Abstracts tagged "Randomized Trial"

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…
Abstract Number: 0593 • ACR Convergence 2024
Value of the Routine Assessment of Patient Index Data 3 in Assessing Disease Severity and Treatment Effect in Patients with Early Oligoarticular Psoriatic Arthritis Treated with Apremilast
Alvin F. Wells¹, Arthur Kavanaugh², William Tillett³, Philip S. Helliwell⁴, Marijn Vis⁵, Yuri Klyachkin⁶, Cynthia Deignan⁷, Lichen Teng⁷, Rebecca Wang⁷ and Alexis Ogdie⁸, ¹Rheumatology and Immunotherapy Center, Franklin, WI, ²University of California San Diego, La Jolla, CA, ³Royal National Hospital of Rheumatic Diseases; Department of Life Sciences, Centre for Therapeutic Innovation, University of Bath, Bath, United Kingdom, ⁴Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK, Leeds, United Kingdom, ⁵Erasmus MC, Rotterdam, Netherlands, ⁶Amgen, Lexington, KY, ⁷Amgen Inc., Thousand Oaks, CA, ⁸Department of Medicine, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA
Background/Purpose: The Routine Assessment of Patient Index Data 3 (RAPID3) score is a composite of 3 patient-reported outcomes (PROs): Health Assessment Questionnaire (HAQ), pain visual…
Abstract Number: 1465 • ACR Convergence 2024
The Use of Disease Activity Thresholds for the Psoriatic Arthritis Impact of Disease Questionnaire to Assess Patient Perceptions of Disease Burden in Patients with Early Oligoarticular Psoriatic Arthritis Treated with Apremilast in a Phase 4 Trial
Laure Gossec¹, Laura Coates², Dafna Gladman³, Alexis Ogdie⁴, Peter Nash⁵, Denis Poddubnyy⁶, Arthur Kavanaugh⁷, April Armstrong⁸, Carlo Selmi⁹, Ruben Queiro Silva¹⁰, Cynthia Deignan¹¹, Rebecca Wang¹¹, Jyotsna Reddy¹¹, Michele Brunori¹¹ and Philip Mease¹², ¹Sorbonne Université, Paris, France, ²University of Oxford, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, Oxford, United Kingdom, ³University of Toronto, Toronto Western Hospital, Toronto, ON, Canada, ⁴Department of Medicine, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, ⁵School of Medicine, Griffith University, Sunshine Coast, Queensland, Australia, ⁶Charite-Universitatsmedizin Berlin, Berlin, Germany, ⁷University of California, San Diego, School of Medicine, La Jolla, CA, ⁸University of California Los Angeles, Los Angeles, CA, ⁹Department of Biomedical Sciences, Humanitas University, Rozzano, Italy, ¹⁰Rheumatology Division, Hospital Universitario Central de Asturias, Oviedo University School of Medicine, Oviedo, Spain, ¹¹Amgen Inc., Thousand Oaks, CA, ¹²Swedish Medical Center/Providence St. Joseph Health; University of Washington School of Medicine, Seattle, WA
Background/Purpose: Oligoarticular psoriatic arthritis (PsA, ≤4 joints affected) is common but understudied, as most clinical trials enroll patients (pts) with ≥3 swollen and tender joints.…

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