Safety and Efficacy of Extended Treatment With Secukinumab in Anti-TNF Inadequate Responders in RA.



Status:Completed
Conditions:Arthritis, Rheumatoid Arthritis
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:September 2013
End Date:May 2015

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A Three Year Extension Study to Evaluate the Long Term Efficacy, Safety and Tolerability of Secukinumab in Subjects With Active Rheumatoid Arthritis

This extension study will provide continuing treatment with secukinumab for up to 3 years
for subjects who completed the phase III core study, CAIN457F2302. Subjects will be offered
maintenance treatment with secukinumab at the 150 mg given subcutaneously every 4 weeks. The
study aims to obtain further long term efficacy, safety and tolerability information on
secukinumab for patients with rheumatoid arthritis.


Inclusion Criteria:

Subjects must give a written informed consent before any assessment is performed.

Subjects must have completed the 104-week treatment period in the core study Subjects who
are deemed by the investigator to benefit from continued secukinumab therapy.

Exclusion Criteria:

Use of other investigational drugs except for secukinumab during the core study.

Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female
after conception and until the termination of gestation, confirmed by a positive hCG
laboratory test.

Women of child-bearing potential, defined as all women physiologically capable of becoming
pregnant, unless they are using effective methods of contraception during dosing of study
treatment.
We found this trial at
19
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Bowling Green, Kentucky 42101
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Asheville, North Carolina 28803
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Caba, Buenos Aires
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Caba,
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Canton, Georgia 30114
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Canton, GA
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Charlotte, North Carolina 28277
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Charlotte, NC
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Eagan, Minnesota 55121
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Eagan, MN
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Greenville, South Carolina 29605
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Greenville, SC
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Houston, Texas 77030
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Houston, TX
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Houston, Texas 77030
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Houston, TX
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Jackson, Tennessee 38305
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Jackson, TN
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Mesquite, Texas 75150
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Mesquite, TX
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Nashville, Tennessee 37205
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Nashville, TN
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Paradise Valley, Arizona 85253
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Paradise Valley, AZ
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Paradise Valley, Arizona 85253
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Peoria, Arizona 85381
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Peoria, AZ
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Tamarac, Florida 33321
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Tamarac, FL
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Tampa, Florida 33613
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Tampa, FL
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Tampa, Florida 33613
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Tampa, FL
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Upland, California 91786
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Upland, CA
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