EUCTR2012-002535-28-IT进行中（未招募）1 期
A Randomised, open labelled study in anti-TNFa inadequate responders to investigate the mechanisms for Response - Resistance to Rituximab versus Tocilizumab in RA (R4-RA) - R4-RA
Joint Research & Development Office (Barts and The London School of Medicine & Dentistry) - Queen Mary University London0 个研究点目标入组 164 人开始时间: 2014年11月4日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 164
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Patients will be recruited with active RA:
- •1. Patients who have failed anti-TNF therapy (inadequate responders – ir). Note: this includes patients that have failed anti-TNF therapy because of reactions.
- •2. Who are eligible for Rituximab therapy according NICE guidlines
- •3. Patients should be receiving a stable dose Methotrexate for at least 4 weeks prior to the biopsy visit.
- •4. 2010 ACR / EULAR Rheumatoid Arthritis classification criteria for a diagnosis of Rheumatoid Arthritis.
- •5. Over 18 years of age
- •6. Patient must be capable of giving informed consent
- •7. Willingness and ability to comply with scheduled visits, treatment plans and laboratory tests and other study procedures
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 3
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 2
排除标准
- •1.Patients will be excluded if they have any contraindication to Rituximab or Tocilizumab therapy.
- •2.Women who are pregnant or breast-feeding
- •3.Women of child-bearing potential, or males whose partners are women of child-bearing potential, unwilling to use effective contraception during the study and for at least 6 months after stopping study treatment.
- •4.History of or current inflammatory joint disease or autoimmune disease other than RA
- •5.Treatment with any investigational agent = 4 weeks prior to baseline or < 5 half lives of the investigational drug
- •6.Intra articular or parenteral corticosteroids = 4 weeks prior to baseline
- •7.Active infection
- •8.Septic arthritis within a native joint within the last 12 months
- •9.Sepsis of a prosthetic joint within 12 months or indefinitely if the joint remains in situ
- •10.Known HIV or hepatitis B/C infection
- •11.Latent TB infection unless they have completed adequate antibiotic prophylaxis
- •12.Malignancy (other than basal cell carcinoma) within the last 10 years
- •13.New York Heart Association (NYHA) grade 3 or 4 congestive cardiac failure
- •14.Demyelinating disease
- •15.Latex allergy or allergy to any excipients of Rituximab
- •16.Any other contra-indication to the study medications as detailed in their summaries of product characteristics
- •17.Receipt of live vaccine <4 weeks prior to first infusion
- •18.Surgery in 3 months prior to first infusion
- •19.Presence of a transplanted organ (with the exception of a corneal transplant >3 months prior to screening)
- •20.Known recent substance abuse (drug or alcohol)
- •21.Poor tolerability of venepuncture or lack of adequate venous access for required blood sampling during the study period.
- •22.Patients unable to tolerate synovial biopsy or in whom this is contraindicated (e.g. patients on anti-coagulants such as warfarin or heparin).
- •23. Other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that would impart, in the judgment of the investigator, excess risk associated with study participation or study drug administration, or which, in the judgment of the investigator, would make the patient inappropriate for entry into this study
研究者
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