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
Sugar Land, Texas 77478
1347
mi
from 91732
Sugar Land, TX
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Anniston, Alabama 36207
1838
mi
from 91732
Anniston, AL
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Austin, Texas 78759
1212
mi
from 91732
Austin, TX
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Aventura, Florida 33180
2320
mi
from 91732
Aventura, FL
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Biloxi, Mississippi 39531
1710
mi
from 91732
Biloxi, MS
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Boca Raton, Florida 33486
2311
mi
from 91732
Boca Raton, FL
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Boston, Massachusetts 02118
2578
mi
from 91732
Boston, MA
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Bowling Green, Kentucky 42101
1776
mi
from 91732
Bowling Green, KY
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Bridgeport, Connecticut 06606
2472
mi
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Bridgeport, CT
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Bridgeport, Connecticut 06606
2472
mi
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Bridgeport, CT
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Carrollton, Texas 75010
1214
mi
from 91732
Carrollton, TX
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Charleston, South Carolina 29407
2184
mi
from 91732
Charleston, SC
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Cincinnati, Ohio 45229
1881
mi
from 91732
Cincinnati, OH
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Clarksburg, West Virginia 26301
2102
mi
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Clarksburg, WV
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Coeur d'Alene, Idaho 83814
942
mi
from 91732
Coeur d'Alene, ID
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Coral Springs, Florida 33065
2304
mi
from 91732
Coral Springs, FL
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Dallas, Texas 75216
1225
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from 91732
Dallas, TX
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Dallas, Texas 75216
1225
mi
from 91732
Dallas, TX
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Eagan, Minnesota 55121
1511
mi
from 91732
Eagan, MN
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El Cajon, California 92020
106
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El Cajon, CA
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Flowood, Mississippi 39232
1611
mi
from 91732
Flowood, MS
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Freemont, California 94538
324
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Freemont, CA
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Hamden, Connecticut 06518
2486
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Hamden, CT
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Hialeah, Florida 33012
2313
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Hialeah, FL
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Houston, Texas 77030
1357
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Houston, TX
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Jackson, Tennessee 38305
1653
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Jackson, TN
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Kansas City, Missouri 64111
1340
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from 91732
Kansas City, MO
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Kingsport, Tennessee 37660
1995
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Kingsport, TN
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Lansing, Michigan 48910
1894
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Lansing, MI
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Leander, Texas 78641
1199
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from 91732
Leander, TX
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Lexington, Kentucky 40509
1888
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from 91732
Lexington, KY
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Miami, Florida 33136
2321
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from 91732
Miami, FL
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Miami, Florida 33136
2321
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Miami, FL
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Michigan City, Indiana 46360
1765
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Michigan City, IN
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Morton Grove, Illinois 60053
1723
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Morton Grove, IL
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230 Park Avenue, 21st Floor
New York, New York 10169
1-888-669-6682)
Novartis Novartis, which was created in 1996 by the merger of the Swiss companies Ciba-Geigy...
2435
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from 91732
New York, NY
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Norfolk, Virginia 23507
2335
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Norfolk, VA
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Oklahoma City, Oklahoma 73104
1165
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Oklahoma City, OK
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Oklahoma City, Oklahoma 73104
1165
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Oklahoma City, OK
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Omaha, Nebraska 68144
1291
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Omaha, NE
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Orlando, Florida 32806
2186
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Orlando, FL
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Palm Harbor, Florida 34684
2118
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Palm Harbor, FL
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Pembroke Pines, Florida 33024
2313
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from 91732
Pembroke Pines, FL
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Pensacola, Florida 32504
1810
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from 91732
Pensacola, FL
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Plantation, Florida 33324
2308
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from 91732
Plantation, FL
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Pomona, California 91767
15
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from 91732
Pomona, CA
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Portland, Oregon 97228
Novartis Novartis, which was created in 1996 by the merger of the Swiss companies Ciba-Geigy...
829
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from 91732
Portland, OR
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Richmond Heights, Missouri 63117
1566
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from 91732
Richmond Heights, MO
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San Antonio, Texas 78207
Novartis Novartis, which was created in 1996 by the merger of the Swiss companies Ciba-Geigy...
1187
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San Antonio, TX
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Sarasota, Florida 34239
2148
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from 91732
Sarasota, FL
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Shreveport, Louisiana 71101
1402
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Shreveport, LA
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Spokane, Washington 99202
939
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Spokane, WA
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Springfield, Illinois 62703
1608
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Springfield, IL
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Tampa, Florida 33613
2133
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Tampa, FL
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Upland, California 91786
20
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Upland, CA
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Van Nuys, California 91405
26
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Van Nuys, CA
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Vestavia, Alabama 35216
1787
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Vestavia, AL
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Waco, Texas 76710
1219
mi
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Waco, TX
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Wichita, Kansas 67207
1186
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from 91732
Wichita, KS
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Zanesville, Ohio 43701
2013
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from 91732
Zanesville, OH
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