EUCTR2005-002396-33-ES进行中（未招募）不适用
Estudio internacional, randomizado, doble ciego, para evaluar la eficacia y seguridad de diversos regímenes de retratamiento con rituximab en combinación con metotrexato, en pacientes con AR que manifiestan una respuesta inadecuada a metotrexato.A randomised, double-blind, international study to evaluate the efficacy and safety of various re-treatment regimens of rituximab in combination with methotrexate in RA patients with an inadequate response to methotrexate.
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
- 375
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. Able and willing to give written informed consent and comply with the requirements of the study protocol.
- •2. Patients with rheumatoid arthritis for at least 6 months, diagnosed according to the revised 1987 ACR criteria for the classification of rheumatoid arthritis.
- •3. Receiving treatment on an outpatient basis.
- •4. Swollen joint count (SJC) = 8 (66 joint count), and tender joint count (TJC) = 8 (68 joint count) at screening and baseline.
- •5. At screening, either CRP = 0.6 mg/dL (6 mg/L) OR ESR = 28 mm/h.
- •6. Minimum age 18 years.
- •7. Glucocorticoids = 10 mg/day prednisolone or equivalent permitted if stable for at least 4 weeks prior to baseline.
- •8. Use of NSAIDs is permitted if stable for at least 2 weeks prior to baseline.
- •9. For patients of reproductive potential (males and females), use of a reliable means of contraception (e.g. hormonal contraceptive, patch, intrauterine device, physical barrier) throughout study participation.
- •10. Must have an inadequate response to MTX and have been receiving and tolerating this at a dose of 10-25 mg/wk (p.o. or parenteral) for at least 12 weeks, with the last 4 weeks prior to baseline at a stable dose.
- •Are the trial subjects under 18?
- •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. Rheumatic autoimmune disease other than RA, or significant systemic involvement secondary to RA (including but not limited to vasculitis, pulmonary fibrosis or Felty’s syndrome). Secondary Sjogren’s syndrome or secondary limited cutaneous vasculitis with RA is permitted.
- •2. Functional class IV as defined by the ACR Classification of Functional Status in Rheumatoid Arthritis.
- •3. History of, or current, inflammatory joint disease other than RA (e.g., gout, reactive arthritis, psoriatic arthritis, seronegative spondyloarthropathy, Lyme disease) or other systemic autoimmune disorder (e.g., SLE, inflammatory bowel disease, scleroderma, inflammatory myopathy, mixed connective tissue disease or other overlap syndrome).
- •4. Diagnosis of juvenile idiopathic arthritis (JIA) or juvenile rheumatoid arthritis (JRA) and/or RA before age 16.
- •5. Any surgical procedure, including bone/joint surgery/Synovectomy (including joint fusion or replacement) within 12 weeks prior to baseline or planned within 48 weeks of randomization.
- •6. Lack of peripheral venous access.
- •7. Pregnancy or lactation.
- •8. Significant cardiac or pulmonary disease (including obstructive pulmonary disease).
- •9. Evidence of significant uncontrolled concomitant disease such as nervous system, renal, hepatic, endocrine or gastrointestinal disorders which, in the investigator’s opinion, would preclude patient participation.
- •10. Primary or secondary immunodeficiency (history of, or currently active), including known history of HIV infection.
- •11. Known active infection of any kind (excluding fungal infections of nail beds), or any major episode of infection requiring hospitalization or treatment with i.v. anti-infectives within 4 weeks of baseline or oral anti-infectives within 2 weeks prior to baseline.
- •12. History of deep space/tissue infection (e.g. fasciitis, abscess, osteomyelitis) within 52 weeks of baseline.
- •13. History of serious recurrent or chronic infection (to check for chest infection a chest x-ray will be performed at screening if not performed within 12 weeks of screening).
- •14. History of cancer, including solid tumors, hematologic malignancies and carcinoma in situ (except basal cell and squamous cell carcinoma of the skin that have been excised and cured).
- •15. Any neurological (congenital or acquired), vascular or systemic disorder which could affect any of the efficacy assessments, in particular, joint pain and swellin (e.g. Parkinson’s disease, cerebral palsy, diabetic neuropathy).
- •16. Currently active alcohol or drug abuse or history of alcohol or drug abuse within 24 weeks prior to baseline.
- •17. History of a severe allergic or anaphylactic reaction to a biologic agent or known hypersensitivity to any component of rituximab or to murine proteins.
- •18. Concurrent treatment with any biologic agent or DMARD other than MTX. Treatment with all DMARDS (including etanercept) must be discontinued 14 days prior to baseline, except for the following: azathioprine = 28 days; leflunomide for = 8 weeks (or = 14 days after 11 days of standard cholestyramine or activated charcoal washout); infliximab = 8 weeks; adalimumab = 8 weeks. In the event that abatacept becomes an approved treatment for RA during the course of this study, this must also be discontinued for = 8 weeks prior to baseline.
- •19. Previous treatment with > 1 biological agent approved for use in RA.
- •20. Previous treatment with any cell depleting therapies, including investigational agents (e.g. CAMPATH, anti- CD4, anti-CD
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