Extension Study up to 3 Years for Secukinumab in Psoriatic Arthritis

Completed · Phase 3 · Has a placebo group

Conditions studied: Psoriatic Arthritis

In brief

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.

Key facts

Study ID

NCT01892436

Run by

Novartis Pharmaceuticals

People needed

460

Starts

2013-09-30

Expected to finish

2018-01-11

Last updated by the study team

2019-06-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Novartis Investigative Site — Mesa, Arizona, United States
• Novartis Investigative Site — Paradise Valley, Arizona, United States
• Novartis Investigative Site — Upland, California, United States
• Novartis Investigative Site — Tamarac, Florida, United States
• Novartis Investigative Site — Eagan, Minnesota, United States
• Novartis Investigative Site — St Louis, Missouri, United States
• Novartis Investigative Site — Lincoln, Nebraska, United States
• Novartis Investigative Site — Freehold, New Jersey, United States
• Novartis Investigative Site — Charlotte, North Carolina, United States
• Novartis Investigative Site — Oklahoma City, Oklahoma, United States
• Novartis Investigative Site — Duncansville, Pennsylvania, United States
• Novartis Investigative Site — Charleston, South Carolina, United States
• Novartis Investigative Site — Columbia, South Carolina, United States
• Novartis Investigative Site — Jackson, Tennessee, United States
• Novartis Investigative Site — Benbrook, Texas, United States
• Novartis Investigative Site — Dallas, Texas, United States
• Novartis Investigative Site — Dallas, Texas, United States
• Novartis Investigative Site — Houston, Texas, United States
• Novartis Investigative Site — League City, Texas, United States
• Novartis Investigative Site — Mesquite, Texas, United States
• Novartis Investigative Site — Seattle, Washington, United States
• Novartis Investigative Site — CABA, Buenos Aires, Argentina
• Novartis Investigative Site — Rosario, Santa Fe Province, Argentina
• Novartis Investigative Site — Buenos Aires, Argentina
• Novartis Investigative Site — Anniston, Alabama, United States

Full record on ClinicalTrials.gov

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