Tapering of Rituximab Based on Interval Prolongation Compared to Disease Activity-Guided Dose Reduction in Patients with Rheumatoid Arthritis: The RITUXERA Trial. - S67309

Z Leuven0 个研究点目标入组 134 人开始时间: 2023年9月7日最近更新: 2024年7月22日

适应症

试验速览

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•Able and willing to give written informed consent and participate in the study before any study procedure., Age = 18 years., Understanding and able to write in Dutch or French., Diagnosis of rheumatoid arthritis according to the 2010 ACR/EULAR Classification Criteria for rheumatoid arthritis., Previous response to rituximab, defined as a minimum of one successful rituximab cycle (= a moderate/good EULAR response 16 weeks after the first administration of rituximab)., Current treatment with rituximab., Need for a subsequent rituximab cycle according to the Belgian reimbursement criteria for the use of rituximab in rheumatoid arthritis (DAS28 score =3.2)., Stable dose of methotrexate or other conventional synthetic disease-modifying antirheumatic drugs (DMARDs) 4 weeks prior to baseline.

•Current treatment with a biological disease modifying antirheumatic drug (bDMARD) other than rituximab., Current treatment with a targeted synthetic DMARD., Pregnancy or pregnancy wish., Hypersensitivity to rituximab or to its excipients., Active severe infection., Severe immune deficiency., Severe heart failure (New York Heart Association (NYHA) Class IV) or other severe uncontrolled cardiac condition.

发起方

Z Leuven