NL-OMON55001尚未招募3 期
A MULTICENTER, OPEN-LABEL EXTENSION STUDY TO ASSESS THE LONG-TERM SAFETY, TOLERABILITY, AND EFFICACY OF BIMEKIZUMAB IN THE TREATMENT OF STUDY PARTICIPANTS WITH ACTIVE AXIAL SPONDYLOARTHRITIS, ANKYLOSING SPONDYLITIS, AND NONRADIOGRAPHIC AXIAL SPONDYLOARTHRITIS - AS0014 246744
CB Pharma0 个研究点目标入组 8 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 8
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
- 年龄范围
- 18 至 99（—）
入选标准
- •To be eligible to participate in this study, all of the following criteria must
- •1. An Institutional Review Board/Independent Ethics Committee approved written
- •Informed Consent Form is signed and dated by the study participant.
- •2. Study participant is considered reliable and capable of adhering to the
- •protocol (eg, able to understand and complete questionnaires), visit schedule,
- •and medication intake according to the judgement of the Investigator.
- •3. In the opinion of the Investigator, the study participant is expected to
- •benefit from participation in this OLE study.
- •4. Study participant completed AS0010 or AS0011 without meeting any withdrawal
- •5. Female study participants must be:
- •* postmenopausal (at least 1 year),
- •* permanently sterilized (eg, tubal occlusion, hysterectomy, bilateral
- •salpingectomy),
- •* or, if of childbearing potential (and engaged in sexual activity that could
- •result in procreation), must be willing to use a highly effective method of
- •contraception until 20 weeks after last administration of IMP, and have a
- •negative pregnancy test at the last visit of AS0010 or AS0011.
- •The following methods are considered highly effective when used consistently
- •and correctly:
- •* combined (estrogen and progestogen) hormonal contraception associated with
- •inhibition of ovulation (oral, intravaginal, or transdermal),
- •* progestogen-only hormonal contraception associated with inhibition of
- •ovulation (oral, injectable, or implantable),
- •* intrauterine device,
- •* intrauterine hormone-releasing system, and
- •* vasectomized partner
- •Abstinence as a form of birth control is generally not allowed in the study
- •unless abstinence is in accordance with a study participant*s preferred and
- •common lifestyle. Study personnel must confirm the continued use of abstinence
- •is still in accordance with the study participant*s lifestyle at regular
- •intervals during the study.
排除标准
- •Study participants are not permitted to enroll in the study if any of the
- •following criterion is met:
- •1. Female study participants who plan to become pregnant during the study or
- •within 20 weeks following final dose of IMP. Male study participants who are
- •planning a partner pregnancy during the study or within 20 weeks following the
- •final dose.
- •2. Study participants who meet any withdrawal criteria in AS0010 or AS0011. For
- •any study participant with an ongoing serious adverse event (SAE), or a history
- •of serious infections (including hospitalizations) in the feeder study, the
- •Medical Monitor must be consulted prior to the study participant*s entry into
- •3. Study participant has a positive or indeterminate interferon gamma release
- •assay in AS0010 or AS0011, unless appropriately evaluated and treated.
研究者
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