IRCT20230923059495N1已完成2 期
Comparison of the effect of tocilizumab and rituximab on rheumatoid arthritis treatment-resistant . Loghman-e Hakim hospital
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 22
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
- no limit 至 no limit（—）
- 性别
- All
入选标准
- •Having written informed consent to participate in the study
- •Age 18 to 65 years•
- •Weight less than 100 kg
- •Definite diagnosis of rheumatism resistant to at least one of the anti-rheumatic drugs (DMARDS) and also having resistance to methotrexate
- •Having moderate to severe rheumatoid arthritis with involvement of at least 4 painful joints and 4 swollen joints with ESR above 30 mm/h and CRP above 10 mg/l at the time of screening and entering the study
- •If taking DMARDS drugs, stop them at least 2 weeks before entering the study
- •The patient does not belong to functional class IV according to the ACR criteria.
- •Has not had a history of rituximab injection within 2 years before entering the study
- •During the 4 weeks before receiving tocilizumab, he has not received oral corticosteroids with a dose of more than 10 mg of prednisolone per day or other corticosteroids with an equivalent dose
- •Do not have a history of increasing the number or dosage of DMARDS drugs or immunosuppressive drugs during the 4 weeks before starting treatment with tocilizumab.•
- •He does not have a history of receiving live or weakened vaccine in less than 4 weeks before the start of the intervention.•
- •Do not have a history of allergy to both mentioned drugs.•
- •Has not had a history of performing plasmapheresis or major joint and cardiovascular surgeries during the 8 weeks prior to entering the study or did not intend to perform it during the 6 months of follow-up.•
- •Do not have a history of other rheumatism and malignancy in the last 5 years.
- •No history of treatment with ciclosporin and tacrolimus within 1 month before the intervention and no history of treatment with tocilizumab.
- •The patient has normal GFR and liver enzymes
- •Do not have a history of thrombocytopenia and AIDS, hepatitis B and C viral infections•
- •Not taking drugs that interfere with rituximab or tocilizumab
排除标准
- •Lack of consent to continue treatment in the study
- •Death of the patient for any reason before the completion of the follow-up
- •Undergoing joint surgery
研究者
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