Efficacy at 24 Weeks and Safety, Tolerability and Long Term Efficacy up to 1 Year of Secukinumab (AIN457) in Patients With Active Rheumatoid Arthritis (RA) and an Inadequate Response to Anti-Tumor Necrosis Factor α (Anti-TNFα) Agents.



Status:Completed
Conditions:Arthritis, Rheumatoid Arthritis
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:September 2011
End Date:February 2015

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A Randomized, Double-blind, Placebo- and Active-controlled Study of Secukinumab to Demonstrate the Efficacy at 24 Weeks and to Assess the Safety, Tolerability and Long Term Efficacy up to 1 Year in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Anti-TNFα Agents

This study will assess the safety and efficacy of secukinumab when added to a background
therapy in patients with active rheumatoid arthritis who are intolerant to or have had an
inadequate response to anti-TNF-α agents.


Inclusion Criteria:

- Male or non-pregnant, non-lactating female patients

- Presence of RA classified by ACR 2010 revised criteria for at least 3 months before
screening

- At Baseline: Disease activity criteria defined by >= 6 tender joints out of 68 and >=
6 swollen joints out of 66

WITH at least 1 of the following at screening:

- Anti-Cyclic Citrullinated Peptide (Anti-CCP) antibodies positive OR

- Rheumatoid Factor positive

AND WITH at least 1 of the following at screening:

- High sensitivity C-Reactive Protein (hsCRP) >= 10 mg/L OR

- Erythrocyte Sedimentation Rate (ESR) >= 28 millimeter (mm)/1st hour

- Patients must have been taking at least one anti-TNF-α agent given at an approved
dose for at least 3 months before randomization and have experienced an inadequate
response to treatment or have been intolerant to at least one administration of an
anti-TNF-α agent

- Patients must be taking MTX or any other DMARD (but not more than 1 DMARD) for at
least 3 months before randomization and have to be on a stable dose at least 4 weeks
before randomization (7.5 to 25 mg/week for MTX or other DMARD at maximum tolerated
dose)

Exclusion Criteria:

- Chest x-ray with evidence of ongoing infectious or malignant process, obtained within
3 months prior to screening and evaluated by a qualified physician

- RA patients functional status class IV according to the ACR 1991 revised criteria

- Patients who have ever received biologic immunomodulating agents except for those
targeting TNFα

- Previous treatment with any cell-depleting therapies

Other protocol-defined inclusion/exclusion criteria may apply.
We found this trial at
48
sites
Oklahoma City, Oklahoma 73104
158
mi
from
Oklahoma City, OK
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Austin, Texas 78759
517
mi
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Austin, TX
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Aventura, Florida 33180
1315
mi
from
Aventura, FL
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Boca Raton, Florida 33486
1298
mi
from
Boca Raton, FL
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Boston, Massachusetts 02118
1444
mi
from
Boston, MA
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Bowling Green, Kentucky 42101
624
mi
from
Bowling Green, KY
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Bridgeport, Connecticut 06606
1329
mi
from
Bridgeport, CT
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Bridgeport, Connecticut 06606
1329
mi
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Bridgeport, CT
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Carrollton, Texas 75010
330
mi
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Carrollton, TX
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Cincinnati, Ohio 45229
727
mi
from
Cincinnati, OH
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Clarksburg, West Virginia 26301
949
mi
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Clarksburg, WV
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Coeur d'Alene, Idaho 83814
1176
mi
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Coeur d'Alene, ID
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Curitiba, PR 80060
5381
mi
from
Curitiba,
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Dallas, Texas 75216
353
mi
from
Dallas, TX
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Dallas, Texas 75216
353
mi
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Dallas, TX
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Eagan, Minnesota 55121
546
mi
from
Eagan, MN
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Freemont, California 94538
1317
mi
from
Freemont, CA
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Hialeah, Florida 33012
1312
mi
from
Hialeah, FL
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Houston, Texas 77030
572
mi
from
Houston, TX
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Jackson, Tennessee 38305
520
mi
from
Jackson, TN
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Kansas City, Missouri 64111
196
mi
from
Kansas City, MO
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Kingsport, Tennessee 37660
843
mi
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Kingsport, TN
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Lansing, Michigan 48910
778
mi
from
Lansing, MI
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Lexington, Kentucky 40509
732
mi
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Lexington, KY
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Miami, Florida 33136
1320
mi
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Miami, FL
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Miami, Florida 33136
1320
mi
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Miami, FL
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Morton Grove, Illinois 60053
608
mi
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Morton Grove, IL
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Oklahoma City, Oklahoma 73104
158
mi
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Oklahoma City, OK
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Omaha, Nebraska 68144
257
mi
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Omaha, NE
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Orlando, Florida 32806
1144
mi
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Orlando, FL
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Palm Harbor, Florida 34684
1099
mi
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Palm Harbor, FL
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Pembroke Pines, Florida 33024
1308
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Pembroke Pines, FL
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Pensacola, Florida 32504
787
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Pensacola, FL
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Plantation, Florida 33324
1302
mi
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Plantation, FL
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Pomona, California 91767
1140
mi
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Pomona, CA
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Richmond Heights, Missouri 63117
411
mi
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Richmond Heights, MO
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Sarasota, Florida 34239
1143
mi
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Sarasota, FL
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Spokane, Washington 99202
1201
mi
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Spokane, WA
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Springfield, Illinois 62703
462
mi
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Springfield, IL
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Sugar Land, Texas 77478
576
mi
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Sugar Land, TX
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Tampa, Florida 33613
1111
mi
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Tampa, FL
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Upland, California 91786
1135
mi
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Upland, CA
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Van Nuys, California 91405
1176
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Van Nuys, CA
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Van Nuys, California 91405
1176
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Van Nuys, CA
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Vestavia, Alabama 35216
687
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Vestavia, AL
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Waco, Texas 76710
430
mi
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Waco, TX
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Wichita, Kansas 67207
32
mi
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Wichita, KS
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Zanesville, Ohio 43701
862
mi
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Zanesville, OH
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