Efficacy of IL-17 Inhibitors on Subclinical Enthesitis in Patients With Moderate to Severe Psoriasis Based on Power Doppler (PD) Ultrasonography (PDUS): a Single-center, Prospective, Exploratory, Open-label Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change of Glasgow Ultrasound Enthesitis Scoring System (GUESS) from baseline to week 24
研究概览
简要总结
It is an observational, single-center, prospective, exploratory, open-label study to assess the efficacy and safety of IL-17 inhibitors on subclinical enthesitis in patients with moderate to severe psoriasis with subclinical enthesitis based on Power Doppler (PD) Ultrasonography (PDUS)
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Adult patients ( ≥ 18 years of age) with chronic plaque-type psoriasis
- •Meet one of the following conditions: Psoriasis Area and Severity Index [PASI] score > 6, or scalp involvement, or nail involvement.
- •Inflammatory changes on ultrasound consistent with OMERACT definition at least at one peripheral attachment point at screening, defined as thickening and/or abnormal echogenicity of tendons or ligaments at the site of their insertion into the bone (within 2 mm of the talar cortex), and active Doppler signals that may indicate structural damage such as bone erosion, syndesmophytes/calcifications
- •Psoriasis is inadequately controlled by current topical therapy or phototherapy
- •Able to sign the informed consent
排除标准
- •Diagnosis of PsA2 according to CASPAR
- •Any known rheumatic disease, positive rheumatoid factor/anti-citrullinated protein antibodies, prior treatment with anti-rheumatic drugs
- •Treatment with systemic corticosteroids within 12 weeks or 5 half-lives of screening
- •Obesity impeded ultrasound examination
- •Pregnant or lactating women or women with plan for conception 5 months before or after treatment
- •Participated in other clinical trials
- •Concurrent significant medical problems, including but not limited to the following: uncontrolled hypertension (systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 95 mmHg), congestive heart failure (NYHA class III or IV), total white blood cell count < 2500/μl, or platelets < 100,000/μl or neutrophils < 1500/μl or hemoglobin < 8.5 g/dL at screening.
- •Any liver function abnormality: aspartate aminotransferase (AST) > 2xULN, alanine aminotransferase (ALT) > 2xULN, total bilirubin (TBIL) > 2xULN
- •Abnormal renal function: serum creatinine > 2.0 mg/dl
- •History of ongoing, chronic or recurrent infectious disease or evidence of tuberculosis infection, defined as a positive PPD skin test or Mycobacterium tuberculosis interferon-gamma release assay (IGRA) test.
- •Current or relevant history of human immunodeficiency virus (HIV), hepatitis B or hepatitis C infection.
- •History of lymphoproliferative disease, or any known malignancy, or history of malignancy of any organ system within the past 5 years
- •Unable or unwilling to undergo repeated venipuncture
- •History of alcohol or drug abuse or evidence of abuse within 6 months prior to baseline
- •History of hypersensitivity to any component of the study drug
- •Did not accept live vaccines within 4 weeks prior to enrollment, do not have plan of vaccination program during the study, and no live vaccines are planned > 6 months after the last dose of the study (herpes zoster vaccine > 12 months)
研究组 & 干预措施
moderate to severe psoriasis with subclinical enthesitis based on PDUS
干预措施: IL-17i (Drug)
结局指标
主要结局
Change of Glasgow Ultrasound Enthesitis Scoring System (GUESS) from baseline to week 24
时间窗: Week 24
Glasgow Ultrasound Enthesitis Scoring System (GUESS) is an ultrasonographic score of lower limb enthesitis including superior pole of the patella-quadriceps tendon enthesis, inferior pole of the patella-proximal patellar ligament enthesis, tibial tuberosity-distal patellar ligament enthesis, superior pole of the calcaneus-achilles tendon enthesis and inferior pole of the calcaneus-plantar aponeurosis enthesis, composed of assessments of degenerative changes such as tendon thickness, existence of enthesitis, bursitis, or erosions. It is calculated as follows: one point was scored for each abnormality at each site examined, giving a possible maximum total score for both lower extremities 36. A higher score of GUESS represents more serve inflammation and involvement of enthesis while a lower score represents better outcomes.
次要结局
- Change of Glasgow Ultrasound Enthesitis Scoring System(GUESS) from baseline to week 4, 12, 36, 52(Week 4, 12, 36, 52)
- Complete resolution of enthesitis from baseline to week 24(Week 24)
- Complete resolution of enthesitis from baseline to week 52(Week 52)
- New bone erosion, bursitis, osteophytes at week 24(Week 24)
- New bone erosion, bursitis, osteophytes at week 52(Week 52)
- Change of patient pain assessment based on Visual Analog Scale (VAS) at week 4, 12, 24, 36, 52(Week 4, 12, 24, 36, 52)
- Change of PASI from baseline to week 24, 52(Week 24, 52)
- Change of BSA% from baseline to week 24, 52(Week 24, 52)
- Change of mNAPSI from baseline to week 24, 52(Week 24, 52)
- Change of PSSI from baseline to week 24, 52(Week 24, 52)
- Change of HAQ-DI from baseline to week 24, 52(Week 24, 52)
- Change of SJC66 and TJC68 from baseline to week 24, 52(Week 24, 52)
- Change of SPARCC enthesitis index from baseline to week 24, 52(Week 24, 52)
- Proportion of patients who progressed to PsA at Week 52(Week 52)
研究者
Wenjun HOU
Dr. Wenjun HOU
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School