Abstracts tagged "Randomized Trial"

Abstract Number: 0401 • ACR Convergence 2024
Biologic Abatement and Capturing Kids Outcomes and Flare Frequency in Juvenile Spondyloarthritis: Baseline Characteristics and Enrollment
Cora Sears¹, Cassandra Muir¹, Timothy Brandon¹, Polly Ferguson², Colleen Correll³, Margalit Rosenkranz⁴, Kevin Baszis⁵, Tzielan Lee⁶, Edward Oberle⁷, Matthew Stoll⁸, Kathryn Cook⁹, Eyal Muscal¹⁰, Hemalatha Srinivasalu¹¹, Daniel Lovell¹², Sampath Prahalad¹³, Michal Cidon¹⁴, Evan Mulvihill¹⁵, Marisa Klein-Gitelman¹⁶, Daniel Kingsbury¹⁷, Jennifer Cooper¹⁸, Natalie Rosenwasser¹⁹, Erin Treemarcki²⁰, Joyce Chang²¹, Stacey Tarvin²², Heather Walters²³, Michael Shishov²⁴, Lisa Buckley²⁵, Mary Toth²⁶, Ashley Cooper²⁷, Rui Xiao²⁸, Emily Neu²⁹, Melanie Kohlheim³⁰, Jenny Leal³¹, Kweli Archie³², English Holland³³, Miles Holland³⁴, Aamena Hameed³⁵, Asad Khan³⁶, Lynn Murphy³⁷, Sean Murphy³⁸, Justin Neu²⁹, Rachel Richmond³⁹, Dylan Suplee⁴⁰, Theresa Suplee⁴¹, Dawn Wiley⁴² and Pamela Weiss⁴³, ¹Children's Hospital of Philadelphia, Philadelphia, PA, ²University of Iowa Carver College of Medicine, Iowa City, IA, ³University of Minnesota, Minneapolis, MN, ⁴UPMC Children's Hospital of Pittsburgh, Pittsburgh, PA, ⁵Washington Univ in St. Louis School of Medicine, St Louis, MO, ⁶Stanford University School of Medicine, Palo Alto, CA, ⁷Nationwide Children's Hospital, Columbus, OH, ⁸University of Alabama at Birmingham, Birmingham, AL, ⁹Akron Children's Hospital, Akron, OH, ¹⁰Baylor College of Medicine, Houston, TX, ¹¹Children's National Hospital, Washington, DC, ¹²Cincinnati Children's Hospital Medical Center, Cincinnati, OH, ¹³Emory + Children's Pediatric Institute, Atlanta, GA, ¹⁴Children's Hospital of Los Angeles, Los Angeles, CA, ¹⁵Nemours/A.I.duPont Hospital for Children, Wilmington, DE, ¹⁶Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, IL, ¹⁷Legacy Health, Portland, OR, ¹⁸University of Colorado/Children's Hospital Colorado, Aurora, CO, ¹⁹Seattle Children's Hospital, Seattle, WA, ²⁰University of Utah, Salt Lake City, UT, ²¹Boston Children's Hospital, Boston, MA, ²²Indiana University School of Medicine, Indianapolis, IN, ²³Northwell Health, New Hyde Park, NY, ²⁴Phoenix Children's Hospital, Phoenix, AZ, ²⁵Monroe Carell Jr. Children's Hospital at Vanderbilt, Nashville, TN, ²⁶Nemours Foundation, Orlando, FL, ²⁷Children's Mercy Kansas City, Kansas City, MO, ²⁸University of Pennsylvania, Philadelphia, PA, ²⁹Parent Partner, Sidney, OH, ³⁰Parent Partner, Granville, OH, ³¹Parent Partner, Columbus, OH, ³²Parent Partner, Philadelphia, PA, ³³Parent Partner, Williamsburg, VA, ³⁴Patient Partner, Williamsburg, VA, ³⁵Parent Partner, Franklin Park, NJ, ³⁶Patient Partner, Franklin Park, NJ, ³⁷Parent Partner, Haddon Heights, NJ, ³⁸Patient Partner, Haddon Heights, NJ, ³⁹Parent Partner, Albuquerque, NM, ⁴⁰Patient Partner, Maple Shade, NJ, ⁴¹Parent Partner, Maple Shade, NJ, ⁴²Parent Partner, Downingtown, PA, ⁴³Children's Hospital of Philadelphia, Philadelphia, PA
Background/Purpose: Inactive disease is the goal for youth with spondyloarthritis (SpA). Many patients are interested in stopping medications after inactive disease is achieved. The risk…
Abstract Number: 1421 • ACR Convergence 2024
Differential Impact of B-cell Targeted Monotherapy and Combination Regimen on the Peripheral Blood Transcriptome of Adults with Active Sjögren Disease
Coziana Ciurtin¹, Lucia Martin-Gutierrez¹, John Casement², Kyle Thompson³, Fai Ng⁴, Andre van Maurik⁵ and Elizabeth Jury¹, ¹University College London, London, United Kingdom, ²Newcastle University, Newcastle, United Kingdom, ³Newcastle University, Newcastle, England, United Kingdom, ⁴Newcastle University, Newcastle upon Tyne, England, United Kingdom, ⁵Precision Medicine, GlaxoSmithKline, Stevenage, United Kingdom
Background/Purpose: Sjögren disease (SD) is characterised by B-cell hyperactivity associated with increased levels of B-lymphocyte stimulator (BlyS), but there are no effective biologic treatments for…
Abstract Number: 1596 • ACR Convergence 2024
Efficacy of Eosinophil-Targeting Therapies According to Disease Severity in Patients with Eosinophilic Granulomatosis with Polyangiitis
Bernhard Hellmich¹, Peter Merkel², David Jayne³, Benjamin Terrier⁴, Florence Roufosse⁵, Parameswaran Nair⁶, Nader Khalidi⁶, David J. Jackson⁷, Shunsuke Furuta⁸, Lena Börjesson Sjö⁹, Sofia Necander⁹, Anat Shavit¹⁰, Claire Walton¹¹ and Michael Wechsler¹², ¹Klinik für Innere Medizin, Rheumatologie, Pneumologie, Nephrologie und Diabetologie, Medius Kliniken, Akademisches Lehrkrankenhaus der Universität Tübingen, Kirchheim unter Teck, Germany, ²University of Pennsylvania, Philadelphia, PA, ³University of Cambridge, Cambridge, United Kingdom, ⁴Service de Médecine interne, Hôpital Cochin, AP-HP, Paris, Ile-de-France, France, ⁵Department of Internal Medicine, Hôpital Erasme, Université Libre de Bruxelles, Brussels, Belgium, ⁶McMaster University and St Joseph’s Healthcare, Hamilton, ON, Canada, ⁷Guy’s Severe Asthma Centre, Guy’s and St Thomas’ NHS Trust; School of Immunology and Microbial Sciences, King’s College London, London, United Kingdom, ⁸Department of Allergy and Clinical Immunology, Chiba University Hospital, Chiba, Japan, ⁹Late-Stage Respiratory and Immunology, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden, ¹⁰BioPharmaceuticals Medical, AstraZeneca, Cambridge, United Kingdom, ¹¹Late-Stage Respiratory and Immunology, BioPharmaceuticals R&D, AstraZeneca, Cambridge, United Kingdom, ¹²National Jewish Health, Denver, CO
Background/Purpose: Eosinophilic granulomatosis with polyangiitis (EGPA) is a rare inflammatory disorder characterized by asthma, eosinophilia, and small-to-medium size vessel vasculitis, with individual manifestations widely ranging…
Abstract Number: 2056 • ACR Convergence 2024
Deucravacitinib Treatment Did Not Impact Immune Response to SARS-CoV-2 Vaccines and Infection in Patients with Plaque Psoriasis: Results from the Phase 3 POETYK Long-Term Extension Trial
Kevin Winthrop¹, Joseph Merola², Akimichi Morita³, Diamant Thaçi⁴, Jianzhong Zhang⁵, Aditi Basu Ba⁶, Ian M. Catlett⁷, John Schwarz⁶ and Yi Luo⁶, ¹School of Medicine, Oregon Health and Science University, Portland, OR, ²UT Southwestern Medical Center, Newton, MA, ³Department of Geriatric and Environmental Dermatology, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan, ⁴Institute and Comprehensive Center for Inflammation Medicine, University of Lübeck, Lübeck, Schleswig-Holstein, Germany, ⁵Department of Dermatology, Peking University People’s Hospital, Beijing, China, ⁶Bristol Myers Squibb, Princeton, ⁷Bristol Myers Squibb, Princeton, NJ
Background/Purpose: Deucravacitinib, an oral, selective, allosteric tyrosine kinase 2 inhibitor, is approved in the US, EU, and other countries for treatment of adults with moderate…
Abstract Number: 2363 • ACR Convergence 2024
“How Quickly Will I Feel Better with This New Drug?” – Rapidity of Treatment Response in Patients with Axial Spondyloarthritis Treated with Bimekizumab: Analysis from Two Phase 3 Studies
Atul Deodhar¹, Elena Nikiphorou², Abhijeet Danve³, Stephen Hall⁴, Vanessa Taieb⁵, Diana Voiniciuc⁶, Marina Magrey⁷ and Xenofon Baraliakos⁸, ¹Division of Arthritis and Rheumatic Diseases, Oregon Health & Science University, Portland, OR, ²King's College London, London, United Kingdom, ³Section of Rheumatology, Department of Medicine, Yale School of Medicine, New Haven, CT, ⁴Cabrini Medical Centre, Monash University, and Emeritus Research, Melbourne, Victoria, Australia, ⁵UCB Pharma, Colombes, France, ⁶UCB Pharma, Slough, United Kingdom, ⁷Case Western Reserve University School of Medicine/University Hospitals, Richfield, OH, ⁸Rheumazentrum Ruhrgebiet Herne, Ruhr-University Bochum, Herne, Germany
Background/Purpose: Bimekizumab (BKZ) is a monoclonal IgG1 antibody that selectively inhibits interleukin (IL)-17F in addition to IL-17A. Two phase 3 studies were conducted where treatment…
Abstract Number: 0502 • ACR Convergence 2024
Similar Efficacy, PK, Safety, and Immunogenicity of Tocilizumab Biosimilar (CT-P47) and Reference Tocilizumab in Patients with Moderate-to-Severe Active Rheumatoid Arthritis: Week 52 Results from the Phase III Single Transition Study
Gerd Burmester¹, Jakub Trefler², Artur Racewicz³, Janusz Jaworski⁴, Agnieszka Zielińska⁵, Marek Krogulec⁶, Sławomir Jeka⁷, Rafał Wojciechowski⁸, Katarzyna Kolossa⁹, Anna Dudek¹⁰, Magdalena Krajewska-Włodarczyk¹¹, Paweł Hrycaj¹², Piotr Adrian Klimiuk¹³, SungHyun Kim¹⁴, JeeHye Suh¹⁴, GoEun Yang¹⁴, Yunah Kim¹⁴, YooBin Jung¹⁴, JiWoo Hong¹⁴ and Josef Smolen¹⁵, ¹Department of Rheumatology and Clinical Immunology, Charité – Universitätsmedizin Berlin, Berlin, Germany, ²REUMA RESEARCH, Wrocław, Poland, ³Zdrowie Osteo-Medic, Warszawa, Poland, ⁴Reumatika-Centrum Reumatologii, Warszawa, Poland, ⁵MICS Centrum Medyczne Warszawa, Warszawa, Poland, ⁶NZOZ Lecznica MAK - MED, Nadarzyn, Poland, ⁷MICS Centrum Medyczne, Polska, Poland, ⁸Department of Rheumatology and Systemic Connective Tissue Diseases, University Hospital No. 2, Bydgoszcz, PL, Bydgoszcz, Poland, ⁹MICS Centrum Medyczne Bydgoszcz, Bydgoszcz, Poland, ¹⁰Centrum Medyczne Amed, Warszawa, Poland, ¹¹University of Warmia and Mazury, Clinic of Rheumatology, Olsztyn, Poland, ¹²Prywatna Praktyka Lekarska Prof. dr hab. med. Paweł, Poznań, Poland, ¹³Medical University of Bialystok and Inter Clinic Piotr Adrian Klimiuk, Department of Rheumatology and Internal Diseases, Białystok, Poland, ¹⁴Celltrion, Inc., Incheon, Republic of Korea, ¹⁵Medical University of Vienna, Vienna, Austria
Background/Purpose: The therapeutic equivalence of CT-P47 (a proposed biosimilar to reference tocilizumab [ref-tocilizumab]) was demonstrated in patients with moderate to severe RA through disease activity…
Abstract Number: 1427 • ACR Convergence 2024
Observed and Simulated Pharmacokinetics and Pharmacodynamics of Nipocalimab, a Fully Human FcRn Blocking Monoclonal Antibody, in Adults with Sjögren’s Disease: Results from a Phase 2, Multicenter, Randomized, Placebo-controlled, Double-blind Study
Sophia G. Liva¹, fudan Zheng¹, Jocelyn H. Leu², Kathy Sivils³, Keying Ma¹, He Li⁴, Steven Leonardo⁵, Kim Lo¹, Jada Idokogi¹, Kim Campbell¹ and Jonathan J. Hubbard¹, ¹Janssen Research & Development, LLC, a Johnson & Johnson Company, Spring House, PA, ²Janssen Research & Development, LLC, a Johnson & Johnson company, Spring House, PA, PA, ³Johnson & Johnson Innovative Medicine, Edmond, OK, ⁴Janssen Research & Development, LLC, Therapeutics Discovery, Spring House, PA, ⁵Janssen Research & Development, LLC, a Johnson & Johnson Company, Cambridge, MA
Background/Purpose: Sjögren’s disease (SjD) is a chronic, progressive autoimmune disease characterized by aberrant B lymphocyte activity, elevated IgG production, and the presence of IgG autoantibodies…
Abstract Number: 1605 • ACR Convergence 2024
Characteristics of Relapses in Patients with Eosinophilic Granulomatosis with Polyangiitis
Peter Merkel¹, David Jayne², Ulrich Specks³, Christian Pagnoux⁴, Parameswaran Nair⁵, Nader Khalidi⁵, Arnaud Bourdin⁶, Lena Börjesson Sjö⁷, Sofia Necander⁷, Anat Shavit⁸, Claire Walton⁹ and Michael Wechsler¹⁰, ¹University of Pennsylvania, Philadelphia, PA, ²University of Cambridge, Cambridge, United Kingdom, ³Mayo Clinic, Rochester, MN, ⁴Mount Sinai Hospital, Toronto, ON, Canada, ⁵McMaster University and St Joseph’s Healthcare, Hamilton, ON, Canada, ⁶Department of Respiratory Diseases, University of Montpellier, CHU Montpellier, PhyMedExp, INSERM, CNRS, Montpellier, France, ⁷Late-Stage Respiratory and Immunology, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden, ⁸BioPharmaceuticals Medical, AstraZeneca, Cambridge, United Kingdom, ⁹Late-Stage Respiratory and Immunology, BioPharmaceuticals R&D, AstraZeneca, Cambridge, United Kingdom, ¹⁰National Jewish Health, Denver, CO
Background/Purpose: Eosinophilic granulomatosis with polyangiitis (EGPA) is a rare inflammatory disorder characterized by asthma, eosinophilia, and small-to-medium size vessel vasculitis. In the Phase 3, double-blind,…
Abstract Number: 2101 • ACR Convergence 2024
Patient Characteristics Associated with Objectively-Assessed Physical Activity in Veterans with Knee Osteoarthritis
Hannah Brubeck¹, David Azizi², Sarah Wetzel², Marianna Olave², Rachel Gillcrist³, Bridget Kramer⁴, Bibiana Ateh⁵, Daniel White⁶, Carla Scanzello⁷, Tuhina Neogi⁸, Alexis Ogdie⁹, Bryant England⁴, Mercedes Quinones¹⁰, Katherine Wysham¹¹ and Joshua Baker⁷, ¹VA Puget Sound Health Care System, Seattle, WA, ²Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA, ³Corporal Michael J. Crescenz VA Medical Center, Philadelphia, ⁴University of Nebraska Medical Center, Omaha, NE, ⁵Washington DC VA Medical Center, Washington, DC, ⁶University of Delaware, Newark, DE, ⁷University of Pennsylvania, Philadelphia, PA, ⁸Boston University Chobanian & Avedisian School of Medicine, Boston, MA, ⁹Department of Medicine, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, ¹⁰Washington DC VA Medical Center, Bethesda, MD, ¹¹VA PUGET SOUND/UNIVERSITY OF WASHINGTON, Seattle, WA
Background/Purpose: Despite strong recommendations for physical activity in knee osteoarthritis (KOA) clinical practice guidelines, only a small fraction of those with KOA meet guidelines for…
Abstract Number: 2367 • ACR Convergence 2024
Updated Long-Term Safety and Tolerability of Bimekizumab in Patients with Axial Spondyloarthritis and Psoriatic Arthritis: Pooled Results from Phase 2b/3 Studies
Philip Mease¹, Denis Poddubnyy², Rajan Bajracharya³, Barbara Ink³, Alexander Marten⁴, Ute Massow⁴, Vishvesh Shende³, Myriam Manente⁵, Luke Peterson⁶, Katy White³, Peter Nash⁷ and Lianne S Gensler⁸, ¹Swedish Medical Center/Providence St. Joseph Health; University of Washington School of Medicine, Seattle, WA, ²Charite-Universitatsmedizin Berlin, Berlin, Germany, ³UCB Pharma, Slough, United Kingdom, ⁴UCB Pharma, Monheim am Rhein, Germany, ⁵UCB Pharma, Braine-l'Alleud, Belgium, ⁶UCB Pharma, Morrisville, NC, ⁷School of Medicine, Griffith University, Sunshine Coast, Queensland, Australia, ⁸Department of Medicine/Rheumatology, University of California, San Francisco, San Francisco, CA

Background/Purpose: Bimekizumab (BKZ) is a monoclonal IgG1 antibody that selectively inhibits interleukin (IL)‑17F in addition to IL‑17A. BKZ was generally well tolerated by patients (pts)…
Abstract Number: 0525 • ACR Convergence 2024
Assess the Effect of Increasing the Dose of Folic Acid Supplementation in Patients of Rheumatoid Arthritis with Methotrexate Intolerance – A Randomised Controlled Trial
Varun Dhir¹, Harshith Sai Koneti², Aman Sharma³, sanjay jain⁴ and shankar naidu⁵, ¹PGIMER, CHD, INDIA, CHANDIGARH, India, ²PGIMER, Chandigarh, Sangareddy, Telangana, India, ³PGIMER, Chandigarh, India, Chandigarh, Chandigarh, India, ⁴PGIMER, Chandigarh, Chandigarh, India, ⁵PGIMER, Chandigarh, India, Chandigarh, India
Background/Purpose: : Methotrexate (MTX) Intolerance continues to occur in 20-40% patients despite low-dose folic acid (5-10mg per week) supplementation. Would a higher dose of folic…
Abstract Number: 1428 • ACR Convergence 2024
A Post-hoc Analysis of Two Phase 2 Randomized Controlled Trials in Patients with Active Sjogren’s Disease Exploring the Novel Composite Endpoint Sjögren’s Tool for Assessing Response (STAR)
Wolfgang Hueber¹, Raphaele Seror², Raphael Porcher³, Gabriel Baron⁴, Linchen He⁵, Wen-Lin Luo⁵, Xavier Mariette⁶ and Peter Gergely¹, and the members of the NECESSITY IMI2 consortium, ¹Novartis Pharma, Basel, Switzerland, ²Service de Rhumatologie, Hôpital Bicêtre, AP-HP, le Kremlin Bicetre, Ile-de-France, France, ³Department of Rheumatology, Bicêtre AP-HP Hôpital, Université Paris-Saclay, Paris, Ile-de-France, France, ⁴Hôpitaux Universitaires Paris-Sud (AP-HP), Paris, Ile-de-France, France, ⁵Novartis Pharma, East Hanover, NJ, ⁶Service de Rhumatologie, Hôpital Bicêtre, AP-HP, Le Kremlin Bicetre, France
Background/Purpose: Two randomized controlled phase 2 trials in patients with active Sjogren’s disease (SjD) were recently completed, the LOUiSSe trial assessing the Bruton Tyrosine kinase…
Abstract Number: 1665 • ACR Convergence 2024
Multicenter Randomized Controlled Trial of Physical Therapy (PT) or Sham PT in Persons with Knee Pain, Meniscal Tear, and Osteoarthritic Imaging Changes
Jeffrey Katz¹, Jamie Collins², Leslie Bisson³, Faith Selzer⁴, Morgan Jones², Heidi Yang², James Irrgang⁵, Clare Safran-Norton², Kurt Spindler⁶ and Elena Losina², ¹Brigham and Women's Hospital, Brookline, MA, ²Brigham and Women's Hospital, Boston, MA, ³University at Buffalo, Buffalo, NY, ⁴Brigham and Women's Hospital, Amesbury, MA, ⁵University of Pittsburgh, Pittsburgh, PA, ⁶Cleveland Clinic, Clev, OH
Background/Purpose: The syndrome of knee pain and meniscal tear (MT) is prevalent and disabling. The TeMPO trial (Treatment of Meniscal Problems in Osteoarthritis (OA)) compares…
Abstract Number: 2113 • ACR Convergence 2024
Discontinuation and Non-publication of Postmenopausal Osteoporosis Clinical Studies: A Cross-sectional Analysis of 345,435 Patients
Mohamed Abdelsalam¹, yasmeen Alabdallat², Yousef Hussein³, Mona Sajed⁴, Maryam Taha⁵, Rawan morse⁶, Wessam Selima⁷ and Ahmed Zabady⁸, ¹Rheumatology, Rehabilitation and Physical medicine department - faculty of medicine -Misr University for science and technology, 6th of October, Al Jizah, Egypt, ²Faculty of medicine - Hashemite university, Zarqa, Jordan, ³Faculty of medicine - Benha university, Benha, Egypt, ⁴Faculty of Pharmacy - Al-Azhar university for girls, Mansoura, Ad Daqahliyah, Egypt, ⁵Faculty of medicine - Ain Shams university, Madinat Nasr, Al Qahirah, Egypt, ⁶Medical Research Group of Egypt, Bur sa'id, Egypt, ⁷Anaesethia & pain management department, Faculty of medicine, Ain Shams University, Cairo, Egypt, ⁸Faculty of science - Damanhour university, Cairo, Egypt
Background/Purpose: Postmenopausal osteoporosis (PMOP) significantly contributes to global fracture rates annually, with its silent progression complicating early detection and intervention. Effective management strategies are crucial,…
Abstract Number: 2369 • ACR Convergence 2024
Impact of Baseline Factors on Disease Progression and Apremilast Efficacy in Early Oligoarticular Psoriatic Arthritis
Philip Mease¹, Laura Coates², Alexis Ogdie³, Dafna Gladman⁴, Alen Zabotti⁵, Xenofon Baraliakos⁶, Cynthia Deignan⁷, Shauna Jardon⁷, Rebecca Wang⁷, Lichen Teng⁷ and Laure Gossec⁸, ¹Swedish Medical Center/Providence St. Joseph Health; University of Washington School of Medicine, Seattle, WA, ²University of Oxford, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, Oxford, United Kingdom, ³Department of Medicine, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, ⁴University of Toronto, Toronto Western Hospital, Toronto, ON, Canada, ⁵Azienda Sanitaria Universitaria del Friuli Centrale, Udine, Udine, Italy, ⁶Rheumazentrum Ruhrgebiet Herne, Ruhr-University Bochum, Herne, Germany, ⁷Amgen Inc., Thousand Oaks, CA, ⁸Sorbonne Université, Paris, France
Background/Purpose: In the FOREMOST study of early oligoarticular psoriatic arthritis (PsA), fewer patients (pts) receiving apremilast (APR) progressed from ≤4 active joints (all joints; oligoarthritis)…

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