Abstracts tagged "Randomized Trial"

Abstract Number: L08 • ACR Convergence 2024
A Phase 2b, Randomized, Double-blind, Placebo-controlled, Dose-ranging and Parallel-group Study to Evaluate the Safety and Efficacy of XG005 in Subjects with Painful Osteoarthritis of the Knee
Limin Ren¹, Wenjie Zheng², Zhenpeng Guan³, Yang Zhang⁴, Zeyu Huang⁵, Tong Li⁶, Yuwei Peng⁷, Qiuli Wu⁸, Wei Gou⁹, Wei Zhao¹⁰, Pengyan Qiao¹¹, Xiaoli Pan¹² and Guang-Liang Jiang¹³, ¹Peking University, People’s Hospital, Rheumatology and Immunology Department, Beijing, China, ²Yantai Yuhuangding Hospital of Qingdao University, Department of Orthopedics, Yantai, China, ³Peking University, Shougang Hospital, Department of Orthopedics, Beijing, China, ⁴Division of Orthopaedic Surgery, Nanfang Hospital, Southern Medical University, Guangzhou, China, ⁵West China Hospital of Sichuan University, Department of Orthopedics, Chengdu, China, ⁶Xiangya Hospital of Central South University, Rheumatology and Immunology Department, Changsha, China, ⁷PingXiang People’s Hospital, Rheumatology and Immunology Department, Pingxiang, China, ⁸Tianjin Medical University General Hospital, Department of Orthopedics, Tianjin, China, ⁹Hebei Petrochina Central Hospital, Rheumatology and Immunology Department, Langfang, China, ¹⁰Central Hospital Affiliated to Shenyang Medical College, Department of Orthopedics, Shenyang, China, ¹¹Shanxi Bethune Hospital, Shanxi Academy of Medical Sciences, Third Hospital of Shanxi Medical University, Tongji Shanxi Hospital, Rheumatology and Immunology Department, Taiyuan, China, ¹²Affiliated Hospital of Zunyi Medical University, Rheumatology and Immunology Department, Zunyi, China, ¹³Xgene Pharmaceutical, Lexington, MA
Background/Purpose: Osteoarthritis (OA) affects 595 million people globally; cases are projected to increase 49-95% for various joints by 2050 as populations age (GBD 2023). OA…
Abstract Number: L14 • ACR Convergence 2024
A Withdrawal Study of Colchicine in Behçet Syndrome
Basak Sirin¹, Sinem Nihal Esatoglu², Hasan Yazıcı³ and Gulen Hatemi⁴, ¹Istanbul University- Cerrahpaşa, Cerrahpaşa Medical Faculty, Department of Internal Medicine, Istanbul, Turkey, ²Istanbul University- Cerrahpaşa, Cerrahpaşa Medical Faculty, Department of Internal Medicine, Division of Rheumatology, Istanbul,Türkiye/Istanbul University- Cerrahpaşa, Behcet's Disease Research Center, Istanbul, Turkey, ³Academic Hospital, Istanbul, Turkey, ⁴Istanbul University- Cerrahpaşa, Cerrahpaşa Medical Faculty, Department of Internal Medicine, Division of Rheumatology, Istanbul,Türkiye/Istanbul University- Cerrahpaşa, Behcet's Disease Research Center, Istanbul,Türkiye, Istanbul, Turkey
Background/Purpose: Previous randomized controlled studies reported conflicting results regarding the effectiveness of colchicine on oral ulcers in Behçet syndrome (BS). A randomized drug discontinuation design…
Abstract Number: L15 • ACR Convergence 2024
LEVI-04, a Novel neurotrophin-3 Inhibitor, Substantially Improves Pain and Function Without Deleterious Effects on Joint Structure in People with Knee Osteoarthritis: A Randomized Controlled Phase II Trial
Philip Conaghan¹, Ali Guermazi², Nathaniel Katz³, Asger Bihlet⁴, Dror Rom⁵, Michael Perkins⁶, Bernadette Hughes⁶, Claire Herholdt⁶, Iwona Bombelka⁶ and Simon Westbrook⁶, ¹University of Leeds, Leeds, United Kingdom, ²Boston University, West Roxbury, MA, ³Rin Sof Innovation, Ltd, Boston, MA, ⁴NBCD A/S, Soeborg, Denmark, ⁵Prosoft Clinical, Chesterbrook, ⁶Levicept Ltd, Ramsgate, United Kingdom
Background/Purpose: There is an urgent need for new therapies to treat OA. Excess neurotrophins (NT) are implicated in OA and other painful conditions. Previous OA…
Abstract Number: L16 • ACR Convergence 2024
Dapirolizumab Pegol Demonstrated Significant Improvement in Systemic Lupus Erythematosus Disease Activity: Efficacy and Safety Results of a Phase 3 Trial
Megan Clowse¹, David Isenberg², Joan Merrill³, Thomas Dörner⁴, Michelle Petri⁵, Edward Vital⁶, Eric Morand⁷, Teri Jimenez⁸, Stephen Brookes⁹, Janine Gaiha-Rohrbach¹⁰, Christophe Martin¹¹, Annette Nelde¹² and Christian Stach¹³, ¹Division of Rheumatology and Immunology, Duke University, Durham, NC, ²Department of Ageing, Rheumatology and Regenerative Medicine, Division of Medicine, University College London, London, United Kingdom, ³Oklahoma Medical Research Foundation, Oklahoma City, OK, ⁴Department of Medicine/Rheumatology and Clinical Immunology, Charité Universitätsmedizin Berlin, Berlin, Germany, ⁵Johns Hopkins University School of Medicine, Baltimore, MD, ⁶Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds and NIHR Leeds Biomedical Research Centre, Leeds Teaching Hospitals NHS Trust, Leeds, United Kingdom, ⁷Centre for Inflammatory Diseases, Monash University, Melbourne, Australia, ⁸UCB, Raleigh, NC, ⁹Biogen, Maidenhead, United Kingdom, ¹⁰Biogen, Cambridge, MA, ¹¹UCB, Slough, United Kingdom, ¹²Biogen, Baar, Switzerland, ¹³UCB, Monheim am Rhein, Germany
Background/Purpose: Dapirolizumab pegol (DZP) is a novel, polyethylene glycol (PEG)-conjugated antigen-binding (Fab') fragment, lacking an Fc domain, that inhibits CD40L signaling. By binding to CD40L,…
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.…
Abstract Number: 1676 • ACR Convergence 2024
Changing Patients’ Mindsets About Non-Severe Side Effects of Methotrexate: A Randomized Controlled Trial
Rachael Yielder¹, Kari Leibowitz², Alia Crum², Paul Manley³, Nicola Dalbeth¹ and Keith Petrie⁴, ¹University of Auckland, Auckland, New Zealand, ²Stanford University, Palo Alto, CA, ³Te Whatu Ora Health New Zealand, Auckland, New Zealand, ⁴The University of Auckland, Auckland, New Zealand
Background/Purpose: Although methotrexate (MTX) is a first-line treatment for inflammatory rheumatic diseases, side effects can lead to poor adherence and persistence. A novel intervention involves…
Abstract Number: 2185 • ACR Convergence 2024
TRACER: Transition to Adulthood Through Coaching and Empowerment in Rheumatology, a Feasibility Study
Megan Clarke¹, Julie Herrington², Tania Cellucci³, Liane Heale⁴, Mark Matsos⁵, KAREN BEATTIE², Roberta A Berard⁶ and Michelle Batthish³, ¹McMaster Universitys, Hamilton, Canada, ²McMaster University, Hamilton, ON, Canada, ³McMaster Children's Hospital, Hamilton, ON, Canada, ⁴McMaster University, Oakville, ON, Canada, ⁵McMaster Lupus Clinic, Division of Rheumatology, Department of Medicine, McMaster University, Hamilton, ON, Canada, ⁶London Health Sciences Centre, London, ON, Canada
Background/Purpose: The transition from pediatric to adult healthcare is a vulnerable time for youth with chronic disease, with risks of disengagement from care and subsequent…
Abstract Number: 2431 • ACR Convergence 2024
DORIS Remission in Patients with SLE Treated with Anifrolumab: Post Hoc Analysis from TULIP-1 and TULIP-2 Trials in Patents with No Reported History of Prior Immunosuppressant Use
doria Andrea¹, Ronald Van Vollenhoven², Eric Morand³, Catharina Lindholm⁴, Jonatan Hedberg⁴, Miina Waratani⁵ and Danuta Kielar⁶, ¹University of Padova, Padova, Italy, ²Department of Rheumatology and Clinical Immunology, Amsterdam University Medical Centers, Amsterdam, Netherlands, ³School of Clinical Sciences, Monash University, Melbourne, Victoria, Australia, ⁴BioPharmaceuticals Medical, AstraZeneca, Gothenburg, Sweden, ⁵Biopharmaceuticals Medical, AstraZeneca, Cambridge, United Kingdom, ⁶Biopharmaceuticals Medicine, AstraZeneca, Cambridge, United Kingdom
Background/Purpose: 2023 EULAR recommendations for the management of SLE open up the option for early treatment initiation with biologics without the requirement to fail immunosuppressants/DMARDs…
Abstract Number: 0620 • ACR Convergence 2024
Clinical Efficacy and Patient-Reported Outcomes in Anti-Ro/Sjögren’s Syndrome–Related Antigen a Antibody–Positive Patients with Active SLE Treated WithDeucravacitinib in the Phase 2 PAISLEY Trial
Benjamin A. Fisher¹, Hendrika Bootsma², Vibeke Strand³, Wan-Fai Ng⁴, Thomas Wegman⁵, Brandon Becker⁶, Jiyoon Choi⁶, Antoine Sreih⁶, Leo Chen⁷, Antonia Christodoulou⁶ and Eric Morand⁸, ¹University of Birmingham, Birmingham, United Kingdom, ²Department of Rheumatology and Clinical Immunology, University of Groningen, University Medical Center Groningen, Groningen, Groningen, Netherlands, ³Division of Immunology/Rheumatology, Stanford University, Palo Alto, CA, ⁴Institute of Cellular Medicine, Newcastle University, Gateshead, United Kingdom, ⁵Bristol Myers Squibb, Beaver Falls, PA, ⁶Bristol Myers Squibb, Princeton, NJ, ⁷Bristol Myers Squibb, Richmond, BC, Canada, ⁸School of Clinical Sciences, Monash University, Melbourne, Victoria, Australia
Background/Purpose: Deucravacitinib is a first-in-class, oral, selective, allosteric tyrosine kinase 2 (TYK2) inhibitor approved in multiple countries for the treatment of adults with moderate to…
Abstract Number: 1466 • ACR Convergence 2024
Apremilast Treatment in Early Oligoarticular Psoriatic Arthritis Improves Clinical and Patient-Reported Outcomes for up to 48 Weeks – Data from a Phase 4 Trial
Laure Gossec¹, Laura Coates², Dafna Gladman³, Alexis Ogdie⁴, Alvin F. Wells⁵, Joseph Merola⁶, Paolo Gisondi⁷, andreas pinter⁸, Mitsumasa Kishimoto⁹, Jyotsna Reddy¹⁰, Hamid Amouzadeh¹⁰, Rebecca Wang¹⁰, Shauna Jardon¹⁰, Michele Brunori¹⁰ and Philip Mease¹¹, 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, ⁵Rheumatology and Immunotherapy Center, Franklin, WI, ⁶UT Southwestern Medical Center, Newton, MA, ⁷Dermatology and Venereology, Department of Medicine, Università di Verona, Verona, Italy, ⁸University Hospital of the Goethe University, Frankfurt am Main, Frankfurt, Germany, ⁹Department of Nephrology and Rheumatology, Kyorin University School of Medicine, Tokyo, Japan, ¹⁰Amgen Inc., Thousand Oaks, CA, ¹¹Swedish Medical Center/Providence St. Joseph Health; University of Washington School of Medicine, Seattle, WA
Background/Purpose: Most clinical trials of Psoriatic Arthritis (PsA) exclude patients with early oligoarticular (oligo) disease and there is limited evidence to drive treatment decisions in…
Abstract Number: 1678 • ACR Convergence 2024
Efficacy, Safety, Pharmacokinetics of Anti-CD40 Antibody Abiprubart in Patients with Rheumatoid Arthritis: A Phase 2, Randomized, Placebo-Controlled 12-week-treatment Proof-of-Concept Study
Eric Jenkins¹, Ingrid Louw², Attila Balog³, Elsa van Duuren⁴, diane Horowitz⁵, Janusz Jaworski⁶, Alan Kivitz⁷, Ilona Kemplerne Ujfalussy⁸, Joe Pirrello¹, Eben Tessari¹, Sheldon Wang¹ and John F Paolini¹, and KPL-404-C211 Investigators, ¹Kiniksa Pharmaceuticals, Lexington, MA, ²Panorama Medical Centre, Cape Town, South Africa, ³Albert Szent-Györgyi Medical School, University of Szeged, Szeged, Hungary, ⁴The Sefako Makgatho Health Science University, Pretoria, South Africa, ⁵Feinstein Institute for Medical Research, New York, NY, ⁶Reumatika-Centrum Reumatologii, Warszawa, Poland, ⁷Altoona Center for Clinical Research, Duncansville, PA, ⁸Medical Centre, Hungarian Defense Forces, Dózsa György út 112, Budapest, Hungary
Background/Purpose: Rheumatoid arthritis (RA) patients (pts) with inadequate response or intolerance to current biologic/targeted synthetic disease-modifying anti-rheumatic drugs (b/tsDMARDs) have limited options. Abiprubart, a humanized…
Abstract Number: 2269 • ACR Convergence 2024
Adalimumab Dose Reduction Using Therapeutic Drug Monitoring to Manage Low Disease Activity in Rheumatoid Arthritis: A Single-Blind, Non-Inferiority, Randomized Clinical Trial
Sadaf Atiqi¹, Maike Wientjes², Maureen Leeuw³, Laura Boekel⁴, Femke Hooijberg¹, Floris Loeff⁵, Charlotte Krieckaert¹, Annick De Vries⁵, Michael Nurmohamed⁶, Theo Rispens⁵, Maarten Boers⁷, Bart van den Bemt⁸, Alfons den Broeder² and Gertjan Wolbink⁹, ¹Reade, Amsterdam, Netherlands, ²Sint Maartenskliniek, Ubbergen, Netherlands, ³Reade, Zeist, Netherlands, ⁴Vrije Universiteit Amsterdam, Amsterdam, Netherlands, ⁵Sanquin Diagnostic Services, Amsterdam, Netherlands, ⁶Reade and Amsterdam UMC, Kortenhoef, Netherlands, ⁷Amsterdam UMC, Vrije Universiteit, Amersfoort, Netherlands, ⁸Sint Maartenskliniek / Radboudumc, Ubbergen, Netherlands, ⁹Reade and Sanquin Diagnostic Services, Amsterdam, Netherlands
Background/Purpose: The latest European and American recommendations support tapering of biological DMARDs (bDMARDs) in patients with persistent remission or low disease activity. Most clinicians use…
Abstract Number: 2563 • ACR Convergence 2024
Efficacy and Safety Results of CT-P41 (Proposed Denosumab Biosimilar) Compared to Reference Denosumab in Postmenopausal Women with Osteoporosis: 78-Week Results from Phase 3 Randomized Controlled Trial
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, ³Krakow Medical Centre, 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 is a proposed biosimilar of the reference denosumab (DEN), a fully human monoclonal antibody that binds the cytokine receptor activator of NF-κb ligand…
Abstract Number: 0662 • ACR Convergence 2024
Deucravacitinib, a First-in-Class, Oral, Selective, Allosteric Tyrosine Kinase 2 Inhibitor, in SLE: Efficacy by Baseline Demographics and Disease Characteristics in the Phase 2 PAISLEY Trial
Eric Morand¹, Cristina Arriens², Laura Geraldino³, Ann E. Clarke⁴, Samantha Pomponi⁵, Coburn Hobar⁵, Thomas Wegman⁶, Ravi Koti⁵, Subhashis Banerjee⁵ and Ronald Van Vollenhoven⁷, ¹School of Clinical Sciences, Monash University, Melbourne, Victoria, Australia, ²Department of Arthritis and Clinical Immunology, Rheumatology, Oklahoma Medical Research Foundation and Department of Medicine, University of Oklahoma Health Sciences Center, Oklahoma City, OK, ³Division of Rheumatology, Department of Medicine, Columbia University, New York, NY, ⁴Division of Rheumatology, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada, ⁵Bristol Myers Squibb, Princeton, NJ, ⁶Bristol Myers Squibb, Beaver Falls, PA, ⁷Department of Rheumatology and Clinical Immunology, Amsterdam University Medical Centers, Amsterdam, Netherlands
Background/Purpose: Deucravacitinib is a first-in-class, oral, selective, allosteric tyrosine kinase (TYK2) inhibitor approved in multiple countries for the treatment of adults with moderate to severe…

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