NCT00771329
已完成
1 期
A Randomized, Double-Blind, Placebo-Controlled, Single-Dose, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BIIB023 (Anti-TWEAK) Administered to Subjects With Rheumatoid Arthritis.
概览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Biogen
- 入组人数
- 53
- 试验地点
- 2
- 主要终点
- Determine the safety and tolerability of single doses of BIIB023 administered intravenously (IV) to subjects with RA.
概览
简要总结
Phase I study designed to determine the safety and tolerability of a single dose of BIIB023 administered intravenously versus placebo to subjects with RA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of adult onset RA (functional class I-III) for at least 6 months
- •Must have been treated with and be tolerating Methotrexate (5-25 mg/week) for 3 months, at a stable dose for at least 4 weeks
- •Must have at least 4 swollen and tender joints due to rheumatoid arthritis
排除标准
- •History of recurrent infections requiring antibiotic treatment within 12 months
- •Serious local infection or systemic infection within 3 months
- •Suffering from rheumatic or autoimmune disease other than RA
- •History of cancer, heart failure, kidney disease, liver disease, HIV infection, tuberculosis or other serious illness
研究组 & 干预措施
2
Placebo Comparator
干预措施: Placebo (sterile normal saline) (Other)
1
Experimental
BIIB023
干预措施: BIIB023 (Drug)
结局指标
主要结局
Determine the safety and tolerability of single doses of BIIB023 administered intravenously (IV) to subjects with RA.
时间窗: Baseline through Day 70
次要结局
- • Estimate the pharmacokinetic (PK) parameters of single doses of BIIB023 administered IV to subjects with RA • Evaluate potential markers of pharmacodynamic (PD) action of BIIB023 and its biological effects(Day -1, 0 (at several timepoints), 1, 2, 7, 14, 21, 28, 42, 56 and Day 70)
研究者
研究点 (2)
Loading locations...
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