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
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 166
- 试验地点
- 1
- 主要终点
- Difference Between Secukinumab and Placebo in Terms of Joint Synovitis as Measured by the Power Doppler Ultrasonography (PDUS) Global OMERACT-EULAR Synovitis Score (GLOESS)
研究概览
简要总结
This study was designed to leverage the sensitivity of ultrasonography available in clinical practice setting to better describe the time course of response to secukinumab (150 mg and 300 mg) on joint synovitis and enthesitis in PsA patients with an inadequate response to non-biologic DMARDs. PDUS changes in joint synovitis will be assessed using the global Outcome Measures in Rheumatology (OMERACT)-European League against Rheumatism (EULAR) synovitis score (GLOESS) and changes in joint enthesitis were assessed using the OMERACT enthesitis score.
详细描述
This was a 52-week, multicenter, international study consisting of a 2 to 4-week Screening period, a 12-week randomized, placebo-controlled double-blind treatment period (Period 1), a 12-week open-label treatment period (Period 2) and a 6-month open-label extension period (Period 3).
Treatment Period 1 is a 12-week placebo-controlled, randomized period primarily designed to demonstrate the early and optimal efficacy of secukinumab vs placebo on joint synovitis using PDUS via the GLOESS and global entheseal score after 12 weeks of treatment.
The main aim of Period 2 was to assess the maintenance or increased magnitude of treatment response on joint synovitis for patients from the original secukinumab groups and to assess the time course of response with secukinumab on joint synovitis in the original placebo group switched to secukinumab from Week 12.
The main aim of Period 3 (extension period) was to allow patients who respond to secukinumab to extend study treatment up to Week 52 or until commercial drug becomes available, whichever occurs sooner.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
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 infusion).
- •At least 1 clinically-involved enthesitis site at Screening and at the Baseline visit (before infusion) defined by SPARCC index different from 0.
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 TNFα 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.
研究组 & 干预措施
Group 1
In Treatment Period-1:
Patients in this group were administered secukinumab with 12 weeks of treatment from baseline.
In Treatment Period-2:
Patients continued to receive the same active dose of secukinumab every 4 weeks until Week 24
In Treatment Period 3 (extension period):
the extension period allowed responder patients the possibility to continue open-label secukinumab treatment up to Week 52
干预措施: AIN457 (secukinumab) (Drug)
Group 2
In Treatment Period-1:
Patients received placebo at baseline and same time points as secukinumab until Week 8.
In Treatment Period-2:
Patients commenced open-label secukinumab every 4 weeks from Week 12, as follows, based on their clinical characteristics at Week 12
In Treatment Period-3:
Open-label secukinumab continued to be assigned to patients
干预措施: AIN457 (secukinumab) (Drug)
Group 2
In Treatment Period-1:
Patients received placebo at baseline and same time points as secukinumab until Week 8.
In Treatment Period-2:
Patients commenced open-label secukinumab every 4 weeks from Week 12, as follows, based on their clinical characteristics at Week 12
In Treatment Period-3:
Open-label secukinumab continued to be assigned to patients
干预措施: Placebo (Drug)
结局指标
主要结局
Difference Between Secukinumab and Placebo in Terms of Joint Synovitis as Measured by the Power Doppler Ultrasonography (PDUS) Global OMERACT-EULAR Synovitis Score (GLOESS)
时间窗: 12 weeks
Mixed model repeated measures (MMRM) analysis of change in Global OMERACT-EULAR Synovitis Score (GLOESS) score at Week 12 (observed data) to compare treatments The range for the GLOESS score is 0 to 144. GLOESS is the ultrasound scoring system measured for 24 pairs of joints. The scoring is from 0 to 3 for each joint; so the minimum score can be 0 and maximum can be 144.
次要结局
- Proportion of Participants With American College of Rheumatology (ACR)-20 Response(Week 12)
- Proportion of Participants With American College of Rheumatology (ACR)-50 Response(Week 12)
- Spondyloarthritis Research Consortium of Canada (SPARCC)(Baseline to Week 12)