NCT00077870已完成1 期
A Randomized, Placebo-Controlled, Multicenter, Blinded Phase I/II Study of the Safety of Escalating Doses of Ocrelizumab (PRO70769) in Subjects With Moderate to Severe Rheumatoid Arthritis Receiving Stable Doses of Concomitant Methotrexate
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 237
- 主要终点
- Safety and tolerability of ocrelizumab in subjects with moderate to severe RA
研究概览
简要总结
This is a randomized, placebo-controlled, multicenter, blinded Phase I/II, investigator and subject-blinded study of the safety of escalating doses of ocrelizumab in combination with MTX in subjects with moderate to severe RA
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ability and willingness to provide written informed consent and to comply with the requirements of the protocol
- •Diagnosis of RA for at least 6 months according to the revised 1987 ACR criteria for the classification of RA
- •Positive serum RF
- •Current treatment for RA on an outpatient basis
- •Contact your local site that is listed for more inclusion criteria
排除标准
- •Bone or joint surgery (including joint fusion) within 8 weeks prior to screening or joint surgery planned within 24 weeks after randomization
- •Rheumatic autoimmune disease other than RA or significant systemic involvement secondary to RA (e.g., vasculitis, pulmonary fibrosis, or Felty�s syndrome)
- •Functional Class IV as defined by the ACR classification of functional status in RA
- •History of or current inflammatory joint disease other than RA (e.g., gout, reactive arthritis, psoriatic arthritis, seronegative spondyloarthropathy, Lyme disease) or other systemic rheumatic disorders (e.g., systemic lupus erythematosus, inflammatory bowel disease, scleroderma, inflammatory myopathy, overlap syndrome)
- •Contact your local site that is listed for more exclusion criteria
结局指标
主要结局
Safety and tolerability of ocrelizumab in subjects with moderate to severe RA
次要结局
- Pharmacokinetics of ocrelizumab
- Pharmacodynamics of ocrelizumab
- Percentage of subjects with clinical responses according to American College of Rheumatology (ACR) criteria
研究者
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