EUCTR2006-006746-33-DE进行中（未招募）不适用
Re-Treatment with Rituximab in patients with rheumatoid arthritis who have had an inadequate response to not more than one aTNF (extension study to ML19070) - Efficacy of re-therapy in anti-TNFalpha IR
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 240
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
- •1. Patients with active rheumatoid arthritis (DAS28 >=2.6) who participated in ML19070 (FIRST trial) and have completed the week 24 visit and who experienced a decrease (between week 16 and 24 in study ML19070) in DAS28 > 0.6
- •2.Eligible for re-treatment by the following criteria:
- •Swollen joint count >=2
- •Tender joint count >=2
- •3. Not more than 1 year have passed since the patient’s first rituximab infusion within study ML19070
- •4. Not more than one TNF-alpha- inhibitor in history
- •5.Willingness and capability to give written informed consent, and willingness to participate and to comply with the study
- •6. Age range: 18 – 80 years at inclusion date in ML19070
- •7. Pregnancy urine test at screening (not earlier than 28 days prior to day 1)
- •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
- •General exclusion criteria
- •1. Patients from ML19070 having received any DMARD except MTX, any TNFalpha inhibitor, leflunomide or any anti-IL or CTLA4 Ig or any biological or investigational agent after the rituximab infusions
- •2. Patients with a response between week 16 and 24 in study ML19070 in DAS28 <=0.6 to rituximab. These Patients will remain in study ML19070 until completion or withdrawal.
- •Exclusion criteria related to RA
- •3. Functional class IV
- •Exclusion criteria related to general health
- •4. Patients with other chronic inflammatory articular disease or systemic autoimmune disease
- •5. Any active infection, a history of recurrent clinically significant infection, a history of recurrent bacterial infections with encapsulated organisms
- •6. Primary or secondary immunodeficiency
- •7. History of cancer with curative treatment not longer than 5 years ago except basal-cell carcinoma of the skin that had been excised
- •8. Evidence of significant uncontrolled concomitant diseases or serious and/or uncon-trolled diseases that are likely to interfere with the evaluation of the patient's safety and of the study outcome
- •9. Neuropathy that can interfere with filling out the patient's questionnaires
- •10. History of a severe psychological illness or condition
- •11. Known hypersensitivity to any component of the product or to murine proteins
- •12. Women lactating, pregnant or of childbearing po¬tential and males of reproductive potential not using a highly effective contraceptive method (i.e. with a failure rate of less than 1% per year, are implants, injectables, com-bined oral contraceptives, IUDs (only hor-mon¬spirals), sexual abstinence or vasecto¬mi¬zed partner. Women of childbearing potential must have a negative pregnancy test (urine) at screening and must confirm in a written form at day 1, day x2, and day x3 that they are not pregnant if the pregnancy test is not repeated.
- •13. History of alcohol, drug or chemical abuse
- •14. Lack of peripheral venous access
- •Exclusion criteria related to medications
- •15. Intolerance to rituximab
- •16. Previous treatment with abatacept
- •17. Treatment with corticosteroids exceeding 10 mg per day prednisone or equivalent 2 weeks prior to day 1
- •18. Patients who have developed known contraindications to high dose corticosteroids (e.g. poorly controlled hypertension or diabetes mellitus, history of psychological events to steroids).
- •19. Intolerance or contraindication to drugs required for the treatment of the side effects of rituximab
- •20. Receipt of a live vaccine within 4 weeks prior to treatment
- •21. Intra- articular or parenteral corticosteroids within 4 weeks prior to treatment
- •Exclusion criteria related to lab findings
- •22. Haemoglobin < 8.5 g/dl
- •23. Neutrophil counts < 1.500/µl
- •24. Platelet count < 75.000/µl
- •25. Serum creatinine > 1.4 mg/dl for women or 1.6 mg/dl for men
- •26. AST or ALT > 2.5 times upper limit of nor-mal
- •27. Positive HIV or hepatitis C serology as well as positive tests for hepatitis B surface antigen (HBsAg) and/or positive tests for hepatitis B core antibody (anti-HBc-Ab)
- •Exclusion criteria related to formal aspects
- •28. Previous (last 30 days) or current participation in another clinical trial with the exception of participation in study ML19070
- •29. Patients who have participated in this study before.
- •30. Patients who are underage or patients who are in¬capable to understand the aim, importance and consequences of the study and to give le-gal informed consent (according to § 40 Abs. 4 and § 41 A
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