EUCTR2015-004477-32-IS进行中（未招募）1 期
A randomized, double-blind, active control, multicenter study to evaluate the efficacy at week 52 of subcutaneously administered secukinumab monotherapy compared with subcutaneously administered adalimumab monotherapy in patients with active psoriatic arthritis - EXCEED 1
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
- 850
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
- •- Diagnosis of PsA classified by CASPAR; Rheumatoid factor and anti-CCP antibodies negative; diagnosis of active plaque psoriasis, with at least one psoriatic plaque of =2cm diameter or nail changes consistent with psoriasis or documented history of plaque psoriasis; inadequate control of symptoms with NSAIDs; inadequate control of symptoms with a conventional DMARD.
- •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 765
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 85
排除标准
- •- Pregnant or nursing women, evidence of ongoing infectious or malignant process; previous exposure to any biologic drug for Psoriatic Arthritis or Psoriasis; subjects taking high potency opioid analgesics; ongoing use of prohibited psoriasis treatments / medications; previous treatment with any cell-depleting therapies including but not limited to anti-CD20, investigational agents
- •Other protocol-defined exclusion criteria may apply.
研究者
相似试验
进行中（未招募）
1 期
Efficacy of secukinumab compared to adalimumab in patients with psoriatic arthritisPsoriatic ArthritisMedDRA version: 21.0Level: LLTClassification code 10037160Term: Psoriatic arthritisSystem Organ Class: 100000004859EUCTR2015-004477-32-PLovartis Pharma AG853
进行中（未招募）
1 期
Efficacy of secukinumab compared to adalimumab in patients with psoriatic arthritisMedDRA version: 21.0 Level: LLT Classification code 10037160 Term: Psoriatic arthritis System Organ Class: 100000004859Psoriatic ArthritisEUCTR2015-004477-32-LTovartis Pharma AG853
进行中（未招募）
1 期
Efficacy of secukinumab compared to adalimumab in patients with psoriatic arthritisPsoriatic ArthritisMedDRA version: 20.0 Level: LLT Classification code 10037160 Term: Psoriatic arthritis System Organ Class: 100000004859EUCTR2015-004477-32-CZovartis Pharma AG853
进行中（未招募）
1 期
Efficacy of secukinumab compared to adalimumab in patients with psoriatic arthritisPsoriatic ArthritisMedDRA version: 21.0 Level: LLT Classification code 10037160 Term: Psoriatic arthritis System Organ Class: 100000004859EUCTR2015-004477-32-DKovartis Pharma AG853
进行中（未招募）
1 期
Efficacy of secukinumab compared to adalimumab in patients with psoriatic arthritisMedDRA version: 20.0Level: LLTClassification code 10037160Term: Psoriatic arthritisSystem Organ Class: 100000004859Psoriatic ArthritisEUCTR2015-004477-32-BGovartis Pharma AG853