NCT00320450已完成2 期
A Randomised, Parallel Group, Placebo-controlled, Double Blind Study to Assess the Safety and Tolerability of SB-681323 at 7.5mg Daily Dose for 28 Days and Its Effect on the Levels of Serum C-reactive Protein (CRP) in Subjects With Rheumatoid Arthritis (RA)
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 78
- 试验地点
- 42
- 主要终点
- Serum levels of CRP at the end of study (after 28 days of treatment) following repeat dosing with SB-681323 (7.5mg/day) compared with placebo.
研究概览
简要总结
The purpose of this research is to find out how effective and safe SB-681323 will be in the treatment of RA when it is added to standard anti-rheumatic treatments.
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
- Double (Participant, Investigator)
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
- •Females cannot be pregnant or lactating.
- •Must use defined contraceptive methods if of child-bearing potential.
- •BMI range: 18.5-35.0 kg/m
- •Diagnosis of RA (rheumatoid arthritis) according to revised 1987 American College of Rheumatology (ACR) criteria.
- •If other RA-medication is used: Disease-Modifying Anti-Rheumatic Drug (DMARDS) must be stable for at least 8 weeks before first trial visit.
- •If other oral anti-RA therapies are used, these must have been stable at least 4 weeks before first trial visit.
- •If Methotrexate medication is used as RA-therapy, Folate supplement must be taken with stable red cell folate levels.
- •Must give informed consent.
- •Must abstain from alcohol during the trial participation.
排除标准
- •Non-responder on biological RA treatment.
- •Has a positive alcohol screen.
- •Any history of liver disease.
- •Positive Hepatitis B surface antigen or Hepatitis C antibody result within 3 months of screening.
- •Have any significant disease that places the subject at unacceptable risk as a participant in this trial.
- •Acute infection.
- •History of active tuberculosis.
- •History of repeated or chronic infection.
- •History of malignancy.
- •History of HIV or other immunosuppressive diseases.
- •Participated in a clinical trial within the last 3 months for non-biological therapies and 6 months for biological therapies.
- •Uncontrolled diabetes or psoriasis.
结局指标
主要结局
Serum levels of CRP at the end of study (after 28 days of treatment) following repeat dosing with SB-681323 (7.5mg/day) compared with placebo.
时间窗: 28 Days
次要结局
- Serum levels of CRP at other available timepoints. The following secondary endpoints will be analysed at all available timepoints: Clinical Symptoms, Safety and Biomarkers, Health Outcome.(28 Days)
研究者
研究点 (42)
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