Abstracts tagged "clinical trial"

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…
Abstract Number: 1639 • ACR Convergence 2022
A Phase 3, 56-Week, Multicenter, Randomized, Double-Blind, Placebo Controlled Trial (OA-11) to Evaluate the Efficacy and Safety of a Single Injection of Lorecivivint Injected in the Target Knee Joint of Moderate to Severe Osteoarthritis Participants
Yusuf Yazici¹, Christopher Swearingen², Heli Ghandehari³, Jon Britt⁴, ismail simsek⁵, Mark Fineman⁶, Sarah Kennedy², Jeyanesh Tambiah⁷ and Timothy McAlindon⁸, ¹New York University School of Medicine, La Jolla, CA, ²Biosplice Therapeutics, Inc, San Diego, CA, ³Biosplice Therapeutics, Inc., San Diego, CA, ⁴Biosplice Therapeutics, Inc., Los Angeles, CA, ⁵Alpine Immunesciences, San Diego, CA, ⁶Biosplice Therapeutics, San Diego, CA, ⁷Biosplice Ther Inc., San Diego, CA, ⁸Tufts 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: 1900 • ACR Convergence 2022
CoLchicine for Treatment of OsteoArthritis of the Knee (CLOAK)-A Double-blind, Placebo-controlled Trial
Jonathan Samuels¹, Michael Pillinger², Michael Toprover³, Svetlana Krasnokutsky Samuels⁴, Apoorva Patil⁵, Fernando Bomfim⁶, Renata La Rocca Vieira⁶, David Wei⁵, Sydney Catron⁵, Maryfe coronel⁵, Annie Kim⁵ and Sarah Moussavi⁵, ¹NYU Langone, Rye Brook, NY, ²NYU Grossman School of Medicine, New York, NY, ³Division of Rheumatology, New York University Grossman School of Medicine and Rheumatology Section, New York Harbor Health Care System, New York Campus of the U.S. Department of Veterans Affairs, New York, NY, ⁴Westmed, Rye Brook, NY, ⁵NYU Langone Health, New York, NY, ⁶NYU Langone, New York, NY
Background/Purpose: Knee osteoarthritis (OA) is an inflammatory disease, with a probable role for IL-1b. Calcium and urate crystals may promote OA by activating the NLRP3…
Abstract Number: 2109 • ACR Convergence 2022
Domains Contributing to Minimal Disease Activity Non-Achievement in Patients with Psoriatic Arthritis Receiving Golimumab: Post Hoc Analysis of a Phase 3, Randomized, Double-blind, Placebo-controlled Study
Arthur Kavanaugh¹, Gordon Lam², Lai-shan Tam³, Natalie Shiff⁴, Youngja Lee⁵, Ana-Maria Bravo Perdomo⁶, May Shawi⁷, Elizabeth Hsia⁸, Emmanouil Rampakakis⁹ and Carlos Enrique Toro Gutiérrez¹⁰, ¹University of California San Diego, La Jolla, CA, ²Arthritis and Osteoporosis Consultants of the Carolinas; Clinical Affiliate, Atrium Health and the Wake Forest School of Medicine, Cornelius, NC, ³The Chinese University of Hong Kong, Hong Kong, China, ⁴Janssen Scientific Affairs, LLC, Horsham, PA, USA/ Department of Community Health and Epidemiology, College of Medicine, University of Saskatchewan, Saskatoon, Canada, Philadelphia, PA, ⁵Immunology Medical Affairs, Janssen Asia Pacific, Yongsan-gu, Seoul, Republic of Korea, ⁶Immunology Medical Affairs, Janssen Latin America, Columbia, Colombia, ⁷Immunology Global Medical Affairs, Janssen Pharmaceutical Companies of Johnson & Johnson, Horsham, PA, ⁸Janssen Research and Development, LLC; University of Pennsylvania School of Medicine, Kennett Square, PA, ⁹McGill University, Department of Pediatrics and JSS Medical Research, Montréal, QC, Canada, ¹⁰Internal Medicine and Rheumatology, Reference Center for Osteoporosis, Rheumatology & Dermatology. Pontificia Javeriana University, Calí, Colombia
Background/Purpose: Sustained minimal disease activity (MDA) is only achieved by a small portion of PsA patients (pts). Levels of disease activity consistent with MDA may…
Abstract Number: 2245 • ACR Convergence 2022
Feasibility and Efficacy of a Peer Education Program to Improve Patient Engagement in Lupus Clinical Trials
Saira Sheikh¹, Caroline Donovan², Carla Menezes², Albert T. Roy², Andrew Simkus³, Diane Gross⁴, Anca Askanase⁵, Rosalind Ramsey-Goldman⁶, Vikas Majithia⁷, Nicole Wanty³, Annie McNeill³, Kristen Holtz³ and S. Sam Lim⁸, ¹University of North Carolina at Chapel Hill, Chapel Hill, NC, ²Lupus Therapeutics, LLC, New York, NY, ³KDH Research & Communication, Atlanta, GA, ⁴Lupus Research Alliance, New York, NY, ⁵Columbia University Medical Center, New York, NY, ⁶Northwestern University Feinberg School of Medicine, Chicago, USA, Chicago, IL, ⁷University of Mississippi Medical Center, Ridgeland, MS, ⁸Emory University, Atlanta, GA
Background/Purpose: To assess outcomes related to Lupus Therapeutics' Patient Advocates for Lupus Studies (LT-PALS) a peer-to-peer clinical trial (CT) education program designed to improve CT…

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