NCT01292265终止3 期
A Phase 3b, Open Label, Multicenter, Exploratory Study to Assess Changes in Joint Inflammation Using Ultrasonography in Subjects With Rheumatoid Arthritis Treated for 12 Weeks With Certolizumab Pegol
适应症
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- UCB Pharma
- 入组人数
- 3
- 试验地点
- 7
- 主要终点
- Change From Baseline (Week 0) in the Modified Ultrasound-7 Joint (mUS7) Sumscore at Week 12
研究概览
简要总结
To evaluate the changes in joint inflammation produced by Cimzia over 12 week Treatment period measured by Power/Color Doppler and Gray scale Ultrasound.
详细描述
Since only 3 subjects were enrolled in this study, the efficacy data is not interpretable and will not be presented. Only Adverse Event (AE) data will be summarized in a table, with frequency counts and percentages.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with adult-onset Rheumatoid Arthritis (RA) >6 months and <3 years
- •Active RA
- •Must have failed at least one disease modifying Anti Rheumatic Drug (DMARD) treatment
- •Subject can have attempted no more than one previous Anti Tumor Necrosis factor (anti-TNF) and discontinued due to drug intolerance
排除标准
- •Subject cannot have a second non-inflammatory musculoskeletal condition
- •Subject cannot have a diagnosis of any other inflammatory arthritis
- •Subject cannot have any previously infected prosthesis
- •Subject cannot have arthroplasties in any of the joints assessed in the study
- •Subject cannot have a history of chronic infections
- •Subject cannot have known Tuberculosis (TB) disease, high risk of acquiring TB, or latent TB infection
- •Subject cannot have a history of or current Lymphoproliferative disorder
- •Subject cannot have known Human Immunodeficiency Virus (HIV) infection
- •Subject cannot have received a live or attenuated vaccine within 8 weeks
- •Subject cannot have current or history of malignancy
- •Subject cannot have a history of blood disorders
- •Subject cannot have a current or recent history of severe, progressive, and/or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological or cerebral disease
- •Subjects must not have a history of adverse reaction to Polyethylene glycol (PEG), a protein medicinal product, or ultrasound gel applied to the skin
结局指标
主要结局
Change From Baseline (Week 0) in the Modified Ultrasound-7 Joint (mUS7) Sumscore at Week 12
时间窗: From Baseline (Week 0) to Week 12
次要结局
- Change From Baseline (Week 0) in Erythrocyte Sedimentation Rate (ESR) at Week 12(From Baseline (Week 0) to Week 12)
- Change From Baseline (Week 0) in the Clinical Disease Activity Index (CDAI) at Week 12(From Baseline (Week 0) to Week 12)
- Change From Baseline (Week 0) in C-reactive Protein (CRP) at Week 12(From Baseline (Week 0) to Week 12)
研究者
研究点 (7)
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