NL-OMON30623尚未招募4 期
Effects of adalimumab on biomarkers in synovial tissue in patients with rheumatoid arthritis - Geen verkorte titel
适应症
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 30
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
- •Disease Activity Score (DAS) 28 ><= 3.2
- •Be > 18 years of age and <85 years.
- •Use concurrent methotrexate treatment (5 - 30 mg/week; stable for at least 28 days before study enrolment) during the study. Subjects may be taking nonsteroidal anti-inflammatory drugs, provided the dose and frequency have been stable for at least 28 days. Subjects may be receiving prednisone therapy * 10 mg/day provided that the dosage has been stable for at least 1 month prior to entry.
排除标准
- •A history of or acute inflammatory joint disease of different origin e.g. mixed connective tissue disease, seronegative spondylarthropathy, psoriatic arthritis, Reiter*s syndrome, systemic lupus erythematosus or any arthritis with onset prior to age 16 years
- •Acute major trauma
- •5)Therapy within the previous 60 days with:
- •* any experimental drug
- •* alkylating agents, e.g. cyclophosphamide, chlorambucil
- •* antimetabolites
- •* monoclonal antibodies
- •* growth factors
- •* other cytokines
- •Therapy within the previous 28 days with:
- •* parenteral or intraarticular corticoid injections
- •* oral corticosteroid therapy exceeding a prednisone equivalent of 10 mg daily
- •* present use of DMARDs other than methotrexate
- •Fever (orally measured > 38°C), chronic infections or infections requiring anti-microbial therapy
- •Other active medical conditions such as inflammatory bowel disease, bleeding diathesis, or severe unstable diabetes mellitus
- •Manifest cardiac failure (stage III or IV according to NYHA classification)
- •Impaired coagulation
- •A congenital or acquired immunodeficiency, a history of cancer or lymphoproliferative disease or treatment with total lymphoid irradiation.
- •* (The known HIV-positive status may be defined either by a positive blood test or clinical diagnosis.)
- •Platelet count less than 100 x 109/l
- •Inability to give informed consent
- •Mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study and/or evidence of an uncooperative attitude.
研究者
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