An Observational Post-authorization Safety Study of Ustekinumab in the Treatment of Pediatric Patients Aged 6 Years and Older With Moderate to Severe Plaque Psoriasis
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 135
- 试验地点
- 49
- 主要终点
- Number of Participants With Adverse Events
研究概览
简要总结
The purpose of this study is to monitor the long-term safety of ustekinumab in pediatric participants (6 years to 17 years of age at the time of inclusion) with moderate to severe plaque psoriasis, through monitoring for the following adverse events potentially related to immune modulation: serious infections, malignancies and autoimmunity; and to monitor the long-term effects of ustekinumab on growth (weight, height, body mass index) and development (sexual maturity based on the Tanner Scale).
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
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have a confirmed diagnosis of moderate to severe chronic plaque psoriasis
- •Either start therapy with ustekinumab for the treatment of psoriasis within 2 months after the first assessment in the study or have started therapy with ustekinumab in the 12-week period before the first assessment in the study; a. the treatment decision must have been taken independently of and prior to a participant's inclusion in the study; b. where participants have started therapy with ustekinumab before the first assessment in the study, appropriate baseline data at the start of ustekinumab treatment must be documented, including psoriasis area and severity index (PASI), physician global assessment of disease (PGA), body surface area (BSA) and children's dermatology life quality index (CDLQI) scores where available
- •Participants (and/or a legally-acceptable representative/guardian where applicable) must sign a participation agreement/informed consent form (ICF) allowing source data collection and verification in accordance with local requirements and the participants (and/or a legally-acceptable representative/guardian where applicable) must be able to understand and complete the requested patient-reported outcomes (PROs)
- •Be willing to participate in the study
排除标准
- •Is enrolled in an interventional clinical study
研究组 & 干预措施
Participants 6-17 years of Age With Moderate to Severe Plaque Psoriasis
All Participants diagnosed with moderate to severe plaque psoriasis who will either start therapy with ustekinumab within 2 months after the first assessment in the study or have started therapy with ustekinumab in the 12-week period before the first assessment in the study as per routine clinical practice, will be monitored for the long-term safety of ustekinumab and long-term effects of ustekinumab on growth and development. The primary data source for the study will be the medical records of participants and standardized questionnaires (completed by the physician and by the participant/parent).
干预措施: Ustekinumab (Drug)
结局指标
主要结局
Number of Participants With Adverse Events
时间窗: Baseline up to end of data collection ((maximum of 8 years)
An adverse event is any untoward medical occurrence in a patient administered a medicinal product. An adverse event does not necessarily have a causal relationship with the treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to that medicinal product. All participants will be monitored for the long-term safety of ustekinumab for the frequency and severity of adverse events potentially related to immune modulation and of clinical interest such as: serious infections, malignancies, and autoimmunity.
Evaluation of Growth: Height
时间窗: Baseline up to end of data collection (maximum of 8 years)
Growth will be based on height recorded at baseline and throughout the observational period.
Evaluation of Growth: Weight
时间窗: Baseline up to end of data collection (maximum of 8 years)
Growth will be based on body weight recorded at baseline and throughout the observational period.
Evaluation of Growth: Body Mass Index (BMI)
时间窗: Baseline up to end of data collection (maximum of 8 years)
Growth will be based on body weight recorded at baseline and throughout the observational period. Sex and age adjusted BMI will be calculated by dividing the body weight (in kilograms) by the square of height (in meters).
Sexual Maturity Based on the Tanner scale
时间窗: Baseline up to end of data collection (maximum of 8 years)
The Tanner scale is used to measure visible changes during puberty commonly referred to as "Tanner stages". It has 3 components: breasts/genitalia, pubic hair, and growth. Female participants are evaluated for breast development and pubic hair distribution and male participants are evaluated for development of external genitalia and pubic hair distribution, based on a 5-stage ordinal scale ranging from TS 1 (prepubertal/preadolescent characteristics) to TS 5 (mature or adult characteristics).
次要结局
- Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) 50 Response(Baseline up to end of data collection (maximum of 8 years))
- Percentage of Participants Achieving PASI 75 Response(Baseline up to end of data collection (maximum of 8 years))
- Percentage of Participants Achieving PASI 90 Response(Baseline up to end of data collection (maximum of 8 years))
- Percentage of Participants Achieving a Physician's Global Assessment (PGA) Score of 0 or 1(Baseline up to end of data collection (maximum of 8 years))
- Percentage of Participant's Body Surface Area (BSA) Covered by Plaque-type Psoriasis(Baseline up to end of data collection (maximum of 8 years))
- Number of Participants With Comorbidities(Baseline up to end of data collection (maximum of 8 years))
- Change From Baseline in Children's Dermatology Life Quality Index (CDLQI)(Baseline up to end of data collection (maximum of 8 years))