ACR Meeting Abstracts

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Abstracts tagged "Randomized Trial"

  • Abstract Number: 0544 • ACR Convergence 2022

    Bimekizumab Improves Signs and Symptoms, Including Inflammation, in Patients with Active Non-Radiographic Axial Spondyloarthritis: 24-Week Efficacy & Safety from a Phase 3, Multicenter, Randomized, Placebo Controlled Study

    Atul Deodhar1, Désirée van der Heijde2, Lianne Gensler3, Huji Xu4, Karl Gaffney5, Hiroaki Dobashi6, Walter P Maksymowych7, Martin Rudwaleit8, Marina Magrey9, Dirk Elewaut10, Marga Oortgiesen11, Carmen Fleurinck12, Natasha de Peyrecave13, Alicia Ellis14, Thomas Vaux15, Julie Shepherd-Smith15 and Xenofon Baraliakos16, 1Oregon Health & Science University, Portland, OR, USA, Portland, OR, 2Department of Rheumatology, Leiden University Medical Center, Leiden, The Netherlands, Leiden, Netherlands, 3Department of Medicine, Division of Rheumatology, University of California San Francisco, San Francisco, CA, 4Department of Rheumatology and Immunology, Shanghai Changzheng Hospital, Affiliated to Second Military Medical University, Shanghai, China, 5Norfolk and Norwich University Hospital NHS Trust, Norfolk, United Kingdom, 6Division of Hematology, Rheumatology and Respiratory Medicine, Department of Internal Medicine, Faculty of Medicine, Kagawa, Kagawa, Japan, 7Department of Medicine, University of Alberta, Edmonton, AB, Canada, 8University of Bielefeld, Klinikum Bielefeld, Bielefeld; Germany Klinikum Bielefeld and Charité Berlin, Germany, and Gent University, Gent, Belgium, 9Case Western Reserve University, University Hospitals, Richfield, OH, 10Department of Rheumatology, Ghent University Hospital, Belgium, VIB-UGent Center for Inflammation Research, Ghent University, Heusden, Belgium, 11UCB Pharma, Raleigh, NC, 12UCB Pharma, Brussels, Belgium, Oosterzele, Belgium, 13UCB Pharma, Brussels, Belgium, 14UCB Pharma, Raleigh, 15UCB Pharma, Slough, United Kingdom, 16Rheumazentrum Ruhrgebiet Herne, Herne, Germany

    Background/Purpose: Bimekizumab (BKZ) is a monoclonal IgG1 antibody that selectively inhibits IL-17F in addition to IL-17A. In patients (pts) with active ankylosing spondylitis (AS), BKZ…
  • Abstract Number: 1822 • ACR Convergence 2022

    A Double-Blind, Placebo-Controlled, Ascending Dose Phase 2a Study of ABP-671, a Novel, Potent and Selective URAT1 Inhibitor, in Patients with Gout or Hyperuricemia

    Marc Gurwith1, Deon Smith2, Paul Bird3, Jessica Leung4, Mark Bloch5, Joshua Kim6, Rahul Mohan7, Anthony Houston8, Oscar Cumming9, Ann Madrid10, Ullrich Schwertschlag11, Jerry Liu12, Roy Wu13, Jason Xu14, Adam Jin14 and William Dongfang Shi15, 1Jiangsu Atom Bioscience and Pharmaceutical Co., Ltd., Los Altos Hills, CA, 2Emeritus Research, Melbourne, Australia, 3Emeritus Research Sydney, Sydney, Australia, 4Austin Health, Preston, Victoria, Australia, 5Holdsworth House Medical Practice, Darlinghurst, Australia, 6Paratus Clinical Pty Ltd., New South Wales, Australia, 7Paratus Clinical Pty Ltd, Western Sydney, Australia, 8Peninsula Private Hospital, Kippa-Ring, Australia, 9Novatrials, Kotara, Australia, 10Novotech Australia, Sydney, Australia, 11Jiangsu Atom Bioscience and Pharmaceutical Co., Ltd., Palo Alto, 12Jiangsu Atom Bioscience and Pharmaceutical Co., Ltd., San Diego, 13Jiangsu Atom Bioscience and Pharmaceutical Co., Ltd., San Francisco, 14Jiangsu Atom Bioscience and Pharmaceutical Co., Ltd., Suzhou, China, 15Jiangsu Atom Bioscience and Pharmaceutical Co., Ltd., Fremont

    Background/Purpose: ABP-671, a novel selective and potent URAT1 inhibitor reduces reabsorption of uric acid (UA) at the renal proximal tubule, and significantly decreases serum uric…
  • Abstract Number: 0545 • ACR Convergence 2022

    Continuing (Full or Reduced Treatment) versus Withdrawing from Golimumab Treatment in Patients with Non-radiographic Spondylarthritis Who Achieved Inactive Disease: Efficacy and Safety Results from a Placebo-Controlled, Randomized Withdrawal and Retreatment Study (GO-BACK)

    Cindy Weinstein1, Paula Sliwinska-Stanczyk2, Tomas Hala3, Marina Stanislav4, Anjela Tzontcheva5, Ruji Yao1, Yuliya Berd1, Sean Curtis1 and George Philip1, 1Merck & Co., Inc., Rahway, NJ, 2Reumatika Centrum Reumatologii, Warsaw, Poland, 3Center for Clinical and Basic Research, Pardubice, Czech Republic, 4Vladimirsky Moscow Regional Scientific Institution, Moscow, Russia, 5MSD Switzerland, Zürich, Switzerland

    Background/Purpose: Non-radiographic axial spondyloarthrits (nr-axSpA) is a rheumatic disease that is predominantly associated with chronic back pain and stiffness.1 Results from the Phase III GO-AHEAD…
  • 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…
  • Abstract Number: 0573 • ACR Convergence 2022

    Telehealth versus Outpatients Clinic Follow up in Rheumatoid Arthritis Patients a Randomized Controlled Study

    Anne Bull Haaversen1, Inge Christoffer Olsen2, Maiju Pesonen3, Andreas Diamantopoulos4 and jannicke Sundsby karlengen5, 1Martina Hansens Hospital, Hosle, Norway, 2Oslo University Hospital, Oslo, Nepal, 3Oslo University, Oslo, Norway, 4Akershus University Hospital, Lørenskog, Norway, 5Martina Hansens Hospital, Baerum, Norway

    Background/Purpose: Most Rheumatoid Arthritis (RA) patients are in remission or low disease activity. Yet, RA patients continue to be followed up by pre-scheduled visits, which…
  • Abstract Number: 1892 • ACR Convergence 2022

    Genicular Nerve Block for Pain Management in Patients with Knee Osteoarthritis: A Randomised Double-blind Placebo Controlled Trial

    Ernst Shanahan1, Fin Cai2, Frank Voyvodic2, Suellen Lyne2, Richard Woodman1, Kokum Dissanayake2, Kate Paddick2, Giovanna Cheung2 and Lucinda Robinson2, 1Flinders University, Adelaide, Australia, 2SALHN, Adelaide, Australia

    Background/Purpose: To determine whether Genicular Nerve Block (GNB) is an efficacious treatment for patients with knee osteoarthritis (OA)Methods: Adults with symptomatic knee OA for greater than 3…
  • 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…
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