Abstracts tagged "clinical trial"

Abstract Number: 0502 • ACR Convergence 2024
Similar Efficacy, PK, Safety, and Immunogenicity of Tocilizumab Biosimilar (CT-P47) and Reference Tocilizumab in Patients with Moderate-to-Severe Active Rheumatoid Arthritis: Week 52 Results from the Phase III Single Transition Study
Gerd Burmester¹, Jakub Trefler², Artur Racewicz³, Janusz Jaworski⁴, Agnieszka Zielińska⁵, Marek Krogulec⁶, Sławomir Jeka⁷, Rafał Wojciechowski⁸, Katarzyna Kolossa⁹, Anna Dudek¹⁰, Magdalena Krajewska-Włodarczyk¹¹, Paweł Hrycaj¹², Piotr Adrian Klimiuk¹³, SungHyun Kim¹⁴, JeeHye Suh¹⁴, GoEun Yang¹⁴, Yunah Kim¹⁴, YooBin Jung¹⁴, JiWoo Hong¹⁴ and Josef Smolen¹⁵, ¹Department of Rheumatology and Clinical Immunology, Charité – Universitätsmedizin Berlin, Berlin, Germany, ²REUMA RESEARCH, Wrocław, Poland, ³Zdrowie Osteo-Medic, Warszawa, Poland, ⁴Reumatika-Centrum Reumatologii, Warszawa, Poland, ⁵MICS Centrum Medyczne Warszawa, Warszawa, Poland, ⁶NZOZ Lecznica MAK - MED, Nadarzyn, Poland, ⁷MICS Centrum Medyczne, Polska, Poland, ⁸Department of Rheumatology and Systemic Connective Tissue Diseases, University Hospital No. 2, Bydgoszcz, PL, Bydgoszcz, Poland, ⁹MICS Centrum Medyczne Bydgoszcz, Bydgoszcz, Poland, ¹⁰Centrum Medyczne Amed, Warszawa, Poland, ¹¹University of Warmia and Mazury, Clinic of Rheumatology, Olsztyn, Poland, ¹²Prywatna Praktyka Lekarska Prof. dr hab. med. Paweł, Poznań, Poland, ¹³Medical University of Bialystok and Inter Clinic Piotr Adrian Klimiuk, Department of Rheumatology and Internal Diseases, Białystok, Poland, ¹⁴Celltrion, Inc., Incheon, Republic of Korea, ¹⁵Medical University of Vienna, Vienna, Austria
Background/Purpose: The therapeutic equivalence of CT-P47 (a proposed biosimilar to reference tocilizumab [ref-tocilizumab]) was demonstrated in patients with moderate to severe RA through disease activity…
Abstract Number: 0659 • ACR Convergence 2024
Obinutuzumab Benefits Patients with Active Lupus Nephritis Irrespective of Baseline Proteinuria Severity: A Post Hoc Analysis of a Phase II Trial
Richard Furie¹, Jorge A. Ross Terres², Elsa Martins³, Imran Hassan⁴, Thomas Schindler³, Jay Garg⁵, William F. Pendergraft III⁶, Ana Malvar⁷ and Brad Rovin⁸, ¹Northwell Health, Manhasset, NY, ²Genentech, Inc,, San Francisco, ³F. Hoffmann-La Roche Ltd, Basel, Switzerland, ⁴Hoffmann-La Roche Ltd, Mississauga, Canada, ⁵Genentech, Inc., South San Francisco, CA, ⁶Genentech, Inc., Chapel Hill, NC, ⁷Organización Médica de Investigación, Buenos Aires, Argentina, ⁸The Ohio State University, Columbus, OH
Background/Purpose: Lupus nephritis (LN) is the most common severe organ-threatening manifestation of systemic lupus erythematosus (SLE). The randomized, placebo-controlled, Phase II NOBILITY trial (NCT02550652) demonstrated…
Abstract Number: 0823 • ACR Convergence 2024
A Randomized, Double-Blind, Placebo-Controlled Trial of Abatacept for the Treatment of Relapsing, Non-Severe, Granulomatosis with Polyangiitis
Carol Langford¹, Nader Khalidi², Jason Springer³, Marcia Friedman⁴, Bernhard Hellmich⁵, Christian Pagnoux⁶, Natasha Dehghan⁷, Ora Singer⁸, Curry Koening⁹, Yih Chang Lin¹⁰, Paul Monach¹¹, Larry Moreland¹², Aurore Fifi-Mah¹³, Oliver Flossmann¹⁴, Lindsy Forbess¹⁵, Peter Lanyon¹⁶, Eamonn Molloy¹⁷, Ulrich Specks¹⁸, Robert Spiera¹⁹, Elaine Yacyshyn²⁰, Carol McAlear²¹, Cristina Burroughs¹⁰, Rachel Jones²², Rennie Rhee²¹, Rula A. Hajj-Ali²³, Kenneth Warrington¹⁸, David Cuthbertson¹⁰, Jeffrey Krischer¹⁰, David Jayne²² and Peter Merkel²¹, and the Vasculitis Clinical Research Consortium and the European Vasculitis Society, ¹Cleveland Clinic, Moreland Hills, OH, ²McMaster University, Hamilton, ON, Canada, ³Vanderbilt University Medical Center, Franklin, TN, ⁴Oregon Health and Science University, Portland, OR, ⁵Medius Kliniken, Kirchheim unter Teck, Germany, ⁶Mount Sinai Hospital, Toronto, ON, Canada, ⁷University of British Columbia - Vancouver, Vancouver, BC, Canada, ⁸University of Michigan, Huntington Woods, MI, ⁹University of Texas Dell Medical School, Austin, TX, ¹⁰University of South Florida, Tampa, FL, ¹¹VA Boston Healthcare System, Boston, MA, ¹²University of Colorado, Denver, CO, ¹³University of Calgary, Calgary, AB, Canada, ¹⁴Royal Berkshire Hospital, Reading, United Kingdom, ¹⁵Cedars-Sinai Medical Center, Los Angeles, CA, ¹⁶University of Nottingham, Nottingham, United Kingdom, ¹⁷St Vincent's University Hospital, Dublin, Ireland, ¹⁸Mayo Clinic, Rochester, MN, ¹⁹Scleroderma, Vasculitis, and Myositis Center, Hospital for Special Surgery, Weill Cornell Medical College, New York, NY, ²⁰University of Alberta, Edmonton, AB, Canada, ²¹University of Pennsylvania, Philadelphia, PA, ²²University of Cambridge, Cambridge, United Kingdom, ²³Cleveland Clinic, Cleveland, OH
Background/Purpose: Granulomatosis with polyangiitis (GPA) is a small-vessel vasculitis associated with frequent relapses. Following encouraging results from an open-label study, a randomized, double-blind, placebo-controlled trial…
Abstract Number: 1376 • ACR Convergence 2024
Comparison of the Efficacy of DMARDs in Phase 3 Trials of Different Populations Used in FDA Approvals for Rheumatoid Arthritis Since 2010
Catherine Emanuel¹ and Ajay Aggarwal², ¹Aclaris Therapeutics Inc., St Louis, MO, ²Aclaris Therapeutics, Inc., Wellesley, MA
Background/Purpose: Varying mechanisms of action are required to address the needs of rheumatoid arthritis patients with different levels of severity. Since 2010, all new FDA…
Abstract Number: 1473 • ACR Convergence 2024
Patient-Reported Symptoms Improved with Stringent Control of Swollen Joints in Patients with Psoriatic Arthritis: Results from Two Phase 3 Studies of Bimekizumab
M. Elaine Husni¹, Philip Mease², Dafna Gladman³, Barbara Ink⁴, Jérémy Lambert⁵, Patrick Healy⁶ and Laure Gossec⁷, ¹Cleveland Clinic, Cleveland, OH, ²Swedish Medical Center/Providence St. Joseph Health; University of Washington School of Medicine, Seattle, WA, ³University of Toronto, Toronto Western Hospital, Toronto, ON, Canada, ⁴UCB Pharma, Slough, United Kingdom, ⁵UCB Pharma, Colombes, France, ⁶UCB Pharma, Morrisville, NC, ⁷Sorbonne Université, Paris, France
Background/Purpose: PsA is characterized by joint and skin inflammation, and associated with debilitating symptoms of pain and fatigue.1 Previous research has shown that pain and…
Abstract Number: 1745 • ACR Convergence 2024
Use of Statins and Its Association with Major Adverse Cardiovascular Outcomes with Tofacitinib versus TNF Inhibitors in a Risk-Enriched Population of Patients with Rheumatoid Arthritis
Jon Giles¹, christina Charles-Schoeman², Maya H. Buch³, Maxime Dougados⁴, Zoltan Szekanecz⁵, Ted Mikuls⁶, Steven R Ytterberg⁷, Gary G Koch⁸, Kenneth Kwok⁹, Mary Jane Cadatal¹⁰, Sujatha Menon¹¹, Yan Chen¹², Annette M Diehl¹², Jose L Rivas¹³, Arne Yndestad¹⁴ and Deepak L Bhatt¹⁵, ¹Cedars Sinai Medical Center, Los Angeles, CA, ²UCLA Medical Center, Santa Monica, CA, ³Division of Musculoskeletal & Dermatological Sciences, University of Manchester, and NIHR Manchester Biomedical Research Centre, Manchester, United Kingdom, ⁴Université de Paris; Department of Rheumatology, Hôpital Cochin; Assistance Publique-Hôpitaux de Paris; and INSERM (U1153): Clinical Epidemiology and Biostatistics, PRES Sorbonne Paris-Cité, Paris, France, ⁵Department of Rheumatology, Faculty of Medicine, University of Debrecen, Debrecen, Hungary, ⁶University of Nebraska Medical Center, Omaha, NE, ⁷Division of Rheumatology, Mayo Clinic, Rochester, MN, ⁸Department of Biostatistics, University of North Carolina at Chapel Hill, Chapel Hill, NC, ⁹Pfizer Inc, New York, NY, ¹⁰Pfizer Inc, Manila, Philippines, ¹¹Pfizer Inc, Groton, CT, ¹²Pfizer Inc, Collegeville, PA, ¹³Pfizer SLU, Madrid, Spain, ¹⁴Pfizer Inc, Oslo, Norway, ¹⁵Mount Sinai Fuster Heart Hospital, Icahn School of Medicine at Mount Sinai, New York, NY
Background/Purpose: ORAL Surveillance (NCT02092467; a post-authorization safety study of tofacitinib 5 and 10 mg twice daily [BID] vs TNF inhibitors [TNFi]) found higher incidence of…
Abstract Number: 2056 • ACR Convergence 2024
Deucravacitinib Treatment Did Not Impact Immune Response to SARS-CoV-2 Vaccines and Infection in Patients with Plaque Psoriasis: Results from the Phase 3 POETYK Long-Term Extension Trial
Kevin Winthrop¹, Joseph Merola², Akimichi Morita³, Diamant Thaçi⁴, Jianzhong Zhang⁵, Aditi Basu Ba⁶, Ian M. Catlett⁷, John Schwarz⁶ and Yi Luo⁶, ¹School of Medicine, Oregon Health and Science University, Portland, OR, ²UT Southwestern Medical Center, Newton, MA, ³Department of Geriatric and Environmental Dermatology, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan, ⁴Institute and Comprehensive Center for Inflammation Medicine, University of Lübeck, Lübeck, Schleswig-Holstein, Germany, ⁵Department of Dermatology, Peking University People’s Hospital, Beijing, China, ⁶Bristol Myers Squibb, Princeton, ⁷Bristol Myers Squibb, Princeton, NJ
Background/Purpose: Deucravacitinib, an oral, selective, allosteric tyrosine kinase 2 inhibitor, is approved in the US, EU, and other countries for treatment of adults with moderate…
Abstract Number: 2355 • ACR Convergence 2024
Efficacy of Risankizumab Across Distinct PsA Phenotypes Identified with Machine Learning Analytics Using Data from Biologic DMARD-Naive Patients in Two Phase 3 Clinical Trials
Laure Gossec¹, Andra Balanescu², Maria Antonietta D'Agostino³, Alexis Ogdie⁴, Philipp Sewerin⁵, Yu Deng⁶, Linyu Shi⁶, Yoshiyuki Sugimoto⁷, Sheng Zhong⁶, Yunzhao Xing⁶, Ralph Lippe⁶ and Mitsumasa Kishimoto⁸, ¹Sorbonne Université, Paris, France, ²UNIVERSITY OF MEDICINE AND PHARMACY CAROL DAVILA, Bucharest, Romania, ³Versailles-Saint-Quentin University (INSERM U1173, Laboratoire d’Excellence INFLAMEX); University Hospital Ambroise Paré, Versailles, France, ⁴Department of Medicine, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, ⁵Rheumazentrum Ruhrgebiet, Ruhr University Bochum, Bochum, Germany, ⁶AbbVie Inc., North Chicago, IL, ⁷AbbVie GK, Tokyo, Tokyo, Japan, ⁸Department of Nephrology and Rheumatology, Kyorin University School of Medicine, Tokyo, Japan
Background/Purpose: Risankizumab (RZB), an IL-23 p19 inhibitor, is well tolerated and provides long-term efficacy through 100 weeks in adults with PsA, demonstrated by the phase…
Abstract Number: 2583 • ACR Convergence 2024
Apremilast Reduces Axial Inflammation in Patients with Psoriatic Arthritis as Assessed by CANDEN MRI Scoring: Results from a Phase 4 Study
Mikkel Ostergaard¹, Walter Maksymowych², Robert Lambert², Mikael Boesen³, Guillermo J. Valenzuela⁴, Michael R. Bubb⁵, Olga Kubassova⁶, Xenofon Baraliakos⁷, Carlo Selmi⁸, Stephen Colgan⁹, Yuri Klyachkin¹⁰, Cynthia Deignan¹¹, Zhenwei Zhou¹¹ and Philip Mease¹², ¹Department of Clinical Medicine, University of Copenhagen and Center for Rheumatology, Copenhagen Center for Arthritis Research, Glostrup, Denmark, ²University of Alberta, Edmonton, AB, Canada, ³Copenhagen University Hospital, Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark, ⁴Guillermo Valenzuela MD PA/ IRIS Rheumatology, Plantation, FL, ⁵University of Florida, Gainesville, FL, ⁶Image Analysis Group, Philadelphia, PA, ⁷Rheumazentrum Ruhrgebiet Herne, Ruhr-University Bochum, Herne, Germany, ⁸Department of Biomedical Sciences, Humanitas University, Rozzano, Italy, ⁹Amgen, Halton Hills, ON, Canada, ¹⁰Amgen, Lexington, KY, ¹¹Amgen Inc., Thousand Oaks, CA, ¹²Swedish Medical Center/Providence St. Joseph Health; University of Washington School of Medicine, Seattle, WA
Background/Purpose: Apremilast is an oral phosphodiesterase-4 inhibitor with a unique immunomodulatory mechanism of action and is approved for the treatment of psoriatic arthritis (PsA). Although…
Abstract Number: 0178 • ACR Convergence 2024
Are Participants in Gout Clinical Trials Representative of People with Gout in the General Population?
Jendy Liu, Gregory Gamble and Nicola Dalbeth, University of Auckland, Auckland, New Zealand
Background/Purpose: Ensuring study participants are representative of the general population is important to ensure that efficacy and safety findings of clinical trials are generalizable in…
Abstract Number: 0511 • ACR Convergence 2024
Do High Rheumatoid Factor Levels Impact Response to Certolizumab Pegol in Patients with Inadequately Controlled Rheumatoid Arthritis? A Post Hoc Analysis of a Phase 3b Trial
Josef Smolen¹, Ted Mikuls², James Galloway³, Ulf Müller-Ladner⁴, Jeffrey Curtis⁵, Motomu Hashimoto⁶, Tsutomu Takeuchi⁷, Ernest Choy⁸, Yoshiya Tanaka⁹, Carlos Cara¹⁰, Bernard Lauwerys¹¹, Nicola Tilt¹², Baran Ufuktepe¹³ and Peter C. Taylor¹⁴, ¹Medical University of Vienna, Vienna, Austria, ²University of Nebraska Medical Center, Omaha, NE, ³Centre for Rheumatic Diseases, King's College London, London, United Kingdom, ⁴Justus-Liebig University Giessen, Bad Nauheim, Germany, ⁵University of Alabama at Birmingham, Hoover, AL, ⁶Osaka Metropolitan University, Osaka, Japan, ⁷Department of Internal Medicine, Keio University, Tokyo, Tokyo, Japan, ⁸Cardiff University School of Medicine, Cardiff, United Kingdom, ⁹Department of Internal Medicine, University of Occupational and Environmental Health, Kitakyushu, Fukuoka, Japan, ¹⁰UCB Pharma, Madrid, Spain, ¹¹UCB Pharma, Brussels, Belgium, ¹²UCB Pharma, Slough, United Kingdom, ¹³UCB Pharma, Istanbul, Turkey, ¹⁴University of Oxford, Oxford, United Kingdom
Background/Purpose: In pts with RA, high RF levels are associated with poor prognosis, higher disease activity, and decreased response to monoclonal antibodies targeting tumor necrosis…
Abstract Number: 0661 • ACR Convergence 2024
Validity, Reliability and Responsiveness of Lupus Impact Tracker and LupusPRO: AURORA Trial
Meenakshi Jolly¹, Matt Truman², Ronald Flauto³ and Kathryn Dao⁴, and AURORA, ¹Rush University Medical Center, Chicago, ²Aurinia Pharmaceuticals, Victoria, BC, Canada, ³Aurinia Pharmaceuticals, Rockville, MD, ⁴Aurinia Pharmaceuticals, Dallas
Background/Purpose: Voclosporin used in addition to Mycophenolate Mofetil and low dose oral steroids in patients with active Lupus Nephritis (LN) was found to be superior…
Abstract Number: 0827 • ACR Convergence 2024
Oral Corticosteroid-Sparing Effects of Mepolizumab in Eosinophilic Granulomatosis with Polyangiitis (EGPA): Results up to 7.4 Years from the Long-Term Access Programme
Paneez Khoury¹, Jared Silver², Gerhard Wolff³, Robert Price⁴, Rejina Verghis⁵, Emmeline Igboekwe² and Michael E Wechsler⁶, ¹National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, ²US Medical Affairs-Respiratory, GSK, Durham, ³Clinical Development-Respiratory, GSK, Collegeville, ⁴Biostatistics, GSK, Stevenage, United Kingdom, ⁵Biostatistics, Development Respiratory, GSK, Brentford, United Kingdom, ⁶Department of Medicine, National Jewish Health, Denver, CO
Background/Purpose: EGPA is a severe, rare, relapsing/remitting inflammatory disease, in which chronic or high oral corticosteroid (OCS) doses lead to adverse effects, adding to disease…
Abstract Number: 1380 • ACR Convergence 2024
Rapid, Clinically Meaningful Pain Improvements Are Associated with Improvements in Other Patient-Reported Outcomes in RA Patients Treated with Upadacitinib
Manish Jain¹, Arthur Kavanaugh², Angela Crowley³, Avani Joshi⁴, Patrick Zueger⁵, Diane Caballero⁶, Andrew Garrison⁶ and Peter C. Taylor⁷, ¹Endeavor Health Swedish Hospital and Captain James A, Chicago, IL, ²University of California San Diego, La Jolla, CA, ³Illinois Bone and Joint Institute, Hinsdale Orthopaedics, Hinsdale, IL, ⁴AbbVie, North Chicago, IL, ⁵AbbVie Inc, North Chicago, IL, ⁶AbbVie Inc., North Chicago, IL, ⁷University of Oxford, Oxford, United Kingdom
Background/Purpose: Pain is a crucial symptom for patients with RA; early and effective treatment can help alleviate it.1 In this post hoc analysis, we investigated…
Abstract Number: 1476 • ACR Convergence 2024
Individualizing NSAIDs in Axial Spondyloarthritis Through a Series of N-of-1 Clinical Trials with Bayesian Analysis
Mark Hwang¹, Seokhun Kim², Shervin Assassi³, Joyce Samuel⁴, Charles Green², Jon Tyson⁴ and John Reveille⁵, ¹Department of Internal Medicine, Division of Rheumatology, John P. and Katherine G. McGovern School of Medicine, UTHealth Houston, Houston, TX, ²UTHealth Houston, Houston, ³UTHealth Houston Division of Rheumatology, Houston, TX, ⁴UTHealth Houston, Houston, TX, ⁵UTHealth Houston Division of Rheumatology, Houston
Background/Purpose: Nonsteroidal anti-inflammatory drugs (NSAIDs) are first line pharmacological treatment for Axial Spondyloarthritis (axSpA), yet individual responses to different NSAIDs vary significantly. This study aims…

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