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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