Comparing Non-TNFi Biologic and Targeted Synthetic DMARD Treatments for Active Rheumatoid Arthritis After TNFi Therapy Failure

What this Trial Is About

Researchers are comparing treatments for people with active rheumatoid arthritis RA who have not responded well to tumor necrosis factor inhibitor TNFi biologics. This study evaluates switching to either a non-TNFi biologic drug including rituximab, abatacept, tocilizumab, or sarilumab or a targeted synthetic DMARD tsDMARD such as tofacitinib, baricitinib, or upadacitinib. The study aims to provide important real-world data on patient-reported outcomes PROs to help guide treatment decisions, as current guidelines are based on limited evidence and often influenced by insurance or physician preference. Participants will be randomized to one of two groups switching to a targeted synthetic DMARD or switching to a non-TNFi biologic drug. Both treatment options are widely used in clinical practice, but have not been directly compared in a pragmatic trial focusing on PROs. The study will allow patients to continue stable doses of conventional synthetic DMARDs like methotrexate if used for at least three months. The trial will assess changes over 12 months, focusing on functional limitation and quality of life. During the trial, participants will be monitored regularly to assess their function and symptoms using patient-reported tools such as the Health Assessment Questionnaire HAQ. Researchers will collect information on treatment effectiveness, side effects, and safety in a real-world population, including those with other health conditions. The study is designed to reflect routine clinical care and will last for at least 12 months, with follow-up to evaluate changes from baseline in physical function and other outcomes important to patients.

RA-PRO PRAGMATIC TRIAL