ISRCTN18043449已完成4 期
A prospective, single-centre, open-label, feasibility study evaluating the prevalence of diagnostic clinical imaging features of subclinical enthesitis in patients with moderate to severe plaque psoriasis and the impact on the MUSculoskeletal system of skin-directed therapy with usTEKinumab
niversity of Leeds (UK)0 个研究点目标入组 73 人开始时间: 2012年9月19日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 73
研究概览
简要总结
2019 results in https://www.ncbi.nlm.nih.gov/pubmed/30468001(added 31/12/2019)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Male and female patients aged 18-80 years
- •2. Diagnosis of plaque psoriasis (dermatologist confirmed)
- •3. Duration of psoriasis greater than twelve months
- •4. Moderate or severe disease [Psoriasis Area and Severity Index (PASI score >10)]
- •5. No prior treatment with systemic or biologic agents
- •6. No current or prior symptoms of psoriatic arthritis (or arthralgia/ articular symptoms)
- •7. Evidence on screening ultrasound of subclinical enthesitis (GUESS score >12)
- •8. All male and female subjects biologically capable of having children must agree to use at least one reliable method of contraception for the duration of the study and for 24 weeks after the end of the study. Acceptable methods of contraception are surgical sterilization, oral, implantable or injectable hormonal methods, intrauterine devices or barrier contraceptives
排除标准
- •1. Patients aged 17 or under, or 81 and over
- •2. Psoriasis of mild to moderate psoriasis (PASI<10)
- •3. Previous treatment with any systemic or biologic agents (for psoriasis or any other indication)
- •4. Patients unable or not willing to attend all imaging, serological and clinical assessments
- •5. Any contraindication to MRI (e.g. pacemaker, aneurysm coil)
- •6. Patients not willing to use adequate contraception
- •7. Pregnancy or breast feeding
- •8. Any contraindication to systemic or biologic therapy:
- •8.1. Active infection, including open leg ulcers, HIV, hepatitis B or C carriers
- •8.2. Active or latent tuberculosis
- •8.3. Malignancy ? current, or previous within the last ten years (except basal cell carcinoma)
- •8.4. Severe heart failure (NYHA grade 3 or more)
- •8.5. Demyelinating disorders
- •8.6. Uncontrolled diabetes
- •8.7. Chronic lung disease (pulmonary fibrosis or bronchiectasis)
- •8.8. Previous PUVA phototherapy (>1000 joules)
- •9. History of other significant medical conditions, including:
- •9.1. Severe pulmonary disease (defined as requiring previous hospital admission or supplemental oxygen)
- •9.2. Active or severe cardiovascular disorders: uncontrolled hypertension, myocardial infarction within the previous twelve months, unstable angina within the previous six months)
- •9.3. Any immunodeficiency disorder
- •9.4. Connective tissue diseases (e.g. primary Sjogrens syndrome, systemic sclerosis, systemic lupus erythematosus, polymyositis)
- •9.5. Renal impairment (creatinine clearance <45ml/min)
- •9.6. Abnormal liver function tests (alanine transferase >3x upper limit of normal)
- •9.7. Blood disorders, i.e. thrombocytopenia (platelets <125x109/l), neutropenia (neutrophils <2.0x109/l) or anaemia (haemoglobin <8g/dl).
- •10. Any forthcoming event that may interrupt participation (e.g. a holiday, elective hospital admission) lasting longer than 14 days
研究者
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