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Etrolizumab versus infliximab for the treatment of moderately to severely active ulcerative colitis (GARDENIA): a randomised, double-blind, double-dummy, phase 3 study
Silvio Danese, Jean‐Frédéric Colombel, Milan Lukáš, Javier P. Gisbert, Geert D’Haens, Remo Panaccione, Hyun‐Soo Kim, Walter Reinisch, Helen E.J. Tyrrell, Young S. Oh, Swati Tole, Akiko Chai, Kirsten Chamberlain-James, Meina Tang, Stefan Schreiber, Nazimuddin Aboo, Tariq Ali Ahmad, Xavier Aldeguer Manté, Matthieu Allez, Sven Almér, Romain Altwegg, Montserrat Andreu García, Ramesh Arasaradnam, Sandro Ardizzone, Alessandro Armuzzi, Ian Arnott, Guy Aumais, Irit Avni‐Biron, Peter Barrow, Ian Beales, Fernando Bermejo San José, Abraham F. Bezuidenhout, Livia Biancone, Michael Blaeker, Stuart Bloom, Bernd Bokemeyer, Fabrizio Bossa, Peter Bossuyt, Guillaume Bouguen, Yoram Bouhnik, Gerd Bouma, Raymond Bourdages, Arnaud Bourreille, Christian Boustière, Tomáš Brabec, Stephan Brand, Carsten Buening, Anthony Buisson, Guillaume Cadiot, Xavier Calvet, Franck Carbonnel, Daniel Carpio, Jae Hee Cheon, Naoki Chiba, Camelia Chioncel, Nicoleta-Claudia Cimpoeru, Martin Clodi, Gino Roberto Corazza, R. Cosintino, José Cotter, Thomas Creed, Fraser Cummings, Gian Luigi De’ Angelis, Marc De Maeyer, Milind Y. Desai, Étienne Désilets, Pierre Desreumaux, Olivier Dewit, Johanna Dinter, Ecaterina Daniela Dobru, Tomáš Douda, Dan L. Dumitraşcu, Matthias Ebert, Magdy Elkhashab, Chang Soo Eun, Brian G. Feagan, R Fejes, Catarina Fidalgo, Sigal Fishman, Bernard Flourié, Sharyle Fowler, Walter Fries, Csaba Fülöp, Mathurin Fuméry, G Kiss, Sonja Gassner, Daniel R. Gaya, Bastianello Germanà, Liliana Gheorghe, Paolo Gionchetti, Adrian-Eugen Goldis, Raquel Gonçalves, Jean–Charles Grimaud, T Gyökeres, Hervé Hagège, Andrei Haidar, Heinz Hartmann, Peter Hasselblatt, Bu Hayee, Xavier Hébuterne, Per M. Hellström, P. Hindryckx, Helena Hlavova, Frank Hoentjen, Stefanie Howaldt, Luděk Hrdlička, Kyu Chan Huh, Maria Isabel Iborra Colomino, Florentina Ioniţă‐Radu, Peter M. Irving, Jørgen Jahnsen, Byung-Ik Jang, Jeroen P. Jansen, Seong Woo Jeon, Rodrigo Jover Martínez, Pascal Juillerat, Per Karlén, Arthur Kaser, Radan Keil, Deepak Kejariwal, Dan Keret, Reena Khanna, Dong‐Woo Kim, Duk Hwan Kim, Hyo Jong Kim, Hyun‐Soo Kim, Joo Sung Kim, Kueongok Kim, Kyung-Jo Kim, Sung Kook Kim, Young‐Ho Kim, Jochen Klaus, Anna Kohn, Vladimír Kojecký, Ja Seol Koo, Robert Kozak, Milan Kremer, Tünde Kristóf, Frederik Cornelius Kruger, David Laharie, Adi Lahat-Zok, Jong Hun Lee, Kang‐Moon Lee, Kook Lae Lee, Yoojin Lee, Frank Lenze, Wee Chian Lim, Jimmy K. Limdi, James O. Lindsay, Pilar López Serrano, Édouard Louis, Stefan Lueth, Giovanni Maconi, Fazia Mana, Steven Mann, John Mansfield, Santino Marchi, Marco Marino, John K. Marshall, María Dolores Martín‐Arranz, Bogdan Mateescu, John McLaughlin, Simon D. McLaughlin, Ehud Melzer, Jessica Mertens, Paul Mitruț, Tamás Resál, Vinciane Muls, Pushpakaran Munuswamy, Charles Murray, Timna Naftali, Visvakuren Naidoo, Yusuf Nanabhay, Lucian Negreanu, Augustin Nguyen, Thomas Ochsenkuehn, Ambrogio Orlando, Maya Paritsky, Dong Il Park, Jihye Park, Luca Pastorelli, Markus Peck‐Radosavljevic, Farhad Peerani, Laurent Peyrin‐Biroulet, Laurence Picon, Marieke Pierik, Terry Ponich, Francisco Portela, Maartens Jeroen Prins, I Rácz, Khan Fareed Rahman, Jean‐Marie Reimund, Max Reinshagen, Xavier Roblin, Rodolfo Rocca, Francesca Rogai, Gerhard Rogler, Á Salamon, Ennaliza Salazar, Zoltán Salló, Sunil Samuel, Miquel de los Santos Sans Cuffi, Edoardo Savarino, Vincenzo Savarino, Guillaume Savoye, Andrada Seicean, Christian P. Selinger, David Martins Serra, Hang Hock Shim, Sung Jae Shin, Britta Siegmund, Jesse Siffledeen, Wayne M Simmonds, Jan Šmíd, Jose D. Sollano, Geun Am Song, Alexander Speight, Ioan Sporea, Dirk Staessen, George Stancu, Alan Steel, David Stepek, Victor Stoica, Andreas Sturm, Gyorgy Szekely, Teck Kiang Tan, John Thomson, Michal Tichý, Gábor Tamás Tóth, Zsolt Tulassay, Marcello Vangeli, Márta Varga, Ana Paula Vieira, Stéphanie Viennot, Erica Villa, Petr Vítek, Harald Vogelsang, P Vyhnálek, Peter J. Wahab, Jens Walldorf, Byong Duk Ye, Christopher Ziady
Bibliographic record
VenueThe Lancet. Gastroenterology & hepatology · 2021
Typearticle
Languageen
FieldBiochemistry, Genetics and Molecular Biology
TopicInflammatory Bowel Disease
Canadian institutionsUniversity of Calgary
FundersF. Hoffmann-La RocheRoche
KeywordsDouble blindUlcerative colitisInfliximabMedicineInternal medicineGardeniaGastroenterologyDouble blind studyTraditional medicineDermatologyPlaceboTumor necrosis factor alphaPathologyDiseaseTraditional Chinese medicineAlternative medicine
Abstract
No abstract in any covered source. Its absence is recorded, not treated as a negative.
No abstract. This is not a gap in this database; OpenAlex has none either. 23.3% of the frame is in this state, and the screen finds HALF as much metaresearch here, so the absence is a measured bias rather than a missing field.
How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
metaresearch head score (Codex)0.000
metaresearch head score (Gemma)0.000
Version: codex-gemma-dda1882f352aValidation status: machine_predicted_unvalidated
Candidate categoriesMeta-epidemiology (narrow)
Consensus categoriesnone
DomainCandidate signal: none · Consensus signal: none
Study designCandidate signal: Randomized trial · Consensus signal: Randomized trial
GenreCandidate signal: Empirical · Consensus signal: Empirical
Teacher disagreement score0.079
Threshold uncertainty score1.000
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.000 | 0.000 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.000 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
Opus teacher head0.047
GPT teacher head0.331
Teacher spread0.284 · how far apart the two teachers sit on this one work
Validation status
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one teacher head, not a consensus.
Study designRandomized trial
Domainnot available
GenreEmpirical
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".
Quick stats
Citations93
Published2021
Admission routes1
Has abstractno