Abstracts tagged "clinical trial"

Abstract Number: 1829 • ACR Convergence 2022
Efficacy and Safety of Allopurinol and Febuxostat in Patients with Gout and Chronic Kidney Disease: A Subgroup Analysis of the STOP Gout Study
Lindsay Helget¹, Anne Davis-Karim², James O'Dell¹, Ted Mikuls³, Jeff Newcomb¹, Maria Androsenko⁴, Mary Brophy⁴, Bryant England¹, Ryan Ferguson⁴, Michael Pillinger⁵, Tuhina Neogi⁶, Hongsheng Wu⁴ and Paul Palevsky⁷, ¹University of Nebraska Medical Center, Omaha, NE, ²VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center, Albuquerque, NM, ³Division of Rheumatology, University of Nebraska Medical Center, Omaha, NE, ⁴VA Boston Cooperative Studies Program Coordinating Center, Boston, MA, ⁵NYU Grossman School of Medicine, New York, NY, ⁶Boston University School of Medicine, Boston, MA, ⁷University of Pittsburgh School of Medicine, Pittsburgh, Pittsburgh
Background/Purpose: Urate lowering therapy (ULT) is a cornerstone in the treatment of gout, which afflicts over 2 million individuals with chronic kidney disease (CKD) in…
Abstract Number: 1997 • ACR Convergence 2022
Effects of Short Chain Fatty Acid Supplementation in Modulation of Gut Microbiome and T-Regulatory Cells in Health and New Onset Rheumatoid Arthritis
Rebecca Blank¹, Alba Boix-Amoros², Renuka Nayak³, Anthony Jimenez Hernandez¹, Sydney Catron⁴, Zakwan Uddin⁴, Erin Reilly⁵, Andrew Patterson⁵, Peter Turnbaugh⁶, Jose Clemente² and Jose Scher⁷, ¹NYU School of Medicine, New York, NY, ²Icahn School of Medicine at Mount Sinai, New York, NY, ³University of California San Francisco, San Francisco, CA, ⁴NYU Langone Health, New York, NY, ⁵Pennsylvania State University, College Park, PA, ⁶UCSF, San Francisco, ⁷New York University School of Medicine, New York, NY
Background/Purpose: The gut microbiome and its metabolites are dysregulated in rheumatoid arthritis. Short chain fatty acids (SCFAs), microbial fermentation byproducts of certain gut microbes, induce…
Abstract Number: 2137 • ACR Convergence 2022
Impact of Patient Characteristics, Including Sex, on the Efficacy of Upadacitinib Compared with Adalimumab in Patients with Psoriatic Arthritis
Lihi Eder¹, Laura Coates², Peter Nash³, Uta Kiltz⁴, Ennio Lubrano⁵, Erin McDearmon-Blondell⁶, Tianming Gao⁷ and Alexis Ogdie⁸, ¹Women’s College Research Institute, Department of Medicine, University of Toronto, Toronto, ON, Canada, ²Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK, Oxford, England, United Kingdom, ³School of Medicine, Griffith University, Brisbane, Australia, ⁴Rheumazentrum Ruhrgebiet, Herne, Germany, ⁵Academic Rheumatology Unit, Dipartimento di Medicina e Scienze della Salute ‘‘Vincenzo Tiberio’’, Università degli Studi del Molise, Campobasso, Italy, ⁶AbbVie, Inc., Mettawa, IL, ⁷AbbVie, Inc., North Chicago, IL, ⁸Department of Medicine, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA
Background/Purpose: Evidence suggests that response to treatment in PsA may vary with patient (pt) characteristics, such as sex.1 This post hoc analysis of the Phase…
Abstract Number: 0003 • ACR Convergence 2022
Rituximab versus Cyclophosphamide for the Treatment of Connective Tissue Disease Associated Interstitial Lung Disease (RECITAL): A Sub-group Analysis of a Multi-centre Randomised Controlled Trial
Toby Maher¹, Veronica Tudor², Peter Saunders³, Michael Gibbons⁴, Sophie Fletcher⁵, Helen Parfrey⁶, Chris Denton⁷, Rachel Hoyles³, Elizabeth Renzoni², Maria Kokosi², Athol Wells², Deborah Ashby⁸, Matyas Szigeti⁸ and Philip Molyneaux⁸, ¹University of Southern California, Los Angeles, CA, ²Royal Brompton Hospital, London, United Kingdom, ³Oxford University Hospitals, Oxford, United Kingdom, ⁴Royal Devon and Exeter Hospital, Exeter, United Kingdom, ⁵Southampton University Hospitals, Southampton, United Kingdom, ⁶Addenbrookes Hospital, Cambridge, United Kingdom, ⁷University College London, London, United Kingdom, ⁸Imperial College London, London, United Kingdom
Background/Purpose: The RECITAL trial (NCT01862926) compared rituximab to cyclophosphamide as first line therapy for patients with severe or progressive interstitial lung disease due to idiopathic…
Abstract Number: 0299 • ACR Convergence 2022
Radiographic Change in Patients with Rheumatoid Arthritis and Estimated Baseline Yearly Progression ≥5 or < 5: Post Hoc Analysis of Two Phase 3 Trials of Filgotinib
Yoshiya Tanaka¹, Tatsuya Atsumi², Daniel Aletaha³, Robert Landewé⁴, Beatrix Bartok⁵, Alena Pechonkina⁶, Ling Han⁶, Kahaku Emoto⁷, Shungo Kano⁷, Vijay Rajendran⁸ and Tsutomu Takeuchi⁹, ¹University of Occupational and Environmental Health, Kitakyusyu Fukuoka, Japan, ²Hokkaido University, Sapporo, Japan, ³Medical University Vienna, Wien, Austria, ⁴Amsterdam University Medical Center, Meerssen, Netherlands, ⁵Gilead Sciences, Inc., La Jolla, CA, ⁶Gilead Sciences, Foster City, CA, ⁷Gilead Sciences, K.K., Tokyo, Japan, ⁸Galapagos NV, Gent, Belgium, ⁹Keio University and Saitama Medical University, Tokyo, Japan
Background/Purpose: In some patients (pts) with rheumatoid arthritis (RA), especially those with joint damage early in the disease, first-line methotrexate (MTX) treatment may not suffice…
Abstract Number: 0403 • ACR Convergence 2022
Efficacy and Safety of Ixekizumab in Chinese Patients with Radiographic Axial Spondyloarthritis: 16-Week Results from a Phase 3 Study
Yu Xue¹, Jiankang Hu², Dongzhou Liu³, Jingyang Li⁴, Huaxiang Wu⁵, Chunyu Tan⁶, Lie Dai⁷, Mengru Liu⁸, Hongying Li⁸ and Hejian Zou¹, ¹Huashan Hospital affiliated to Fudan University, Shanghai, China, ²Jiangxi Pingxiang People’s Hospital, Shanghai, China, ³Shenzhen People’s Hospital （The Second Clinical Medical College of Jinan University）, Shanghai, China, ⁴Zhuzhou Central Hospital, Shanghai, China, ⁵The Second Affiliated Hospital Zhejiang University School of Medicine, Shanghai, China, ⁶West China Hospital of Sichuan University, Shanghai, China, ⁷Sun Yat-sen Memorial Hospital of Sun Yat-sen University, Shanghai, China, ⁸Eli Lilly and Company, Shanghai, China
Background/Purpose: Ixekizumab, a high-affinity monoclonal antibody that selectively targets interleukin-17A, has demonstrated efficacy in global clinical trials in patients with radiographic axial spondyloarthritis (r-axSpA)/ankylosing spondylitis…
Abstract Number: 0763 • ACR Convergence 2022
Immunogenicity Analysis from the VOLTAIRE Trials in Patients with Rheumatoid Arthritis, Crohn’s Disease, and Chronic Plaque Psoriasis
Vibeke Strand¹, Shaun Bender² and Dorothy McCabe³, ¹Stanford University School of Medicine, Stanford, CA, ²Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT, ³Boehringer Ingelheim Pharmaceuticals, Inc, Ridgefield, CT
Background/Purpose: The VOLTAIRE trials program compared the safety, efficacy, and immunogenicity of biosimilar BI 695501 with adalimumab reference product (RP) for indications including moderate-severely active…
Abstract Number: 1037 • ACR Convergence 2022
Performance of BASDAI vs. ASDAS in Evaluating Axial Involvement in Patients with PsA Treated with Guselkumab: Pooled Analysis of Two Phase 3 Studies
Xenofon Baraliakos¹, Dafna Gladman², Soumya Chakravarty³, Cinty Gong⁴, May Shawi⁵, Emmanouil Rampakakis⁶, Kishimoto Mitsumasa⁷, Enrique R Soriano⁸ and Philip J Mease⁹, ¹Rheumazentrum Ruhrgebiet Herne, Herne, Germany, ²Toronto Western Hospital, Schroeder Arthritis Institute, Toronto, ON, Canada, ³Janssen Scientific Affairs, LLC; Drexel University College of Medicine, Villanova, PA, ⁴Janssen Scientific Affairs, LLC, Horsham, PA, ⁵Immunology Global Medical Affairs, Janssen Pharmaceutical Companies of Johnson & Johnson, Horsham, PA, ⁶McGill University, Department of Pediatrics and JSS Medical Research, Montréal, QC, Canada, ⁷Department of Nephrology and Rheumatology, Kyorin University School of Medicine, Tokyo, Japan, ⁸Rheumatology Unit and University Institute, Hospital Italiano de Buenos Aires, Buenos Aires, Argentina, ⁹Swedish Medical Center/Providence St. Joseph Health, Seattle, WA
Background/Purpose: Although the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) is used to assess the activity of axial disease in patients (pts) with PsA, only…
Abstract Number: 1549 • ACR Convergence 2022
Toward Safer Glucocorticoid Therapy
Xingyu Pan¹, Qiongqiong Hou¹, Jiahui Xu¹, Yake Ma¹, Jiawen Li¹, Min Li¹, Jing Su¹, Xuerou Shi¹, William Bracken² and David Katz², ¹WuXi AppTec, Nantong, China, ²Sparrow Pharmaceuticals, Portland, OR
Background/Purpose: SPI-62 is a potent 11b-hydroxysteroid dehydrogenase type 1 (HSD-1) inhibitor entering Phase 2 development as adjunctive therapy to prednisolone in polymyalgia rheumatica, as well…
Abstract Number: 1831 • ACR Convergence 2022
Establishing a Scientific Bridge to Historic VIOXX to Enable a Reintroduction of Rofecoxib: Pharmacokinetic Evaluation of TRM‑201 (Rofecoxib)
Judith Boice¹, Travis Helm¹, Maria Bermudez², Mark Corrigan¹ and Bradford Sippy¹, ¹Tremeau Pharmaceuticals, Inc, Concord, MA, ²Clinical Pharmacology of Miami, LLC, Miami, FL
Background/Purpose: TRM-201 (rofecoxib) is a cyclooxygenase-2 (COX-2) selective inhibitor being developed for the treatment of hemophilic arthropathy (HA) and acute migraine. Previously marketed as VIOXX,…
Abstract Number: 2000 • ACR Convergence 2022
Tapering of Long-term, Low Dose Glucocorticoids in Senior Rheumatoid Arthritis Patients: Follow up of the Pragmatic, Multicentre, Placebo-controlled GLORIA Trial
Abdullah Almayali¹, Maarten Boers², Linda Hartman³, Daniela OPRIS-BELINSKI⁴, Reinhard Bos⁵, Marc Kok⁶, Jose Pereira da Silva⁷, Eduard N Griep⁸, Ruth Klaasen⁹, CF Allaart¹⁰, Paul Baudoin¹¹, Hennie Raterman¹², Zoltan Szekanecz¹³, Frank Buttgereit¹⁴, Pavol MASARYK¹⁵, Willem Lems¹⁶, Maurizio Cutolo¹⁷ and Marieke ter Wee³, ¹Amsterdam University Medical Centers, Vrije Universiteit, Purmerend, Noord-Holland, Netherlands, ²Amsterdam UMC, Vrije Universiteit, Amsterdam, Netherlands, ³Amsterdam University Medical Centers, Vrije Universiteit, Amsterdam, Netherlands, ⁴Carol Davila University, Bucharest, Romania, ⁵Medical Centre Leeuwarden, Department of Rheumatology, Leeuwarden, Netherlands, ⁶Department of Rheumatology and Clinical immunology, Maasstad Hospital, Rotterdam, Netherlands, ⁷University of Coimbra, Rheumatology, Columbia, Portugal, ⁸Department of Rheumatology, Antonius Hospital, Leeuwarden, Netherlands, ⁹Department of Rheumatology, Meander Medical Center, Amersfoort, Netherlands, ¹⁰Leiden University Medical Center, Leiden, Netherlands, ¹¹Reumazorg Flevoland, Almere, Netherlands, ¹²Department of Rheumatology, Northwest Clinics, Alkmaar, Netherlands, ¹³Division of Rheumatology, Faculty of Medicine, Debrecen, Hungary, ¹⁴Charité Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin / DRFZ Berlin, Berlin, Germany, ¹⁵National Institute for the Rheumatic Diseases, Piešťany, Slovakia, ¹⁶Amsterdam University Medical Centers, Amsterdam, Netherlands, ¹⁷Laboratory of Experimental Rheumatology and Academic Division of Clinical Rheumatology, Department of Internal Medicine, University of Genova, IRCCS San Martino Polyclinic Hospital, Genova, Italy
Background/Purpose: Guidelines suggest glucocorticoids (GC) should be used as bridge therapy in rheumatoid arthritis (RA), but many patients are on chronic treatment, and the effects…
Abstract Number: 2139 • ACR Convergence 2022
Sustained Response to Guselkumab Regardless of Baseline Demographic, Disease, and Medication Characteristics in Patients with Active Psoriatic Arthritis and an Inadequate Response to TNF Inhibitors: Results from a Phase 3b Trial
Iain B McInnes¹, Philipp Sewerin², Mohamed Sharaf³, Michela Efficace⁴, May Shawi⁵, Michelle Perate⁶, Miriam Zimmermann⁷ and Laura Coates⁸, ¹Institute of Infection, Immunity and Inflammation, College of Medical, Veterinary and Life Sciences, University of Glasgow, Glasgow, Scotland, United Kingdom, ²Rheumazentrum Ruhrgebiet, Ruhr-Universität-Bochum, Herne, Germany, ³Johnson & Johnson, Middle East FZ LLC, Dubai, United Arab Emirates, ⁴Janssen Cilag SpA, Imperia, Italy, ⁵Immunology Global Medical Affairs, Janssen Pharmaceutical Companies of Johnson & Johnson, Horsham, PA, ⁶Janssen Scientific Affairs, LLC, Horsham, PA, ⁷Janssen Scientific Affairs, LLC, Zug, Switzerland, ⁸Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK, Oxford, England, United Kingdom
Background/Purpose: Guselkumab (GUS) is a human monoclonal antibody targeting the IL-23 p19 subunit. In the Phase 3b COSMOS trial (NCT03796858), GUS significantly improved disease signs/symptoms…
Abstract Number: 0036 • ACR Convergence 2022
Patient-specific and Disease-related Determinants for Cardiovascular Disease (CVD) Risk Stratification in the APPLE (Atherosclerosis Prevention in Paediatric Lupus Erythematosus) Clinical Trial Cohort
Junjie Peng¹, George Robinson¹, Stacy P Ardoin², Laura Schanberg³, Elizabeth Jury¹ and Coziana Ciurtin⁴, ¹University College London, London, United Kingdom, ²Division of Rheumatology, Nationwide Children's Hospital and Department of Pediatrics, The Ohio State University, Columbus, OH, ³Duke University Medical Center, Durham, NC, ⁴Centre for Adolescent Rheumatology Versus Arthritis, Department of Medicine, University College London, London, United Kingdom
Background/Purpose: The risk of developing cardiovascular disease (CVD) through atherosclerosis in juvenile-onset systemic lupus erythematosus (JSLE) patients is significantly increased. This study aimed to stratify…
Abstract Number: 0304 • ACR Convergence 2022
Rheumatoid Arthritis Patients Who Switched Treatment from Adalimumab to Upadacitinib Demonstrate a Robust Reduction of Inflammation-related Biomarkers: Proteomics Analysis from the SELECT-COMPARE Phase 3 Study
Thierry Sornasse¹, Fang Cai², Heidi Camp³, In-Ho Song⁴ and Iain B McInnes⁵, ¹AbbVie, South San Francisco, CA, ²AbbVie, Redwood City, CA, ³Abbvie, Winnetka, IL, ⁴AbbVie, Inc., North Chicago, IL, ⁵Institute of Infection, Immunity and Inflammation, College of Medical, Veterinary and Life Sciences, University of Glasgow, Glasgow, Scotland, United Kingdom
Background/Purpose: Upadacitinib 15 mg QD (UPA), an oral JAK inhibitor, showed greater efficacy compared to adalimumab (ADA) in patients (pts) with active rheumatoid arthritis (RA)…
Abstract Number: 0411 • ACR Convergence 2022
Bimekizumab Improves Signs and Symptoms Including Inflammation in Patients with Active Ankylosing Spondylitis: 24-Week Efficacy & Safety from a Phase 3, Multicenter, Randomized, Placebo Controlled Study
Désirée van der Heijde¹, Xenofon Baraliakos², Maxime Dougados³, Matthew Brown⁴, Denis Poddubnyy⁵, Filip Van den bosch⁶, Nigil Haroon⁷, Huji Xu⁸, Tetsuya Tomita⁹, Lianne Gensler¹⁰, Marga Oortgiesen¹¹, Carmen Fleurinck¹², Natasha de Peyrecave¹³, Thomas Vaux¹⁴, Alexander Marten¹⁵ and Atul Deodhar¹⁶, ¹Department of Rheumatology, Leiden University Medical Center, Leiden, The Netherlands, Leiden, Netherlands, ²Rheumazentrum Ruhrgebiet Herne, Herne, Germany, ³Department of Rheumatology, Hôpital Cochin, Paris, France, Paris, France, ⁴Genomics England, London, United Kingdom, ⁵Department of Gastroenterology, Infectious Diseases and Rheumatology, Charité – Universitätsmedizin Berlin, Berlin, Germany, ⁶Department of Internal Medicine and Paediatrics, Ghent University and VIB Centre for Inflammation Research, Ghent, Belgium, ⁷Schroeder Arthritis Institute, University Health Network; University of Toronto, Toronto, ON, Canada, ⁸Department of Rheumatology and Immunology, Shanghai Changzheng Hospital, Affiliated to Second Military Medical University, Shanghai, China, ⁹Department of Orthopaedic Biomaterial Science, Osaka University Graduate School of Medicine, Osaka, Japan, Suita Osaka, Japan, ¹⁰Department of Medicine, Division of Rheumatology, University of California San Francisco, San Francisco, CA, ¹¹UCB Pharma, Raleigh, NC, ¹²UCB Pharma, Brussels, Belgium, Oosterzele, Belgium, ¹³UCB Pharma, Brussels, Belgium, ¹⁴UCB Pharma, Slough, United Kingdom, ¹⁵UCB Pharma, Monheim am Rhein, Germany, ¹⁶Oregon Health & Science University, Portland, OR, USA, Portland, OR
Background/Purpose: Bimekizumab (BKZ) is a monoclonal IgG1 antibody that selectively inhibits IL-17F in addition to IL-17A. In a phase 2b study, BKZ showed rapid and…

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