NL-OMON34549尚未招募4 期
Effects of abatacept (Orencia®) on biomarkers in synovial tissue in patients with rheumatoid arthritis - Effects of abatacept on synovial tissue in RA
适应症
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 16
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Males and females with a diagnosis of active rheumatoid arthritis (with a DAS28 CRP > 3,2) who have failed MTX therapy, with an inflamed knee, ankle or wrist joint.
排除标准
- •Pregnancy, breastfeeding
- •subjects who are impaire, incapacitated or incapable of completing study related assessments
- •subjects who meet diagnostic criteria for any other rheumatic disease (e.g. lupus erythematous)
- •subjects who have previously received treatment with an investigational biologic RA therapy, antie-TNF theray, rituximab, tocilizumab or abatacept
- •subjects with active vasculitus of a major organ system with the exception of rheumatoid nodules
- •Subjects with current symptoms of severe, progressive, or uncontrolled renal,
- •hepatic, hematological, gastrointestinal, pulmonary, cardiac, neurological, or
- •cerebral disease, or other medical conditions that, in the opinion of the
- •investigator, might place the subject at unacceptable risk for participation in this
- •Subjects with a history of cancer within the last five years (other than nonmelanoma
- •skin cell cancers cured by local resection). Existing non-melanoma
- •skin cell cancers must be removed prior to dosing.
- •Subjects who have clinically significant drug or alcohol abuse.
- •Subjects with any serious bacterial infection within the last 3 months, unless
- •treated and resolved with antibiotics, or any chronic bacterial infection (such as
- •chronic pyelonephritis, osteomyelitis and bronchiectasis).
- •Subjects at risk for tuberculosis (TB). Specifically, subjects with:
- •a) A history of active TB within the last 3 years even if it was treated
- •b) A history of active TB greater than 3 years ago unless there is documentation
- •that the prior anti-TB treatment was appropriate in duration and type
- •c) Current clinical, radiographic or laboratory evidence of active TB
- •d) Latent TB which was not successfully treated
- •Subjects with herpes zoster or cytomegalovirus (CMV) that resolved less than 2
- •months prior to signing informed consent.
- •Subjects with evidence (as assessed by the Investigator) of active or latent
- •bacterial or viral infections at the time of potential enrollment, including subjects
- •with evidence of Human Immunodeficiency Virus (HIV), Hepatitis B or Hepatitis
- •C infection detected during screening.
- •Subject who have received any live vaccines within 3 months of the anticipated
- •first dose of study medication or who will have need of a live vaccine at any time
- •following Day 1 of the study
研究者
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