ACTRN12610000694011尚未招募1 期
A Multi-center, Randomized, Observer-blinded, Multiple–Ascending-Dose, Placebo-controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO5310074 FollowingMultiple Intravenous Administrations in Subjects with Psoriatic Arthritis
适应症
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 21
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 75 Years（—）
- 性别
- All
入选标准
- •1. Male and female subjects, 18 to 75 years of age, inclusive, with psoriatic arthritis diagnosed by the Moll and Wright criteria with peripheral joint involvement of at least 6 months duration; this includes subjects with
- •psoriatic arthritis subtypes such as arthritis affecting Distal Inter-Phalangeal (DIP) joints, arthritis
- •mutilans, asymmetric peripheral arthritis, polyarticular arthritis with absence of rheumatoid nodes, and spondylitis with peripheral arthritis
- •2. Either a high sensitivity C-reactive protein (hsCRP) greater than or equal to 0.7 mg/dL or a
- •erythrocyte sedimentation rate (ESR) greater than or equal to 20 mm/hr
- •3. If currently taking Methotrexate (MTX), patients must be willing to receive oral folic acid at a stable dose of at least 5 mg/week
- •4. A body mass index (BMI) between 18 and 35 kg/m2, inclusive
- •5. A normal screening ECG
- •6. Women of child bearing age must be willing to use a reliable method of birth control.
排除标准
- •1. Prior treatment of any biologic Disease Modifying Anti-Rheumatic Drugs (DMARDS)
- •2. Topical therapy for treatment of psoriasis within 14 days prior to administration of study drug.
- •3. Abnormal laboratory tests.
- •4. Any prior immune diseases.
- •5. History of any other inflammatory joint disease (other than psoriatic arthritis).
- •6. History of any skin conditions that would interfere with the evaluation of psoriasis.
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