ISRCTN36847425已完成不适用
Identification of predictive factors in synovial samples for the clinical response to tumour necrosis factor-alpha blockade in rheumatoid arthritis
Academic Medical Centre (AMC) (The Netherlands)0 个研究点目标入组 143 人开始时间: 2007年2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
- 143
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
- 性别
- All
入选标准
- •1. Men/women suffering from rheumatoid arthritis, based on the American Rheumatism Association (ARA) 1987 criteria, who failed at least one Disease Modifying Anti-Rheumatic Drug (DMARD) including methotrexate, will be included in the study
- •2. Patients in ARA functional classes I, II, and III may be included
- •3. In addition the patients must fulfill the following criteria at baseline:
- •a. Disease Activity Score (DAS 28) more than 3.2
- •b. patients global evaluation of his/her rheumatoid condition assessed as fair, poor or very poor and
- •investigators global evaluation of patients rheumatoid condition assessed as fair, poor or very poor
- •c. more than 18 years of age and less than or equal to 85 years
- •d. 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 of less than or equal to 10 mg/day provided that the dosage has been stable for at least two months prior to entry
排除标准
- •1. Pregnancy
- •2. Breastfeeding
- •3. 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
- •4. Acute major trauma
- •5. Previous therapy at any time with: TNF-alpha directed monoclonal antibodies or p75 TNF receptor fusion protein
- •6. Therapy within the previous 60 days with:
- •a. any experimental drug
- •b. alkylating agents, e.g. cyclophosphamide, chlorambucil
- •c. antimetabolites
- •d. monoclonal antibodies
- •e. growth factors
- •f. other cytokines
- •7. Therapy within the previous 28 days with:
- •a. parenteral or intra-articular corticoid injections
- •b. oral corticosteroid therapy exceeding a prednisone equivalent of 10 mg daily
- •c. present use of DMARDs other than methotrexate
- •8. A history of hypersensitivity to the study medication or to drugs with similar chemical structure
- •9. Fever (orally measured as more than 38°C), chronic infections or infections requiring anti-microbial therapy
- •10. Known positive reaction to hepatitis B surface antigen
- •11. Other active medical conditions such as inflammatory bowel disease, bleeding diathesis, or severe unstable diabetes mellitus
- •12. Manifest cardiac failure (stage III or IV according to New York Heart Association [NYHA] classification)
- •13. Progressive fatal disease/terminal illness
- •14. Impaired coagulation
- •15. A congenital or acquired (known Human Immunodeficiency Virus [HIV]-positive status) 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), or a haematopoietic disease
- •16. A white cell count less than 3.5 x 10^9/l
- •17. Platelet count less than 100 x 10^9/l
- •18. Haemoglobin of less than 5.3 mmol/l
- •19. Body weight of less than 45 kg
- •20. History of drug or alcohol abuse
- •21. Any concomitant medical condition which would, in the investigators opinion, compromise the patients ability to tolerate, absorb, metabolise or excrete the study medication
- •22. Inability to give informed consent
- •23. 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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