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临床试验/NCT04541810
NCT04541810已完成不适用

Post-marketing Surveillance to Evaluate the Safety and Effectiveness of Upadacitinib in Korean Patients

AbbVie116 个研究点 分布在 1 个国家目标入组 2,369 人开始时间: 2021年1月26日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
2,369
试验地点
116
主要终点
Percentage of Participants With Adverse Events

研究概览

简要总结

Rheumatoid Arthritis (RA) is an inflammatory disease of the joints characterized by the swelling of multiple joints and tenderness caused by progressive inflammatory synovitis, which leads to serious and debilitating diseases. Atopic dermatitis (AD) is a skin condition that may cause a rash and itching due to inflammation of the skin. Ankylosing Spondylitis (AS) is a form of chronic arthritis causing inflammation in the spine. This can cause pain and stiffness in the back. Psoriatic arthritis (PsA) is a type of arthritis (swelling and stiffness in the joints) that is frequently seen in trial participants who also have the skin condition psoriasis. It is caused by the body's immune system mistakenly attacking healthy joint tissue causing inflammation, joint damage, disability, and a reduced life expectancy. This study will assess the adverse events and change in disease symptoms in Korean participants with RA, AD, AS or PsA.

Upadacitinib is a drug approved for the treatment of moderately to severely active rheumatoid arthritis, atopic dermatitis, ankylosing spondylitis or psoriatic arthritis. Korean participants who have been prescribed upadacitinib by their physicians will be enrolled. Approximately, 3600 participants will be enrolled this study, in multiple sites within Korea.

Participants will receive Upadacitinib as prescribed by the physician and will be followed for approximately 28 weeks.

There will be no additional burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the course of the study at a hospital or clinic and will be asked to provide additional information by questionnaire at each visit.

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
12 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult participants (>= 19 years of age), Atopic dermatitis includes both adolescents (>= 12 years of age) and adults.
  • Participants suitable for the treatment with upadacitinib according to the approved local label.

排除标准

  • - Participants for whom the drug is contraindicated in the approved local label.

研究组 & 干预措施

Participants receiving Upadacitinib

Participants receiving Upadacitinib as prescribed by their physician per local label.

结局指标

主要结局

Percentage of Participants With Adverse Events

时间窗: Up to approximately 6 years

An adverse event (AE) is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with their treatment.

Percentage of Participants Achieving Responder Status Based on Eczema Area and Severity Index (EASI) (Atopic Dermatitis Participants Only)

时间窗: Up to 16 weeks

Responder is a participant who achieve EASI 75.

Percentage of Participants Achieving the Responder status Based on Active Joint Count (Psoriatic Arthritis Participants Only)

时间窗: Up to 12 weeks

Responder is a participant who achieve 30% or more reduction in Tender Joint Count and Swollen Joint Count compared to Baseline.

Percentage of Participants Achieving Responder Status Based on Disease Activity Score 28 Joints (DAS28) (Rheumatoid Arthritis Participants Only)

时间窗: Up to 24 weeks

Responder is a participant whose DAS28 at week 24 decreased by 1.2 or more compared to baseline.

Percentage of Participants Achieving Responder Status Based on Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) (Ankylosing Spondylitis Participants Only)

时间窗: Up to 12 weeks

Responder is a participant whose BASDAI at week 12 decreased by 50% or more than 2 compared to the baseline.

次要结局

未报告次要终点

研究者

发起方
AbbVie
申办方类型
Industry
责任方
Sponsor

研究点 (116)

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