A Phase IV Open Label, Multicentre, Investigational Study of the Therapeutic Options for Subjects Discontinuing Efalizumab Therapy and Experiencing Inflammatory Disease Recurrence
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 41
- 主要终点
- Physician's Global Assessment (PGA) of Change Over Time (Good or Better)
研究概览
简要总结
This is a pilot investigational study of the appropriate therapeutic regimens to treat subjects experiencing inflammatory recurrence (rebound) of psoriatic disease upon discontinuation of efalizumab therapy and of the biological mechanisms involved in inflammatory disease recurrence and control.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participation in Genentech study ACD2601g, Genentech study HUPA 600 or Serono study IMP
- •Inflammatory psoriasis disease recurrence occurring up to 2 months after discontinuation of efalizumab that required immediate therapeutic control in the opinion of the Investigator. Psoriasis had to be rapidly developing, symptomatic and inflammatory in nature.
- •Written informed consent, given prior to any study-related procedure not part of the subject's normal medical care, with the understanding that the subject could withdraw consent at any time without prejudice to his or her future medical care.
- •Female subjects had to be neither pregnant nor breast-feeding, and had to lack childbearing potential, as defined by either:
- •Being post-menopausal or surgically sterile, or
- •Using an accepted form of contraception.
- •Confirmation that the subject was not pregnant had to be established by a negative urinary hCG test at SD
- •A pregnancy test was not required if the subject was post-menopausal or surgically sterile.
- •Outpatient status at the time of enrolment.
排除标准
- •Disease recurrence that was part of the natural disease progression, was not inflammatory in nature, and was not related to efalizumab study medication in the previous study.
研究组 & 干预措施
Cyclosporin
Starting dose 4.0 - 5.1 mg/kg/day until clinical improvement. Upon clinical improvement, cyclosporin dose to be tapered by 50% every two weeks.
干预措施: Cyclosporins (Drug)
Retinoids
Starting dose 25 - 50 mg/day until clinical improvement. Upon clinical improvement, retinoid dose to be reduced by 50%. Thereafter, treatment to be continued for 8 weeks and then stopped.
干预措施: Retinoids (Drug)
Systemic corticosteroids
Starting dose 0.25 - 0.5 mg/kg/day until clinical improvement. Upon clinical improvement, corticosteroid dose to be reduced by 50%. Thereafter, corticosteroids to be weaned by 50% every 2 weeks.
干预措施: Systemic corticosteroids (Drug)
Methotrexate
Starting dose 20 - 25 mg per week until clinical improvement. Upon clinical improvement, dose to be reduced by 25%. Thereafter, methotrexate dose to be reduced by 25% every two weeks.
干预措施: Methotrexate (Drug)
Systemic corticosteroids/methotrexate
Corticosteroid starting dose 0.25 - 0.5 mg/kg/day until clinical improvement. Upon clinical improvement, corticosteroid dose to be reduced by 50%.
Thereafter, to be weaned by 50% every 2 weeks. Methotrexate starting dose 20 - 25 mg per week until clinical improvement. Upon clinical improvement, dose to be reduced by 25%. Thereafter, to be reduced by 25% every two weeks.
干预措施: Systemic corticosteroids/methotrexate (Drug)
结局指标
主要结局
Physician's Global Assessment (PGA) of Change Over Time (Good or Better)
时间窗: 12 weeks
The PGA response was classified according to the following categories by changes in all clinical signs and symptoms as compared to baseline: Cleared: Remission except for residual manifestations such as mild erythema (100% improvement) Excellent: Improvement of 75%-99% except for residual manifestations such as mild erythema Good: Improvement of 50%-74%
次要结局
- Patient's Global Psoriasis Assessment (PGPA)(12 weeks)