A Prospective and Observational Study for Safety and Effectiveness Evaluation of Rhofanib® (Tofacitinib) in Patients With Alopecia.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 296
- 试验地点
- 1
- 主要终点
- Safety assessment
研究概览
简要总结
The goal of this observational study is to evaluate safety of Rhofanib® (Tofacitinib) in male or female participants with the age of 18 years or older having clinical diagnosis of Alopecia. The main questions are aim to answer:
- Is Rhofanib® (Tofacitinib) safe in Alopecia?
- Is Rhofanib® (Tofacitinib) work to treat Alopecia?
In this study, there is no comparison group. Participants received Rhofanib® (Tofacitinib) with or without adjuvant prednisolone.
详细描述
This study is a phase IV, post-marketing, observational, cohort study for the safety and effectiveness evaluation of Rhofanib® (Tofacitinib) use in Iranian participants with alopecia with at least 40% scalp hair loss, alopecia totalis, or alopecia universalis.
Researchers and investigators gathered data in booklets. Exposure to Rhofanib® (Tofacitinib) in this study was defined as administration of Rhofanib® (Tofacitinib) with a suggested dose of 5 mg twice daily with or without adjuvant prednisolone.
The primary objective of this study was safety assessment, including the incidence of the most common adverse events (AEs), serious adverse events, and death during the study period.
The secondary objective is the effectiveness of Rhofanib® (Tofacitinib) by assessment of the Severity of Alopecia Tool (SALT) score, disease relapse (Patchy or complete scalp hair loss), eyebrow and eyelash status affected by alopecia, and also participants' quality of life-based on Dermatology life quality index (DLQI) during the study period.
This study was a single arm and the sample size of this study was 353 participants.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female with the age of 18 years or older
- •Clinical diagnosis of alopecia areata with at least 40% scalp hair loss, alopecia totalis, or alopecia universalis who are prescribed Rhofanib®
- •Stable or worsening disease for at least 6 months
- •Patients who have given written authorization to use their personal health data for the purpose of this study.
排除标准
- 未提供
研究组 & 干预措施
Participants received Rhofanib® (Tofacitinib)
干预措施: Tofacitinib (Drug)
结局指标
主要结局
Safety assessment
时间窗: Study period ( Up to 6 months)
Safety assessment, including the incidence of AEs. All AEs are classified based on the Medical Dictionary for Regulatory Activities (MedDRA Desktop Browser 4.0 Beta) terms as System Organ Class (SOC) and Preferred Term (PT). All the reported events are graded according to the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0). Moreover, seriousness of AEs is assessed according to International Council for Harmonisation (ICH-E2B) guidelines. The causality relation is assessed based on the World Health Organization (WHO) criteria.
次要结局
- The percentage of change from baseline in the Severity of Alopecia Tool (SALT) Score(Study period (up to 6 months))
- The frequency of relapse disease (Patchy or complete scalp hair loss).(Study period (up to 6 months))
- The frequency and proportion of participants achieved greater or equivalent to one grade improvement in eyelash/ eyebrow scores(Study period (up to 6 months))
- Change in Dermatology Life Quality Index Total Score (DLQI)(Study period (up to 6 months))