Abstracts tagged "Randomized Trial"

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…
Abstract Number: 1472 • ACR Convergence 2024
Achievement of Low Disease Activity/Remission in Guselkumab-Treated Patients with Moderately-Highly Active Psoriatic Arthritis Regardless of Baseline Characteristics: Pooled Post-Hoc Analysis of Two Phase 3/Randomized Studies
Philip Mease¹, Alice Gottlieb², Iain McInnes³, Natalie J. Shiff⁴, Anthony Todd⁵, Emmanouil Rampakakis⁶, Francois Nantel⁷, Jenna Parrett⁵, Frederic Lavie⁸ and Proton Rahman⁹, ¹Swedish Medical Center/Providence St. Joseph Health; University of Washington School of Medicine, Seattle, WA, ²Icahn School of Medicine at Mount Sinai, Department of Dermatology, Seattle, WA, ³University of Glasgow, College of Medical Veterinary and Life Sciences, Glasgow, United Kingdom, ⁴Janssen Scientific Affairs, LLC / University of Saskatchewan, Adjunct, Community Health and Epidemiology, Horsham, PA, ⁵Janssen Scientific Affairs, LLC, Horsham, PA, ⁶McGill University, Department of Pediatrics / Scientific Affairs, JSS Medical Research Inc., Montreal, QC, Canada, ⁷Nantel Medsci Consult, Montreal, QC, Canada, ⁸Janssen Cilag Global Medical Affairs, Immunology Global Medical Affairs, Issy les Moulineaux, France, ⁹Memorial University of Newfoundland, Faculty of Medicine, Division of Rheumatology, St. John's, Canada
Background/Purpose: Guselkumab (GUS), a fully human IL-23p19-subunit inhibitor, has demonstrated multidomain efficacy (swollen/tender joints, psoriasis, enthesitis and dactylitis) in patients (pts) with active PsA in…
Abstract Number: 1680 • ACR Convergence 2024
Reporting Quality of Non-inferiority and Equivalence Rheumatoid Arthritis Randomized Clinical Trials: A Systematic Review
Osama Alalwan¹ and Majeed Haider², ¹Salmaniya Medical Complex, Bahrain, Bahrain, ²Salmaniya Medical Complex, Manama, Bahrain
Background/Purpose: The number of non-inferiority/equivalence randomized clinical trials (NI/EQ-RCTs) in the rheumatoid arthritis (RA) field has recently increased for various reasons. These designs require special…
Abstract Number: 2274 • ACR Convergence 2024
Efficacy and Safety of the Biased Melanocortin Receptor Agonist AP1189/resomelagon in Combination with Methotrexate in DMARD-naïve Rheumatoid Arthritis Patients: The EXPAND Trial
Asger Reinstrup Bihlet¹, Philip G Conaghan², Thomas Boesen³, Mette Arnum Jensen³, Alejandro Castillo Mondragón⁴, Ema Erkocevic Petersen⁴, Cathrine Borgsted Bak⁴ and Thomas EN Jonassen³, ¹NBCD A/S, Soeborg, Denmark, ²Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, and NIHR Leeds Biomedical Research Centre, Leeds Teaching Hospitals NHS Trust, Leeds, United Kingdom, ³Synact Pharma ApS, Holte, Denmark, ⁴NBCD A/S, Soborg, Denmark
Background/Purpose: AP1189 is a novel, first-in-class, oral, biased melanocortin (MC)1 and MC3 receptor agonist in development for Rheumatoid Arthritis (RA) treatment. Through multiple actions including…
Abstract Number: 2582 • ACR Convergence 2024
Efficacy and Safety of Sonelokimab, a Novel IL-17A- and IL-17F-Inhibiting Nanobody, in Patients with Active PsA: 24-Week Results from a Global, Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial
Iain McInnes¹, Laura Coates², Philip Mease³, Alexis Ogdie⁴, Arthur Kavanaugh⁵, Lihi Eder⁶, Georg Schett⁷, Alan Kivitz⁸, Nuala Brennan⁹, Alex Godwood⁹, Eva Cullen⁹, Kristian Reich⁹, Christopher Ritchlin¹⁰ and Joseph F. Merola¹¹, ¹University of Glasgow, College of Medical Veterinary and Life Sciences, Glasgow, United Kingdom, ²University of Oxford, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, Oxford, United Kingdom, ³Swedish Medical Center/Providence St. Joseph Health; University of Washington School of Medicine, Seattle, WA, ⁴Department of Medicine, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, ⁵University of California San Diego, La Jolla, CA, ⁶University of Toronto, Women’s College Hospital and Department of Medicine, Toronto, ON, Canada, ⁷Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen, Germany, ⁸Altoona Center for Clinical Research, Duncansville, PA, ⁹MoonLake Immunotherapeutics AG, Zug, Switzerland, ¹⁰Department of Medicine, Allergy, Immunology, and Rheumatology Division, University of Rochester Medical School, Canandaigua, NY, ¹¹UT Southwestern Medical Center, Dallas, TX
Background/Purpose: Sonelokimab is a novel humanized Nanobody designed to inhibit IL-17A and IL-17F and penetrate clinically relevant sites of inflammation. The 24-week Phase 2 ARGO…
Abstract Number: 0670 • ACR Convergence 2024
A Randomized, Open-Label, Phase III Trial Comparing Efficacy and Safety of Intravenous Cyclophosphamide, Mycophenolate Mofetil, or Tacrolimus as Induction Therapy in Lupus Nephritis
Alekhya Amudalapalli, Ashlesha Shukla, Abhichandra Maddineni, Sandeep Nagar, Sudhish Gadde, Harish BV, Rashmi Ranjan Sahoo and Pradeepta Sekhar Patro, IMS and SUM Hospital, Bhubaneswar, India
Background/Purpose: The optimal treatment for lupus nephritis is challenging due to its heterogeneity and the lack of prognostic factors favoring one immunosuppressive drug over another.…
Abstract Number: 1474 • ACR Convergence 2024
Efficacy of Guselkumab in Bionaive Psoriatic Arthritis Patients with Severe Disease Activity: Post-hoc Analysis of a Phase 3, Randomized, Double-Blind, Placebo-Controlled Study
Christopher Ritchlin¹, Ennio Lubrano², Maria Sole Chimenti³, Evan Leibowitz⁴, Mohamed Sharaf⁵, Oyediran Adelakun⁶, Emmanouil Rampakakis⁷, Francois Nantel⁸, Frederic Lavie⁹ and Atul Deodhar¹⁰, ¹Department of Medicine, Allergy, Immunology, and Rheumatology Division, University of Rochester Medical School, Canandaigua, NY, ²Vincenzo Tiberio Department of Medicine and Health Sciences, University of Molise, Campobasso, Italy, ³Rheumatology, Allergology and Clinical Immunology, System Medicine Department, University of Rome Tor Vergata, Rome, Italy, ⁴Immunology, Janssen Scientific Affairs, LLC, Horsham, PA, ⁵Johnson & Johnson, Middle East FZ LLC, Dubai, UAE, Dubai, United Arab Emirates, ⁶Janssen Research & Development, LLC, Titusville, NJ, ⁷McGill University, Department of Pediatrics / Scientific Affairs, JSS Medical Research Inc., Montreal, QC, Canada, ⁸Nantel Medsci Consult, Montreal, QC, Canada, ⁹Janssen Cilag Global Medical Affairs, Immunology Global Medical Affairs, Issy les Moulineaux, France, ¹⁰Division of Arthritis and Rheumatic Diseases, Oregon Health & Science University, Portland, OR
Background/Purpose: In previous DISCOVER (D)1 and 2 analyses, the fully human IL-23p19-subunit inhibitor guselkumab (GUS) was associated with robust and sustained improvement in PsA signs/symptoms…
Abstract Number: 1695 • ACR Convergence 2024
Efficacy of Upadacitinib in Patients with Giant Cell Arteritis: Subgroup Analysis of the SELECT-GCA Phase 3 Trial
Peter Merkel¹, Arathi Setty², Ricardo Blanco-Alonso³, Ravi Suppiah⁴, Thomas Daikeler⁵, Valerie Devauchelle⁶, Elisabeth Brouwer⁷, Hiromichi Tamaki⁸, Liu Meng², Yang Yang², Avani Joshi², Charles Phillips², Peter K. Wung² and Cristina Ponte⁹, ¹Division of Rheumatology, Department of Medicine, University of Pennsylvania, Philadelphia, PA, ²AbbVie, North Chicago, IL, ³Division of Rheumatology, Hospital Universitario Marqués de Valdecilla. IDIVAL, Immunopathology group, Santander, Spain, ⁴Health New Zealand, Te Toka Tumai Auckland, Auckland, New Zealand, ⁵university hospital, Basel, Switzerland, ⁶UBO, Brest, France, ⁷University Medical Center Groningen, Groningen, Netherlands, ⁸St. Luke's International Hospital, Tokyo, Japan, ⁹Unidade Local de Saúde Santa Maria, Serviço de Reumatologia e Doenças Ósseas Metabólicas, Lisboa, Portugal., Lisbon, Portugal
Background/Purpose: Giant cell arteritis (GCA) is a chronic systemic vasculitis with limited targeted therapeutic options. The recent SELECT-GCA phase 3 trial demonstrated a favorable benefit-risk…
Abstract Number: 2294 • ACR Convergence 2024
Pharmacodynamic Effects of Nipocalimab on Disease Biomarkers in Patients with Moderate-to-Severe Active Sjögren’s Disease: Results from a Multicenter, Randomized, Double-blinded, Placebo-controlled Phase 2 Study
Kathy Sivils¹, Steven Leonardo², He Li³, Keying Ma⁴, Matthew J. Loza⁵, Jonathan J. Hubbard⁴, Kim Campbell⁴ and Sheng Gao⁴, ¹Johnson & Johnson Innovative Medicine, Edmond, OK, ²Janssen Research & Development, LLC, a Johnson & Johnson Company, Cambridge, MA, ³Janssen Research & Development, LLC, Therapeutics Discovery, Spring House, PA, ⁴Janssen Research & Development, LLC, a Johnson & Johnson Company, Spring House, PA, ⁵Janssen Research & Development, LLC, a Johnson & Johnson company, Spring House, PA, USA, Spring House, PA
Background/Purpose: Nipocalimab is a fully human, immunoglobulin G (IgG) 1 monoclonal antibody that selectively binds to the IgG-binding site of the neonatal crystallizable fragment receptor…
Abstract Number: 2584 • ACR Convergence 2024
Zasocitinib (TAK-279), an Oral, Selective Tyrosine Kinase 2 Inhibitor: Achievement of Remission and Additional Improvements in Disease Activity in Patients with Psoriatic Arthritis Enrolled in a Phase 2b Trial
Philip Mease¹, Alan Kivitz², Elena Muensterman³, Apinya Lertratanakul⁴, Ting Hong⁴, Jingjing Chen⁴, Ejim Mark⁵ and Xenofon Baraliakos⁶, ¹Swedish Medical Center/Providence St. Joseph Health; University of Washington School of Medicine, Seattle, WA, ²Altoona Center for Clinical Research, Duncansville, PA, ³Takeda Development Center Americas, Cambridge, MA, ⁴Takeda Development Center Americas, Inc., Cambridge, MA, ⁵Takeda Development Center Americas Inc., Cambridge, ⁶Rheumazentrum Ruhrgebiet Herne, and Ruhr-University Bochum, Bochum, Germany
Background/Purpose: Zasocitinib (TAK-279) is an oral, selective TYK2 inhibitor under investigation for the treatment of immune-mediated inflammatory diseases including psoriatic arthritis (PsA). In a phase…
Abstract Number: 0770 • ACR Convergence 2024
Efficacy and Safety of Upadacitinib in Patients with Giant Cell Arteritis (SELECT-GCA): A Double-Blind, Randomized Controlled Phase 3 Trial
Peter Merkel¹, Sara Penn², Arathi Setty², Wolfgang Schmidt³, Andrea Rubbert-Roth⁴, Ellen Margrethe Hauge⁵, Helen Keen⁶, Tomonori Ishii⁷, Nader Khalidi⁸, Liu Meng², weihan zhao², Ivan Lagunes⁹, Ana B. Romero², Peter Wung¹⁰ and daniel blockmans¹¹, ¹Division of Rheumatology, Department of Medicine, University of Pennsylvania, Philadelphia, PA, ²AbbVie, North Chicago, IL, ³Immanuel Krankenhaus Berlin, Berlin, Germany, ⁴Cantonal Hospital St Gallen, St Gallen, Switzerland, ⁵Aarhus Universitetshospital, Aarhus, Denmark, ⁶University of Western Australia, Daglish, Western Australia, Australia, ⁷Tohoku Medical and Pharmaceutical University / Department of Hematology and Rheumatology, sendai, Japan, ⁸McMaster University, Hamilton, ON, Canada, ⁹Abbvie, Inc, North Chicago, IL, ¹⁰AbbVie Inc., North Chicago, IL, ¹¹Department of General Internal Medicine, University Hospitals Leuven, Leuven, Belgium; Department of Microbiology, Immunology, and Transplantation, KU Leuven, Leuven, Belgium, Leuven, Belgium
Background/Purpose: The objective was to assess the efficacy and safety of UPA vs placebo (PBO), in combination with a GC taper regimen, in patients with…

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