Study to Evaluate the Long Term Efficacy, Safety and Tolerability of Secukinumab in Patients With Rheumatoid Arthritis



Status:Recruiting
Conditions:Arthritis, Rheumatoid Arthritis
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:18 - Any
Updated:10/24/2015
Start Date:September 2012
End Date:February 2019
Contact:Novartis Pharmaceuticals
Phone:1-888-669-6682

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A Four Year Extension Study to Evaluate the Long Term Efficacy, Safety and Tolerability of Secukinumab in Patients With Active Rheumatoid Arthritis

This extension study is designed as a 4-year extension to the phase III (core) study
CAIN457F2309. It aims to provide continuous treatment with secukinumab in pre-filled
syringes (PFS) for subjects with rheumatoid arthritis who completed the phase III study
CAIN457F2309, to obtain further long term efficacy, safety and tolerability information.


Inclusion criteria:

1. Subjects who provide a written, signed and dated informed consent before any study
assessment is performed

2. Subjects must have participated in phase III study CAIN457F2309, must have completed
the entire treatment period and must have received secukinumab during phase III study
(either from start of phase III study or after re-assignment to one of the
secukinumab arms after week 16/24)

3. Subjects who are deemed by the investigator to benefit from continued secukinumab
therapy

Exclusion criteria:

1. Any subject taking other concomitant biologic immunomodulating agent(s) except
secukinumab

2. Any subject who is deemed not to be benefiting from the study drug based upon lack of
improvement or worsening of their symptoms

3. Any subject who continued to receive abatacept after week 16 during the phase III
study CAIN457F2309

Other protocol-defined inclusion/exclusion criteria may apply
We found this trial at
60
sites
Shreveport, Louisiana 71101
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Anniston, Alabama 36207
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Austin, Texas 78759
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Aventura, Florida 33180
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Biloxi, Mississippi 39531
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Boca Raton, Florida 33486
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Boston, Massachusetts 02118
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Boston, MA
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Bowling Green, Kentucky 42101
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Bridgeport, Connecticut 06606
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Bridgeport, CT
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Bridgeport, Connecticut 06606
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Carrollton, Texas 75010
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Charleston, South Carolina 29407
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Cincinnati, Ohio 45229
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Clarksburg, West Virginia 26301
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Coeur d'Alene, Idaho 83814
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Coral Springs, Florida 33065
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Dallas, Texas 75216
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Dallas, Texas 75216
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Eagan, Minnesota 55121
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El Cajon, California 92020
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Flowood, Mississippi 39232
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Freemont, California 94538
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Hamden, Connecticut 06518
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Hialeah, Florida 33012
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Houston, Texas 77030
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Jackson, Tennessee 38305
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Kansas City, Missouri 64111
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Kingsport, Tennessee 37660
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Lansing, Michigan 48910
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Leander, Texas 78641
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Lexington, Kentucky 40509
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Miami, Florida 33136
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Miami, Florida 33136
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Michigan City, Indiana 46360
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Morton Grove, Illinois 60053
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230 Park Avenue, 21st Floor
New York, New York 10169
1-888-669-6682)
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Norfolk, Virginia 23507
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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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Omaha, Nebraska 68144
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Orlando, Florida 32806
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Palm Harbor, Florida 34684
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Pembroke Pines, Florida 33024
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Pensacola, Florida 32504
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Plantation, Florida 33324
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Pomona, California 91767
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Portland, Oregon 97228
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Richmond Heights, Missouri 63117
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San Antonio, Texas 78207
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Sarasota, Florida 34239
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Spokane, Washington 99202
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Springfield, Illinois 62703
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Sugar Land, Texas 77478
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Tampa, Florida 33613
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Upland, California 91786
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Van Nuys, California 91405
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Vestavia, Alabama 35216
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Waco, Texas 76710
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Wichita, Kansas 67207
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Zanesville, Ohio 43701
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