houston, TX
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Jackson, Tennessee 38305
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Jackson, TN
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Lees Summit, Missouri 64086
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Lees Summit, MO
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Mar del Plata, Buenos Aires
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Mar del Plata,
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Mesquite, Texas 75150
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Mesquite, TX
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Miami, Florida 33136
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Miami, FL
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Nashville, Tennessee 37205
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Nashville, TN
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North Charleston, South Carolina 29420
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North Charleston, SC
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Oklahoma City, Oklahoma 73104
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Oklahoma City, OK
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Oklahoma City, Oklahoma 73104
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Oklahoma City, OK
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Pembroke Pines, Florida 33024
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Pembroke Pines, FL
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Peoria, Arizona 85381
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Peoria, AZ
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Reno, Nevada 89502
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Reno, NV
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Santa Monica, California 90404
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Santa Monica, CA
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St. Louis, Missouri 63110
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St. Louis, MO
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Tupelo, Mississippi 38801
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Tupelo, MS
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Upland, California 91786
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Upland, CA
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Zanesville, Ohio 43701
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Zanesville, OH
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Zephyrhills, Florida 33542
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Zephyrhills, FL
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