NL-OMON35697尚未招募3 期
Exploratory trial on intra-articular etanercept treatment in inflammatory arthritis - Enbrel i.a
适应症
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1.Provision of a written informed consent
- •2.Age range 18-85
- •3.Presence of active knee, ankle, wrist, elbow or MCP arthritis
- •4.Presence of rheumatoid arthritis, ankylosing spondylitis or psoriatic arthritis
- •-Patients with RA for at least 3 months, diagnosed according to the revised 1987 ACR criteria for the classification of RA
- •-Patients with AS or PsA for at least 3 months, diagnosed according to the modified New York criteria and CASPAR criteria respectively
排除标准
- •- Contra-indication for TNF-blockade or intra-articular treatment
- •- Bone or joint surgery 8 weeks prior to inclusion
- •- Arthroscopy within 2 weeks prior to inclusion, or arthroscopy planned during the time of the study
- •- Intra-articular or parenteral corticosteroids within 3 months prior to inclusion.
- •- Oral corticosteroid therapy exceeding a prednisone equivalent of 10 mg daily within 4 weeks prior to inclusion.
- •- Use of DMARDs other than methotrexate (MTX) within 4 weeks prior to inclusion.
- •- Receipt of a live vaccine within 4 weeks prior to randomization.
- •- Treatment with Etanercept (Enbrel) or any other form of systemic anti-TNFa therapy within 3 months prior to inclusion
- •- Known active bacterial, viral, fungal, mycobacterial or other infection (including tuberculosis, or atypical mycobacterial disease, but excluding fungal infections of nail beds), or any major episode of infection requiring hospitalization or treatment with IV antibiotics within 4 weeks of screening or oral antibiotics within 2 weeks prior to screening. Patients with a positive PPD skin test should take isoniazide for at least 4 weeks before they can be included in the study.
- •- History of recurrent significant infection or history of recurrent bacterial infections.
- •- Primary or secondary immunodeficiency (history of, or currently active).
- •- Pregnant women or nursing (breastfeeding) mothers.
- •- History of cancer in the past 10 years, including solid tumors and hematologic malignancies (except basal cell or squamous cell carcinoma of the skin that have been excised and cured) or a history of cancer more than 10 years ago without curative treatment
- •- Sever heart, kidney, and/or lung disease
研究者
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Exploratory trial on intra-articular etanercept treatment in inflammatory arthritisRheumatoid arthritisPsoriatic arthritisAnkylosing spondylitisReumatoide artritisArtritis psoriaticaZiekte van BechterewNL-OMON23874Prof. dr. P.P. Tak, internist-reumatoloogAfd. Klinische immunologie en reumatologieF4-218Meibergdreef 91105 AZ AmsterdamT 020-566217160
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