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.
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Upland, California 91786
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Austin, Texas 78759
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Bridgeport, Connecticut 06606
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Bridgeport, Connecticut 06606
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Curitiba, PR 80060
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Dallas, Texas 75216
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Freemont, California 94538
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Houston, Texas 77030
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Morton Grove, Illinois 60053
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