5496W-13: Mease Novartis CAIN457F2306-E1

Extension Study up to 3 Years for Secukinumab in Psoriatic Arthritis

Type of Study
Rheumatology - Psoriatic Arthritis
Short Description

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.


Status
Open
Principal Investigator
Philip J. Mease, MD
Eligibility Notes
Criteria

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, unwilling to use effective contraception during the study and for 16 weeks after stopping treatment

Other protocol-defined inclusion/exclusion criteria may apply

Start Date
12/12/2013
Contact Name
Jodie Davila, RN
Phone
206-386-6252
Alternate Phone
206-386-6248
Email
Jodie.Davila@swedish.org
Alternate Email
Sephren.Barrow@swedish.org