This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. A steering committee of clinical researchers involved with rheumatoid arthritis (RA) trials was formed to design the Treatment of Early Aggressive Rheumatoid Arthritis (TEAR) trial as part of an NIH-Funded Clinical Trails Planning Grant (R21AR48343, PI, Moreland). The multicenter TEAR trial represents the first 2-year trial to prospectively analyze the long-term outcomes of treatment of early, 'aggressive' RA with combinations of currently Food and Drug Administration (FDA) approved biologic agents and traditional disease-modifying anti-rheumatic drugs (DMARDs). TEAR is an investigator-initiated trial utilizing available FDA approved medications; the over riding goal of this study is to help establish appropriate standard of care for patients with early 'aggressive' RA. The TEAR trial design is a 2x2 factorial design comparing 2 different combinations (the tumor necrosis factor [TNF] antagonist etanercept, plus methotrexate [MTW] versus MTX plus hydroxychloroquine [HCQ] plus sulfasalazine [SSZ] in patients with early RA who have an 'aggressive' clinical phenotype defined by presence of active synovitis of multiple joints. The results will provide novel information on the best treatment approach for patients with early RA.
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