None listed
Conditions
Interventions
The AIN457F2305 core study used a double-blind, randomized, parallel-group, placebocontrolled
design. A screening period running 4 weeks before randomization was used to
assess eligibility follo
inhibitor incomplete responders (TNFIR)
or TNFα
inhibitor naïve subjects. Approximately 30% of subjects were TNF-IR to ensure
a representative population for the assessment of efficacy and safety.
Sponsors
NOVARTIS BIOSCIENSES PERU S.A.,
Eligibility
Sex/Gender
All
Age
16 Years to 17 Years
Inclusion criteria
Inclusion criteria: 1. Written informed consent must be obtained before any assessment is performed 2. Subjects must have completed the core study 3. Subjects who are deemed by the investigator to benefit from continued secukinumab Therapy
Exclusion criteria
Exclusion criteria: 1. History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes 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. Use of any investigational drug except for secukinumab during the core study 4. Any subject taking other concomitant biologic immunomodulating agent(s) except secukinumab during the core study 5. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test. 6. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during dosing of study treatment and for 16 weeks after stopping treatment. Effective contraception methods include:
Countries
Belgium, Bulgaria, Canada, France, Germany, Italy, Mexico, Peru, Russian Federation, Switzerland, Taiwan, Turkey, United Kindgdom, United States
Outcome results
None listed