Status:
COMPLETED
Extension Study up to 3 Years for Secukinumab in Psoriatic Arthritis
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Psoriatic Arthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 complete...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
September 30 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 11 2018
Estimated Enrollment :
460 Patients enrolled
Trial Details
Trial ID
NCT01892436
Start Date
September 30 2013
End Date
January 11 2018
Last Update
June 12 2019
Active Locations (94)
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1
Novartis Investigative Site
Anniston, Alabama, United States, 36207-5710
2
Novartis Investigative Site
Mesa, Arizona, United States, 85202
3
Novartis Investigative Site
Paradise Valley, Arizona, United States, 85253
4
Novartis Investigative Site
Upland, California, United States, 91786