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
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Wichita, Kansas 67207
780
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Wichita, KS
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Austin, Texas 78759
1065
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Aventura, Florida 33180
982
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Aventura, FL
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Boca Raton, Florida 33486
955
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Boca Raton, FL
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Boston, Massachusetts 02118
643
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Boston, MA
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Bowling Green, Kentucky 42101
278
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Bowling Green, KY
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Bridgeport, Connecticut 06606
521
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Bridgeport, CT
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Bridgeport, Connecticut 06606
521
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Bridgeport, CT
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Carrollton, Texas 75010
907
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Cincinnati, Ohio 45229
95
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Clarksburg, West Virginia 26301
150
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Coeur d'Alene, Idaho 83814
1749
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Coeur d'Alene, ID
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Curitiba, PR 80060
5013
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Curitiba,
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Dallas, Texas 75216
914
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Dallas, TX
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Dallas, Texas 75216
914
mi
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Dallas, TX
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Eagan, Minnesota 55121
616
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Eagan, MN
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Freemont, California 94538
2088
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Freemont, CA
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Hialeah, Florida 33012
986
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Hialeah, FL
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Houston, Texas 77030
995
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Houston, TX
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Jackson, Tennessee 38305
436
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Jackson, TN
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Kansas City, Missouri 64111
619
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Kingsport, Tennessee 37660
237
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Kingsport, TN
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Lansing, Michigan 48910
204
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Lansing, MI
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Lexington, Kentucky 40509
154
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Lexington, KY
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Miami, Florida 33136
993
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Miami, FL
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Miami, Florida 33136
993
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Miami, FL
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Morton Grove, Illinois 60053
286
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Morton Grove, IL
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Oklahoma City, Oklahoma 73104
848
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Oklahoma City, OK
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Oklahoma City, Oklahoma 73104
848
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Omaha, Nebraska 68144
691
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Omaha, NE
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Orlando, Florida 32806
797
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Orlando, FL
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Palm Harbor, Florida 34684
821
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Pembroke Pines, Florida 33024
976
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Pensacola, Florida 32504
695
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Plantation, Florida 33324
970
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Plantation, FL
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Pomona, California 91767
1944
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Pomona, CA
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Richmond Heights, Missouri 63117
400
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Richmond Heights, MO
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Sarasota, Florida 34239
874
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Spokane, Washington 99202
1778
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Springfield, Illinois 62703
350
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Sugar Land, Texas 77478
1008
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Tampa, Florida 33613
821
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Upland, California 91786
1940
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Van Nuys, California 91405
1979
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Van Nuys, California 91405
1979
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Vestavia, Alabama 35216
497
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Waco, Texas 76710
983
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Zanesville, Ohio 43701
53
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Zanesville, OH
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