A Three-year Extension Study to Evaluate the Long Term Efficacy, Safety and Tolerability of Secukinumab in Patients With Active Psoriatic Arthritis
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Last updated:1st Sep 2013
Primary Sponsor: Novartis Pharmaceuticals
This study is designed as a 3-year extension to the phase III core study CAIN457F2306. It aims 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 will complete the assessments associated with the core study visit and will subsequently continue in the extension study on the same dose that they were receiving during the core study. The regular assessments of disease activity will ensure that subjects who are experiencing worsening of disease in any of the treatment groups can exit the study upon their own wish or based on the advice of the investigator at any time.
|Date last updated at source||2016-01-11|
|Study start date||2013-09-01|
|Estimated primary completion date||2017-11-01|