Study Description
The purpose of this study is to assess long term safety in participants who have
completed a Novartis trial with secukinumab, have been judged by the investigator to
benefit from continued treatment with secukinumab, and are unable to obtain the marketed
secukinumab formulation.
Interventions
Secukinumab s.c. injection
Eligibility Criteria
Inclusion Criteria:
1. Signed informed consent must be obtained for adult participants before any
assessment is performed. Written informed assent and parental permission (age as per
local law) must be obtained for pediatric participants before any assessment is
performed. If participants reach age of consent (age as per local law) during the
study, they will need to also sign the corresponding study informed consent(s).
2. Ability to communicate effectively with the investigator, to understand and willing
to comply with the requirements of the study.
3. Participant has completed treatment per protocol in a Novartis study of secukinumab
(unless otherwise specified in a parent study protocol). Participants, who derive
benefit from the treatment with secukinumab but have not completed the treatment in
certain parent studies, due to parent study termination by Novartis, may be eligible
if the termination was due to reasons other than safety or lack of efficacy
(technical / administrative reasons).
4. Participant is deriving benefit from secukinumab, investigator believes he/she would
continue to derive benefit from secukinumab and the benefit outweighs the risk,
based on the investigator's judgement.
5. Participant is unable to obtain access to the marketed secukinumab formulation per
local prescription and/or reimbursement guidelines.
Exclusion Criteria:
1. Participant has prematurely discontinued study treatment in the parent protocol.
2. Women of childbearing potential, defined as all women physiologically capable of
becoming pregnant, unless they are using methods of contraception during the entire
study or longer if required by locally approved prescribing information (e.g., in
European Union (EU) 20 weeks).
Worldwide Contacts
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