Abstracts tagged "Randomized Trial"

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…
Abstract Number: 1477 • ACR Convergence 2024
Zasocitinib (TAK-279), a Highly Selective Oral Tyrosine Kinase 2 (TYK2) Inhibitor, Elicits Early Skin Responses and Minimal Disease Activity in Patients with Active Psoriatic Arthritis: Results from a Randomized Phase 2b Study
Alice Gottlieb¹, Elena Muensterman², Alan Kivitz³, Eva Dokoupilova⁴, Apinya Lertratanakul⁵, Ting Hong⁵, Jingjing Chen⁵ and Xenofon Baraliakos⁶, ¹Icahn School of Medicine at Mount Sinai, Department of Dermatology, Seattle, WA, ²Takeda Development Center Americas, Cambridge, MA, ³Altoona Center for Clinical Research, Duncansville, PA, ⁴Medical Plus, s.r.o., Uherske Hradiste, and Masaryk University, Faculty of Pharmacy, Department of Pharmaceutical Technology, Prague, Czech Republic, ⁵Takeda Development Center Americas, Inc., Cambridge, MA, ⁶Rheumazentrum Ruhrgebiet Herne, and Ruhr-University Bochum, Bochum, Germany
Background/Purpose: Zasocitinib (TAK-279) is a highly selective, oral, allosteric tyrosine kinase 2 (TYK2) inhibitor. In a phase 2b trial in patients with active psoriatic arthritis…
Abstract Number: 1696 • ACR Convergence 2024
Comparison of Mycophenolate Mofetil Plus Methotrexate versus Cyclophosphamide with Sequential Azathioprine for Active Takayasu’s Arteritis: An Open-Label, Randomized-Controlled Trial
XIAOCHUAN SUN¹, Jing Li¹, Xinwang Duan², Liyun Zhang³, Dongyun Yao⁴, Jing Xue⁵, zhenbiao wu⁶, Yi Zhao⁷, Lijun Wu⁸, HONGFENG ZHANG⁹, MENGTAO LI¹, Xiaofeng Zeng¹⁰, Peter Merkel¹¹ and Xinping Tian¹², ¹Peking Union Medical College Hospital, Beijing, China, ²The Second Affiliated Hospital of Nanchang University, Nanchang, China (People's Republic), ³Shanxi Bethune Hosptial, Taiyuan, China (People's Republic), ⁴Jiaozuo People's Hospital, Jiaozuo, Henan, China (People's Republic), ⁵Second Affiliated Hospital,Zhejiang University School of Medcine, Hangzhou, China (People's Republic), ⁶Xijing Hospital, Fourth Military Medical University, Xi'an, China (People's Republic), ⁷Xuanwu Hospital, Beijing, China, ⁸People's Hospital of Xinjiang Uygur Autonomous Region, Xinjiang, China (People's Republic), ⁹The First Affiliated Hospital of Dalian Medical University, Dalian, ¹⁰Department of Rheumatology, Peking Union Medical College Hospital (PUMCH), Chinese Academy of Medical Sciences National Clinical Research Center for Dermatologic and Immunologic Diseases (NCRC-DID), Beijing, China, ¹¹University of Pennsylvania, Philadelphia, PA, ¹²Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China
Background/Purpose: The management of Takayasu’s arteritis (TAK) is challenging for lack of large-scale, high-quality clinical trials. Cyclophosphamide (CYC) is a conventional first-line immunosuppressant but is…
Abstract Number: 2316 • ACR Convergence 2024
Gene Expression Profile Is Different Between Men and Women in Psoriatic Disease
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 heterogenous chronic inflammatory condition. Recent publications highlight differences between men and women in disease manifestation and response to…
Abstract Number: 2634 • ACR Convergence 2024
Transcriptomic Stratification Predicts Response to Rituximab, Abatacept or the Association of Hydroxychloroquine and Leflunomide in 3 Randomized Controlled Clinical Trials in Sjögren’s Disease
Baptiste Chevet¹, Valerie Devauchelle², Elena Pontarini³, Valentin Baloche⁴, Michele Bombardieri⁵, Simon Bowman⁶, Michael Barnes⁷, Antoine Sreih⁸, Jinqi Liu⁸, Sheila Kelly⁹, Antonia Christodoulou⁸, Hussain Badani¹⁰, Philippe Moigeon¹¹, Laurence LAIGLE¹², Perrine Soret¹³, Christelle Le dantec¹⁴, Jacques-Olivier Pers¹⁵, Marta Alarcon-Riquelme¹⁶, Guillermo Barturen¹⁷, Xavier Mariette¹⁸, Joel Van Roon¹⁹, Raphaele Seror²⁰, Gaetane Nocturne¹⁸, Divi Cornec²¹ and Nathan Foulquier¹⁴, and PRECSEADS Clinical Consortium and NECESSITY consortium, ¹University Hospital of Brest, Brest, France, ²UBO, Brest, France, ³William Harvey Research Institute, London, United Kingdom, ⁴University Medical Center, Utrecht, Utrecht, Netherlands, ⁵Centre for Experimental Medicine and Rheumatology, The William Harvey Research Institute, Queen Mary University of London, London, United Kingdom, ⁶Department of Rheumatology, University Hospital Birmingham, Birmingham, United Kingdom, ⁷William Harvey Research institute, Centre for Translational Bioinformatics, London, United Kingdom, ⁸Bristol Myers Squibb, Princeton, NJ, ⁹Bristol Myers Squibb, Doylestown, PA, ¹⁰Bristol Myers Squibb, Lawrence Township, NJ, ¹¹Servier Laboratories, France, Gif sur Yvette, France, ¹²Servier Laboratories, France, SURESNES, France, ¹³Servier, Paris-Saclay, Paris, Ile-de-France, France, ¹⁴LBAI. UMR 1227, University of Brest, Brest, France, ¹⁵University of Brest, Brest, France, ¹⁶Fundación Progreso y Salud, Andalusian Government, Granada, Spain, ¹⁷Center for Genomics and Oncological Research (GENYO), Andalusia, Spain, ¹⁸Service de Rhumatologie, Hôpital Bicêtre, AP-HP, Le Kremlin Bicetre, France, ¹⁹University Medical Center Utrecht, Utrecht, Netherlands, ²⁰Service de Rhumatologie, Hôpital Bicêtre, AP-HP, le Kremlin Bicetre, Ile-de-France, France, ²¹Service de Rhumatologie, CHU de Brest, Brest, France
Background/Purpose: Sjögren’s disease (SjD) is a clinically and biologically heterogeneous disease. To date, no phase-III trial showed efficacy in reducing the symptoms or systemic activity…
Abstract Number: 0823 • ACR Convergence 2024
A Randomized, Double-Blind, Placebo-Controlled Trial of Abatacept for the Treatment of Relapsing, Non-Severe, Granulomatosis with Polyangiitis
Carol Langford¹, Nader Khalidi², Jason Springer³, Marcia Friedman⁴, Bernhard Hellmich⁵, Christian Pagnoux⁶, Natasha Dehghan⁷, Ora Singer⁸, Curry Koening⁹, Yih Chang Lin¹⁰, Paul Monach¹¹, Larry Moreland¹², Aurore Fifi-Mah¹³, Oliver Flossmann¹⁴, Lindsy Forbess¹⁵, Peter Lanyon¹⁶, Eamonn Molloy¹⁷, Ulrich Specks¹⁸, Robert Spiera¹⁹, Elaine Yacyshyn²⁰, Carol McAlear²¹, Cristina Burroughs¹⁰, Rachel Jones²², Rennie Rhee²¹, Rula A. Hajj-Ali²³, Kenneth Warrington¹⁸, David Cuthbertson¹⁰, Jeffrey Krischer¹⁰, David Jayne²² and Peter Merkel²¹, and the Vasculitis Clinical Research Consortium and the European Vasculitis Society, ¹Cleveland Clinic, Moreland Hills, OH, ²McMaster University, Hamilton, ON, Canada, ³Vanderbilt University Medical Center, Franklin, TN, ⁴Oregon Health and Science University, Portland, OR, ⁵Medius Kliniken, Kirchheim unter Teck, Germany, ⁶Mount Sinai Hospital, Toronto, ON, Canada, ⁷University of British Columbia - Vancouver, Vancouver, BC, Canada, ⁸University of Michigan, Huntington Woods, MI, ⁹University of Texas Dell Medical School, Austin, TX, ¹⁰University of South Florida, Tampa, FL, ¹¹VA Boston Healthcare System, Boston, MA, ¹²University of Colorado, Denver, CO, ¹³University of Calgary, Calgary, AB, Canada, ¹⁴Royal Berkshire Hospital, Reading, United Kingdom, ¹⁵Cedars-Sinai Medical Center, Los Angeles, CA, ¹⁶University of Nottingham, Nottingham, United Kingdom, ¹⁷St Vincent's University Hospital, Dublin, Ireland, ¹⁸Mayo Clinic, Rochester, MN, ¹⁹Scleroderma, Vasculitis, and Myositis Center, Hospital for Special Surgery, Weill Cornell Medical College, New York, NY, ²⁰University of Alberta, Edmonton, AB, Canada, ²¹University of Pennsylvania, Philadelphia, PA, ²²University of Cambridge, Cambridge, United Kingdom, ²³Cleveland Clinic, Cleveland, OH
Background/Purpose: Granulomatosis with polyangiitis (GPA) is a small-vessel vasculitis associated with frequent relapses. Following encouraging results from an open-label study, a randomized, double-blind, placebo-controlled trial…

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