ong term effectiveness of Rituximab (RTX) in patients of rheumatoid arthritis (RA) with active disease despite supervised standard rheumatology care (with methotrexate as a pivotal drug) - CRD/RTX/2016/001

CENTER FOR RHEUMATIC DISEASES0 个研究点目标入组 60 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•1.Age 18-70 years
•2.Seropositive RA and fulfilling the requirements of 2010 American College of Rheumatology ACR/EULAR classification criteria for RA
•3.Disease duration between 6 months and 5 years.
•4.Patients with >= 6 tender joints and >= 4 swollen joints (based on 66 swollen joints and 68 painful joints) and a DAS28 (ESR) score >= 3.2
•5.Ambulant and standard ACR functional class I, II or III
•6.Patients must be able to understand and comply with instructions
•7.Men and women of child bearing potential must be using adequate birth control measures and agree to continue such precautions for 6 months after receiving the last dose
•8.Menopausal females must have experienced their last period more than 12 months prior to study entry to be classified as not of child bearing potential
•9.The screening laboratory tests must meet the following criteria:
•Haemoglobin >=8.0 g/dL; WBC >=3.5 x 109/L; Neutrophils >= 1.5 x 109/L; Lymphocytes < 1000/mm3; Platelets >= 100 x 109/L; Serum transaminase not >= 2 times the upper limit of normal; Serum creatinine not >= 1.7 mg/dL

•1.Patients with contraindications to Rituximab use
•2.Patients with hypersensitivity to Rituximab or any of its components
•3.Patients who have received any Biologic DMARD in past 6 months
•4.Prior use of disease modifying anti rheumatic drugs, other than methotrexate, hydroycholoroquine or sulfasalazine within 4 weeks prior to screening
•5.Patients suffering from acute or chronic, disseminated or localized (bacterial/fungal/viral) infections (except fungal nail bed infection) or sepsis or patients with a history of recurring infections or at increased risk of developing infections or sepsis.
•6.Patients presently suffering from tuberculosis

发起方

CENTER FOR RHEUMATIC DISEASES