DRKS00010485已完成不适用
Prospective multicenter Study to evaluate the Effect of tight and systematic monitoring by Ultrasound on Therapy and Outcome in Patients with early rheumatoid Arthritis - US Impera Study
Charité Universitätsmedizin Berlin -Med. Klinik mit SP Rheumatologie und Klin. Immunologie0 个研究点目标入组 453 人开始时间: 2016年6月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 453
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 性别
- All
入选标准
- •Patients, at least 18 years of age, with currently active RA with or without re-ceiving DMARDs. Active disease is defined as DAS 28 > 3.2 and at least swollen joint count (SJC) = 3 and tender joint count (TJC) = 3 included in the 28 joint count.
- •Early RA (= 2 years from time of onset of arthritic symptoms)
排除标准
- •Patients receiving biologics
- •Patients with other chronic inflammatory articular disease or systemic autoimmune disease
- •Patients with erosions in conventional radiography taken less than 3 months before start of study
- •Patients participating in other studies
- •Any active infection, a history of recurrent clinically significant infection, a history of recurrent bacterial infections with encapsulated organisms (known Hepatitis B, C and HIV)
- •Primary or secondary immunodeficiency
- •History of cancer with curative treatment not longer than 5 years ago except basal-cell carcinoma of the skin that had been excised
- •Evidence of significant uncontrolled concomitant diseases or serious and / or uncontrolled diseases that are likely to interfere with the evaluation of the patient's safety and of the study outcome
- •Women lactating, pregnant, nursing or of childbearing potential with a positive pregnancy test or planned pregnancy.
- •Women of childbearing potential without adequate contraception (medically acceptable methods are contraceptive implant, contraceptive injection, intrauterine device (IUD), or oral contraceptives taken for at least 3 months, which the patient agrees to continue using during the study, or a double-barrier method which must consist of a combination of any of the following: diaphragma, cervical cap, comdom, or spermicide)
- •History of alcohol, drug or chemical abuse (defined as impaired / questionable reliability) as well as neurotic personality.
- •Neuropathy that can interfere with filling out the patient's questionnaires
- •History of a severe psychological illness or condition
- •Severe heart failure (New York Heart Association Class III and IV) or severe, uncontrolled cardiac disease
- •Women lactating, pregnant, nursing or child bearing potential with a positive pregnancy test or planned pregnancy.
- •Women of childbearing potential without adequate contraception (medically acceptable methods are contraceptive implant, contraceptive injection
- •no written consent
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