NCT03383263已完成不适用
Prospective Multi-Center Observational Study to Assess Persistence, Adherence and Changes in Disease Activity in the Children Population of Juvenile Arthritis Patients Treated With Adalimumab (HUMIRA) in the Routine Clinical Settings in the Russian Federation (PETITE)
AbbVie14 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2018年5月4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
- 70
- 试验地点
- 14
- 主要终点
- Assessing Humira persistence
研究概览
简要总结
The objective of this study is to assess persistence, adherence and changes in disease activity in the children population of juvenile arthritis patients treated with adalimumab (HUMIRA®) in the routine clinical settings in the Russian Federation.
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
- 2 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed diagnosis of polyarticular Juvenile Idiopathic Arthritis (JIA) according to International League of Associations for Rheumatology (ILAR) criteria .
- •Planned treatment with HUMIRA according to the local product label and prescription guidelines. Alternatively, subjects assigned to HUMIRA treatment not more than 1 month prior to inclusion can be enrolled.
- •Negative result of tuberculosis (TB) screening procedure and TB specialist permission to start biologic therapy.
- •Patient's informed consent form signed by the parent or guardian/and by the child, if applicable.
排除标准
- •Has contraindications for the treatment with HUMIRA according to the latest version of the locally approved label.
- •Any biologic drugs taken prior to 3 months of enrolment in the study.
- •Patients treated with any biosimilar version of HUMIRA
- •Previous participation and dropout from this study.
- •Patients participating in another clinical and/or observational study priory 3 months before the enrolment to this study.
结局指标
主要结局
Assessing Humira persistence
时间窗: Up to 30 days after the last dose of the study drug (approximately 52 weeks)
Persistence is defined as the time (in days) between the start date of HUMIRA (adalimumab) treatment and the earliest date of discontinuation of Humira (adalimumab) or drop out of study, or lost to follow up.
次要结局
- Proportion of patients with Humira adherence(Up to Week 48 of treatment)
- Change from baseline in patient (if appropriate in age) or parent overall well-being(From Week 0 to Week 48 of the treatment period)
- Change from baseline in Erythrocyte Sedimentation Rate (ESR)(From Week 0 to Week 48 of the treatment period)
- Proportion of patients with 30% American College of Rheumatology (ACR) pediatric responses(Up to Week 48 of treatment)
- Proportion of patients with predefined Extra-articular manifestations (EAMs)(Up to 48 weeks of the treatment period)
- Proportion of patients with any comorbidity(Up to 48 weeks of the treatment period)
- Change from baseline in number of joints with limited range of motion(From Week 0 to Week 48 of the treatment period)
- Proportion of patient with low diseases activity (1.1 - 2 score)(Up to 48 weeks of the treatment period)
- Change from baseline in 10-joint Juvenile Arthritis Disease Activity Score (JADAS10)(From Week 0 to Week 48 of the treatment period)
- Proportion of patients with 50% American College of Rheumatology (ACR) pediatric responses(Up to Week 48 of treatment)
- Proportion of patients with 70% American College of Rheumatology (ACR) pediatric responses(Up to Week 48 of treatment)
- Change from baseline in physician overall disease activity(From Week 0 to Week 48 of the treatment period)
- Assessing Childhood Health Assessment Questionnaire-Disability Index (CHAQ-DI) score(Up to 48 weeks of the treatment period)
- Change from baseline in number of joints with active arthritis(From Week 0 to Week 48 of the treatment period)
- Proportion of patient with moderate disease activity (2.1 - 4.2 score)(Up to 48 weeks of the treatment period)
- Proportion of patients with missed dosed of HUMIRA(Up to 48 weeks of the treatment period)
研究者
研究点 (14)
Loading locations...
相似试验
已完成
不适用
A Study to Assess Retention Rate, Persistence and Adherence in Population of Spondylarthritis (Ankylosing Spondylitis and Psoriatic Arthritis) Patients Treated With Adalimumab in Routine Clinical Settings in Russian FederationSpondylarthritisAnkylosing Spondylitis (AS)Psoriatic ArthritisNCT02988674AbbVie139
招募中
不适用
Retrospective Observational Study on Infective Complications and Outcome of Patients With ALL Treated With INOInfectionsBacterial InfectionsViral InfectionAcute Lymphoblastic Leukemia, AdultAcute Lymphoblastic Leukemia, in RelapseAcute Lymphoblastic LeukemiaFungal InfectionNCT06025682Gruppo Italiano Malattie EMatologiche dell'Adulto158
终止
不适用
An Observational Study of Pegasys (Peginterferon Alfa-2a) in Patients With HBeAg-Positive Chronic Hepatitis B in VietnamHepatitis B, ChronicNCT01886300Hoffmann-La Roche16
已完成
不适用
Secondary Prevention of Osteoporotic Fractures: a Multiple Center Fracture Liaison Service in GreeceOsteoporosisNCT02637180Hellenic Society for the Study of Bone Metabolism397
已完成
不适用
Multicenter Retrospective Observational Study of Acute Myocarditis in KoreaMyocarditis AcuteNCT05933902Samsung Medical Center841