NL-OMON32681尚未招募4 期
Prospective study on the effects of etanercept treatment in patients with rheumatoid arthritis who are naive for TNF-alpha blocking therapy or are non-responders to prior treatment with other anti-TNF-alpha medication - Not applicable
适应症
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 200
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 至 99（—）
入选标准
- •1) Patients with the diagnosis rheumatoid arthritis according to the American Rheumatism Association (ARA) 1987 criteria and in ACR 1991 functional classes I, II, and III (see appendix)
- •2) The patient is naive for anti-TNF-alpha therapy or has failed other prior TNF-alpha blockers
- •3) DAS 28 > or <= 3.2
- •4) Failure on two previously used DMARDs
- •5) Age > 18 and < or <= 85 years old
- •6) Use concurrent methotrexate treatment (5 - 30 mg/week; stable since at least 28 days before initiation) 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 < or <= 10 mg/day provided that the dosage has been stable for at least 28 days prior to entry.
排除标准
- •1) Pregnancy
- •2) Breastfeeding
- •3) A history of or current 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
- •4) Acute major trauma
- •5) Therapy within the previous 60 days with:
- •* any experimental drug
- •* alkylating agents, e.g. cyclophosphamide, chlorambucil
- •* antimetabolites
- •* monoclonal antibodies (including infliximab and adalimumab)
- •* growth factors
- •* other cytokines
- •6) 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
- •7) Receipt of any live (attenuated) vaccines within 4 weeks prior to baseline
- •8) Fever (orally measured > 38 °C), chronic infections or infections requiring anti-
- •microbial therapy
- •9) Other active medical conditions such as inflammatory bowel disease, bleeding
- •diathesis, or severe unstable diabetes mellitus
- •10) Manifest cardiac failure (stage III or IV according to NYHA classification)
- •11) Progressive fatal disease/terminal illness
- •12) a history of lymphoproliferative disease or treatment with total lymphoid
- •irradiation.
- •13) A white cell count less than 3.5 x 10^9/l
- •14) Platelet count less than 100 x 10^9/l
- •15) Haemoglobin of less than 5.3 mmol/l
- •16) Body weight of less than 45 kg
- •17) History of drug or alcohol abuse
- •18) Any concomitant medical condition which would in the investigator*s opinion compromise the patient*s ability to tolerate, absorb, metabolize or excrete the study medication.
- •19) Inability to give informed consent
- •20) 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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