Abstracts tagged "Randomized Trial"

Abstract Number: L15 • ACR Convergence 2022
Effect of Secukinumab versus Adalimumab Biosimilar on Radiographic Progression in Patients with Radiographic Axial Spondyloarthritis: A Randomized Phase IIIb Study
Xenofon Baraliakos¹, Mikkel Østergaard², Denis Poddubnyy³, Désirée van der Heijde⁴, Atul Deodhar⁵, Pedro M. Machado⁶, Victoria Navarro-Compán⁷, Kay Geert Hermann⁸, Mitsumasa Kishimoto⁹, Eun Young Lee¹⁰, Lianne S Gensler¹¹, Uta Kiltz¹, Marco Eigenmann¹², Patricia Pertel¹³, Aimee Readie¹⁴, Hanno B. Richards¹², Brian Porter¹⁵ and Juergen Braun¹, ¹Rheumazentrum Ruhrgebiet, Herne, Ruhr-Universität Bochum, Bochum, Nordrhein-Westfalen, Germany, ²Copenhagen Center for Arthritis Research, Center for Rheumatology and Spine Diseases, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark, ³Charité - Universitätsmedizin Berlin and German Rheumatism Research Centre, Berlin, Germany, ⁴Department of Rheumatology, Leiden University Medical Center, Leiden, Netherlands, ⁵Division of Arthritis and Rheumatic Diseases, Oregon Health & Science University, Portland, OR, ⁶Centre for Rheumatology & Department of Neuromuscular Diseases, University College London, London, United Kingdom, ⁷Department of Rheumatology, University Hospital La Paz, IdiPaz, Madrid, Spain, ⁸Department of Radiology, University Hospital Charité - Campus Mitte, Charitéplatz, Berlin, Germany, ⁹Department of Nephrology and Rheumatology, Kyorin University School of Medicine, Tokyo, Japan, ¹⁰Division of Rheumatology, Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Republic of Korea, ¹¹Department of Medicine, Division of Rheumatology, University of California San Francisco, San Francisco, CA, ¹²Novartis Pharma AG, Basel, Switzerland, ¹³Novartis Pharma AG, Reinach, Switzerland, ¹⁴Novartis Pharmaceuticals Corporation, East Hanover, NJ, ¹⁵Novartis Pharmaceuticals Corporation, Far Hills, NJ
Background/Purpose: Biologics are clinically efficacious in patients (pts) with axial spondyloarthritis (axSpA) including radiographic axSpA (r-axSpA). Limited data exist on the effect of biologics in…
Abstract Number: L05 • ACR Convergence 2022
Effect of Denosumab on Structure Modification in Erosive Hand Osteoarthritis: Results of a 48-Week, Monocentric, Randomized, Placebo-controlled, Double-blind Phase 2 Study and Open Label Extension Phase
Ruth Wittoek¹, August Verbruggen², Tine Vanhaverbeke² and Dirk Elewaut³, ¹Dept. of Rheumatology, Ghent University Hospital, Ghent University, Ghent, Oost-Vlaanderen, Belgium, ²Ghent University Hospital, Ghent, Belgium, ³Ghent University and VIB Center for Inflammation Research, Ghent, Belgium
Background/Purpose: Erosive hand osteoarthritis (OA) is a disabling disease with limited therapeutic options. Denosumab, a Receptor Activator of Nuclear Factor kappa-b Ligand inhibitor, affects bone…
Abstract Number: L07 • ACR Convergence 2022
Telitacicept, a Human Recombinant Fusion Protein Targeting B Lymphocyte Stimulator (BlyS) and a Proliferation-Inducing Ligand (APRIL), in Systemic Lupus Erythematosus (SLE): Results of a Phase 3 Study
Di Wu¹, Jing Li¹, Dong Xu¹, Li Wang¹, Jianmin Fang², Dan Ross³ and Fengchun Zhang⁴, ¹Department of Rheumatology and Clinical Immunology Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing 100730, China, Beijing, China, ²Shanghai Tongji Hospital, Tongji University, Shanghai 200065, China School of Life Science and Technology, Tongji University, Shanghai 200092, China, Shanghai, China, ³RemeGen Co., San Diego, CA, ⁴Department of Rheumatology and Clinical Immunology Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing 100730, China; Key Laboratory of Rheumatology & Clinical Immunology, Ministry of Education, Beijing, China, Beijing, China
Background/Purpose: Telitacicept is a novel recombinant fusion protein constructed with the extracellular domain of the human transmembrane activator and calcium modulator and cyclophilin ligand interactor…
Abstract Number: L14 • ACR Convergence 2022
Bimekizumab Maintains Improvements in Efficacy Endpoints and Has a Consistent Safety Profile Through 52 Weeks in Patients with Non-Radiographic Axial Spondyloarthritis and Ankylosing Spondylitis: Results from Two Parallel Phase 3 Studies
Xenofon Baraliakos¹, Atul Deodhar², Désirée van der Heijde³, Marina Magrey⁴, Walter Maksymowych⁵, Tetsuya Tomita⁶, Huji Xu⁷, Marga Oortgiesen⁸, Ute Massow⁹, Carmen Fleurinck¹⁰, Alicia M Ellis⁸, Tom Vaux¹¹, Julie Shepherd-Smith¹¹, Alexander Marten⁹ and Lianne S Gensler¹², ¹Rheumazentrum Ruhrgebiet, Herne, Ruhr-Universität Bochum, Bochum, Nordrhein-Westfalen, Germany, ²Division of Arthritis and Rheumatic Diseases, Oregon Health & Science University, Portland, OR, ³Department of Rheumatology, Leiden University Medical Center, Leiden, Netherlands, ⁴Case Western Reserve University, MetroHealth Medical Center, Cleveland, OH, US, Richfield, OH, ⁵Department of Medicine, University of Alberta, Edmonton, AB, Canada, ⁶Graduate School of Health Science, Morinomiya University of Medical Science, Osaka City, Osaka City, Osaka, Japan, ⁷Department of Rheumatology and Immunology, Shanghai Changzheng Hospital, Affiliated to Second Military Medical University, Shanghai, China (People's Republic), ⁸UCB Pharma, Morrisvile, NC, ⁹UCB Pharma, Monheim am Rhein, Nordrhein-Westfalen, Germany, ¹⁰UCB Pharma, Brussels, Brussels Hoofdstedelijk Gewest, Belgium, ¹¹UCB Pharma, Slough, United Kingdom, ¹²Department of Medicine, Division of Rheumatology, University of California San Francisco, San Francisco, CA
Background/Purpose: Bimekizumab (BKZ) is a monoclonal IgG1 antibody that selectively inhibits IL-17F in addition to IL‑17A. In the phase 3 BE MOBILE 1 and 2…
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: 1894 • ACR Convergence 2022
A Phase 2, 104-Week Study of Repeat Lorecivivint Injections Evaluating Safety, Efficacy, and Bone Health Utilizing Quantitative Computed Tomography (qCT) in Knee Osteoarthritis (OA-06)
Yusuf Yazici¹, Christopher Swearingen², Heli Ghandehari³, Jon Britt⁴, ismail simsek⁵, Mark Fineman⁶, Sarah Kennedy², Jeyanesh Tambiah⁷ and Nancy Lane⁸, ¹New York University School of Medicine, La Jolla, CA, ²Biosplice Therapeutics, Inc, San Diego, CA, ³Biosplice Therapeutics, Inc., San Diego, CA, ⁴Biosplice Therapeutics, Inc., Los Angeles, CA, ⁵Alpine Immunesciences, San Diego, CA, ⁶Biosplice Therapeutics, San Diego, CA, ⁷Biosplice Ther Inc., San Diego, CA, ⁸University of California Davis, Hillsborough, CA
Background/Purpose: Knee osteoarthritis (OA) is a common joint disorder associated with pain, disability, and joint damage. There is a large unmet need for safe and…
Abstract Number: 0997 • ACR Convergence 2022
Withdrawal of Maintenance Glucocorticoid versus Other Immunosuppressants Among Patients with Systemic Lupus Erythematosus in Long Term Clinical Remission: Interim Analysis of a Non-inferiority Randomised Controlled Trial
Aishwarya Gopal¹, Chengappa Kavadichanda², Devender Bairwa³, Molly Mary Thabah⁴ and Vir Singh Negi⁵, ¹Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Pondicherry, Puducherry, India, ²JIPMER, Pondicherry, Puducherry, India, ³Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry, Puducherry, India, ⁴JIPMER, Puducherry, Puducherry, India, ⁵AIIMS Bilaspur, Puducherry, Puducherry, India
Background/Purpose: Attempts to stop glucocorticoids among Systemic Lupus Erythematosus(SLE) patients in long term remission have been successful. Continuing other immunosuppressive (IS) agents indefinitely is currently…
Abstract Number: 1899 • ACR Convergence 2022
A Phase 3, 28-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial (OA-10) to Evaluate the Efficacy and Safety of a Single Injection of Lorecivivint Injected in the Target Knee Joint of Moderately to Severely Symptomatic Osteoarthritis Subjects
Yusuf Yazici¹, Christopher Swearingen², Heli Ghandehari³, Victor Lopez⁴, ismail simsek⁵, Mark Fineman⁶, Sarah Kennedy⁷, Jeyanesh Tambiah⁸ and Timothy McAlindon⁹, ¹New York University School of Medicine, La Jolla, CA, ²Samumed LLC, San Diego, CA, ³Biosplice Therapeutics, Inc., San Diego, CA, ⁴Biosplice Therapeutics, Santa Clarita, CA, ⁵Alpine Immunesciences, San Diego, CA, ⁶Biosplice Therapeutics, San Diego, CA, ⁷Biosplice Therapeutics, Inc, San Diego, CA, ⁸Biosplice Ther Inc., San Diego, CA, ⁹Tufts Medical Center, Arlington, MA
Background/Purpose: Knee osteoarthritis (OA) is a common joint disorder associated with pain, disability, and joint damage. There remains a large unmet need for treatments that…
Abstract Number: 1001 • ACR Convergence 2022
Effect of Atacicept on Renal Function in Patients with Systemic Lupus Erythematosus (SLE)
David Isenberg¹, Celia Lin², Amy Kao³, Aida Aydemir⁴ and Caroline Gordon⁵, ¹University College London, London, United Kingdom, ²Vera Therapeutics, Inc, Burlingame, CA, ³EMD Serono, Billerica, MA, ⁴EMD Serono Research & Development Institute, Inc, Billerica, MA, ⁵Rheumatology Research Group, Institute of Inflammation and Ageing, College of Medical and Dental Sciences, University of Birmingham, Birmingham, United Kingdom
Background/Purpose: Atacicept is a fusion protein that blocks B-lymphocyte stimulator and a proliferation-inducing ligand, which are increased in patients with SLE. APRIL-SLE was a double-blind,…
Abstract Number: 1960 • ACR Convergence 2022
Impact of Delaying Initiation of Methotrexate by One Month on the Outcome of RA at One Year
Theresa Than¹, Emmanuelle Dernis², Olivier BROCQ³, Bruno Fautrel⁴, Helena HUGUET⁵, Liana Euller-Ziegler⁶, Lindsay BUSTAMENTE-CENCI⁶, Olivier Vittecoq⁷, Marie-christine PICOT⁵, Cédric Lukas⁸, Claire DAIEN⁹, Charlotte Hua¹⁰, Marlène Genty⁵, Helene Che⁵, Anouck REMY-MOULARD¹¹, Frederic LIOTE¹², Martin Soubrier¹³, Cécile GAUJOUX-VIALA¹⁴, Arnaud Constantin¹⁵, Alain Saraux¹⁶, Emilie Ducourau¹⁷, Stephanie RIST¹⁸, CARINE SALLIOT¹⁹, Nada IBRAHIM-NASSER¹⁸, Clara qUINTEN¹⁸, Vincent Goeb²⁰ and Jacques Morel¹, ¹University and CHU Montpellier, Montpellier, France, ²LE MANS general hospital, LE MANS, France, ³Centre hospitalier Princesse-Grace, Monaco, France, ⁴Sorbonne University Paris, France and Pierre Louis Institute of Epidemiology and Public Health, Paris, France, Paris, France, ⁵CHU Montpellier, Montpellier, France, ⁶CHRU Nice, Nice, France, ⁷CHU de Rouen, ROUEN, France, ⁸University Hospital Centre Montpellier, University of Montpellier, Montpellier, France, ⁹University Hospital, Saint-Gély-du-Fesc, France, ¹⁰La Lettre du Rhumatologue, Paris, France, ¹¹CHU Montpellier, Montpellier, Chad, ¹²University of Paris, Paris, France, ¹³Gabriel-Montpied Hospital, Clermont-Ferrand, France, ¹⁴CHU Nîmes, Univ Montpellier (IDESP), Nîmes, France, ¹⁵Toulouse University Hospital, Toulouse, France, ¹⁶CHU Brest, Brest, France, ¹⁷CH Orleans, Chambray Les Tours, France, ¹⁸CH orleans, Orleans, France, ¹⁹CHR orleans, Orleans, France, ²⁰CHU Amiens, Amiens, France
Background/Purpose: It is recommended that vaccinations should be performed prior to start methotrexate (MTX) knowing that delaying initiation of background therapy may have an impact…
Abstract Number: 0173 • ACR Convergence 2022
Cutaneous Manifestations, Clinical Trials, Safety Efficacy and Safety of Lenabasum in the Phase 3 DeterMine Trial in Dermatomyositis
Victoria Werth¹, Barbara White², Josef Concha³, Josh Dan¹, Nancy Dgetluck², Kathleen Hally², Scott Constantine², Rohit Aggarwal⁴, David Fiorentino⁵, Ingrid Lundberg⁶ and Chester Oddis⁷, ¹Philadelphia VAMC, Philadelphia, PA, USA and Department of Dermatology, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, ²Corbus Pharmaceuticals, Norwood, MA, ³Universiity of Pennsylvania/Dermatology, Philadelphia, PA, ⁴University of Pittsburgh, Division of Rheumatology, Pittsburgh, PA, ⁵Stanford university/Department of Dermatology, Palo Alto, CA, ⁶Karolinska Institute, Stockholm, Sweden, ⁷University of Pittsburgh, Pittsburgh, PA
Background/Purpose: Safe and effective treatments are of significant unmet need in DM. Lenabasum, a CB2 agonist that activates resolution of inflammation, improved skin disease, patient-reported…
Abstract Number: 1007 • ACR Convergence 2022
Metabolic Disorders and Abnormal Dietary Patterns and Their Association with Psoriatic Arthritis Activity: The Dietary Intervention in PsA (DIPSA) Study
Lihi Eder¹, Charlene Compher², Helen Emanoilidis³, Ryan F. Quinn², Dafna Gladman⁴, Vinod Chandran⁵, Jose Scher⁶ and Alexis Ogdie⁷, ¹Women’s College Research Institute, Department of Medicine, University of Toronto, Toronto, ON, Canada, ²University of Pennsylvania, Philadelphia, PA, ³Women's College Hospital, Toronto, ON, Canada, ⁴Toronto Western Hospital, Schroeder Arthritis Institute, Toronto, ON, Canada, ⁵Departments of Medicine and Laboratory Medicine and Pathobiology, University of Toronto/ Schroeder Arthritis Institute, Krembil Research Institute, University Health Network, Toronto, ON, Canada, ⁶New York University School of Medicine, New York, NY, ⁷Department of Medicine, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA
Background/Purpose: Psoriatic Arthritis (PsA) is associated with obesity and its related metabolic abnormalities. The role of diet as an adjunct therapy in PsA remains unclear.…
Abstract Number: 1985 • ACR Convergence 2022
The BEGIN Study: A Double-blind, Multi-center, Two-part, Randomized, Placebo-controlled Study of the Safety, Tolerability, and Efficacy of 4 Weeks of Treatment with AP1189 in Early Rheumatoid Arthritis (RA) Patients with Active Joint Disease
Thomas Jonassen¹, Irene Sandholdt², Birgitte Telmer² and Ellen-Margrethe Hauge³, ¹SynAct Pharma, Holte, Denmark, ²CroxxMed, Hørsholm, Denmark, ³Department of Rheumatology, Aarhus University Hospital, Aarhus, Denmark
Background/Purpose: Melanocortin (MC) type 1 and type 3 receptor stimulation is associated with anti-inflammatory activity and the promotion of inflammatory resolution. AP1189 is novel biased…
Abstract Number: 0199 • ACR Convergence 2022
Izokibep, a Novel IL-17A Inhibitor, Improves Patient-reported Outcomes – 16-Week Results from a Placebo-controlled Phase 2 Study in Patients with Active Psoriatic Arthritis
Peter Taylor¹, Frank Behrens², Philip J Mease³, Dieter Wetzel⁴, Paul Peloso⁵, Nicolai Brun⁴, Brian Wiens⁶, Jan Brandt-Juergens⁷, Edit Drescher⁸, Eva Dokoupilova⁹, Anna Rowińska-Osuch¹⁰, Nadia Abdel- Kader Martin¹¹ and Kurt de Vlam¹², ¹University of Oxford, Oxford, United Kingdom, ²Rheumatology University Hospital & Fraunhofer Institute Translational Medicine and Pharmacology, Goethe-University Frankfurt, Frankfurt Am Main, Germany, ³Swedish Medical Center/Providence St. Joseph Health, Seattle, WA, ⁴Affibody AB, Solna, Sweden, ⁵ACELYRIN, Naples, FL, ⁶ACELYRIN, Inc., Los Angeles, CA, ⁷Rheumatologische Schwerpunktpraxis, Berlin, Germany, ⁸Veszprem Megyei Csolnoky Ferenc Korhaz, Budapest, Hungary, ⁹Medical Plus, s.r.o. & Masaryk University, Faculty of Pharmacy, Department of Pharmaceutical Technology, Brno, Prague, Czech Republic, ¹⁰ETG Network - Rheumatology, Warsaw, Poland, ¹¹Hospital Infanta Luisa Quiron, Rheumatology, Sevilla, Spain, ¹²University Hospitals Leuven, Leuven, Belgium
Background/Purpose: Izokibep is a unique IL-17A inhibitor with high potency and small molecular size designed to overcome the limitations of monoclonal antibodies. IL-17 is a…
Abstract Number: 1036 • ACR Convergence 2022
Efficacy and Safety of Tofacitinib in Patients with Psoriatic Arthritis or Ankylosing Spondylitis by History of Cigarette Smoking
Alexis Ogdie¹, Lars Erik Kristensen², Enrique R Soriano³, Servet Akar⁴, Yanhui Sun⁵, David Gruben⁶, Lara Fallon⁷, Cassandra D Kinch⁸ and Dafna Gladman⁹, ¹Department of Medicine, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, ²The Parker Institute, Copenhagen University Hospital, Copenhagen, Denmark, ³Rheumatology Unit and University Institute, Hospital Italiano de Buenos Aires, Buenos Aires, Argentina, ⁴Izmir Katip Celebi University School of Medicine, Izmir, Turkey, ⁵Pfizer CRDC, Shanghai, China, ⁶Pfizer Inc, Groton, CT, ⁷Pfizer Inc, Montréal, QC, Canada, ⁸Pfizer Canada ULC, Kirkland, Canada, ⁹Toronto Western Hospital, Schroeder Arthritis Institute, Toronto, ON, Canada
Background/Purpose: In patients (pts) with PsA and AS, smoking may be associated with an increased comorbidity burden, and greater responses to TNF inhibitors (TNFi) are…

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