Recruiting NCT04638647

Secukinumab Open Label Roll-over Extension Protocol

Phase IV Interventional Autoimmunity, Inflammation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Secukinumab s.c. injection.
Who it may be relevant to: Registry conditions: Autoimmunity, Inflammation. Basic parameters: 6 years — 100 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States, Brazil, Bulgaria, China, Colombia +14
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

An Open-label, Multi-center Protocol for Patients Who Have Completed a Previous Novartis Sponsored Secukinumab Study and Are Judged by the Investigator to Benefit From Continued Secukinumab Treatment

Overview

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

Biological Secukinumab s.c. injection
Secukinumab pre-filled syringes (PFS) for s.c. injection

Primary outcome measures

To evaluate long term safety as assessed by occurrence of AEs/SAEs [Time frame: up to 2 years]

Eligibility criteria

Inclusion criteria

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).
Ability to communicate effectively with the investigator, to understand and willing to comply with the requirements of the study.
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).
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.
Participant is unable to obtain access to the marketed secukinumab formulation per local prescription and/or reimbursement guidelines.

Exclusion criteria

Participant has prematurely discontinued study treatment in the parent protocol.
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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: N/A
Model: Single group
Masking: Open label
Primary purpose: Treatment

Study locations

China · 36 centers

Novartis Investigative Site — Hefei
Novartis Investigative Site — Hefei
Novartis Investigative Site — Beijing
Novartis Investigative Site — Chongqing
Novartis Investigative Site — Xiamen
Novartis Investigative Site — Guangzhou
Novartis Investigative Site — Guangzhou
Novartis Investigative Site — Guangzhou
… and 28 more centers

United States · 28 centers

Providence Medical Foundation — Fullerton
Purushotham Akther and Roshan Kotha MD Inc — La Mesa
Precn Comprehensive Clnl Rsch Solns — San Leandro
Orrin Troum MD and Medical Associates — Santa Monica
Inland Rheumatology Clinical Trials INC — Upland
Medvin Clinical Research — Van Nuys
Center for Rheumatology Research — West Hills
Denver Arthritis Clinic — Denver
… and 20 more centers

Russia · 22 centers