Humans

Effect of tapered versus stable treatment with tumour necrosis factor inhibitors on disease flares in patients with rheumatoid arthritis in remission: a randomised, open label, non-inferiority trial
OBJECTIVES: Many patients with rheumatoid arthritis (RA) require treatment with tumour necrosis factor inhibitor (TNFi) to reach …
Siri Lillegraven, Nina Paulshus Sundlisæter, Anna-Birgitte Aga, Joseph Sexton, Inge Christoffer Olsen, Åse Stavland Lexberg, Tor Magne Madland, Hallvard Fremstad, Christian A. Høili, Gunnstein Bakland, Cristina Spada, Hilde Haukeland, Inger Myrnes Hansen, Ellen Moholt, Till Uhlig, Daniel H. Solomon, Désirée van der Heijde, Tore K. Kvien, Espen A. Haavardsholm
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Certolizumab pegol, abatacept, tocilizumab or active conventional treatment in early rheumatoid arthritis: 48-week clinical and radiographic results of the investigator-initiated randomised controlled NORD-STAR trial
BACKGROUND: The optimal first-line treatment in early rheumatoid arthritis (RA) is debated. We compared clinical and radiographic …
Mikkel Østergaard, Ronald F. van Vollenhoven, Anna Rudin, Merete Lund Hetland, Marte Schrumpf Heiberg, Dan C. Nordström, Michael T. Nurmohamed, Bjorn Gudbjornsson, Lykke Midtbøll Ørnbjerg, Pernille Bøyesen, Kristina Lend, Kim Hørslev-Petersen, Till Uhlig, Tuulikki Sokka, Gerdur Grondal, Simon Krabbe, Joakim Lindqvist, Inger Gjertsson, Daniel Glinatsi, Meliha Crnkic Kapetanovic, Anna-Birgitte Aga, Francesca Faustini, Pinja Parmanne, Tove Lorenzen, Cagnotto Giovanni, Johan Back, Oliver Hendricks, Daisy Vedder, Tuomas Rannio, Emma Grenholm, Maud Kristine Ljoså, Eli Brodin, Hanne Lindegaard, Annika Söderbergh, Milad Rizk, Alf Kastbom, Per Larsson, Line Uhrenholt, Søren Andreas Just, David J. Stevens, Trine Bay Laurbjerg, Gunnstein Bakland, Inge Christoffer Olsen, Espen A. Haavardsholm, Jon Lampa, NORD-STAR study group
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The international Unity study for antivirals against mpox is a blueprint for future epidemics
Erica Telford, Beatriz Grinsztejn, Inge Christoffer Olsen, Nicolas Pulik, France Mentré, Skerdi Haviari, Maxime Hentzien, Olivier Ségéral, Miquel B. Ekkelenkamp, Dimie Ogoina, Nathalie Strub-Wourgaft, Alpha Diallo, Yazdan Yazdanpanah, Alexandra Calmy
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Effects of remdesivir in patients hospitalised with COVID-19: a systematic review and individual patient data meta-analysis of randomised controlled trials
BACKGROUND: Interpretation of the evidence from randomised controlled trials (RCTs) of remdesivir in patients treated in hospital for …
Alain Amstutz, Benjamin Speich, France Mentré, Corina Silvia Rueegg, Drifa Belhadi, Lambert Assoumou, Charles Burdet, Srinivas Murthy, Lori Elizabeth Dodd, Yeming Wang, Kari A. O. Tikkinen, Florence Ader, Maya Hites, Maude Bouscambert, Mary Anne Trabaud, Mike Fralick, Todd C. Lee, Ruxandra Pinto, Andreas Barratt-Due, Fridtjof Lund-Johansen, Fredrik Müller, Olli P. O. Nevalainen, Bin Cao, Tyler Bonnett, Alexandra Griessbach, Ala Taji Heravi, Christof Schönenberger, Perrine Janiaud, Laura Werlen, Soheila Aghlmandi, Stefan Schandelmaier, Yazdan Yazdanpanah, Dominique Costagliola, Inge Christoffer Olsen, Matthias Briel
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Implementation of a centralized pharmacovigilance system in academic pan-European clinical trials: Experience from EU-Response and conect4children consortia
Setting-up a high quality, compliant and efficient pharmacovigilance (PV) system in multi-country clinical trials can be more …
Vida Terzić, Léa Levoyer, Mélanie Figarella, Elisabetta Bigagli, Noémie Mercier, Lucie De Gastines, Séverine Gibowski, Marius Trøseid, Jacques Demotes, Inge Christoffer Olsen, Maya Hites, Florence Ader, José Ramón Arribas Lopez, France Mentré, Hélène Esperou, Dominique Costagliola, John-Arne Røttingen, Julien Poissy, Jean-Christophe Rozé, Adilia Warris, Jackie O'Leary, Ricardo M. Fernandes, Lambert Assoumou, Regis Hankard, Mark A. Turner, Yazdan Yazdanpanah, Alpha Diallo, EU-Response safety group, c4c safety group
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Investigating survival, quality of life and cognition in PROton versus photon therapy for IDH-mutated diffuse grade 2 and 3 GLIOmas (PRO-GLIO): a randomised controlled trial in Norway and Sweden
INTRODUCTION: The use of proton therapy increases globally despite a lack of randomised controlled trials demonstrating its efficacy …
Liv Cathrine Heggebø, Ida Maria Henriksen Borgen, Hillevi Rylander, Cecilie Kiserud, Tonje Haug Nordenmark, Taran Paulsen Hellebust, Morten Egeberg Evensen, Magnus Gustavsson, Christina Ramberg, Mette Sprauten, Henriette Magelssen, Hanne Blakstad, Janani Moorthy, Karin Andersson, Ingela Raunert, Thomas Henry, Cecilie Moe, Carin Granlund, Dorota Goplen, Jorunn Brekke, Tor-Christian Aase Johannessen, Tora Skeidsvoll Solheim, Kirsten Marienhagen, Øyvind Humberset, Per Bergström, Måns Agrup, Ludvig Dahl, Michael Gubanski, Helene Gojon, Carl-Johan Brahme, Isabelle Rydén, Asgeir S. Jakola, Einar O. Vik-Mo, Hanne C. Lie, Lars Asphaug, Maziar Hervani, Ingrid Kristensen, Corina Silvia Rueegg, Inge C. Olsen, Rolf J. Ledal, Eskil Degsell, Katja Werlenius, Malin Blomstrand, Petter Brandal
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Efficacy and safety of baricitinib in hospitalized adults with severe or critical COVID-19 (Bari-SolidAct): a randomised, double-blind, placebo-controlled phase 3 trial
BACKGROUND: Baricitinib has shown efficacy in hospitalized patients with COVID-19, but no placebo-controlled trials have focused …
Marius Trøseid, José R. Arribas, Lambert Assoumou, Aleksander Rygh Holten, Julien Poissy, Vida Terzić, Fulvia Mazzaferri, Jesús Rodríguez-Baño, Joe Eustace, Maya Hites, Michael Joannidis, José Artur Paiva, Jean Reuter, Isabel Püntmann, Thale D. J. H. Patrick-Brown, Elin Westerheim, Katerina Nezvalova-Henriksen, Lydie Beniguel, Tuva Børresdatter Dahl, Maude Bouscambert, Monika Halanova, Zoltan Peterfi, Sotirios Tsiodras, Michael Rezek, Matthias Briel, Serhat Unal, Martin Schlegel, Florence Ader, Karine Lacombe, Cecilie Delphin Amdal, Serge Rodrigues, Kristian Tonby, Alexandre Gaudet, Lars Heggelund, Joy Mootien, Asgeir Johannessen, Jannicke Horjen Møller, Beatriz Diaz Pollan, Anders Aune Tveita, Anders Benjamin Kildal, Jean-Christophe Richard, Olav Dalgard, Victoria Charlotte Simensen, Aliou Baldé, Lucie De Gastines, Marta del Álamo, Burç Aydin, Fridtjof Lund-Johansen, Mary Anne Trabaud, Alpha Diallo, Bente Halvorsen, John-Arne Røttingen, Evelina Tacconelli, Yazdan Yazdanpanah, Inge C. Olsen, Dominique Costagliola, EU SolidAct study group
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Immunocompromised patients have been neglected in COVID-19 trials: a call for action
Marius Trøseid, Maxime Hentzien, Florence Ader, Sandra Wagner Cardoso, José R. Arribas, Jean-Michel Molina, Nicolas Mueller, Maya Hites, Fabrice Bonnet, Oriol Manuel, Dominique Costagliola, Beatriz Grinsztejn, Inge Christoffer Olsen, Yazdan Yazdapanah, Alexandra Calmy, EU RESPONSE, COMBINE
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Risk factors for anti-drug antibody formation to infliximab: Secondary analyses of a randomised controlled trial
BACKGROUND: Anti-drug antibodies (ADAb) frequently form early in the treatment course of infliximab and other tumour necrosis factor …
Marthe Kirkesaether Brun, Guro Løvik Goll, Kristin Kaasen Jørgensen, Joseph Sexton, Johanna Elin Gehin, Øystein Sandanger, Inge Christoffer Olsen, Rolf Anton Klaasen, David John Warren, Cato Mørk, Tore K. Kvien, Jørgen Jahnsen, Nils Bolstad, Espen A. Haavardsholm, Silje Watterdal Syversen
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Early food intervention and skin emollients to prevent food allergy in young children (PreventADALL): a factorial, multicentre, cluster-randomised trial
BACKGROUND: Primary prevention of food allergy by early introduction of allergenic foods seems promising. We aimed to determine whether …
Håvard Ove Skjerven, Anine Lie, Riyas Vettukattil, Eva Maria Rehbinder, Marissa LeBlanc, Anna Asarnoj, Kai-Håkon Carlsen, Åshild Wik Despriee, Martin Färdig, Sabina Wärnberg Gerdin, Berit Granum, Hrefna Katrín Gudmundsdóttir, Guttorm Haugen, Gunilla Hedlin, Geir Håland, Christine Monceyron Jonassen, Linn Landrø, Caroline-Aleksi Olsson Mägi, Inge Christoffer Olsen, Knut Rudi, Carina Madelen Saunders, Marius Kurås Skram, Anne Cathrine Staff, Cilla Söderhäll, Sandra G. Tedner, Sigve Aadalen, Hilde Aaneland, Björn Nordlund, Karin C. Lødrup Carlsen
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