Comparative Study Between Apremilast and Adalimumab in Psoriatic Arthritis Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Disease Activity Index for Psoriatic Arthritis
研究概览
简要总结
The aim of this work is to compare the efficacy of Apremilast combined with Methotrexate versus Adalimumab combined with Methotrexate
详细描述
Psoriatic arthritis is a heterogeneous chronic systemic auto-immune disease, with variable musculoskeletal involvement as well as skin and nail disease . Up to 30% of patients with psoriasis may develop Psoriatic arthritis over the course of their lifetime. Musculoskeletal manifestations of Psoriatic arthritis include peripheral arthritis, spondylitis, dactylitis and enthesitis.
The pathogenesis of Psoriatic arthritis is still unclear, due to the heterogeneity of the pathogenic pathways involved, the variable clinical manifestations, and different responses to treatment.
A predisposing genetic background in the presence of environmental factors, such as infections, microbiota (dysbiosis), obesity, biomechanical stress could activate the immune system and precipitate the onset of the disease.
Objectives:
- Assessment of the effect of the studied drugs on the disease activity clinically and laboratory in PsA patients.
- Assessment of the effect of the studied drugs on functional status of PsA patients.
- Evaluation of the effect of the studied drugs on the musculoskeletal ultrasound findings of PsA patients
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 (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •This study will include 60 adult Psoriatic arthritis patients >18 years old, fulfilling the (CASPAR) classification criteria of Psoriatic arthritis and have an inadequate response to methotrexate therapy for at least 3 months.
- •Psoriatic arthritis patients with peripheral musculoskeletal domains (peripheral arthritis, dactylitis and enthesitis) as well as skin and nail domains
排除标准
- •Patients who received previous biologic agents or Janus kinase inhibitors.
- •Patients with axial and ocular involvement.
- •Current or recent serious infection including tuberculosis or hepatitis B/C .
- •Current or past history of malignancy (within five year).
- •Pregnant or breastfeeding women or women planning pregnancy during the study period .
- •Severe uncontrolled comorbidities such as heart failure, severe liver disease, or chronic kidney disease (eGFR <30 mL/min/1.73m²) .
研究组 & 干预措施
Group I
consists of 30 PsA patients who will receive Adalimumab with methotrexate therapy for 3 months.
干预措施: Adalimumab (Drug)
Group II
consists of 30 PsA patients who will receive Apremilast with methotrexate therapy for 3 months.
干预措施: Apremilast (Drug)
结局指标
主要结局
Disease Activity Index for Psoriatic Arthritis
时间窗: 3 months
Assessment of disease activity in psoriatic arthritis patients by Disease Activity Index for Psoriatic Arthritis
次要结局
- Health assessment questionnaire disability index(3 months)
- Psoriasis Area and Severity Index(3 months)
研究者
MenaaAllah Mohamed Elmalla
Assistant Lecturer of Rheumatology, Rehabilitation & Physical Medicine
Tanta University