PER-007-07已完成未知
A Randomized, Phase 3, Controlled, Double-Blind, Parallel-Group, Multicenter Study to Evaluate the Safety and Efficacy of Rituximab in Combination With Methotrexate (MTX) Compared to MTX Alone, in Methotrexate-Naive Patients With Active Rheumatoid Arthritis
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 35
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 0 至 0（—）
入选标准
- •1. Be willing to grant written informed consent and comply with the requirements of the study protocol.
- •2. Patients with active rheumatoid arthritis diagnosed for at least 8 weeks but not more than 4 years.
- •3. Virgin patients to, and considered to be candidates for, treatment with methotrexate.
- •4. Swollen joint count (SJC) ≥ 8, and Painful joint count (TJC) ≥ 8.
- •5. CRP ≥12 mg / dL.
- •6. From 18 to 80 years of age.
- •7. Glucocorticoids ≤ 10 mg / day of prednisolone or equivalent allowed if it is stable at least 4 weeks before the baseline visit.
- •8. The use of NSAIDs is allowed if it is stable for at least 2 weeks before the baseline visit.
- •9. For patients of reproductive age (men and women), use reliable contraceptive methods throughout their participation in the study.
- •10. They must agree to receive oral folate.
- •11. Only for RF negative patients: Radiographic evidence of at least one joint with erosion attributable to rheumatoid arthritis (RA).
- •12. Patients who are going to receive or who are currently receiving, treatment for RA as outpatients.
排除标准
- •1. Autoimmune rheumatic disease different from RA, or with significant systemic manifestations.
- •2. Functional class IV.
- •3. History of inflammatory joint disease different from RA.
- •4. Diagnosis of juvenile idiopathic arthritis before the age of 16 years.
- •5. Any surgical procedure.
- •6. Lack of peripheral venous access.
- •7. Pregnancy or breastfeeding, maternal.
- •8. Significant pulmonary or cardiac disease.
- •9. Evidence of significant uncontrolled concomitant disease.
- •10. Primary or secondary immunodeficiency.
- •11. Known active infection of any kind, or any significant episode of infection requiring hospitalization or treatment with IV antibiotics within 4 weeks prior to the baseline visit or the termination of oral antibiotics within 2 weeks before the baseline visit.
- •12. History of deep tissue / space infections within 52 weeks before the baseline visit.
- •13. History of severe chronic or recurrent infection.
- •14. History of cancers.
- •15. Any vascular or systemic neurological disorder that could affect any of the efficacy evaluations.
- •16 Current alcoholism or drug addiction or history of drug addiction or alcoholism in the 24 weeks prior to the initial visit.
- •17. History of severe anaphylactic or allergic reaction to a biological agent or known hypersensitivity to any component of rituximab or to human proteins.
- •18. Pre-treatment with any biological agent under investigation or approved for RA.
- •19. Pre-treatment with an anti-alpha4 integrin antibody or costimulation modulator.
- •20 Concomitant treatment with a biological agent other than MTX.
- •21 Pre-treatment with any therapy to reduce cells.
- •22 Treatment with any agent under investigation within 28 days of the baseline visit or 5 half lives of the investigational medication.
- •23. The reception of any vaccine within 28 days prior to the baseline visit.
- •24. Parenteral or intra-articular glucocorticoids within the 4 weeks prior to the baseline visit.
- •25. Intolerance or contraindications to glucocorticoids IV.
- •26. Positive human chorionic gonadotropin.
- •27. Positive tests for hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb) or serology for hepatitis C.
- •28. Hemoglobin <8.0 g dL.
- •29- Serum IgG and / or IgM concentrations below 5.0 and 0.40 mg / mL.
- •30. Absolute neutrophil count <1.5 x 10-3 / uL.
- •31. ALT or AST> 2.5 times the normal upper limit.
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