Open-Label Pre and Post Treatment Arthroscopic Synovial Biopsy Study for the Assessment of Certolizumab Pegol Immunomodulatory Synovial Effects on Select Biomarkers and Gene Expression
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Percent Change From Baseline in Synovial TNFa, CXCL13, IL-8, IL-6, IL-1b, IL-10, IP-10, BCL3, CD3E, DUSP4, FOXP3, CD79A, CD138, MMP-3, and MMP-1 After 12 Weeks of Treatment With Certolizumab Pegol (CZP) in Patients With Rheumatoid Arthritis
研究概览
简要总结
The purpose of this study is to conduct an Investigator-Sponsored Study to determine the potential immunomodulatory effects of Certolizumab Pegol (CZP) treatment at the site of disease activity (synovial lining) in subjects with rheumatoid arthritis (RA), using pre treatment and post treatment arthroscopic synovial biopsies and ex vivo on gene expression.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 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
- •Signed and dated informed consent document
- •Subjects must be at least 18 years of age or older
- •Subject must be willing and able to comply with scheduled visits, arthroscopy, laboratory tests, and other procedures
- •Diagnosis of RA based on American College of Rheumatology (ACR) 1987 Revised Criteria
- •Active disease at screening visit
- •Methotrexate taken continuously for at least 12 weeks at a stable dosage
- •Sexually active women of child-bearing potential and men whose partners are women of child-bearing potential are required to use adequate contraceptive methods during participation on this trial
- •Treatment with non-steroidal anti-inflammatory drugs (NSAIDS)and oral corticosteroids (less than or equal to 10 mg/day prednisone or equivalent)is accepted
排除标准
- •Diagnosis of any other inflammatory arthritis
- •History of infected joint prosthesis that is still in situ
- •History of allergy to local anesthetic agents
- •Pregnant or lactating women
- •Current or recent history of uncontrolled clinically significant conditions(e.g..,kidney disease, liver disease, class III or IV congestive heart failure, according to the New York Heart Association)
- •History or suspected demyelinating disease of the central nervous system, e.g. multiple sclerosis or optic neuritis
- •Current participation in clinical trial
研究组 & 干预措施
Certolizumab Pegol (CZP)
Certolizumab Pegol (CZP) liquid formulation 200 mg sc -(initial loading dose of 400 mg sc at 0 (Baseline), 2, and 4 weeks), then 200 mg sc every 2 weeks at 6, 8, and 10 weeks with arthroscopic synovial tissue biopsy pre- and post-treatment.
干预措施: Certolizumab Pegol (CZP) (Drug)
Certolizumab Pegol (CZP)
Certolizumab Pegol (CZP) liquid formulation 200 mg sc -(initial loading dose of 400 mg sc at 0 (Baseline), 2, and 4 weeks), then 200 mg sc every 2 weeks at 6, 8, and 10 weeks with arthroscopic synovial tissue biopsy pre- and post-treatment.
干预措施: Arthroscopic synovial tissue biopsy (Procedure)
结局指标
主要结局
Percent Change From Baseline in Synovial TNFa, CXCL13, IL-8, IL-6, IL-1b, IL-10, IP-10, BCL3, CD3E, DUSP4, FOXP3, CD79A, CD138, MMP-3, and MMP-1 After 12 Weeks of Treatment With Certolizumab Pegol (CZP) in Patients With Rheumatoid Arthritis
时间窗: Baseline and Week 12
Synovial tissue biopsy samples were taken at baseline and at 12 weeks after starting treatment with CZP. These samples were analyzed to determine the concentrations of select biomarkers and to determine the percent change in concentration from baseline to week 12.
次要结局
- Percent Change From Screening in Disease Activity Score (DAS) 28 ESR After 14 Weeks of Treatment(Screening and Week 14)
研究者
Nathan Wei, MD, FACP, FACR:
Nathan Wei, MD, FACP, FACR
Arthritis Treatment Center, Maryland