EUCTR2015-002394-38-NL进行中（未招募）1 期
A 52-week, multicenter study to assess the time course of response to secukinumab on joint inflammation using Power Doppler ultrasonography in patients with active psoriatic arthritis
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 164
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
- •- Patient must be able to understand and communicate with the
- •Investigator and comply with the requirements of the study and must
- •provide written, signed and dated informed consent before any study
- •assessment is performed.
- •- Male or female patients at least 18 years of age.
- •- Diagnosis of PsA as per CASPAR with active PsA for at least 6 months
- •and a TJC = 3 of 78 and SJC = 3 of 76 at Baseline.
- •- Patients must have a total synovitis PDUS score = 2 and inflammation
- •related to PD signal = 1 for at least 2 (affected joints as observed via
- •PDUS) of 48 joints at the Screening visit and at the Baseline visit (before
- •- At least 1 clinically-involved enthesitis site at Screening and at the
- •Baseline visit (before infusion) defined by SPARCC index different from
- •Other protocol defined inclusion criteria may apply.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 145
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 19
排除标准
- •-Chest X-ray or chest MRI with evidence of ongoing infectious or malignant process obtained within 3 months prior to Screening and evaluated by a qualified physician.
- •-Previous exposure to secukinumab or other biologic drug directly targeting IL-17 or IL-17 receptor.
- •-Any change in the dose of oral corticosteroids in the last 4 weeks prior to the Baseline visit or use of i.v. intramuscular or intra-articular corticosteroid during the last 4 weeks prior to the enrollment visit.
- •-Patients who have previously been treated with TNFa inhibitors (investigational or approved).
- •-History of hypersensitivity to the study drug or its excipients or to drugs of similar classes.
- •-Previous treatment with any cell-depleting therapies including but not limited to anti CD20 investigational agents (e.g. CAMPATH, anti-CD4, anti-CD5, anti-CD3, anti CD19).
- •-Prohibited psoriasis treatments/medications with topical corticosteroids in the last 4 weeks prior to randomization.
- •-Pregnant or nursing (lactating) women.
- •Other protocol defined exclusion criteria may apply.
研究者
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