Abstracts tagged "Randomized Trial"

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: 1628 • ACR Convergence 2022
The Sjogren Tool for Assessing Response (STAR): Assessment of Response Rates Overall, According to Baseline Activity and by Domain: Reanalysis of 9 Clinical Trials in Primary Sjogren Syndrome
Raphaèle Seror¹, Gabriel Baron², Divi CORNEC³, Elodie Perrodeau², Marine Camus⁴, Professor Simon Bowman⁵, Michele Bombardieri⁶, Hendrika Bootsma⁷, Suzanne Arends⁷, jacques-eric gottenberg⁸, Benjamin A. Fisher⁹, Wolfgang Hueber¹⁰, Joel Van Roon¹¹, Valerie Devauchelle¹², Liseth de Wolff¹³, Peter Gergely¹⁴, Xavier Mariette¹⁵ and Raphaël Porcher¹⁶, ¹University Hospital Paris-Saclay, Le Kremlin Bicêtre, France, ²AP-HP Hôtel Dieu Hospital, Université Paris Descartes, Paris, France, ³CHRU Brest, Brest, France, ⁴Department of Rheumatology, Université Paris-Saclay, APHP Hôpital Bicêtre, Le Kremlin Bicêtre, France, ⁵University Hospitals Birmingham, Birmingham, United Kingdom, ⁶Experimental Medicine and Rheumatology, William Harvey Research Institute, Queen Mary University, London, United Kingdom, ⁷University Medical Center Groningen, Groningen, Netherlands, ⁸Strasbourg University Hospital, Strasbourg, France, ⁹University of Birmingham, Birmingham, United Kingdom, ¹⁰Novartis Pharmaceuticals, Basel, Switzerland, ¹¹Rheumatology & Clinical Immunology, University of Utrecht, Utrecht, Netherlands, ¹²Université de Bretagne Occidentale, Brest, France, ¹³UMCG, Zwolle, Netherlands, ¹⁴Novartis Pharma, Basel, Switzerland, ¹⁵Paris-Saclay University, Rueil Malmaison, Ile-de-France, France, ¹⁶Université Paris Cité, Hôtel-Dieu, Paris, France
Background/Purpose: The ESSDAI and ESSPRI, used alone, are not able to capture all features of primary Sjögren's syndrome (pSS). The NECESSITY consortium developed the Sjögren's…
Abstract Number: 2273 • ACR Convergence 2022
Waning Vaccine Response After Primary Vaccine Series: Results from the Covid19 Vaccine Response in Rheumatology Patients (COVER) Study
Amy Mudano¹, Gary Cutter², Ted Mikuls³, Geoffrey Thiele⁴, Mark Law⁴, Bart Hamilton⁴, Michael Zikry⁵, Kelly Y. Chun⁶, Monique Bastidas⁷, Michael George⁸, Lisa Williams⁹, Kevin Winthrop¹⁰, Mark Busch¹¹, Stanley Cohen¹², Roman Czubatyj¹³, Rajesh Kataria¹⁴, Reshma Khan¹⁵, Soha Mousa¹⁶, Jose Pando¹⁷, Elizabeth Perkins¹⁸, Shanmugapriya Reddy¹⁹, Delfin Santos²⁰, Joy Schechtman²¹, Frank Scott²², Sucharitha Shanmugam²³, Atul Singhal²⁴, John Tesser²⁵, John Tower²⁶, Swamy Venuturupalli²⁷, Sean Joseph Wollaston²⁸, Conrad Ziembinski²⁹ and Jeffrey Curtis³⁰, ¹Illumination Health, Hoover, AL, ²University of Alabama at Birmingham, Birmingham, AL, ³Division of Rheumatology, University of Nebraska Medical Center, Omaha, NE, ⁴University of Nebraska Medical Center, Omaha, NE, ⁵LabCorp, Burlington, NC, ⁶Labcorp, Calabasas, CA, ⁷LabCorp, Northridge, CA, ⁸University of Pennsylvania, Philadelphia, PA, ⁹Illumination Heath, Hoover, AL, ¹⁰Oregon Health & Science University, Portland, OR, ¹¹Family Arthritis Center-Jupiter, Jupiter, FL, ¹²Metroplex Clinical Research Center, Pittsburgh, PA, ¹³Arthritis Physicians LLC, Rochester Hills, MI, ¹⁴Southern Ohio, Wheelersburg, OH, ¹⁵Palm Beach Rheumatology and Wellness, Jupiter, FL, ¹⁶Arthritis and Rheumatology of Southwest Ohio, Liberty Township, OH, ¹⁷Rheumatology Consultants of DE, Lewes, DE, ¹⁸Rheumatology Care Center, Hoover, AL, ¹⁹Southwest Florida Rheumatology, Riverview, FL, ²⁰Rochester Rheumatology, Rochester Hills, MI, ²¹SunValley Arthritis Center, Peoria, AZ, ²²Arthritis Medical Center, Arroyo Grande, CA, ²³Rheumatology and Arthritis Care Center, Exton, PA, ²⁴Southwest Rheumatology Research, Mesquite, TX, ²⁵Arizona Arthritis & Rheumatology Associates, Phoenix, AZ, ²⁶Arthritis Physicians LLC, Rochester, MI, ²⁷Cedars-Sinai Medical Center, Los Angeles, CA, ²⁸Rheumatology Associates, North Hollywood, CA, ²⁹CZ Rheumatology, Coral Springs, FL, ³⁰Division of Clinical Immunology & Rheumatology, University of Alabama at Birmingham, Birmingham, AL
Background/Purpose: Given possible increased risk of COVID-19 in patients with autoimmune conditions, there is a need to better understand the immunogenicity and safety of SARS-CoV-2…
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…

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