EUCTR2020-004284-98-BG进行中（未招募）1 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
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 628
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 14
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 361
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 253
排除标准
- •1. Participant has Prematurely 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).
- •Contraception methods include:
- •· Total abstinence, when this is in line with the preferred and usual lifestyle of the participant. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.
- •· Female sterilization (have had surgical bilateral oophorectomy [with or without hysterectomy], total hysterectomy or bilateral tubal ligation at least six weeks before taking study treatment). In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow-up hormone level assessment.
- •· Male sterilization (at least 6 months before taking study treatment). For female participants on the study, the vasectomized male partner should be the sole partner for that participant.
- •· Barrier methods of contraception: Condom or Occlusive cap (diaphragm or cervical/vault caps). For United Kingdom: with spermicidal foam/gel/film/cream/vaginal suppository.
- •· Use of oral (estrogen and progesterone), injected or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate <1%), for example hormone vaginal ring or transdermal hormone contraception or placement of an intrauterine device (IUD) or intrauterine system (IUS).
- •In case of use of oral contraception, women should have been stable on the same pill for a minimum of 3 months before taking study treatment.
- •In case local regulations deviate from the contraception methods listed above, local regulations apply and will be described in the informed consent form (ICF).Note: Women are considered post-menopausal and not of childbearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g., age appropriate, history of vasomotor symptoms).Women are considered not of childbearing potential if they
- •are post-menopausal or have had surgical bilateral oophorectomy (with or without hysterectomy), total hysterectomy or tubal ligation at least six weeks prior to enrollment. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow-up hormone level assessment is she considered not of childbearing potential.3.Use of prohibited medications.
研究者
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