2023-508077-85-00招募中3 期
A multi-center, open-label extension study of subcutaneous secukinumab to evaluate the long-term safety and tolerability in polymyalgia rheumatica (PMR)
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 163
- 试验地点
- 63
- 主要终点
- Incidence of adverse events (AEs) and serious adverse events (SAEs)
研究概览
简要总结
To evaluate long-term safety as assessed by occurrence of adverse events/serious adverse events (AEs/SAEs)
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Participants who have completed 52-week Treatment Period as per protocol in a Novartis study of secukinumab in PMR patients (the “core study” - Study CAIN457C22301), AND • who have experienced a relapse during the treatment-free follow-up period of the core study, AND • who have not been on rescue treatment. Relapse is defined as recurrence of symptoms of PMR or as detection of signs and symptoms of a new-onset GCA that requires an increase of GC dose, re-initiation of GC treatment, or other changes in treatment of PMR.
- •The participant would potentially derive benefit from secukinumab, and the benefit outweighs the risk, based on the investigator’s judgement.
排除标准
- •Use of prohibited medications as specified in Section 6.8.2
- •History of ongoing, chronic or recurrent infectious disease (i.e., human immunodeficiency virus (HIV), hepatitis B (HBV), hepatitis C (HCV), active tuberculosis infection (TB))
- •History of lymphoproliferative disease or any known malignancy or history of malignancy of any organ system within the past 5 years (except for basal cell carcinoma or actinic keratosis that have been treated with no evidence of recurrence in the past 3 months carcinoma in situ of the cervix or non-invasive malignant colon polyps that have been removed).
- •Live vaccinations (e.g., monkey pox vaccine, oral polio vaccine, varicella/zoster vaccines) within 6 weeks prior to Baseline
- •Subjects whose participation in the extension study could expose them to an undue safety risk including but not limited to below: • Current severe progressive or uncontrolled disease which in the judgment of the investigator renders the subject unsuitable for the study. • Underlying conditions (including, but not limited to metabolic, hematologic, renal, hepatic, pulmonary, neurologic, endocrine, cardiac, infectious or gastrointestinal, such as active inflammatory bowel disease), which in the opinion of the investigator significantly immunocompromises the patient and/or places the patient at unacceptable risk for receiving an immunomodulatory therapy.
结局指标
主要结局
Incidence of adverse events (AEs) and serious adverse events (SAEs)
Incidence of adverse events (AEs) and serious adverse events (SAEs)
次要结局
未报告次要终点
研究者
Novartis Pharma Arzneimittel GmbH
Scientific
Novartis Pharma AG
研究点 (63)
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