Study to Evaluate the Long Term Efficacy, Safety and Tolerability of Secukinumab in Patients With Rheumatoid Arthritis
Status: | Recruiting |
---|---|
Conditions: | Arthritis, Rheumatoid Arthritis |
Therapuetic Areas: | Rheumatology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 10/24/2015 |
Start Date: | September 2012 |
End Date: | February 2019 |
Contact: | Novartis Pharmaceuticals |
Phone: | 1-888-669-6682 |
A Four Year Extension Study to Evaluate the Long Term Efficacy, Safety and Tolerability of Secukinumab in Patients With Active Rheumatoid Arthritis
This extension study is designed as a 4-year extension to the phase III (core) study
CAIN457F2309. It aims to provide continuous treatment with secukinumab in pre-filled
syringes (PFS) for subjects with rheumatoid arthritis who completed the phase III study
CAIN457F2309, to obtain further long term efficacy, safety and tolerability information.
CAIN457F2309. It aims to provide continuous treatment with secukinumab in pre-filled
syringes (PFS) for subjects with rheumatoid arthritis who completed the phase III study
CAIN457F2309, to obtain further long term efficacy, safety and tolerability information.
Inclusion criteria:
1. Subjects who provide a written, signed and dated informed consent before any study
assessment is performed
2. Subjects must have participated in phase III study CAIN457F2309, must have completed
the entire treatment period and must have received secukinumab during phase III study
(either from start of phase III study or after re-assignment to one of the
secukinumab arms after week 16/24)
3. Subjects who are deemed by the investigator to benefit from continued secukinumab
therapy
Exclusion criteria:
1. Any subject taking other concomitant biologic immunomodulating agent(s) except
secukinumab
2. Any subject who is deemed not to be benefiting from the study drug based upon lack of
improvement or worsening of their symptoms
3. Any subject who continued to receive abatacept after week 16 during the phase III
study CAIN457F2309
Other protocol-defined inclusion/exclusion criteria may apply
We found this trial at
60
sites
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