Active conventional treatment and three different biological treatments in early rheumatoid arthritis : Phase IV investigator initiated, randomised, observer blinded clinical trial

• Published in: BMJ
• Main Authors: Hetland, Merete Lund, Haavardsholm, Espen A., Rudin, Anna, Nordström, Dan, Nurmohamed, Michael, Gudbjornsson, Bjorn, Lampa, Jon, Hørslev-Petersen, Kim, Uhlig, Till, Grondal, Gerdur, Østergaard, Mikkel, Heiberg, Marte S., Twisk, Jos, Lend, Kristina, Krabbe, Simon, Hyldstrup, Lise Hejl, Lindqvist, Joakim, Hultgård Ekwall, Anna Karin, Grøn, Kathrine Lederballe, Kapetanovic, Meliha, Faustini, Francesca, Tuompo, Riitta, Lorenzen, Tove, Cagnotto, Giovanni, Baecklund, Eva, Hendricks, Oliver, Vedder, Daisy, Sokka-Isler, Tuulikki, Husmark, Tomas, Ljoså, Maud Kristine Aga, Brodin, Eli, Ellingsen, Torkell, Söderbergh, Annika, Rizk, Milad, Olsson, Åsa Reckner, Larsson, Per, Uhrenholt, Line, Just, Søren Andreas, Stevens, David John, Laurberg, Trine Bay, Bakland, Gunnstein, Olsen, Inge C., Van Vollenhoven, Ronald
• Other Authors: Faculty of Medicine, Internal Medicine and Emergency Services, Other departments, Landspitali - The National University Hospital of Iceland
• Format: Article in Journal/Newspaper
• Language: English
• Published: 2020
• Subjects: Medicine (all); Norway; Myers; Iceland
• Online Access: https://hdl.handle.net/20.500.11815/3394; https://doi.org/10.1136/bmj.m4328

Funding was obtained through public sources: Academy of Finland (grant No 258536), Finska Läkaresällskapet, grant from the South-Eastern Health Region, Norway, HUCH Institutional grant, Finland (grant No 1159005), Icelandic Society for Rheumatology, interregional grant from all health regions in Norway, NordForsk (grant No 70945), Regionernes Medicinpulje, Denmark (grant No 14/217), Stockholm County Council, Sweden (grant No 20100490), Swedish Medical Research Council (grant No C0634901, D0342301, 2015-00891_5), Swedish Rheumatism Association, The Research Fund of University Hospital, Reykjavik, Iceland (A2015017). UCB supported the work in the context of an investigator initiated study where UCB provided certolizumab pegol at no cost. UCB had no role in study design, collection, analysis, and interpretation of data, in the writing of the report, or in the decision to submit for publication. Bristol-Myers Squibb (BMS) provided abatacept at no cost. In addition, the Karolinska Institute received several unrestricted grants from BMS; these were subsequently transferred to the principal investigators of Denmark, Finland, and the Netherlands to help defray various trial related costs at the local level. BMS had no role in study design, collection, analysis, and interpretation of data, in the writing of the report, or in the decision to submit for publication. The final manuscript was provided for courtesy review to UCB and BMS in line with Good Publication Practice (GPP3). We confirm the independence of researchers from funders and that all authors, external and internal, had full access to all of the data (including statistical reports and tables) in the study and can take responsibility of the integrity of the data and the accuracy of the data analysis. Publisher Copyright: © AbstractObjective To evaluate and compare benefits and harms of three biological treatments with different modes of action versus active conventional treatment in patients with early rheumatoid arthritis. Design Investigator initiated, ...