An Efficacy Study of Secukinumab in Enthesitis of Psoriatic Arthritis Patients as Measured by Imaging Test
试验速览
- 阶段
- 1 期
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change from Baseline in the Madrid Sonographic Enthesis Index (MASEI) ultrasound enthesitis score
研究概览
简要总结
Given the role of IL-17 in the development of entheseal-driven pathology, a therapeutic strategy aimed at blocking IL-17 would be a logical option for the treatment of enthesitis in psoriatic arthritis patients. This study will be the first randomized trial of a biologic therapy in participants with psoriatic arthritis, using imaging test.
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
- None
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
- •aged 18 years or older,;
- •had received a diagnosis of psoriatic arthritis at least 6 months previously, fulfilled the Classification Criteria for Psoriatic Arthritis (CASPAR);
- •had at least 1 active enthesitis (confirmed by ultrasound) ;
- •had active arthritis (at least 3 tender/painful and 3 swollen joints) ;
- •had active plaque psoriasis (there was no criteria for minimum psoriasis severity) at screening and baseline.
排除标准
- •History of surgery or trauma at the site examined by ultrasound (hand, elbow, knee, ankle, etc.);
- •Local injection of glucocorticoids or other drugs at the site examined by ultrasound in recent 6 weeks;
- •Peripheral neuropathy;
- •Use of IL-17 or IL-12/23 inhibitors in the last 12 months;Use of infliximab, adamumab, golimumab, and cetuzumab in the last 10 weeks;PUVA treatment for the last 4 weeks;Use of topical treatment or UVB phototherapy that may have an effect on psoriasis in the last 2 weeks;
- •recent history of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, metabolic, endocrine, pulmonary, cardiovascular, or neurologic disease; evidence of active or latent or inadequately treated Mycobacterium tuberculosis; aspartate transaminase (AST) or alanine transaminase (ALT) >3x upper limit of normal (ULN) at screening; estimated creatinine clearance <40 mL/min.
研究组 & 干预措施
Secukinumab 300mg
Randomized in a 1:1:1 ratio to secukinumab 300mg or secukinumab 150mg or MTX 15mg qw
干预措施: Secukinumab 300 MG (Drug)
Secukinumab 150mg
Randomized in a 1:1:1 ratio to secukinumab 300mg or secukinumab 150mg or MTX 15mg qw
干预措施: Secukinumab 150 MG (Drug)
methotrexate
methotrexate
干预措施: Methotrexate (Drug)
结局指标
主要结局
Change from Baseline in the Madrid Sonographic Enthesis Index (MASEI) ultrasound enthesitis score
时间窗: Baseline，Week 12 and Week 24
Twelve entheses will be scored in terms of inflammatory and morphological components according to the OMERACT enthesitis composite semi-quantitative scale (0 to 3). The lowest OMERACT score a participant can have at baseline is 1 (based on Inclusion Criterion, which requires at least 1 points in the B-mode or the Doppler mode in at least one active enthesis ). The highest OMERACT score expected at baseline will be 136, assuming that each of the 12 entheses assessed shows a maximum of 3 points in the gray scale score, and a maximum of 3 points in the Doppler score.
次要结局
- Change from Baseline in the OMERACT Heel Enthesitis MRI Scoring System(HEMRIS)(Baseline and Week 24)
- Change from Baseline in HAQ-DI score(Baseline and Week 24)
- Number of participants who achieve Psoriasis Area and Severity Index 75 (PASI 75)(Baseline，Week 12 and Week 24)
- Change from Baseline in the PsASon13 unilateral ultrasound composite score of synovitis(Baseline，Week 12 and Week 24)
- Proportion of patients achieving ACR20、ACR50 and ACR70 response.(Baseline，Week 12 and Week 24)
- Change from Baseline in Dermatology Life Quality Index (DLQI) score(Baseline and Week 24)