A LONG-TERM, PROSPECTIVE, OBSERVATIONAL COHORT STUDY OF THE SAFETY AND EFFECTIVENESS OF ETANERCEPT IN THE TREATMENT OF PAEDIATRIC PSORIASIS PATIENTS IN A NATURALISTIC SETTING: A POST-AUTHORISATION SAFETY STUDY (PASS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 72
- 试验地点
- 29
- 主要终点
- Number of Participants Who Discontinued From Etanercept After Initial Treatment Period: Prospective Participants
研究概览
简要总结
Psoriasis is a chronic, often severe, autoimmune condition that affects approximately 2% of the world's population. The epidemiology of pediatric psoriasis has not been well documented and no treatment guidelines exist for pediatric psoriasis.
Etanercept is a biologic drug and has been licensed for the treatment of chronic severe plaque psoriasis in children and adolescents (6-17 years of age) who are inadequately controlled by or are intolerant to, other systemic therapies or phototherapies. Although the long-term safety and efficacy of etanercept in children with juvenile idiopathic arthritis (JIA) has been studied and the short-term safety profile of etanercept in both JIA and pediatric psoriasis appears similar, there is limited data available about the long-term effects of etanercept in pediatric psoriasis, especially with respect to malignancy. The aim of this study is to assess the safety and effectiveness of etanercept for the treatment of pediatric psoriasis in Europe. Patients aged <=17 with plaque psoriasis diagnosed by a dermatologist will be invited to participate in the registry only after a clinical decision has been made to prescribe etanercept. The safety of the drug and how well the drug works will be evaluated during the follow-up period. The follow-up period will last 5 years and patients will be followed up every 3 months for the first 2 years and every 6 months for the next 3 years or until the end of study.
详细描述
Non-probability sample
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
- •17 years of age or younger
- •Diagnosed with plaque psoriasis by a dermatologist.
- •Prior to enrollment, there must be a clinical decision to initiate etanercept for the treatment of plaque psoriasis and etanercept must then be initiated.
- •Actively being treated with etanercept, regardless of length of treatment prior to enrollment
- •Willing to provide written informed consent
排除标准
- •Prior therapy with any biologic agent other than etanercept
- •History of malignancy
研究组 & 干预措施
1
pediatric patients with plaque psoriasis on etanercept
干预措施: Etanercept (Drug)
结局指标
主要结局
Number of Participants Who Discontinued From Etanercept After Initial Treatment Period: Prospective Participants
时间窗: Week 24 up to Week 216
Initial treatment period is defined as the period during which participants received Etanercept treatment for a duration of at least 24 weeks.
Percentage of Participants Who Required Subsequent Treatment With Etanercept or Other Systemic Therapies After Completion of Initial Treatment Period: Prospective Participants
时间窗: Week 24 up to Week 216
Participants those who completed the initial treatment period of at least 24 weeks and entered the follow up period, and during the follow up period who required subsequent treatment with etanercept or other systemic therapies were reported.
Number of Participants With Serious Infections, Opportunistic Infections of Interest and Malignancies: Prospective Participants
时间窗: Baseline up to 5 years
Serious infections were defined as any infections those were life-threatening or resulted in disability, infections requiring intravenous antibiotic treatment and hospitalisation. Opportunistic infections of interest included protocol-specified infections due to bacteria: Salmonella bacteremia, Campylobacteriosis, Shigellosis, Mycobacterium tuberculosis, Mycobacterium avium, Mycobacterium kansasii, Syphilis, Pseudomonas aeruginosa, Acinetobacter baumannii, Listeriosis, Nocardiosis, Legionellosis, Actinomycosis, Bartonellosis; Fungal: Aspergillosis, Invasive Candida albicans, Coccidioidomycosis, Cryptococcosis, Histoplasmosis, Blastomycosis, Paracoccidioidomycosis, Sporotrichosis, Penicilliosis, Zygomycosis and Pneumocystosis; Protozoans: Cryptosporidiosis, Isosporiasis, Microsporidiosis, Acanthamoebiasis, Toxoplasmosis, Trypanosomiasis and Leishmaniasis; Viral: Cytomegalovirus, John Cunningham Virus, Disseminated or central nervous system herpes zoster, Kaposi's sarcoma and BK virus.
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs): Prospective Participants
时间窗: Baseline up to 28 days after last dose of study drug (up to 61 months)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both serious and non-serious adverse events.
Number of Participants Who Discontinued From Etanercept During Initial Treatment Period: Prospective Participants
时间窗: Baseline up to 24 weeks
Initial treatment period is defined as the period during which participants received Etanercept treatment for a duration of at least 24 weeks.
次要结局
- Duration of Subsequent Etanercept Treatment After Completion of Initial Treatment Period(Week 24 up to Week 216)