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临床试验/EUCTR2006-001682-42-SE
EUCTR2006-001682-42-SE进行中（未招募）不适用

Rituximab phase IIIb open-label, multi-centre assessment of safety and effectiveness in patients with RA following inadequate response to one prior anti-TNF inhibitor (RESET). - RESET

Roche AB0 个研究点目标入组 100 人开始时间: 2006年6月7日最近更新:
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适应症
相关药物

试验速览

阶段
不适用
状态
进行中（未招募）
发起方
Roche AB
入组人数
100
研究概览入排标准研究者记录与标识符相似试验

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. Ages 18-80 years, inclusive.
  • •3. Patients with documented moderate to severe active rheumatoid arthritis at screening as follows:
  • •tender joint count = 6 (28 joint count)
  • •swollen joint count = 6 (28 joint count)
  • •C-reactive protein (CRP) or Erythrocyte sedimentation rate (ESR) levels elevated above the upper limit of normal (as per local laboratory), or morning stiffness lasting =30 minutes.
  • •4. Patients who are to receive, or who are currently receiving treatment for RA on an outpatient basis.
  • •5. Documented inadequate response to a single previous or current treatment with the anti–TNF–alfa agents etanercept, infliximab, or adalimumab because of toxicity or inadequate efficacy (inadequate efficacy requires treatment with etanercept for >= 3 months at 25 mg twice a week or 50 mg weekly; or at least 3 infusions of infliximab at >= 3 mg/kg; or adalimumab for >= 3 months at 40 mg every other week).
  • •6. Must have received MTX at a dose of 10-25 mg/week (p.o. or parenteral) for at least 12 weeks prior to screening, at a stable dose over the last 4 weeks prior to day 1.
  • •7. Corticosteroids (<= 10 mg/day prednisone or equivalent) are permitted if stable for at least 4 weeks prior to day 1 and NSAIDs permitted if stable for at least 2 weeks prior to day 1.
  • •8. Must be willing to receive oral folate.
  • •9. Patients of reproductive potential (males and females) must be willing to use a reliable means of contraception (e.g., hormonal contraceptive, intrauterine device, physical barrier) during the study.
  • •10. If female and of childbearing potential, a negative serum pregnancy test.
  • •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

  • •Exclusion Criteria Related to RA
  • •1. Patients with severe rheumatoid arthritis (functional class IV as defined by the ACR Classification of Functional Status in RA) that requires either a wheelchair or results in the patient being bed bound.
  • •2. Bone/joint surgery within 8 weeks prior to day 1, or joint surgery planned within 48 weeks of day 1.
  • •Exclusions Related to Medications
  • •1. History of severe allergic or anaphylactic reactions to monoclonal antibodies
  • •2. Previous treatment with rituximab (Rituxan/Mabthera).
  • •3. Use of an anti–TNF–alfa agent within 8 weeks of Day 1 (or 4 weeks in the case of etanercept).
  • •4. Concurrent treatment with any DMARD other than methotrexate. Treatment with all DMARDS must be discontinued at least 14 days prior to Day 1 except for the following:
  • •azathioprine for =4 weeks;
  • •etanercept for =4 weeks;
  • •leflunomide for =8 weeks;
  • •infliximab or adalimumab for =8 weeks
  • •5. In the event that abatacept is approved as a treatment for RA during the course of this study, this must also be discontinued for =8 weeks prior to day 1.
  • •6. Receipt of any vaccine within 4 weeks prior to day 1 (it is recommended that a patient’s vaccination record and the need for immunization prior to receiving rituximab should be carefully investigated).
  • •7. Intra-articular or parenteral glucocorticoids within 4 weeks prior to day 1.
  • •8. Treatment with any investigational agent within 4 weeks of day 1 or within 5 half-lives of the investigational drug (which ever is the longer).
  • •9. Previous treatment with any cell-depleting therapies, including investigational agents (e.g. CAMPATH, anti-CD4, anti-CD5, anti-CD3, anti-CD19, anti-CD11a, anti-CD22, anti-BLys/BAFF)
  • •Exclusions for General Safety/Health
  • •1. Evidence of any severe or significant medical condition(s) or disease(s) that, in the view of the investigator, prohibits participation in the study.
  • •2. Significant cardiac or pulmonary disease (including obstructive pulmonary disease).
  • •3. 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 day 1 or oral anti-infectives within 2 weeks prior to day 1.
  • •4. Primary or secondary immunodeficiency (history of, or currently active), including known history of HIV infection.
  • •5. History of serious recurrent or chronic infection.
  • •6. Pregnancy or lactation.
  • •7. History of cancer, including solid tumours, hematological malignancies and carcinoma in situ (except basal cell and squamous cell carcinoma of the skin that have been excised and cured).
  • •8. Currently active alcohol or drug abuse or history of alcohol or drug abuse within 24 weeks prior to baseline.
  • •Exclusions Related to Laboratory Findings
  • •1. Hemoglobin < 9.0 g/dL.
  • •2. Absolute neutrophil count < 1.5 x 103/µL.
  • •3. Levels of IgG <5.0 mg/mL.
  • •4. Levels of IgM < 0.40 mg/mL.
  • •5. Positive tests for hepatitis B surface antigen (HBsAg) and/or positive tests for hepatitis B core antibody (HBcAb) associated with detectable hepatitis B viral DNA (HBV DNA) or hepatitis C serology.
  • •6. Positive serum test for human chorionic gonadotropin (pregnancy).

研究者

发起方
Roche AB

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