PER-082-05已完成未知
MULTICENTER, NON-COMPARATIVE STUDY TO ASSESS THE SAFETY OF RITUXIMAB (MONOCLONAL ANTIBODY ANTICD20) IN PATIENTS WITH RHEUMATOID ARTHRITIS (SER)
PRODUCTOS ROCHE Q.F.S.A.,0 个研究点目标入组 0 人开始时间: 2006年3月1日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
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 able and willing to provide written informed consent and meet the requirements of the study.
- •2. Patients with Rheumatoid Arthritis diagnosed at least 6 months before.
- •3. Be under treatment in outpatient clinic.
- •4. Failure to treat with at least one but no more than five DMARDs or biological medications.
- •5. Have received methotrexate at a dose of 10-25 mg / week for at least 12 weeks, with a stable dose during the 4 weeks prior to screening.
- •6. Suspend all DMARDs other than methotrexate at least 4 weeks before randomization (8 weeks for infliximab, adalimumab, etanercept, and leflunomide).
- •7. Have Inflated Joint Count> 8 and Painful Joint Count> 8 during the count.
- •8. During the count, have: C-reactive protein> 1.5 mg / dl (15 mg / l) or Globular Sedimentation Rate> 28 mm / hr.
- •9. Age between 18-80 years.
- •10. The use of non-steroidal anti-inflammatory drugs is allowed if your dose has been stable for at least 2 weeks prior to screening.
- •11. If the patient has reproductive potential, he should use adequate contraceptive methods.
- •12. Women of reproductive age should have a negative pregnancy test in urine during the 2 weeks prior to inclusion in the study.
- •13. Positive rheumatoid factor.
排除标准
- •1. Bone / joint surgery during the 8 weeks prior to scrutiny or joint surgery planned during the 24 weeks prior to inclusion.
- •2. Rheumatoid autoimmune disease other than Rheumatoid Arthritis or significant generalized disease secondary to Rheumatoid Arthritis.
- •3. Functional class IV defined based on the Rheumatoid Arthritis functionality criteria of the ACR.
- •4. History or current manifestation of inflammatory joint disease other than Rheumatoid Arthritis or other generalized rheumatic disease.
- •5. Concomitant treatment with any DMARD (except methotrexate) or therapy with any anti-TNF or other biological therapy.
- •6. Treatment with any investigational medication during the previous 3 months.
- •7. Previous treatment with therapies that decrease the number of cells.
- •8. Treatment with y-globulin IV or with Prosorba® column during the previous 6 months.
- •9. Intra-articular or parenteral corticosteroids during the 4 weeks prior to inclusion.
- •10. Administration of a vaccine with live agents during the 4 weeks prior to the start of the study.
- •11. Previous treatment with Rituximab (MabThera®).
- •12. History of severe allergy or anaphylactic reactions induced by monoclonal antibodies humanized or of murine origin.
- •13. Significant cardiac or pulmonary disease.
- •14. Evidence of significant uncontrollable concomitant disease.
- •15. Active viral, mycotic, bacterial, mycobacterial or other infection or any episode of infection that has required hospitalization or IV treatment with antibiotics during the 4 weeks prior to the scrutiny or oral antibiotics during the 2 weeks prior to the scrutiny.
- •16. History of significant recurrent infection or history of recurrent bacterial infections.
- •17. History or presence of primary or secondary immunodeficiency
- •18. History of cancer, including solid tumors and hematologic disease.
- •19. Pregnant or lactating women.
- •20. History of alcohol, drugs or drug abuse during the 6 months prior to the count.
- •21. Neuropathies and neurovascular diseases that could interfere with the assessment of pain.
- •22. Inaccessible peripheral veins.
- •23. Intolerance or contraindications to corticosteroids IV
- •24. Serum creatinine> 1.4 mg / dL for women or 1.6 mg / dL for men.
- •25. Aspartate aminotransferase or alanine aminotransferase> 2.5 x ULN.
- •26. Platelets <100,000 / uL.
- •27. Hemoglobin <8.5 g / dL.
- •28. Neutropenia <1.5 x 10 3 / uL.
- •29. Positive serological diagnosis of hepatitis B or C.
- •30. HIV positive.
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