EUCTR2015-002394-38-IT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 - Study of application of Power Doppler ultrasonography (PDUS) to measure response to secukinumab trea
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
- 166
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
- •Patients eligible for inclusion in this study have to fulfill all of the following criteria:
- •1.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.
- •2.Male or female patients at least 18 years of age.
- •3.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.
- •4.Patients must have a total synovitis PDUS score = 2 and inflammation related to PD signal = 2 for at least 2 (affected joints as observed via PDUS) of 48 joints at the Screening visit and at the Baseline visit (before injection).
- •5.At least 1 clinically-involved enthesitis site at Screening and at the Baseline visit (before injection) defined by SPARCC index different from 0.
- •6.Rheumatoid factor and anti-cyclic citrullinated peptide (anti-CCP) negative at Screening.
- •7.Patients with PsA who are taking NSAIDs should be on a stable dose for at least 2 weeks prior to enrollment and remain on a stable dose throughout the 24-week study period.
- •8.Patients with PsA who are taking steroids must have received steroids at least 3 months prior to the Baseline visit and be on a stable dose of = 10 mg equivalent prednisone for at least 4 weeks prior to Baseline visit and remain on a stable dose throughout the 24-week study period unless tolerance issues.
- •9.Patients with PsA who are taking MTX or DMARDs must have received them at least 3 months prior to Baseline visit and be on a stable dose of = 25 mg/week of MTX or stable standard doses of other DMARD(s) (according to the Investigator’s judgment) for at least 4 weeks prior to the Baseline visit and remain on a stable dose throughout the 24-week study period.
- •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 193
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 25
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
相似试验
进行中（未招募）
1 期
Study of application of Power Doppler ultrasonography (PDUS) to measure response to secukinumab treatment in patients with active psoriatic arthritis (PsA)Psoriatic ArthritisMedDRA version: 21.0Level: LLTClassification code 10037160Term: Psoriatic arthritisSystem Organ Class: 100000004859EUCTR2015-002394-38-NLovartis Pharma Services AG164
已完成
3 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 arthritisgewrichtsaandoeningen, reumatische aandoeningenactive psoriatic arthritis10040792NL-OMON47596ovartis10
进行中（未招募）
1 期
Study of application of Power Doppler ultrasonography (PDUS) to measure response to secukinumab treatment in patients with active psoriatic arthritis (PsA)Psoriatic ArthritisEUCTR2015-002394-38-BEovartis Pharma Services AG218
进行中（未招募）
1 期
Study of application of Power Doppler ultrasonography (PDUS) to measure response to secukinumab treatment in patients with active psoriatic arthritis (PsA)Psoriatic ArthritisMedDRA version: 20.0Level: LLTClassification code 10037160Term: Psoriatic arthritisSystem Organ Class: 100000004859EUCTR2015-002394-38-CZovartis Pharma Services AG164
进行中（未招募）
1 期
Study of application of Power Doppler ultrasonography (PDUS) to measure response to secukinumab treatment in patients with active psoriatic arthritis (PsA)MedDRA version: 20.0Level: LLTClassification code 10037160Term: Psoriatic arthritisSystem Organ Class: 100000004859Psoriatic ArthritisEUCTR2015-002394-38-NOovartis Pharma Services AG164