Evaluation of TWEAK in Plaque Psoriasis and Psoriatic Arthritis Patients Treated With Adalimumab and Methotrexate: Case Control Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Treatment of psoriasis vulgaris and psoriatic arthritis
研究概览
简要总结
Psoriasis vulgaris is associated with significant comorbidity including depression, increased risk of cardiovascular events, diminished quality of life, as well as overall increased mortality.
Moreover, concomitant psoriatic arthritis is present in up to 40% of psoriasis patients or will develop in the future.
To enhance quality of life and potentially lower the risk of concomitant disease in psoriasis patients, effective treatment of this immune-mediated systemic inflammatory disease is required
详细描述
Psoriasis vulgaris is associated with significant comorbidity including depression, increased risk of cardiovascular events, diminished quality of life, as well as overall increased mortality.
The cytokine tumor necrosis factor (TNF)-related weak inducer of apoptosis (TWEAK), in cooperation with its sole receptor, Fn14, is involved in miscellaneous biological and pathological processes .
The main role of TWEAK is in the induction of pro-inflammatory cytokines and chemokines. The upregulation of TWEAK and Fn14 occurs in many human skin disorders, including cutaneous lupus erythematosus, bullous pemphigoid, and dermatomyositis . There is a lack of studies examining the role of TWEAK in patients with psoriasis or psoriatic arthritis.
The introduction of anti-tumor necrosis factor-α inhibitors (anti-TNF agents) has significantly improved outcomes among patients with PsA but a proportion of patients have an inadequate response or poor tolerability to these agents.
Adalimumab treatment continuation in routine clinical practice may lead to benefits for remission and low disease activity among patients with psoriasis, psoriatic arthritis, or axial spondyloarthritis who did not achieve their treatment goals at 12 weeks, according to recent findings.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients of both sexes with psoriasis vulgaris and Psoriatic arthritis.
- •Active PsA with three or more tender and swollen joints and met the CASPAR, despite previous treatment with NSAIDs, DMARDs or anti-TNFs
排除标准
- •Previously received biologic immunomodulating agents, except for those targeting TNF
- •Previously been treated with three or more different TNF inhibitors
- •Active, ongoing inflammatory diseases other than PsA
- •Active TB (patients with latent TB had to commence treatment for latent TB before study entry)
- •A history of hepatitis B or C, human immunodeficiency virus, or any active systemic infection within the 2 weeks before baseline
- •History of ongoing, chronic or recurrent infections, or evidence of active TB infection
- •History of malignancy within the past 5 years (except for basal cell carcinoma or actinic keratosis that has been treated with no evidence of recurrence in the past 3 months, in situ cervical cancer or non-invasive malignant colon polyps that had been removed)
- •Underlying metabolic, hematological, renal, hepatic, pulmonary, neurological, endocrine, cardiac, infectious or gastrointestinal conditions which, in the opinion of the investigator, immunocomprimised the patient and/or placed the patient at unacceptable risk for participation
- •Pregnant or nursing (lactating) women and women of child-bearing potential unwilling to use effective contraception during the study and for 16 weeks after stopping treatment
研究组 & 干预措施
Group A : (Adalimumab therapy)
About 30 patients suffering from Plaque Psoriasis and will take Adalimumab therapy orally.
Correlation between serum& TWEAK levels and Psoriasis Area and Severity Index (PASI) score and the ACR score pre and post Adalimumab therapy
干预措施: Adalimumab (Drug)
Group B : (methotrexate therapy)
About 30 patients suffering from Psoriatic arthritis and will take methotrexate therapy orally.
Correlation between serum& TWEAK levels and Psoriasis Area and Severity Index (PASI) score and the ACR score pre and post methotrexate therapy
干预措施: Adalimumab (Drug)
Group C: (control Group):
About 40 healthy individuals selected as control group as related to age, sex ,BMI matching with healthy individuals
干预措施: Adalimumab (Drug)
结局指标
主要结局
Treatment of psoriasis vulgaris and psoriatic arthritis
时间窗: 1 year
to see the efficacy of drug study in improving the prognosis of patients with psoriasis vulgaris and psoriatic arthritis.
次要结局
- Evaluation of serum TWEAK(1 year)