Extension Study up to 3 Years for Secukinumab in Psoriatic Arthritis



Status:Completed
Conditions:Arthritis, Psoriasis
Therapuetic Areas:Dermatology / Plastic Surgery, Rheumatology
Healthy:No
Age Range:18 - Any
Updated:12/22/2018
Start Date:September 30, 2013
End Date:January 11, 2018

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A Three-year Extension Study to Evaluate the Long Term Efficacy, Safety and Tolerability of Secukinumab in Patients With Active Psoriatic Arthritis

This study was designed as a 3-year extension to the phase III core study CAIN457F2306. It
aimed to provide continuous treatment with secukinumab in pre-filled syringes (PFS) for
subjects who completed the core study CAIN457F2306, to obtain further long term efficacy,
safety and tolerability information in subjects with active psoriatic arthritis receiving
secukinumab every 4 weeks. At Week 104 of the study CAIN457F2306, eligible subjects completed
the assessments associated with the core study visit and subsequently continued in this
extension study on the same dose that they were receiving during the core study. The regular
assessments of disease activity ensure that subjects who are experienced worsening of disease
in any of the treatment groups could exit the study upon their own wish or based on the
advice of the investigator at any time.


Inclusion criteria

- Subjects must be able to understand and communicate with the investigator and comply
with the requirements of the study and must give a written, signed and dated informed
consent before any study assessment is performed

- Subjects must have participated in core study CAIN457F2306, and must have completed
the entire treatment period

- Subjects must be deemed by the investigator to benefit from continued secukinumab
therapy

Exclusion criteria

- Any subject taking other concomitant biologic immunomodulating agent(s) except
secukinumab

- Any subject who is deemed not to be benefiting from the study treatment based upon
lack of improvement or worsening of their symptoms

- Pregnant or nursing (lactating) women

- Women of child-bearing potential, unless they are using effective methods of
contraception during the entire study or longer if required by locally approved
prescribing information (e.g., 20 weeks in EU)

Other protocol-defined inclusion/exclusion criteria may apply
We found this trial at
25
sites
Dallas, Texas 75216
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Anniston, Alabama 36207
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Anniston, AL
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Benbrook, Texas 76126
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Benbrook, TX
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Caba, Buenos Aires
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Caba,
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Charleston, South Carolina 29407
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Charleston, SC
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Charlotte, North Carolina 28277
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Charlotte, NC
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Columbia, South Carolina 29201
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Columbia, SC
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Dallas, Texas 75216
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Dallas, TX
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Duncansville, Pennsylvania 16635
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Duncansville, PA
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Eagan, Minnesota 55121
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Eagan, MN
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Freehold, New Jersey 07728
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Freehold, NJ
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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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League City, Texas 77573
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League City, TX
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Lincoln, Nebraska 68506
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Lincoln, NE
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Mesa, Arizona 85205
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Mesa, AZ
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Mesa, Arizona 85205
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Mesa, AZ
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Mesquite, Texas 75150
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Mesquite, TX
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Oklahoma City, Oklahoma 73104
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Oklahoma City, OK
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Paradise Valley, Arizona 85253
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Paradise Valley, AZ
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Saint Louis, Missouri 63128
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Saint Louis, MO
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Seattle, Washington 98103
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Seattle, WA
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Tamarac, Florida 33321
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Tamarac, FL
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Upland, California 91786
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Upland, CA
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