EUCTR2006-005640-81-GB进行中（未招募）1 期
A PLACEBO CONTROLLED STUDY OF THE EFFECT OF EXTENDED TREATMENT WITH RITUXIMAB ON RESISTANT RHEUMATOID ARTHRITIS: - EXXTRA
niversity of Leeds0 个研究点目标入组 60 人开始时间: 2007年7月27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
- 60
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
入选标准
- •1. Patients with rheumatoid arthritis for at least 6 months, diagnosed according to the revised 1987 ACR criteria for the classification of rheumatoid arthritis
- •2. Patients who have experienced an inadequate response to previous or current treatment with etanercept, infliximab or adalimumab because of toxicity or inadequate efficiency or be unsuitable for treatment with anti-TNF therapy because of contra-indication
- •3. Patients must have received methotrexate at a dose of 10-25mg/week (po or parenteral) at a stable dose for 4 weeks prior to screening
- •4. DAS28 >5.1
- •5. Age 18-80 years
- •6. Corticosteroids (=10mg/day prednisolone or equivalent) permitted if stable for at least 4 weeks prior to screening and NSAIDs permitted if stable for at least 2 weeks prior to screening.
- •7. Patients of reproductive potential (males and females) using a reliable means of contraception (eg contraceptive pill, IUD, physical barrier)
- •8. Presence of erosive joint disease of at least 1 joint on x-ray ( except if DIP joint of the hand)
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Bone/joint surgery within 8 weeks prior to therapy or joint surgery planned within 24 weeks of therapy
- •2. Rheumatic autoimmune disease other than RA or significant systemic involvement secondary to RA
- •3. History of, or current, inflammatory joint disease other than RA or other systemic rheumatic disorder
- •4. Concurrent treatment with any DMARD (apart from methotrexate) or any anti-TNF therapy or other biologic agent
- •5. Treatment with any investigational agent within 4 weeks of screening or 5 half lives of the investigational drug
- •6. Previous treatment with any cell depleting therapy therapies.
- •7. Intra-articular or parenteral steroids within 4 weeks prior to therapy (except for joints undergoing ultrasound or MRI where IA steroids are not permitted within 12 weeks prior to therapy or assessment)
- •8. Previous treatment with Rituximab
- •9. History of severe allergic or anaphylactic reactions to humanised or murine monoclonal antibodies.
- •10. Evidence of significant uncontrolled concomitant diseases.
- •11. Known active bacterial, viral, fungal mycobacterial infection or any episode of infection requiring hospitalisation or treatment with iv antibiotics within 4 weeks of therapy or oral antibiotics within 2 weeks of therapy
- •12. History of, or currently active, primary or secondary immunodeficiency
- •13. History of solid organ malignancy in the past 5 years (excluding basal cell or squamous cell carcinomas of the skin which have been excised and cured)
- •14. Pregnant women or breastfeeding mothers
- •15. History of alcohol, drug or chemical abuse within 6 months prior to screening
- •16. Neuropathies or neurovasculopathies which might interfere with pain evaluation
- •17. Significant laboratory abnormalities.
研究者
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