Abstracts tagged "Randomized Trial"

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)…
Abstract Number: 0533 • ACR Convergence 2024
Using Adalimumab Serum Concentration to Choose a Subsequent DMARD in Rheumatoid Arthritis Patients Failing Adalimumab Treatment (ADDORA-switch): Results of a Blinded Randomized Test Treatment Trial
Maike Wientjes¹, Sadaf Atiqi², Gertjan Wolbink³, Michael Nurmohamed⁴, Maarten Boers⁵, Femke Hooijberg², Theo Rispens⁶, Annick De Vries⁶, Floris Loeff⁶, Ronald Van Vollenhoven⁷, Sofia Ramiro⁸, Noortje van Herwaarden⁹, Bart van den Bemt¹⁰ and Alfons den Broeder¹, ¹Sint Maartenskliniek, Ubbergen, Netherlands, ²Reade, Amsterdam, Netherlands, ³Reade and Sanquin Diagnostic Services, Amsterdam, Netherlands, ⁴Reade and Amsterdam UMC, Kortenhoef, Netherlands, ⁵Amsterdam UMC, Vrije Universiteit, Amersfoort, Netherlands, ⁶Sanquin Diagnostic Services, Amsterdam, Netherlands, ⁷Department of Rheumatology and Clinical Immunology, Amsterdam University Medical Centers, Amsterdam, Netherlands, ⁸Leiden University Medical Center, Bunde, Netherlands, ⁹Sint Maartenskliniek, Nijmegen, Netherlands, ¹⁰Sint Maartenskliniek / Radboudumc, Ubbergen, Netherlands
Background/Purpose: Adalimumab is an effective and safe treatment for RA, however a substantial proportion of RA patients discontinue its use due to inefficacy. Upon failure,…
Abstract Number: 1458 • ACR Convergence 2024
Synovial Transcriptomic Sex-Specific Differences in the Response to Biologics in Psoriatic Arthritis Patients
Pauline KRUG¹, angela De Sousa Leite², Frédéric Lecouvet¹, Maria Simona stoenoiu¹ and Adrien Nzeusseu Toukap³, ¹Cliniques universitaires St-Luc, Brussel, Belgium, ²Cliniques universitaires St-Luc, Brussels, Belgium, ³Cliniques universitaires Saint-Luc,, St.-Lambrechts-Woluwe, Belgium
Background/Purpose: Psoriatic arthritis (PsA) is a highly heterogeneous disease. The response to therapy is variable among patients (ref.). Therefore, we need a tailored approach. Biologic…
Abstract Number: 1666 • ACR Convergence 2024
Preliminary Effects of a Fully-Remote Online Physical Activity Program Following Knee Replacement
Scott Jamieson¹, Jessica Unick², Kailyn Horn¹, Halle Prine¹, Chih-Hsiang Yang¹ and Christine Pellegrini¹, ¹University of South Carolina, Columbia, SC, ²Brown Alpert Medical School at Brown University, Providence, RI
Background/Purpose: After knee replacement (KR), most adults fail to meet recommended levels of physical activity. Virtual options to promote physical activity in clinical populations have…
Abstract Number: 2144 • ACR Convergence 2024
Impact of Immunogenicity on Clinical Outcomes in Postmenopausal Women with Osteoporosis: Results from a Randomized Controlled Phase 3 Study to Compare CT-P41 (Proposed Denosumab Biosimilar) and Reference Denosumab
Jean-Yves Reginster¹, Stuart L. Silverman², Edward Czerwinski³, Przemyslaw Borowy⁴, Tomasz Budlewski⁵, Joanna Kwiatek⁶, Svitlana Postol⁷, Airi Põder⁸, Jerzy Supronik⁹, SungHyun Kim¹⁰, JeeHye Suh¹⁰, GoEun Yang¹⁰, NooRi Han¹⁰, NaHyun Kim¹⁰ and SeoHee Bae¹⁰, ¹Biochemistry Dept, College of Science, King Saud University, Riyadh, Kingdom of Saudi Arabia, CLARENS, Switzerland, ²OMC clinical research center and Cedars Sinai Medical Center, Beverly Hills, CA, ³Krakowskie Centrum Medyczne, Kraków, Poland, ⁴Krakowskie Centrum Medyczne, Krakow, Poland, ⁵Department of Rheumatology, Medical University of Lodz, Lodz, Poland, ⁶Centrum Medyczne Poznan - PRATIA, Skorzewo, Poland, ⁷Medical Center of Medbud - Clinic LLC, Kyiv, Ukraine, ⁸Clinical Research Centre Ltd, Tartu, Estonia, ⁹Osteo-Medic s.c., Białystok, Poland, ¹⁰Celltrion, Inc., Incheon, Republic of Korea

Background/Purpose: CT-P41 has been developed as a proposed biosimilar of the reference denosumab (DEN), a fully human monoclonal antibody that binds the cytokine receptor activator…
Abstract Number: 2402 • ACR Convergence 2024
Belimumab Reduces Disease Flares versus Placebo in Adults with Early Active Systemic Lupus Erythematosus: Results of a Large Integrated Analysis
Marta Mosca¹, Karen Costenbader², Joan Merrill³, Holly Quasny⁴, Christine Henning⁵, Steven Bloom⁶, Julia Harris⁶, Ciara O’Shea⁷, Tatsuya Atsumi⁸ and Ronald Van Vollenhoven⁹, ¹University of Pisa, Department of Clinical and Experimental Medicine - Rheumatology Unit, Pisa, Italy, ²Brigham and Women's Hospital/ Harvard Medical School, Boston, MA, ³Oklahoma Medical Research Foundation, Oklahoma City 73104, OK, ⁴GSK, Clinical Sciences, Durham, NC, ⁵GSK, Global Medical Affairs, Durham, NC, ⁶GSK, Immunology Biostatistics, Brentford, United Kingdom, ⁷GSK, Rheumatology, Global Medical Affairs, Dublin, Ireland, ⁸Department of Rheumatology, Endocrinology and Nephrology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo, Japan, Sapporo, Japan, ⁹Department of Rheumatology and Clinical Immunology, Amsterdam University Medical Centers, Amsterdam, Netherlands
Background/Purpose: SLE flares are associated with increased risk of organ damage/mortality; flare prevention is a key treatment goal.1 Initiating treatment earlier has benefits in autoimmune…

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