NL-OMON20706已完成不适用
Prospective study on the effects of adalimumab treatment in patients with rheumatoid arthritis .
AMC, Division of Clinical Immunology & Rheumatology0 个研究点目标入组 50 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
研究概览
简要总结
/A
研究设计
- 研究类型
- Interventional
入排标准
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 ;
- •2. The patient is naïve for anti-TNF-alpha therapy or has failed other prior TNF-alpha blockers;
- •3. DAS 28 => 3.2;
- •4. Age 18 - 85 years old;
- •5. 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 <= 10 mg/day rovided that the dosage has been stable for at least 2 months 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:
- •a. Any experimental drug;
- •b. Alkylating agents;
- •c. Antimetabolites;
- •d. Monoclonal antibodies (including infliximab and etanercept);
- •e. Growth factors;
- •f. Other cytokines;
- •6. Therapy within the previous 28 days with:
- •a. Parenteral or intraarticular corticoid injections;
- •b. Oral corticosteroid therapy exceeding a prednisone equivalent of 10 mg daily;
- •c. 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 ¢XC), chronic infections or infections requiring anti-microbial therapy;
- •9. Known positive reaction to hepatitis B surface antigen or Hepatitis C antigen;
- •10. Other active medical conditions such as inflammatory bowel disease, bleeding
- •diathesis, or severe unstable diabetes mellitus;
- •11. Manifest cardiac failure (stage III or IV according to NYHA classification);
- •12. Progressive fatal disease/terminal illness;
- •13. A congenital or acquired (known HIV-positive status) immunodeficiency;
- •14. A history of lymphoproliferative disease or treatment with total lymphoid
- •irradiation;
- •15. A white cell count less than 3.5 x 109/l;
- •16. Platelet count less than 100 x 109/l;
- •17. Haemoglobin of less than 5.3 mmol/l;
- •18. Body weight of less than 45 kg;
- •19. History of drug or alcohol abuse;
- •20. 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;
- •21. Inability to give informed consent;
- •22. 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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