EUCTR2012-002760-27-HUActive, not recruitingNot Applicable
A four year extension study to evaluate the long term efficacy, safety and tolerability of secukinumab in patients with active rheumatoid arthritis
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- ovartis Pharma AG
- Enrollment
- 345
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 276
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 69
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 exclusion criteria may apply
Investigators
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