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临床试验 NCT06421740 (REACH-AD) 针对特应性皮炎目前招募中。请查看临床试验雷达卡片视图和 AI 发现工具了解所有详情,或在此提出任何问题。 | ||
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An Observational Study to Assess Real-World Use of Upadacitinib Tablets in Adolescent and Adult Participants With Moderate to Severe Atopic Dermatitis in China (REACH-AD) 1,000 真实世界证据 青少年 观察性
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临床试验NCT06421740 (REACH-AD)是一项针对特应性皮炎的观察研究试验,目前试验状态为招募中。试验始于2024年6月7日,计划招募1,000名患者。该研究由艾伯维主导,预计于2026年6月1日完成。试验数据来源于ClinicalTrials.gov,最后更新时间为2026年3月12日。
简要概括
Atopic dermatitis (AD) is a skin condition that may cause a rash and itching due to inflammation of the skin.
Upadacitinib is an approved drug for treating AD. Approximately 1000 adolescents and adult participants who are prescribed upadacitinib by their physician in accordance with local label will be enrolled in up to 40 sites in China.
Participants will receive oral upadacitinib tablets as prescribed by their ph...
显示更多官方标题
REal-world Utilization and Treatment Target ACHievement With Upadacitinib in Adolescents and Adults With Moderate to Severe Atopic Dermatitis in China
疾病
特应性皮炎其他研究标识符
- REACH-AD
- P24-965
NCT编号
实际开始日期
2024-06-07
最近更新发布
2026-03-12
预计完成日期
2026-06
计划入组人数
1,000
研究类型
观察研究
试验状态
招募中
关键词
Upadacitinib
Rinvoq
Rinvoq
试验组/干预措施
| 参与者组/试验组 | 干预措施/治疗方法 |
|---|---|
Upadacitinib Participants will receive upadacitinib as prescribed by their physician according to local label. | 不适用 |
主要终点
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Number of participants with a dose change | Dose change includes: Changed dose, dose escalation or dose tapering. | 12 Months |
Number of participants with Upadacitinib drug compliance | The participants missed medication, regardless of reason, or incompliance with the prescription as per medical advice are to be recorded in the eDiary, choosing the reason: "Forgot, Self-reduction of medication, interruption because of AE, interruption not due to safety/tolerability, for other reasons".
If no eDiary entries are found within 30 days before the visit, the participant will need to complete the following question in ePRO: timely Upadacitinib intake per medical advice in past 30 days (yes/no); if "no", days-off-drug, intentionally or accidentally, and if "intentionally", reason for incompliance with medical prescription. | 12 Months |
Number of participants with interruption or permanent discontinuation | Interruption: Upadacitinib is temporarily interrupted due to atopic dermatitis disease condition, economic, tolerance, AE, or personal reasons, and the investigator considers there is still possibility of Upadacitinib re-initiating within the patient's study follow-up period.
Discontinuation: Upadacitinib is permanently discontinued for safety or any other reasons, and the investigator considers Upadacitinib will not be used again, at least within the participant's study follow-up period. | 12 Months |
参与助手
资格标准
适龄参与研究
儿童, 成人, 老年人
最低年龄要求
12 Years
适龄性别
全部
- Adolescents (body weight >= 40 kg at the Baseline Visit for patients between >= 12 and < 18 years of age) and adults at the time of enrollment.
- Clinical diagnosis of moderate to severe atopic dermatitis at the time of enrollment.
- UPA treatment is indicated for AD and prescribed as per Chinese label / SmPC.
- The decision to prescribe UPA is made prior to and independent of study participation.
- The participant should not be treated with UPA prior to this study.
- Participants who are willing and able to participate in the collection of patient-reported data, including ePROs and eDiary via apps.
- The participant (legal representative for adolescents) voluntarily signed an informed consent before any study-related activities are conducted.
- The participant is currently participating in interventional research (not including noninterventional study, observational study, or registry participation).
- Any circumstances that the investigator believes may limit the patient's participation and compliance with study procedures.
研究中心联系人
联系人: Judy Yu, [email protected]
38 位于 1 个国家/地区的研究中心
Beijing Municipality
Beijing Anzhen Hospital /ID# 273443, Beijing, Beijing Municipality, 100029, China
进行中(不再招募)
China-Japan Friendship Hospital /ID# 274778, Beijing, Beijing Municipality, 100029, China
进行中(不再招募)
Peking University First Hospital /ID# 274865, Beijing, Beijing Municipality, 100034, China
进行中(不再招募)
Peking Unversity Third hospital /ID# 274864, Beijing, Beijing Municipality, 100191, China
进行中(不再招募)
Peking Union Medical College Hospital (East) - Dongdan Campus /ID# 264193, Beijing, Beijing Municipality, 100730, China
进行中(不再招募)
Fujian
The First Affiliated Hospital Of Fujian Medical University /ID# 268210, Fuzhou, Fujian, 350005, China
进行中(不再招募)
Changgeng Hospital /ID# 268209, Xiamen, Fujian, 361022, China
招募中
Guangdong
Guangzhou Dermatology Hospital /ID# 271684, Guangzhou, Guangdong, 510095, China
进行中(不再招募)
The Fifth Affiliated Hospital Of Sun Yat-Sen University /ID# 268618, Zhuhai, Guangdong, 519000, China
招募中
Hainan
Hainan Fifth People's Hospital /ID# 269747, Hainan, Hainan, 200000, China
招募中
Hebei
Hebei Engineering University Affiliated Hospital /ID# 268660, Handan, Hebei, 200000, China
招募中
Heilongjiang
The Second Affiliated Hospital Of Harbin Medical University /ID# 270872, Harbin, Heilongjiang, 150001, China
招募中
Henan
People's Hospital of Henan Province /ID# 269744, Zhengzhou, Henan, 450003, China
招募中
Hubei
Wuhan Integrated TCM & Western Medicine Hospital(Wuhan No.1 Hospital) /ID# 272374, Wuhan, Hubei, 430022, China
招募中
Tongji Hospital /ID# 269745, Wuhan, Hubei, 430030, China
招募中
Hunan
Xiangya Hospital Central South University /ID# 272373, Changsha, Hunan, 410008, China
进行中(不再招募)
Jiangsu
Nanjing Drum Tower Hospital /ID# 268616, Nanjing, Jiangsu, 210008, China
招募中
Affiliated Hospital Of Nantong University /ID# 269743, Nantong, Jiangsu, 226001, China
招募中
The First Affiliated Hospital of Soochow University /ID# 269742, Suzhou, Jiangsu, 215006, China
招募中
The Affiliated Hospital of Xuzhou Medical College /ID# 268208, Xuzhou, Jiangsu, 221006, China
招募中
Liaoning
Dalian Dermatosis Hospital /ID# 272495, Dalian, Liaoning, 116041, China
进行中(不再招募)
The People's Hospital of Liaoning Province /ID# 268206, Shenyang, Liaoning, 110016, China
已完成
Shandong
Shandong Provincial Hospital /ID# 268661, Jinan, Shandong, 250001, China
招募中
Jining Medical University - Affiliated Hospital /ID# 270873, Jining, Shandong, 272029, China
招募中
Weifang People'S Hospital /ID# 268659, Weifang, Shandong, 261041, China
招募中
Shanghai Municipality
Ruijin Hospital /ID# 268658, Shanghai, Shanghai Municipality, 200025, China
进行中(不再招募)
Huashan Hospital Of Fudan University /ID# 270277, Shanghai, Shanghai Municipality, 200040, China
招募中
Shanghai Sixth People'S Hospital /ID# 268617, Shanghai, Shanghai Municipality, 200233, China
招募中
Shanghai Skin Disease Hospital /ID# 268657, Shanghai, Shanghai Municipality, 200443, China
招募中
Sichuan
West China Hospital of Sichuan University /ID# 268313, Chengdu, Sichuan, 610041, China
进行中(不再招募)
Sichuan Provincial People's Hospital /ID# 268314, Chengdu, Sichuan, 610072, China
招募中
The Affiliated Hospital Of Southwest Medical University /ID# 268207, Luzhou, Sichuan, 646600, China
招募中
Xinjiang
People's Hospital of Xinjiang Uygur Autonomous Region /ID# 269746, Ürümqi, Xinjiang, 830001, China
招募中
Yunnan
The First Affiliated Hospital of Kunming Medical College /ID# 273451, Kunming, Yunnan, 650032, China
招募中
Zhejiang
Zhejiang Provincial Hospital of Chinese Medicine /ID# 268613, Hangzhou, Zhejiang, 310006, China
招募中
Ningbo No.6 hospital /ID# 268315, Ningbo, Zhejiang, 315040, China
招募中
Taizhou Central Hospital /ID# 268211, Taizhou, Zhejiang, 318000, China
招募中
Zhuji People'S Hospital /ID# 268614, Zhuji, Zhejiang, 315000, China
招募中