CTRI/2021/12/038694招募中4 期
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
ovartis Healthcare Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.Signed informed consent must be obtained before any assessment is performed.
- •2. Ability to communicate effectively with the investigator, to understand and willing to comply with the requirements of the study.
- •3. Participant has completed the parent study until end of the follow-up period (unless otherwise specified in the parent protocol).
- •4. Participant is deriving benefit from secukinumab and the benefit outweighs the risk, based on the investigator’s judgement.
- •5. Participant is unable to obtain the marketed secukinumab formulation due to unavailable local registration or reimbursement.
排除标准
- •1. Participant has discontinued study treatment in the parent protocol for any reason.
- •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).
研究者
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