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 |
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.
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
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