NCT00963703已完成不适用
Treatment of TNFa Naive Patients With Poor Prognosis Rheumatoid Arthritis Using Rituximab: A Pilot Study Evaluating Synovial Outcomes
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- To define the synovial effects of rituximab treatment in TNFa naive patients with early rheumatoid arthritis
研究概览
简要总结
The purpose of this study is to determine how well Rituximab works in early stages of disease and the effects it has on an inflamed joint and blood cells.
This will allow the investigators to get a better understanding of how this treatment affects the inflamed joints of rheumatoid arthritis (RA) patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with documented rheumatoid arthritis by ACR criteria
- •Disease duration < 5 years
- •May have previously been treated with methotrexate,hydroxychloroquine or sulfasalazine, either as a single DMARD or in combination
- •Tender joint count >= 6, swollen joint count >= 6, and one must be a knee
- •Corticosteroids <= 10 mg per day permitted on stable doses for at least 4 weeks
- •Patients must consent to 2 arthroscopic synovial biopsy procedures
排除标准
- •History of severe allergic or anaphylactic reactions to monoclonal antibodies
- •Previous treatment with Rituximab
- •Previous treatment with Arava
- •Injected with steroids within 4 weeks of day 1 of study
- •Treatment with any investigational agent within 4 weeks of day of study
- •Any severe or significant medical condition or disease or known active infection
- •Pregnancy or nursing at present
研究组 & 干预措施
Rituximab
Experimental
干预措施: Rituximab (Drug)
结局指标
主要结局
To define the synovial effects of rituximab treatment in TNFa naive patients with early rheumatoid arthritis
时间窗: Biopsies of inflamed joint at beginning and at week 8 of study
次要结局
- To define the effects of rituximab treatment on the phenotype and function of peripheral blood T and B cells(Collected at beginning of study and week 8)
研究者
研究点 (1)
Loading locations...
相似试验
招募中
不适用
The study on efficacy of Rituximab in new onset Type 1 diabetes mellitusType 1 diabetes mellitusJPRN-UMIN000013622niversity of Occupational and Environmental Health, Japan, First Department of Internal Medicine, School of Medicine10
已完成
4 期
Very Early Versus Delayed Etanercept in Patients With RARheumatoid ArthritisNCT02433184University of Leeds120
进行中（未招募）
不适用
Efficacy of Rituximab treatment in patients with rheumatoid arthritis having inadequate response to TNF blockerTo investigate the efficacy of treatment with Rituximab (MabThera®) in patients with active RA whose current treatment with one or more TNF-blocker (Etanercept - Enbrel®, Infliximab – Remicade® or Adalimumab - Humira®) alone or in combination with MTX is insufficient measured by DAS28 activity index.EUCTR2006-004673-98-HURoche (Hungary) Ltd.20
已完成
3 期
A Safety and Efficacy Study for Infliximab (Remicade) With Methotrexate in Patients With Early Rheumatoid ArthritisRheumatoid ArthritisNCT00236028Centocor, Inc.607
进行中（未招募）
不适用
Pilot study to evaluate the effect of Rituximab in combination with MTX in the inhibition of progression of synovitis, bone marrow edema, and erosions evaluated by magnetic resonance imaging (MRI) in the hand of patients with rheumatoid arthritis. - NDMedDRA version: 9.1Level: LLTClassification code 10039073Term: Rheumatoid arthritisRheumatoid arthritisEUCTR2007-001754-11-ITROCHE