Abstracts tagged "Randomized Trial"

Abstract Number: 0640 • ACR Convergence 2025
Impact of Clinically Important Improvements in Patient-Reported Outcomes on Disease Activity in Patients With Systemic Lupus Erythematosus Treated With Upadacitinib or Placebo: Results From the Phase 2 SLEek Study
Vibeke Strand¹, Zahi Touma², Anca Askanase³, Christopher Saffore⁴, Denise Kruzikas⁵, Karim Masri⁵, Siran Fang⁵, Yi Peng⁶, Patti Katz⁷ and Marta Mosca⁸, ¹Stanford University School of Medicine, Palo Alto CA, Portola Valley, CA, ²University of Toronto, Toronto, ON, Canada, ³Columbia University Medical Center, New York, NY, ⁴AbbVie Inc., waukegan, IL, ⁵AbbVie Inc., North Chicago, IL, ⁶AbbVie Inc., Maple Grove, MN, ⁷UCSF, San Rafael, CA, ⁸University of Pisa, Pisa, Pisa, Italy
Background/Purpose: This analysis evaluated associations between clinically important improvements in patient-reported outcomes (PROs) and reduced disease activity from the phase 2 SLEek trial evaluating upadacitinib…
Abstract Number: 0454 • ACR Convergence 2025
Models to predict flare and sustained remission in Rheumatoid Arthritis patients on optimization treatment with bDMARDs: clinical and molecular insights
Laura Galindo Domínguez¹, Belen Acasuso¹, Vanesa Balboa², Juan Cañete³, Benjamin Fernández-Gutiérrez⁴, Isidoro Gonzalez-Alvaro⁵, jose Luis Pablos⁶, Carmen Bejerano-Herreria⁷, Maite silva⁸, Ignacio rego Pérez⁹, Cristina Ruiz-Romero¹⁰, Francisco J De-Toro-Santos¹¹, Natividad Oreiro¹² and francisco J Blanco¹³, ¹Grupo de Investigación en Reumatología (GIR). INIBIC-Complejo Hospitalario Universitario A Coruña (CHUAC). SERGAS, A Coruña, Galicia, Spain, ²Grupo de Investigación de Reumatología (GIR). Instituto de Investigación Biomédica de A Coruña (INIBIC), Complexo Hospitalario Universitario de A Coruña (CHUAC), Sergas, coruña, Spain, ³Rheumatology Department, Hospital Clínic and IDIBAPS, Barcelona, Spain, Barcelona, Spain, ⁴Department of Rheumatology and Health Research Institute (IdISSC), Hospital Clínico San Carlos, Madrid, Spain., Madrid, Madrid, Spain, ⁵Department of Rheumatology, Hospital Universitario La Princesa, IIS, Madrid Spain, Madrid, Spain, ⁶Department of Rheumatology, Instituto de Investigación Hospital ¹² de Octubre, Complutense University of Madrid, Madrid, Madrid, Spain, ⁷Division of Rheumatology, Hospital Universitario Marqués de Valdecilla, IDIVAL, Immunopathology Group, Santander , Spain, Santander, Spain, ⁸Complexo Hospitalario Universitario de A Coruña (CHUAC), Sergas, A Coruña, Spain, A Coruña, Galicia, Spain, ⁹Department of Rheumatology, Rheumatology Research Group (GIR) Biomedical Re-search Institute (INIBIC), A Coruña, Spain, ¹⁰Department of Rheumatology, Rheumatology Research Group (GIR) Biomedical Re-search Institute (INIBIC),, A Coruña, Spain, ¹¹Complexo Hospitalario Universitario de A Coruña (CHUAC), Sergas, A Coruña, Spain, A Coruña, ¹²CHUAC, La Coruna, Spain, ¹³INIBIC-University of A Coruña, A Coruña, Galicia, Spain
Background/Purpose: Optimization of biologic DMARDs (bDMARDs) in patients with rheumatoid arthritis (RA) may be feasible in those who have maintained remission for at least six…
Abstract Number: 2084 • ACR Convergence 2025
Predictors of Change in Physical Activity Level Among Veterans with Knee Osteoarthritis in a Behaviorally Designed Incentive Program
Criswell Lavery¹, Ori Needleman¹, Bryant England², Katherine Wysham³, Mercedes Quinones⁴, Marianna Olave⁵, Sarah Wetzel⁶, Hannah Brubeck⁷, Rachel Gillcrist⁸, Natalie Keller⁹, Kimberly Hayes¹⁰, Bibiana Ateh¹¹, Bridget Kramer², Rui Xiao¹, Kaitian Jin¹, Alexis Ogdie¹², Daniel K. White¹³, Tuhina Neogi¹⁴, Carla Scanzello¹ and Joshua Baker¹, ¹University of Pennsylvania, Philadelphia, PA, ²University of Nebraska Medical Center, Omaha, NE, ³VA PUGET SOUND/UNIVERSITY OF WASHINGTON, Seattle, WA, ⁴Washington DC VA Medical Center, Bethesda, MD, ⁵Brown University, Philadelphia, PA, ⁶Drexel University, Pittsburgh, PA, ⁷VA Puget Sound Health Care System, Seattle, WA, ⁸Dartmouth College, Lebanon, NH, ⁹University of Oklahoma, Philadelphia, PA, ¹⁰Teachers College, Columbia University, Philadelphia, PA, ¹¹Washington VA Medical Center, Washington, District of Columbia, ¹²Department of Medicine, Perelman School of Medicine at the University of Pennsylvania, Wilmington, DE, ¹³University of Delaware, Newark, DE, ¹⁴Boston University School of Medicine, Boston, MA
Background/Purpose: Physical activity may help reduce symptoms in adults with knee osteoarthritis (KOA), yet few meet the recommended levels. This analysis identified participant characteristics associated…
Abstract Number: 1450 • ACR Convergence 2025
The Novel Digital Therapeutic Axia Improves Disease Activity, Functionality, and Quality of Life in Axial Spondyloarthritis Patients: Results from a Randomized Controlled Trial (Bechterew-App Trial)
Patrick-Pascal Strunz¹, Tobias Heusinger², Maxime Le Maire², Anna Fleischer³, Karsten Sebastian Luetkens⁴, Patricia Possler², Michael Gernert¹, Hannah Labinsky⁵, Robert Leppich⁶, Astrid Schmieder⁷, Ludwig Hammel⁸, Billy Sperlich⁹, Matthias Fröhlich¹ and Marc Schmalzing¹⁰, ¹University Hospital of Wuerzburg, Department of Medicine II, Rheumatology/ Immunology, Wuerzburg, Germany, ²University of Wuerzburg, Wuerzburg, Germany, ³University Hospital of Wuerzburg, Department of Medicine II, Psychosomatics, Wuerzburg, Germany, ⁴University Hospital of Wuerzburg, Institute of Diagnostic and Interventional Radiology, Wuerzburg, Germany, ⁵University Hospital of Wuerzburg, Würzburg, Germany, ⁶University Hospital of Wuerzburg, Chair of Software Engineering (Informatik II), Department of Computer Science, Wuerzburg, Germany, ⁷University Hospital Würzburg, Department of Dermatology, Venereology, and Allergology, Wuerzburg, Germany, ⁸Deutsche Vereinigung Morbus Bechterew e. V., Schweinfurt, Germany, ⁹Integrative and Experimental Exercise Science and Training, Institute for Sports Science, Wuerzburg, Germany, ¹⁰Department of Medicine II, Rheumatology/ Immunology,University Hospital of Wuerzburg, Wuerzburg, Bayern, Germany
Background/Purpose: Axia is a novel digital therapeutic (DTx) specifically designed for patients with axial spondyloarthritis (axSpA), in compliance with the European Medical Device Regulation (MDR).…
Abstract Number: 0590 • ACR Convergence 2025
Effect of Deucravacitinib Treatment on Disease Activity–Associated Plasma Biomarkers in Patients With Active Psoriatic Arthritis: Results From 2 Phase 3 Studies
Vinod Chandran¹, Oliver FitzGerald², Philip J. Mease³, Lihi Eder⁴, Jose Scher⁵, Christopher Ritchlin⁶, Dafna D. Gladman⁷, Walter P Maksymowych⁸, Coryandar Gilvary⁹, Aditi Basu Bal⁹, Eleni Vritzali¹⁰ and Jinqi Liu⁹, ¹Division of Rheumatology, Departments of Medicine and Laboratory Medicine and Pathobiology, University of Toronto, and Gladman Krembil Psoriatic Arthritis Research Program, Krembil Research Institute, University Health Network, Toronto, Canada, ²UCD, Dublin ⁶, Dublin, Ireland, ³Department of Rheumatology, Providence-Swedish Medical Center and University of Washington, Seattle, WA, ⁴University of Toronto, Toronto, ON, Canada, ⁵New York University School of Medicine, New York, NY, ⁶University of Rochester Medical Center, Canandaigua, NY, ⁷Schroeder Arthritis Institute, Krembil Research Institute, Toronto Western Hospital, Division of Rheumatology, Toronto, ON, Canada, ⁸Department of Medicine, University of Alberta, Edmonton, AB, Canada, ⁹Bristol Myers Squibb, Princeton, NJ, ¹⁰Bristol Myers Squibb, Boudry, Switzerland
Background/Purpose: Understanding how treatments affect disease-relevant biomarker expression is essential for advancing targeted therapies. Deucravacitinib, an oral, selective, allosteric tyrosine kinase 2 (TYK2) inhibitor, has…
Abstract Number: 0420 • ACR Convergence 2025
Long-term efficacy of intra-articular triamcinolone hexacetonide injections in juvenile idiopathic arthritis patients starting tumor necrosis factor inhibitor therapy: 48 weeks results from a randomized, open-label, blinded-assessor multicenter phase 4 trial – the MyJIA trial
Pernille Büyesen¹, Anna-Birgitte Aga¹, Vibke Lilleby¹, Maiju Pesonen¹, Marite Rygg², Ellen Nordal³, Bjørn Barstad⁴, Karin Tylleskär⁵, Helga Sanner¹, Siri Hetlevik¹, Nina Martine Sande¹, Inge Christoffer Olsen¹, Siri Lillegraven⁶, Espen Haavardsholm⁷, Athimalaipet Ramanan⁸, Oyvind Molberg⁹ and Berit Flatø¹, ¹Oslo University Hospital, Oslo, Norway, ²Department of Clinical and Molecular Medicine, NTNU - Norwegian University of Science and Technology and Department of Pediatrics, St. Olavs Hospital, Trondheim, Norway., Trondheim, Norway, ³University Hospital of North Norway, Tromsø, Nepal, ⁴Stavanger University Hospital, Stavanger, Norway, ⁵Haukeland University Hospital, Bergen, Norway, ⁶Diakonhjemmet Hospital, Oslo, Norway, ⁷Center for treatment of Rheumatic and Musculoskeletal Diseases (REMEDY), Diakonhjemmet Hospital, Oslo, Norway, ⁸Bristol Royal Hosp for Children, Bristol, United Kingdom, ⁹Oslo University Hospital, Oslo, Nepal
Background/Purpose: Modern therapies have improved outcomes in patients with JIA, but up to 60% of patients treated with TNF-α inhibitors (TNFi) have persisting disease activity…
Abstract Number: 2082 • ACR Convergence 2025
Pharmacokinetic Profile of MM-II Following a Single Intra-Articular Injection in Patients with Knee Osteoarthritis in a Phase 2b Randomized, Controlled, Dose-Ranging Trial
Thomas Schnitzer¹, Xavier Chevalier², Helene Rovsing³, Edith Lau⁴, Sidsel Boll⁵, Ballari Brahmachari⁶, Richard Chou⁷, Tarini Joshi⁸, Roni Wechsler⁹, Sveta Weiner¹⁰, Mudgal Kothekar¹¹, Asger Bihlet¹² and Philip Conaghan¹³, ¹Northwestern University Feinberg School of Medicine, Chicago, IL, ²Henri Mondor Hospital, University Paris XII UPEC, Créteil, France, ³Sanos Clinic, Gandrup, Denmark, ⁴Hong Kong Center for Clinical Research, Hong Kong, Hong Kong, ⁵Sanos Clinic, Vejle, Denmark, ⁶Sun Pharmaceuticals Industries Ltd., mumbai, Maharashtra, India, ⁷Sun Pharmaceutical Industries, Inc., Princeton, NJ, ⁸Sun Pharmaceutical Industries Limited, Mumbai, India, ⁹Moebius Medical, Tel Aviv, Israel, ¹⁰Sun Pharma Advanced Research Company Limited, Princeton, NJ, ¹¹Sun Pharma Advanced Research Company Limited, Andheri (E), Princeton, NJ, ¹²NBCD A/S, Herlev, Denmark, ¹³University of Leeds, Leeds, United Kingdom
Background/Purpose: MM-II is a first-in-class investigational treatment for knee OA pain that consists of a one-time IA injection of empty liposomes comprised of phospholipids dipalmitoylphosphatidylcholine…
Abstract Number: 1443 • ACR Convergence 2025
Long-Term Safety and Efficacy of Upadacitinib in Patients With Psoriatic Arthritis: 5-Year Results From the Phase 3 SELECT-PsA 1 Study
Iain McInnes¹, Koji Kato², Marina Magrey³, Joseph Merola⁴, mitsumasa kishimoto⁵, Derek Haaland⁶, Ivan Lagunes⁷, Laura Coates⁸, Yanxi Liu⁹, Erin Mancl¹⁰, Bhumik Parikh¹¹ and Charles Phillips¹², ¹University of Glasgow, Glasgow, United Kingdom, ²Abbvie. Inc, North Chicago, IL, ³Case Western Reserve University School of Medicine/University Hospitals Cleveland, Richfield, OH, ⁴UT Southwestern Medical Center, Dallas, TX, ⁵Kyorin University School of Medicine, Tokyo, Japan, ⁶The Waterside Clinic, Oro Medonte, ON, Canada, ⁷Abbvie Inc, North Chicago, IL, ⁸Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, England, United Kingdom, ⁹Abbvie Inc, Florham Park, NJ, ¹⁰AbbVie, Chicago, IL, ¹¹AbbVie, Hillsborough Township, NJ, ¹²AbbVie Inc, Princeton, NJ
Background/Purpose: We evaluated safety and efficacy of upadacitinib (UPA) versus adalimumab (ADA) at week 260 (5-years) from the long-term extension of SELECT-PsA 1.Methods: Randomized patients…
Abstract Number: 0589 • ACR Convergence 2025
Comparing Efficacy of Upadacitinib in Male and Female Patients with axSpA: Results from the SELECT-AXIS 1 and 2 Trials
Sofia Ramiro¹, Anna Molto², Elena Nikiphorou³, Marcelo Pinheiro⁴, Jamie Urbanik⁵, Tianming Gao⁶, Shirley Chen⁷, Jayne Stigler⁸, Jessica A. Walsh⁹ and Lihi Eder¹⁰, ¹Leiden University Medical Center, Bunde, Netherlands, ²Assistance Publique Hôpitauxde Paris, Paris, France, ³King's College London, London, United Kingdom, ⁴UNIFESP/ EPM, São Paulo, São Paulo, Brazil, ⁵AbbVie, Grayslake, IL, ⁶AbbVie, North Chicago, IL, ⁷AbbVie, Somerset, NJ, ⁸AbbVie, Round Lake, IL, ⁹Division of Rheumatology, Salt Lake City Veterans Affairs Health and University of Utah Health, Salt Lake City, UT, ¹⁰University of Toronto, Toronto, ON, Canada
Background/Purpose: Evidence suggests that the treatment effectiveness of TNFis and IL-17is is higher in male (M) vs female (F) patients (pts) with axSpA.1,2 Data comparing…
Abstract Number: 0338 • ACR Convergence 2025
Fractures and Changes in Bone Mineral Density During Two Years of Low Dose Glucocorticoid Treatment for Rheumatoid Arthritis: A Systematic Literature Review and Individual Participant Data Meta-Analysis
Andriko Palmowski¹, Tobias Haugegaard², Ingiäld Hafstörm³, Henning Bliddal⁴, Judith Oldenkott⁵, Siegfried Wassenberg⁶, Ernest Choy⁷, John Kirwan⁸, Robin Christensen⁹, Maarten Boers¹⁰ and FRANK BUTTGEREIT¹¹, ¹Charité – Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany, ²The Parker Institute, Kopenhagen, Denmark, ³Karolinska Institutet, Stockholm, Sweden, ⁴The Parker Institute, Frederiksberg, Denmark, ⁵Charité, Berlin, Germany, ⁶Rheumazentrum Ratingen, Ratingen, Germany, ⁷Division of Infection and Immunity, CREATE Centre, Cardiff University, Cardiff, United Kingdom, ⁸University of Bristol, Bristol, United Kingdom, ⁹Musculoskeletal Statistics Unit, The Parker Institute, Copenhagen, Hovedstaden, Denmark, ¹⁰Amsterdam UMC, Vrije Universiteit, Amersfoort, Netherlands, ¹¹Charité University Medicine Berlin, Berlin, Berlin, Germany
Background/Purpose: It is unclear to what extent low dose glucocorticoids (GCs) impact bone health in patients with rheumatoid arthritis (RA). RA leads to bone loss…
Abstract Number: 2006 • ACR Convergence 2025
Storytelling and Navigation to Improve Gout Follow-up: A Multicenter, Randomized Controlled Trial
Lesley Jackson¹, Rahima Begum², Gary Cutter², Hyon K. Choi³, Brett Faine⁴, Nora G. Singer⁵, Natalie McCormick⁶, hamid shokoohi⁷, Blair Parry⁷, Oliva Nelson⁷, James Booth¹, Zachary Armor¹, John Osborne¹, Kenneth Saag⁸ and Maria I. ("Maio") Danila⁹, ¹University of Alabama at Birmingham, Birmingham, AL, ²University of Alabama at Birmingham, Birmingham, ³MASSACHUSETTS GENERAL HOSPITAL, Lexington, MA, ⁴University of Iowa, Iowa City, IA, ⁵The MetroHealth System at Case Western Reserve University School of Medicine, Cleveland, OH, ⁶Massachusetts General Hospital, Boston, ⁷Massachusetts General Hospital, Boston, MA, ⁸The University of Alabama at Birmingham, Birmingham, AL, ⁹University of Alabama at Birmingham (UAB), Birmingham VA Medical Center, Birmingham, AL
Background/Purpose: Patients with gout are frequently treated in the emergency department (ED) for flares but may not receive consistent outpatient care. Approaches to mitigate this…
Abstract Number: 1353 • ACR Convergence 2025
Phase 3 Study of the Efficacy, Safety and Immunogenicity of the Proposed Tocilizumab Biosimilar RGB-19, Intravenously Administered to Participants With Active Rheumatoid Arthritis: 52-Week Data
Gerd Burmester¹, Hiroaki Matsuno², Ernest Choy³, Masato Okada⁴, Roshan Dias⁵, Károly Horvát-Karajz⁵, Gordana Dancer⁵, Yusuke Karibe⁶, Suguru Masuda⁶, Joachim Kiefer⁵ and Paul Emery⁷, ¹Department of Rheumatology and Clinical Immunology, Charité – Universitätsmedizin Berlin, Berlin, Germany, ²Matsuno Clinic for Rheumatic Disease, Toyama, and Immuno-Rheumatology Center, St. Luke's International Hospital, Tokyo, Japan, ³Division of Infection and Immunity, CREATE Centre, Cardiff University, Cardiff, United Kingdom, ⁴Immuno-Rheumatology Center, St. Luke's International Hospital, Tokyo, Japan, ⁵Gedeon Richter Plc, Budapest, Hungary, ⁶Mochida Pharmaceutical Co., Ltd, Tokyo, Japan, ⁷University of Leeds, Leeds, England, United Kingdom
Background/Purpose: RGB-19 is a proposed biosimilar to tocilizumab, a monoclonal antibody that competitively inhibits the binding of interleukin-6 (IL-6) to its receptor. Results of a…
Abstract Number: 0576 • ACR Convergence 2025
Factors impacting progression from oligoarticular to polyarticular PsA: Data from the FOREMOST study
Laura Coates¹, Philip J. Mease², Joseph Merola³, Lourdes Perez Chada⁴, Dafna D. Gladman⁵, Alen Zabotti⁶, Ulrich Mrowietz⁷, mitsumasa kishimoto⁸, Cynthia Deignan⁹, Siddharth Chaudhari¹⁰, Lichen Teng¹¹ and Laure Gossec¹², ¹Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, England, United Kingdom, ²Department of Rheumatology, Providence-Swedish Medical Center and University of Washington, Seattle, WA, ³UT Southwestern Medical Center, Dallas, TX, ⁴Harvard Medical School, Wayland, MA, ⁵Schroeder Arthritis Institute, Krembil Research Institute, Toronto Western Hospital, Division of Rheumatology, Toronto, ON, Canada, ⁶Division of Rheumatology, Department of Medicine (DMED), Academic Hospital "Santa Maria della Misericordia", ASUFC, University of Udine, Udine, Italy, Udine, Italy, ⁷Department of Dermatology, University Medical Center Schleswig-Holstein, Kiel, Germany, ⁸Kyorin University School of Medicine, Tokyo, Japan, ⁹Amgen, Inc., Agoura Hills, CA, ¹⁰Amgen Inc., Thousand Oaks, CA, ¹¹Amgen Inc., Thousand Oaks, ¹²Sorbonne Universite and Pitie-Salpetriere Hospital, Paris, France
Background/Purpose: FOREMOST (NCT03747939)1 offers novel insights on early oligoarticular (oligo, ≤4 active joints) PsA. Our aim was to analyse progression to polyarticular (poly; >4 active…
Abstract Number: 0335 • ACR Convergence 2025
Discontinuation and Non-Publication of Osteoarthritis Clinical Studies: A Cross-Sectional Analysis of 10,686,413 Patients
Mohamed Abdelsalam¹, Hadeer Hafez², Maryam Lasheen³, Bassant Elaraby Elsayed Badwy⁴, Omar Sameh Nabil El Sedafy¹, Abdelrahman M Hafez⁵, Omnia Samy El-Sayed⁴, Menat Alla Ayman Ali Mahdy⁴, Ali Tarek Hassanin³, Mohamed Reda Awad⁶ and Mohammed Safwat Kamal Hamza⁷, ¹Misr University For Science and Technology, ⁶ october, Al Jizah, Egypt, ²⁶th October University, ⁶ october, Al Jizah, Egypt, ³Misr University For Science and Technology, Helwan, Al Qahirah, Egypt, ⁴Misr University For Science and Technology, Nasr City, Al Qahirah, Egypt, ⁵Faculty of medecine, Damietta university, Mansoura, Ad Daqahliyah, Egypt, ⁶Al Azhar University, Cairo, Egypt, Giza, Al Jizah, Egypt, ⁷Faculty of Medicine, Misr University for Science and Technology, ⁶ october, Al Jizah, Egypt
Background/Purpose: Osteoarthritis (OA) is rising at an alarming rate, affecting millions worldwide and threatening mobility, independence, and quality of life. High-quality evidence is essential to…
Abstract Number: 1999 • ACR Convergence 2025
Characterization of Infusion Reactions Within 1 Hour of Treatment With Nanoencapsulated Sirolimus Plus Pegadricase: Pooled Results From the Phase 3 DISSOLVE I and DISSOLVE II Trials
Herbert Baraf¹, Andrew J. Sulich², Guillermo J. Valenzuela³, Rehan Azeem⁴, Ben Peace⁵, Bhavisha Desai⁶ and Puja Khanna⁷, ¹The Center for Rheumatology and Bone Research, Rheumatology, Wheaton, Maryland, USA; Division of Rheumatology, The George Washington University, Washington, DC, ²Shores Rheumatology, St. Clair Shores, MI, ³Iris Rheumatology, Plantation, FL, ⁴Global MACD, Sobi Inc., Waltham, MA, ⁵Statistical Science, Sobi, Stockholm, Sweden, ⁶Sobi, Glastonbury, CT, ⁷Division of Rheumatology, University of Michigan, Ann Arbor, MI
Background/Purpose: Uricase-based therapies may profoundly lower serum uric acid (sUA) in patients (pts) with uncontrolled gout (UG) but often lead to anti-drug antibody (ADA) formation,…

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