Abstracts tagged "clinical trial"

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…
Abstract Number: 0890 • ACR Convergence 2022
Long Term Efficacy of a 2-year MRI Treat-to-target Treatment Strategy on Disease Activity, MRI Inflammation and Physical Function in Rheumatoid Arthritis Patients in Clinical Remission: Five Year Follow-up of the IMAGINE-RA Cohort
Signe Møller-Bisgaard¹, Kim Hørslev-Petersen², Daniel Glinatsi³, Bo Ejbjerg⁴, Merete Lund Hetland⁵, Jakob Møllenbach Møller⁶, Robin Christensen⁷, Sabrina Mai Nielsen⁸, Mikael Boesen⁹, Kristian Stengaard-Pedersen¹⁰, Ole Rintek Madsen¹¹, Bente Jensen¹², Jan Alexander Villadsen¹³, Ellen Margrethe Hauge¹⁰, Oliver Hendricks², Hanne Merete Lindegaard¹⁴, Niels Steen Krogh¹⁵, Anne Grethe Jurik¹⁶, Henrik Thomsen¹⁷ and Mikkel Østergaard¹⁸, ¹Copenhagen Center for Arthritis Research, Center for Rheumatology and Spine Diseases, Rigshospitalet, Copenhagen, Denmark, ²Department of Rheumatology, Danish Hospital for Rheumatic Diseases, Sønderborg, Denmark, ³Copenhagen Center for Arthritis Research, Center for Rheumatology and Spine Diseases, Rigshospitalet, Glostrup, Denmark, ⁴Department of Rheumatology, Slagelse Hospital, Slagelse, Denmark, ⁵Copenhagen University Hospital - Rigshospitalet, Glostrup, Denmark, ⁶Department of Radiology, Herlev-Gentofte Hospital, Copenhagen, Denmark, ⁷Musculoskeletal Statistics Unit, The Parker Institute, Copenhagen, Denmark, ⁸The Parker Institute, Section for Biostatistics and Evidence-Based Research, Bispebjerg-Frederiksberg Hospital, Frederiksberg, Denmark, ⁹Department of Radiology, Bispebjerg-Frederiksberg Hospital, Copenhagen, Denmark, ¹⁰Department of Rheumatology, Aarhus University Hospital, Aarhus, Denmark, ¹¹Center for Rheumatology and Spine Diseases, Copenhagen University Hospital Herlev-Gentofte, Copenhagen, Denmark, ¹²Center for Rheumatology and Spine Diseases, Bispebjerg-Frederiksberg Hospital, Copenhagen, Denmark, ¹³Department of Rheumatology, Silkeborg Hospital, Silkeborg, Denmark, ¹⁴Department of Rheumatology, Odense University Hospital, Odense, Denmark, ¹⁵ZiteLab ApS, Frederiksberg, Denmark, ¹⁶Department of Radiology, Aarhus University Hospital, Aarhus, Denmark, ¹⁷Department of Radiology, Herlev and Gentofte Hospital, Copenhagen, Denmark, ¹⁸Rigshospitalet, University of Copenhagen, Glostrup, Denmark
Background/Purpose: Targeting MRI remission in rheumatoid arthritis (RA) patients in clinical remission may improve long term clinical, functional and MRI outcomes. The purpose of the…
Abstract Number: 1077 • ACR Convergence 2022
Safety of Avacopan in ANCA-Associated Vasculitis: Combined Data from Three Clinical Trials
Pirow Bekker¹, Peter Merkel² and David Jayne³, ¹ChemoCentryx, San Juan Capistrano, CA, ²U of Pennsylvania, Philadelphia, PA, ³University of Cambridge, Cambridge, United Kingdom
Background/Purpose: Avacopan is approved as adjunctive treatment for adults with ANCA-associated vasculitis (AAV). This study aimed to combine and report on data of the safety…
Abstract Number: 1579 • ACR Convergence 2022
The TICOG Study: Tight Control of Gout – A Randomized, Controlled Trial of Targeted versus Conventional Treatment for Gout Including Ultrasonography
Sarah Black, Natalie McKee, Jonathan McKnight, Annmarie McShane, Adrian Pendleton, Taggart Alister and Gary Wright, Musgrave Park Hospital, Belfast Health and Social Care Trust, Belfast, Northern Ireland, United Kingdom
Background/Purpose: Gout is a common inflammatory arthritis triggered by deposition of monosodium urate crystals in joints, bone and soft tissues, with a prevalence of 1-4%…
Abstract Number: 1832 • ACR Convergence 2022
Efficacy and Safety Similarity of Biosimilar Adalimumab-aqvh to Adalimumab in Patients with Moderate-to-Severe Chronic Plaque Psoriasis: A Phase III Study
Barbara Finck, Helen Tang, Kathy Jensen, Francesca Civoli and Suzanna Tatarewicz, Coherus BioSciences, Redwood City, CA
Background/Purpose: This study aimed to demonstrate that there were no clinically meaningful differences between adalimumab-aqvh, a US Food and Drug Administration–approved biosimilar, and adalimumab in…

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