NCT02132234Unknown4 期
Effects of Biological Treatment on Blood Pressure and Endothelial Function in Patients With Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis
Jagiellonian University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2013年6月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change from baseline in blood pressure
研究概览
简要总结
The aim of this study is to evaluate the influence of anti tumor necrosis factor-alpha (TNF-α) treatment on blood pressure, endothelial function and immune cell phenotype in patients with rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •For patients suffering from rheumatoid arthritis:
- •rheumatoid arthritis diagnosed based on The American Rheumatism Association Criteria from 1987
- •ineffective treatment with 2 disease-modifying antirheumatic drugs (DMARDs) for 6 months each, including treatment with maximal doses of methotrexate for at least 3 months (or intolerance to treatment)
- •high disease activity - Disease Activity Score 28 (DAS 28) > 5,1 measured twice, with a 1-month interval
- •for patients with mainly lower limbs affected with DAS 28 > 3,7
- •For patients suffering from Ankylosing Spondylitis:
- •Ankylosing Spondylitis diagnosed based on Modified New York Criteria
- •ineffective treatment with 2 non-steroidal anti-inflammatory drugs (administered separately) in maximal recommended or maximal tolerated dose for 3 months
- •high disease activity -Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) > 4 measured twice, with a 12-week interval
- •spinal pain > 4cm on 10cm Visual Analogue Scale (VAS) measured twice, with a 12-week interval
- •general disease activity assessment > 5 (0-10 scale) performed after the 2nd VAS and BASDAI assessment
- •For patients suffering from Psoriatic Arthritis:
- •Psoriatic arthritis diagnosed based on the Bennett or Classification Criteria for Psoriatic Arthritis (CASPAR Criteria)
- •If peripheral joints are affected:
- •active disease assessed twice, with a 4-week interval on stable treatment, after 2 DMARDs treatment for at least 4 months
- •Criteria of active disease (all have to be met):
- •At least 5 out of 66 joints swollen - assessed twice, with a 4-week interval
- •At least 5 out of 68 joints tender - assessed twice, with a 4-week interval
- •general disease activity assessment of 4 or 5 in the Likert scale (0- 5 scale) performed by patient
- •general disease activity assessment of 4 or 5 in the Likert scale (0- 5 scale) performed by physician
- •general disease activity assessment > 5 (0-10 scale) performed after 2nd assessment of number of tender and swollen joints
- •If axial joints are affected:
- •Sacroiliac joints affected according to the New York Criteria of Ankylosing Spondylitis
- •Active and severe disease assessed twice, with a 12-week interval, stable treatment, ineffective treatment with 2 nonsteroidal anti-inflammatory drugs (administered separately) in maximal recommended or maximal tolerated dose for 3 months each
- •Criteria of active disease (all must be present):
- •BASDAI > 4 measured twice, with a 12-week interval
- •spinal pain > 4cm on 10 cm in the VAS measured twice, with a 12-week interval
- •general disease activity assessment > 5 (0-10 scale) Patients can take steroid in stable dose within one month - maximal dose 10mg/day of prednisone.
排除标准
- •non-consenting patient
- •pregnancy
- •breast-feeding
- •allergy for the drug or any component
- •cardiac insufficiency (NYHA III or IV)
- •active infection
- •infection within the last 3 months: hepatitis, pneumonia, pyelonephritis
- •opportunistic infection within the last 2 months: active infection of cytomegalovirus, Pneumocystis carinii
- •joint infection within the last 12 months
- •endoprosthesis infection within the last 12 months or any time if the joint was not replaced
- •exacerbation of lung-, kidney-, liver- or heart insufficiency during treatment
- •demyelinating disease or its symptoms
- •pancytopenia or aplastic anemia
- •pre-cancer stage
- •neoplasm within the last 5 years including solid tumors and neoplasm of haematopoietic or lymphatic system with risk of recurrence or progression
- •active alcoholic disease
- •chronic liver disease
研究组 & 干预措施
Biological treatment
Experimental
Patients with high disease activity receiving biological treatment according to rheumatologic indication:
- etanercept 50 mg s.c. every week
- adalimumab 40 mg s.c. every 2 weeks
- certolizumab 400 mg s.c. every 2 weeks for 4 weeks, then 200mg every 2 weeks
- infliximab 3 or 5 mg/kg i.v. 2 and 6 weeks from the first admission, then every 8 weeks
干预措施: Etanercept (Drug)
Biological treatment
Experimental
Patients with high disease activity receiving biological treatment according to rheumatologic indication:
- etanercept 50 mg s.c. every week
- adalimumab 40 mg s.c. every 2 weeks
- certolizumab 400 mg s.c. every 2 weeks for 4 weeks, then 200mg every 2 weeks
- infliximab 3 or 5 mg/kg i.v. 2 and 6 weeks from the first admission, then every 8 weeks
干预措施: Adalimumab (Drug)
Biological treatment
Experimental
Patients with high disease activity receiving biological treatment according to rheumatologic indication:
- etanercept 50 mg s.c. every week
- adalimumab 40 mg s.c. every 2 weeks
- certolizumab 400 mg s.c. every 2 weeks for 4 weeks, then 200mg every 2 weeks
- infliximab 3 or 5 mg/kg i.v. 2 and 6 weeks from the first admission, then every 8 weeks
干预措施: Certolizumab (Drug)
Biological treatment
Experimental
Patients with high disease activity receiving biological treatment according to rheumatologic indication:
- etanercept 50 mg s.c. every week
- adalimumab 40 mg s.c. every 2 weeks
- certolizumab 400 mg s.c. every 2 weeks for 4 weeks, then 200mg every 2 weeks
- infliximab 3 or 5 mg/kg i.v. 2 and 6 weeks from the first admission, then every 8 weeks
干预措施: Infliximab (Drug)
结局指标
主要结局
Change from baseline in blood pressure
时间窗: prior to receiving anti-TNF-α treatment, 12 weeks
Ambulatory Blood Pressure Monitoring (ABPM)
次要结局
- Change from baseline in endothelial function(prior to receiving anti-TNF-α treatment, 12 weeks)
研究者
Tomasz Guzik
MD, PhD
Jagiellonian University
研究点 (1)
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