Abstracts tagged "clinical trial"

Abstract Number: 2212 • ACR Convergence 2022
Long-term Efficacy and Safety of Subcutaneous Tocilizumab in Patients with Polyarticular or Systemic Juvenile Idiopathic Arthritis – an Extension Study of 2 Phase 1b Clinical Trials
Hermine Brunner¹, Athimalaipet Ramanan², Gerd Horneff³, Kirsten Minden⁴, Inmaculada Calvo Penades⁵, Mauro Zucchetto⁶, Laura Brockwell⁷, Oliver Gordon⁷ and Fabrizio De Benedetti⁸, ¹Division of Rheumatology, Cincinnati Children's Hospital Medical Center, University of Cincinnati, Department of Pediatrics, Cincinnati, OH, ²Bristol Royal Hospital for Children, Bristol, United Kingdom, ³Pediatrics, Asklepios Klinik Sankt Augustin GmbH, Sankt Augustin, Germany, ⁴Charité Universitätsmedizin Berlin, Berlin, Germany, ⁵Pediatric Rheumatology Unit, Hospital Universitario y Politécnico La Fe, València, Spain, ⁶Parexel International, Milano, Italy, ⁷Roche Products Ltd, Welwyn Garden City, United Kingdom, ⁸Division of Rheumatology, IRCCS Ospedale Pediatrico Bambino Gesu', Rome, Italy
Background/Purpose: Dosing regimens for subcutaneous tocilizumab (SC-TCZ) in patients with polyarticular-course or systemic juvenile idiopathic arthritis (pJIA or sJIA) were determined for SC-TCZ in 2…
Abstract Number: 0159 • ACR Convergence 2022
B Cell Phenotype in Adult Patients with Idiopathic Inflammatory Myositis (IIM) Before and After Belimumab
Tam Quach¹, Anne Davidson² and Galina Marder³, ¹Feinstein Institute for Medical Research, Manhasset, NY, ²Feinstein Institutes for Medical Research, Manhasset, NY, ³Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Great Neck, NY
Background/Purpose: Recent observations suggest the importance of the BAFF pathway in the pathogenesis of Idiopathic Inflammatory Myositis (IIM). Elevated serum levels of circulating BAFF in…
Abstract Number: 0356 • ACR Convergence 2022
Early Reductions in Proteinuria with Voclosporin Treatment Across Lupus Nephritis Biopsy Classes: Pooled Data from the AURA-LV and AURORA 1 Trials
Anca Askanase¹, Lucy Hodge², Vanessa Birardi³ and Henry Leher³, ¹Columbia University Medical Center, New York, NY, ²Aurinia Pharmaceuticals, Seattle, WA, ³Aurinia Pharmaceuticals Inc, Rockville, MD
Background/Purpose: Voclosporin, a novel calcineurin inhibitor, is approved for the treatment of adults with lupus nephritis in combination with background immunotherapy and was successfully tested…
Abstract Number: 0520 • ACR Convergence 2022
Combination Therapy of Mycophenolate Mofetil and Pirfenidone vs. Mycophenolate Alone: Results from the Scleroderma Lung Study III
Dinesh Khanna¹, Cathie Spino², Elana Bernstein³, Jonathan Goldin⁴, Donald Tashkin⁴, Michael roth⁴ and On Behalf of SLS III Investigators², ¹Division of Rheumatology, Department of Internal Medicine, Scleroderma Program, University of Michigan, Ann Arbor, MI, ²University of Michigan, Ann Arbor, MI, ³Columbia University, New York, NY, ⁴University of California Los Angeles, Los Angeles, CA
Background/Purpose: Scleroderma Lung Study (SLS) II established mycophenolate mofetil (MMF) as an active therapy for scleroderma-related interstitial lung disease (SSc-ILD) and the need to consider…
Abstract Number: 0987 • ACR Convergence 2022
A Randomized Placebo-Controlled Phase 1 Study in Healthy Adult Volunteers of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ALPN-303, a Potent Dual BAFF/APRIL Antagonist for the Treatment of Systemic Lupus Erythematosus and Other Autoantibody-Associated Diseases
Stacey Dillon¹, Pille Harrison², Jason Lickliter³, Kristi Manjarrez¹, Alina Smith¹, Mary Lessig¹, Lori Blanchfield¹, Russell Sanderson¹, Allison Chunyk¹, Tiffany Blair¹, Amanda Enstrom¹, Martin Wolfson¹, Mark Rixon¹, Hany Zayed⁴, Rupert Davies¹ and Stanford Peng¹, ¹Alpine Immune Sciences, Seattle, WA, ²Alpine Immune Sciences, Taunton, United Kingdom, ³Nucleus Network, Melbourne, Australia, ⁴Alpine Immune Sciences, San Francisco, CA
Background/Purpose: B cell activating factor (BAFF) and a proliferation-inducing ligand (APRIL) are tumor necrosis factor (TNF) superfamily members that bind TACI (transmembrane activator and CAML…
Abstract Number: 1427 • ACR Convergence 2022
Impact of Upadacitinib versus Abatacept on Individual Disease Outcomes in Patients with Rheumatoid Arthritis and Inadequate Responses to Biologic DMARDs
Ronald van Vollenhoven¹, Andrea Rubbert-Roth², Stephen Hall³, Ricardo Xavier⁴, Anna K Shmagel⁵, Yanna Song⁵, Samuel Anyanwu⁵ and Vibeke Strand⁶, ¹Amsterdam University Medical Centers, Amsterdam, Netherlands, ²Division of Rheumatology, Cantonal Clinic St Gallen, St.Gallen, Switzerland, ³Emeritus Research and Monash University, Melbourne, Australia, ⁴Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil, ⁵AbbVie, Inc., North Chicago, IL, ⁶Stanford University School of Medicine, Stanford, CA
Background/Purpose: The phase 3 SELECT-CHOICE trial of patients with rheumatoid arthritis (RA) and prior inadequate response to biologic DMARD(s) (bDMARD-IR) demonstrated superiority of the JAK…
Abstract Number: 1614 • ACR Convergence 2022
Females with Non-Radiographic but Not with Radiographic Axial Spondyloarthritis Are Less Likely to Achieve Inactive Disease State Than Males: Results from a Multicountry Prospective Observational Study
Denis Poddubnyy¹, Joachim Sieper², Servet Akar³, Santiago Muñoz-Fernández⁴, Hildrun Haibel², Torsten Diekhoff⁵, Mikhail Protopopov⁶, Elisabeth Altmaier⁷, Fabiana Ganz⁸ and Robert Inman⁹, ¹Department of Gastroenterology, Infectious Diseases and Rheumatology, Charité – Universitätsmedizin Berlin, Berlin, Germany, ²Charité - Universitätsmedizin, Berlin, Berlin, Germany, ³Izmir Katip Celebi University School of Medicine, Izmir, Turkey, ⁴Servicio de Reumatología, Hospital Universitario Infanta Sofía, Universidad Europea, Madrid, Spain, ⁵Department of Radiology, Charité-Universitätsmedizin Berlin, Berlin, Germany, ⁶Charité Universitätsmedizin Berlin, Berlin, Germany, ⁷GKM Gesellschaft für Therapieforschung mbH, Munich, Germany, ⁸AbbVie, Inc., Luzern, Switzerland, ⁹University Health Network, Toronto, ON, Canada
Background/Purpose: Emerging evidence suggests that men and women experience axial spondyloarthritis (axSpA) differently. Some studies suggested that the probability of treatment response was lower in…
Abstract Number: 1899 • ACR Convergence 2022
A Phase 3, 28-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial (OA-10) to Evaluate the Efficacy and Safety of a Single Injection of Lorecivivint Injected in the Target Knee Joint of Moderately to Severely Symptomatic Osteoarthritis Subjects
Yusuf Yazici¹, Christopher Swearingen², Heli Ghandehari³, Victor Lopez⁴, ismail simsek⁵, Mark Fineman⁶, Sarah Kennedy⁷, Jeyanesh Tambiah⁸ and Timothy McAlindon⁹, ¹New York University School of Medicine, La Jolla, CA, ²Samumed LLC, San Diego, CA, ³Biosplice Therapeutics, Inc., San Diego, CA, ⁴Biosplice Therapeutics, Santa Clarita, CA, ⁵Alpine Immunesciences, San Diego, CA, ⁶Biosplice Therapeutics, San Diego, CA, ⁷Biosplice Therapeutics, Inc, San Diego, CA, ⁸Biosplice Ther Inc., San Diego, CA, ⁹Tufts Medical Center, Arlington, MA
Background/Purpose: Knee osteoarthritis (OA) is a common joint disorder associated with pain, disability, and joint damage. There remains a large unmet need for treatments that…
Abstract Number: 2108 • ACR Convergence 2022
Changes in Serum Cytokines by Week 24 Correlate with Long-Term Efficacy of Guselkumab Through Two Years in Bio-Naïve Adults with PsA
Stefan Siebert¹, Georg Schett², Siba P. Raychaudhuri³, Monica Guma⁴, Warner Chen⁵, Sheng Gao⁵, Soumya Chakravarty⁶, May Shawi⁷ and Proton Rahman⁸, ¹Institute of Infection, Immunity and Inflammation, University of Glasgow, Glasgow, Scotland, United Kingdom, ²Universitätsklinikum Erlangen, Erlangen, Germany, ³Rheumatology, Allergy, and Clinical Immunology, University of California Davis, School of Medicine, Sacramento, CA, ⁴Division of Rheumatology, Allergy, and Immunology, Department of Medicine, University of California San Diego, La Jolla, CA, ⁵Janssen Research and Development, LLC, Spring House, PA, ⁶Janssen Scientific Affairs, LLC; Drexel University College of Medicine, Villanova, PA, ⁷Immunology Global Medical Affairs, Janssen Pharmaceutical Companies of Johnson & Johnson, Horsham, PA, ⁸Memorial University, St. John's, NL, Canada
Background/Purpose: The IL-23p19 inhibitor guselkumab has shown robust efficacy vs placebo (PBO) in the phase 3 DISCOVER-1 and DISCOVER-2 studies of adults with active PsA,1,2…
Abstract Number: 2235 • ACR Convergence 2022
Clinical Impact of a Digital Behavioral Therapy for Fibromyalgia Management in a Decentralized Trial
Yifei Dai¹, Michael Rosenbluth², Michael Gendreau³, Nicolette Vega⁴, Zunera Ghalib⁴, Allison Kraus⁴ and Brian Keefe⁵, ¹Swing Therapeutics, Gainesville, FL, ²Swing Therapeutics, San Francisco, CA, ³GENDREAU CONSULTING, LLC, Poway, CA, ⁴Swing Therapeutics, San Francisco, ⁵Swing Therapeutics, New York, NY
Background/Purpose: Cognitive behavioral therapy (CBT) has demonstrated level 1A evidence for management of fibromyalgia (FM). Acceptance and Commitment Therapy (ACT), a form of CBT, has…
Abstract Number: 0173 • ACR Convergence 2022
Cutaneous Manifestations, Clinical Trials, Safety Efficacy and Safety of Lenabasum in the Phase 3 DeterMine Trial in Dermatomyositis
Victoria Werth¹, Barbara White², Josef Concha³, Josh Dan¹, Nancy Dgetluck², Kathleen Hally², Scott Constantine², Rohit Aggarwal⁴, David Fiorentino⁵, Ingrid Lundberg⁶ and Chester Oddis⁷, ¹Philadelphia VAMC, Philadelphia, PA, USA and Department of Dermatology, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, ²Corbus Pharmaceuticals, Norwood, MA, ³Universiity of Pennsylvania/Dermatology, Philadelphia, PA, ⁴University of Pittsburgh, Division of Rheumatology, Pittsburgh, PA, ⁵Stanford university/Department of Dermatology, Palo Alto, CA, ⁶Karolinska Institute, Stockholm, Sweden, ⁷University of Pittsburgh, Pittsburgh, PA
Background/Purpose: Safe and effective treatments are of significant unmet need in DM. Lenabasum, a CB2 agonist that activates resolution of inflammation, improved skin disease, patient-reported…
Abstract Number: 0357 • ACR Convergence 2022
Voclosporin Is Effective in Achieving Proteinuria Treatment Targets in Lupus Nephritis Defined by EULAR/ERA Recommendations
Hans-Joachim Anders¹, Raymond Federico², Vanessa Birardi³ and Henry Leher³, ¹University of Munich, Munich, Germany, ²Aurinia Pharmaceuticals, Inc., Victoria, BC, Canada, ³Aurinia Pharmaceuticals Inc, Rockville, MD
Background/Purpose: Pooled data from the Phase 2 AURA-LV and Phase 3 AURORA 1 studies demonstrated that adding voclosporin, a novel calcineurin inhibitor, to mycophenolate mofetil…
Abstract Number: 0522 • ACR Convergence 2022
Cohort Enrichment Strategies for Progressive Interstitial Lung Disease in Systemic Sclerosis from EUSTAR
Anna-Maria Hoffmann-Vold¹, Cathrine Brunborg¹, Paolo Airò², Lidia P. Ananyeva³, László Czirják⁴, Serena Guiducci⁵, Eric Hachulla⁶, MENGTAO LI⁷, Carina Mihai⁸, Gabriela Riemekasten⁹, Petros P. Sfikakis¹⁰, Gabriele Valentini¹¹, Otylia Kowal-Bielecka¹², Yannick Allanore¹³ and Oliver Distler⁸, ¹Oslo University Hospital, Oslo, Norway, ²Rheumatology and Clinical Immunology Unit, ASST Spedali Civili, Brescia, Italy, ³V.A. Nasonova Research Institute of Rheumatology, Moscow, Russia, ⁴Medical school of Pécs, Pecs, Hungary, ⁵University of Firenze, Firenze, Italy, ⁶University of Lille, Lille, France, ⁷Department of Rheumatology and Clinical Immunology, Peking Union Medical College Hospital, Peking Union Medical College & Chinese Academy of Medical Sciences, National Clinical Research Center for Dermatologic and Immunologic Diseases, Ministry of Science & Technology, Key Laboratory of Rheumatology and Clinical Immunology, Ministry of Education, State Key Laboratory of Complex Severe and Rare Diseases, Ministry of Science & Technology, Beijing, China, ⁸Department of Rheumatology, University Hospital Zurich, University of Zurich, Zürich, Switzerland, ⁹University Clinic Schleswit-Holstein (UKSH), Luebeck, Germany, ¹⁰Joint Academic Rheumatology Program, National and Kapodistrian University of Athens, School of Medicine, Athens, Greece, ¹¹Università della Campania “Luigi Vanvitelli”, Napoli, Italy, ¹²Medical University of Bialystok, Bialystok, Poland, ¹³Department of Rheumatology A, Descartes University, APHP, Cochin Hospital, Paris, France, Paris, France
Background/Purpose: Enrichment strategies from clinical trials for progressive systemic sclerosis-associated interstitial lung disease (SSc-ILD) have been partly successful but have not been tested in a…
Abstract Number: 0989 • ACR Convergence 2022
Regulatory T Cell Defects in SLE and Therapy with a Novel IL-2 Mutein: Phase 1 Clinical Results with Efavaleukin Alfa
Nandita Sarkar¹, Xuguang Hu¹, Nadia Tchao¹, Richard Furie², Alan Kivitz³, Stanley B Cohen⁴ and Kevin Gorski⁵, ¹Amgen Inc., South San Francisco, CA, ²Northwell Health, Great Neck, NY, ³Department of Rheumatology, Altoona Center for Clinical Research, Duncansville, PA, ⁴Metroplex Clinical Research Center and University of Texas Southwestern Medical Center, Dallas, TX, ⁵Amgen, Inc., Thousand Oaks, CA
Background/Purpose: Regulatory T cells (Treg) are critical for maintaining self-tolerance and preventing autoimmunity, and IL-2 is essential for their development, survival and suppressive function. Defects…
Abstract Number: 1431 • ACR Convergence 2022
Impact of Tofacitinib on Fracture Risk in Rheumatoid Arthritis
Karen E Hansen¹, Mahta Mortezavi², Edward Nagy³, Cunshan Wang⁴, Carol A Connell⁴, Zaher Radi⁵, Heather J Litman⁶, Giovanni Adami⁷ and Maurizio Rossini⁷, ¹Rheumatology Division, Department of Medicine, University of Wisconsin School of Medicine and Public Health, Madison, WI, ²Pfizer Inc, New York, NY, ³Pfizer Ltd, Tadworth, United Kingdom, ⁴Pfizer Inc, Groton, CT, ⁵Pfizer Inc., Cambridge, MA, ⁶CorEvitas, LLC, Waltham, MA, ⁷Rheumatology Unit, Department of Medicine, University of Verona, Verona, Italy
Background/Purpose: Preclinical data suggest that tofacitinib stimulates osteoblast function and would have a protective effect on bone health and fracture risk in RA.1 We report…

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