TY - JOUR T1 - Effect of nurse-led care on outcomes in patients with ACPA/RF-positive rheumatoid arthritis with active disease undergoing treat-to-target: a multicentre randomised controlled trial JF - RMD Open JO - RMD Open DO - 10.1136/rmdopen-2021-001627 VL - 7 IS - 1 SP - e001627 AU - Juliana Rachel Hoeper AU - Jan Zeidler AU - Sara Eileen Meyer AU - Georg Gauler AU - Patricia Steffens-Korbanka AU - Martin Welcker AU - Jörg Wendler AU - Florian Schuch AU - Ulrich von Hinüber AU - Andreas Schwarting AU - Torsten Witte AU - Dirk Meyer-Olson AU - Kirsten Hoeper Y1 - 2021/04/01 UR - http://rmdopen.bmj.com/content/7/1/e001627.abstract N2 - Objective To determine the non-inferiority of nurse-led care (NLC) in patients with anticitrullinated protein antibody (ACPA)-positive and/or rheumatoid factor (RF)-positive rheumatoid arthritis (RA) with active disease who are starting disease-modifying antirheumatic drug therapy, following treat-to-target (T2T) recommendations.Methods A multicentre, pragmatic randomised controlled trial was conducted to assess clinical effectiveness, anxiety, depression and patient satisfaction following a non-inferiority design. The participants were 224 adults with ACPA/RF-positive RA who were randomly assigned to either NLC or rheumatologist-led care (RLC). The primary outcome was the Disease Activity Score in 28 Joints measured with C reactive protein (DAS28-CRP) assessed at baseline and after 3, 6, 9 and 12 months. A DAS28-CRP difference of 0.6 was set as the non-inferiority margin. Mean differences between the groups were assessed following per-protocol and intention-to-treat strategies.Results Demographic data and baseline characteristics of patients in the NLC group (n=111) were comparable to those of patients in the RLC group (n=113). The improvement in disease activity (change in DAS28-CRP, primary outcome) over the course of 12 months was significant in both groups (p<0.001). No significant differences were observed between the NLC and RLC groups (p=0.317). Non-inferiority of NLC was shown for the primary outcome and all secondary outcomes.Conclusion This study supported the non-inferiority of NLC in managing T2T and follow-up care of patients with RA with moderate to high disease activity and poor prognostic factors in addition to RLC.Trial registration number DRKS00013055.All data relevant to the study are included in the article or uploaded as supplementary information. ER -