EUCTR2011-000276-34-IT进行中（未招募）不适用
Studio multicentrico, randomizzato, in doppio cieco, controllato verso placebo, per dimostrare l’efficacia di secukinumab a 24 settimane e per valutare la sicurezza, la tollerabilita' e l’efficacia a lungo termine fino a 2 anni in pazienti con artropatia psoriasica attiva
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 600
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Male or non-pregnant, non-lactating female subjects at least 18 years of age 2. Diagnosis of PsA classified by CASPAR criteria (see Appendix 2) and with symptoms for at least 6 months with moderate to severe PsA who must have at Baseline =3 tender joints out of 78 and =3 swollen joints out of 76 (dactylitis of a digit counts as one joint each) 3. RF and anti-CCP antibodies negative. 4. Diagnosis of active plaque psoriasis, with at least one psoriatic plaque of =2 cm diameter (but not in intertriginous areas such as armpits, or chest between breasts, or groin) or nail changes consistent with psoriasis or a documented history of plaque psoriasis. SEE PROTOCOL FOR MORE DETAILS
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 568
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 32
排除标准
- •1. Chest X-ray with evidence of ongoing infectious or malignant process, obtained within 3 months of screening and evaluated by a qualified physician. 2. Subjects who have previously been treated with more than 3 different TNFa inhibitors (investigational or approved). 3 Subjects taking high potency opioid analgesics (e.g., methadone, hydromorphone, or morphine). 4 Subjects who have ever received biologic immunomodulating agents except for those targeting TNFa, investigational or approved. 5 Previous exposure to secukinumab or any other biologic drug directly targeting IL-17 or IL-17 receptor. 6 Previous treatment with any cell-depleting therapies including but not limited to anti-CD20 and investigational agents (e.g., CAMPATH, anti-CD4, anti-CD5, anti-CD3, anti-CD19)
研究者
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