Efficacy at 24 Weeks and Safety, Tolerability and Long Term Efficacy up to 2 Years of Secukinumab (AIN457) in Patients With Active Rheumatoid Arthritis and an 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:August 2011
End Date:September 2015

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A Randomized, Double-blind, Placebo-controlled Study of Secukinumab to Demonstrate the Efficacy at 24 Weeks and to Assess the Safety, Tolerability and Long Term Efficacy up to 2 Years 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 (RA) who are intolerant to or have had
an inadequate response to anti-tumor necrosis factor (TNF)-α agents.


Inclusion criteria:

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

- Presence of RA classified by American College of Rheumatology (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 (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 mm/1st hr

- 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 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 Japan
only: 6 to 25 mg/week)

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 including but not limited to
anti-CD20, investigational agents (e.g., CAMPATH, anti-CD4, anti-CD5, anti-CD3,
anti-CD19)

- Other protocol-defined inclusion/exclusion criteria may apply.
We found this trial at
43
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Houston, Texas 77030
995
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Houston, TX
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Asheville, North Carolina 28803
304
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Asheville, NC
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Bowling Green, Kentucky 42101
278
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Bowling Green, KY
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Caba, Buenos Aires
5386
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Caba,
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Canton, Georgia 30114
403
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Canton, GA
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Charlotte, North Carolina 28277
360
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Charlotte, NC
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Charlotte, North Carolina 28277
360
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Charlotte, NC
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Columbia, South Carolina 29201
427
mi
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Columbia, SC
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Dallas, Texas 75216
914
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Dallas, TX
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Durham, North Carolina 27710
352
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Durham, NC
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Eagan, Minnesota 55121
616
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Eagan, MN
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Gallipolis, Ohio 45631
91
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Gallipolis, OH
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Greenville, South Carolina 29605
360
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Greenville, SC
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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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Johnson City, Tennessee 37604
256
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Johnson City, TN
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Kansas City, Missouri 64111
619
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Kansas City, MO
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Largo, Florida 33773
835
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Largo, FL
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Las Vegas, Nevada 89135
1756
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Las Vegas, NV
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Little Rock, Arkansas 72204
627
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Little Rock, AR
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Mesa, Arizona 85205
1644
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Mesa, AZ
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Mesa, Arizona 85205
1644
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Mesa, AZ
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Mesquite, Texas 75150
901
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Mesquite, TX
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Miami, Florida 33136
993
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Miami, FL
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Nashville, Tennessee 37205
339
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Nashville, TN
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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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Palm Harbor, FL
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Paradise Valley, Arizona 85253
1653
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Paradise Valley, AZ
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Paradise Valley, Arizona 85253
1653
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Peoria, Arizona 85381
1666
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Peoria, AZ
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Pittsburgh, Pennsylvania 15224
165
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Pittsburgh, PA
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Portland, Oregon 97228
Novartis Novartis, which was created in 1996 by the merger of the Swiss companies Ciba-Geigy...
2028
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Portland, OR
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Salt Lake City, Utah 84103
1513
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Salt Lake City, UT
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Santa Monica, California 90404
1984
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Santa Monica, CA
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South Miami, Florida 33143
997
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South Miami, FL
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Stanford, California 94305
2101
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Stanford, CA
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Tamarac, Florida 33321
963
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Tamarac, FL
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Tampa, Florida 33613
821
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Tampa, Florida 33613
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Torrance, California 90502
1980
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Torrance, CA
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Upland, California 91786
1940
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Upland, CA
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Wheaton, Maryland 20902
325
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Wheaton, MD
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