ANTI TNF ANTIBODY D2E7 IV INJECTION IN RHEUMATOID ARTHRITIS

抗TNF抗体D2E7静脉注射治疗类风湿性关节炎

• 批准号: 6265190
• 负责人: MICHAEL H WEISMAN
• 金额: $ 1.15万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN DIEGO
• 依托单位国家: 美国
• 财政年份: 1998
• 资助国家: 美国
• 起止时间: 1998-12-01 至 1999-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6265190
• 关键词: antibody; clinical research; clinical trial phase I; combination chemotherapy; dosage; drug screening /evaluation; drug tolerance; human subject; human therapy evaluation; immunogenetics; intravenous administration; methotrexate; rheumatoid arthritis; sign /symptom; skeletal disorder chemotherapy; synovitis; tumor necrosis factor alpha

Investigate the clinical pharmacology profile, safety, tolerability, immunogenicity and early signs of clinical efficacy following repeated administration of ascending doses of D2E7 in patients with rheumatoid arthritis treated concomitantly with methotrexate. Evaluate onset, magnitude and duration of effects of a combination of D2E7 and methotrexate on inflammatory synovitis, assessed by standard clinical and laboratory parameters.

研究类风湿关节炎患者联合甲氨蝶呤治疗后反复递增剂量D2E7的临床药理学特征、安全性、耐受性、免疫原性和临床疗效的早期迹象。通过标准临床和实验室参数评估D2E7和甲氨蝶呤联合治疗炎性滑膜炎的发病、程度和持续时间。