ACR Meeting Abstracts

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Abstracts tagged "Randomized Trial"

  • 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: L07 • ACR Convergence 2023

    3-year Results of Tapering TNFi to Withdrawal Compared to Stable TNFi Among Rheumatoid Arthritis Patients in Sustained Remission: A Multicenter Randomized Trial

    Kaja Kjørholt1, Nina Sundlisæter1, Anna-Birgitte Aga1, Joseph Sexton1, Inge Christoffer Olsen2, Åse Lexberg3, Tor Magne Madland4, Hallvard Fremstad5, Christian A. Høili6, Gunnstein Bakland7, Cristina Spada8, Hilde Haukeland9, Inger Myrnes Hansen10, Ellen Moholt1, Karen Holten1, Till Uhlig1, Tore Kvien1, Daniel Solomon11, Désirée van der Heijde12, Espen Haavardsholm1 and Siri Lillegraven1, 1Center for treatment of Rheumatic and Musculoskeletal Diseases (REMEDY), Diakonhjemmet Hospital, Oslo, Norway, 2Department of Research Support for Clinical Trials, Oslo University Hospital, Oslo, Nepal, 3Department of Rheumatology, Drammen Hospital, Vestre Viken HF, Drammen, Norway, 4Department of Rheumatology, Haukeland University Hospital, Bergen, Norway, 5Department of Rheumatology, Møre og Romsdal Hospital Trust, Ålesund, Norway, 6Department of Rheumatology, Østfold Hospital Trust, Moss, Norway, 7Department of Rheumatology, University Hospital of North Norway, Tromsø, Norway, 8Department of Rheumatology, Revmatismesykehuset AS, Lillehammer, Norway, 9Department of Rheumatology, Martina Hansens Hospital, Bærum, Norway, 10Deptartment of Rheumatology, Helgelandssykehuset, Mo i Rana, Norway, 11Division of Rheumatology, Brigham and Women's Hospital, Newton, MA, 12Department of Rheumatology, Leiden University Medical Center, Meerssen, Netherlands

    Background/Purpose: Tapering of tumor necrosis factor inhibitor (TNFi) treatment in patients who have reached sustained remission is debated in current guidelines, and further data are…
  • Abstract Number: L14 • ACR Convergence 2023

    Efficacy and Safety of Benralizumab Compared with Mepolizumab in the Treatment of Eosinophilic Granulomatosis with Polyangiitis in Patients Receiving Standard of Care Therapy: Phase 3 MANDARA Study

    Michael Wechsler1, Parameswaran Nair2, Benjamin Terrier3, Bastian Walz4, Arnaud Bourdin5, David Jayne6, David Jackson7, Florence Roufosse8, Lena Börjesson Sjö9, Ying Fan10, Maria Jison10, Christopher McCrae11, Sofia Necander9, Anat Shavit12, Claire Walton12 and Peter Merkel13, 1National Jewish Health, Denver, CO, 2McMaster University, Hamilton, ON, Canada, 3Cochin Hospital, Paris, France, 4University of Tübingen, Kirchheim-Teck, Germany, 5University of Montpellier, CHU Montpellier, INSERM, Montpellier, Montpellier, France, 6Addenbrooke's Hospital, Cambridge, United Kingdom, 7Guy's Severe Asthma Centre, School of Immunology & Microbial Sciences, King's College London,, London, United Kingdom, 8Hôpital Erasme, Université Libre de Bruxelles, Brussels, Belgium, 9Late-stage Respiratory & Immunology, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden, 10Late-stage Respiratory & Immunology, BioPharmaceuticals R&D, AstraZeneca,, Gaithersburg, MD, 11Translational Science & Experimental Medicine, Early Respiratory & Immunology, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD, 12BioPharmaceutials Medical, AstraZeneca, Cambridge, United Kingdom, 13University of Pennsylvania, Philadelphia, PA

    Background/Purpose: Eosinophilic inflammation is a key pathophysiological mechanism of eosinophilic granulomatosis with polyangiitis (EGPA). Oral glucocorticoids (OGCs) and immunosuppressants remain the basis for the standard…
  • Abstract Number: L10 • ACR Convergence 2023

    Dazodalibep, a CD40L Antagonist, in a Phase 2, Randomized, Double-Blind, Placebo-Controlled, Crossover Trial of Subjects with Sjögren’s Disease Having Unacceptable Symptomatic Burden but Limited Extraglandular Organ Involvement

    E. William St. Clair1, Liangwei Wang2, Ilias Alevizos2, William A. Rees2, Alan N. Baer3, Wan-Fai Ng4, Ghaith Noaiseh5 and Chiara Baldini6, 1Department of Medicine, Duke University Medical Center, Durham, NC, USA, Durham, NC, 2Horizon Therapeutics plc, Rockville, MD, 3Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA, Baltimore, MD, 4Translational and Clinical Research Institute, Newcastle University, Newcastle, United Kingdom, 5Division of Allergy, Clinical Immunology and Rheumatology, Department of Medicine, University of Kansas, Kansas City, KS, USA, Kansas CIty, KS, 6Department of Clinical and Experimental Medicine, Rheumatology Unit, University of Pisa, Pisa, Italy

    Background/Purpose: Dazodalibep (DAZ) is a non-antibody fusion protein that acts as a CD40L antagonist and blocks costimulatory signals between immune cells, including T cells, B…
  • Abstract Number: L15 • ACR Convergence 2023

    AR882, an Efficacious and Selective URAT1 Inhibitor for Patients with Chronic Gouty Arthritis and Subcutaneous Tophi: Results from a Global, Prospective, Proof-of-Concept Trial Using Dual Energy Computed Tomography

    Robert Keenan1, James Cheng-Chung WEI2, Sarah Morris3, Pamella Mundell3, Wen Wei3, Ke Shi3, Zancong Shen3, Vijay Hingorani4, Shunqi Yan3, Bahram Kiani5 and Litain Yeh3, 1Arthrosi Therapeutics, Inc., Chapel Hill, NC, 2Chung Shan Medical University, Taichung, Taiwan (Republic of China), 3Arthrosi Therapeutics, Inc., San Diego, CA, 4Vanguard Healthsciences, Inc., San Diego, CA, 5Wake Forest University School of Medicine, Winston-Salem, NC

    Background/Purpose: AR882 is a novel and selective URAT1 inhibitor currently in clinical stage development for the treatment of gout and tophaceous gout and has demonstrated…
  • Abstract Number: L12 • ACR Convergence 2023

    Efficacy and Safety Outcomes of TAK-279, a Selective Oral Tyrosine Kinase 2 (TYK2) Inhibitor, from a Randomized, Double-blind, Placebo-controlled Phase 2b Trial in Patients with Active Psoriatic Arthritis

    Alan Kivitz1, Elena Tomaselli Muensterman2, Arthur Kavanaugh3, Désirée van der Heijde4, Piotr A. Klimiuk5, Guillermo Valenzuela6, Eva Dokoupilova7, Gabrielle Poirier8, Bhaskar Srivastava8, Sue Dasen8, Xinyan Zhang8, Mona Trivedi2, Haoling Holly Weng9, Ting Hong10, Peter Pothula10 and Xenofon Baraliakos11, 1Altoona Center for Clinical Research, Duncansville, PA, 2Takeda Development Center Americas, Inc., Cambridge, MA, 3Division of Rheumatology, Allergy & Immunology, University of California San Diego Medical School, San Diego, CA, 4Department of Rheumatology, Leiden University Medical Center, Meerssen, Netherlands, 5Department of Rheumatology and Internal Diseases, Medical University of Bialystok and Inter Clinic Piotr Adrian Klimiuk, Białystok, Poland, 6Integral Rheumatology & Immunology Specialists, Plantation, FL, 7Department of Pharmaceutical Technology, Faculty of Pharmacy, Masaryk University and MEDICAL PLUS, s.r.o., Brno and Uherské Hradiště, Czech Republic, 8Nimbus Discovery, Inc., Boston, MA, 9HW MedAdvice LLC, San Diego, CA, 10Takeda Development Center Americas, Inc., Boston, MA, 11Rheumazentrum Ruhrgebiet, Ruhr-University Bochum, Bochum, Germany

    Background/Purpose: TYK2 mediates signaling by key cytokines involved in the pathogenesis of immune-mediated inflammatory diseases such as psoriatic arthritis (PsA) and psoriasis (PsO). TAK-279 is…
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All abstracts accepted to ACR Convergence are under media embargo once the ACR has notified presenters of their abstract’s acceptance. They may be presented at other meetings or published as manuscripts after this time but should not be discussed in non-scholarly venues or outlets. The following embargo policies are strictly enforced by the ACR.

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