Abstracts tagged "clinical trial"

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…
Abstract Number: 0280 • ACR Convergence 2022
Safety of Filgotinib in Patients with RA: Laboratory Analysis Results from a Long-Term Extension Study
Maya Buch¹, James Galloway², Ennio Giulio Favalli³, Arnaud Constantin⁴, Patrick Durez⁵, Paul Van Hoek⁶, Christopher Watson⁷, Pieter-Jan Stiers⁶, Vijay Rajendran⁸, Katrien Van Beneden⁶, Tsutomu Takeuchi⁹ and BERNARD COMBE¹⁰, ¹University of Manchester and NIHR Manchester Biomedical Research Centre, Manchester, United Kingdom, ²King's College London, London, United Kingdom, ³University of Milan, ASST Gaetano Pini-CTO Institute, Milano, Italy, ⁴Toulouse University Hospital and University Toulouse III Paul Sabatier, Toulouse, France, ⁵Rheumatology, Cliniques Universitaires Saint-Luc – Université catholique de Louvain (UCLouvain) – Institut de Recherche Expérimentale et Clinique (IREC), Brussels, Belgium, ⁶Galapagos NV, Mechelen, Belgium, ⁷Galapagos Biotech Ltd, Cambridge, United Kingdom, ⁸Galapagos NV, Gent, Belgium, ⁹Keio University and Saitama Medical University, Tokyo, Japan, ¹⁰Montpellier University, Montpellier, France
Background/Purpose: Filgotinib (FIL) is a Janus kinase (JAK) 1 preferential inhibitor, approved for treatment of moderate to severe active RA in Europe, the UK, and…
Abstract Number: 0358 • ACR Convergence 2022
Long-term Safety and Efficacy of Voclosporin in Hispanic and Latino Patients with Lupus Nephritis
Ellen M. Ginzler¹, Amit Saxena², Victoria Bal³, Vanessa Birardi⁴ and Henry Leher⁴, ¹SUNY Downstate Health Sciences University, Department of Medicine, Brooklyn, NY, ²NYU School of Medicine, New York, NY, ³Aurinia Pharmaceuticals, Inc., Victoria, BC, Canada, ⁴Aurinia Pharmaceuticals Inc, Rockville, MD
Background/Purpose: The AURORA 1 study demonstrated that addition of voclosporin to MMF and low-dose steroids significantly increased complete renal response rates at 52 weeks, with…
Abstract Number: 0524 • ACR Convergence 2022
A Randomized, Double-Blind, Phase II Study of Glucocorticoid Replacement by Vilobelimab, an Anti-C5a Monoclonal Antibody, in ANCA-Associated Vasculitis
Peter Merkel¹, Bernhard Hellmich², Anja Pfaff³, Carina Müller⁴, Elena Startseva³ and David Jayne⁵, ¹University of Pennsylvania, Philadelphia, PA, ²Klinik für Innere Medizin, Rheumatologie & Immunologie, Medius Kliniken, Universität Tübingen, Plochingen, Germany, ³InflaRx, Jena, Germany, ⁴Metronomia Clinical Research, Munich, Germany, ⁵University of Cambridge, Cambridge, United Kingdom
Background/Purpose: Induction of remission for severe ANCA-associated vasculitis [granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA)] utilizes rituximab (RTX) or cyclophosphamide (CYC) and tapering doses…
Abstract Number: 0990 • ACR Convergence 2022
KPG-818, a Novel Cereblon (CRBN) Modulator, in Patients with SLE: Results of a Phase Ib Multiple Ascending Dose Study
RAMESH C. GUPTA¹, Paul Lunseth², Robert Levin³, Philip Waller⁴, Amber Khan⁵, Lester Hernandez⁵, Kai Wei⁶, Baisong Liao⁶, Tao Wang⁷, Kaiyue Hao⁷, Yanjiao Yin⁷ and Yong Guo⁷, ¹Shelby Research LLC, Memphis, TN, ²Clinical Research of West Florida, Tampa, FL, ³Clinical Research of West Florida. Inc., Clearwater, FL, ⁴Accurate Clinical Research, Houston, TX, ⁵Accurate Clinical Management, LLC., Houston, TX, ⁶Kangpu Biopharmaceuticals, Ltd., Shanghai, China, ⁷Kangpu Biopharmaceuticals, Ltd, Shanghai, China
Background/Purpose: KPG-818 is a novel CRL4-CRBN E3 ubiquitin ligase modulator that binds to CRBN with high affinity and leads to rapid and effective degradation of…
Abstract Number: 1432 • ACR Convergence 2022
Pharmacokinetic Evaluation of a Proposed Adalimumab Biosimilar MSB11022 versus the US-Licensed Reference Product: Results of a Randomized, Double-Blind, 3-Arm Parallel-Group, Single-Dose Trial in Healthy Subjects
Anna Dryja¹, Anna Lucia Buccarello², Isabelle Gaillard² and Joëlle Monnet², ¹MTZ Clinical Research Sp. z o.o.,, Warsaw, Poland, ²Fresenius Kabi Swiss BioSim, Eysins, Switzerland
Background/Purpose: Adalimumab, a recombinant fully human monoclonal immunoglobulin G1 antibody, is a biologic directed against tumor necrosis factor-alpha indicated for use in a range of…
Abstract Number: 1652 • ACR Convergence 2022
Long-term Safety and Efficacy of Anifrolumab in Adult Patients with Systemic Lupus Erythematosus: A Multicenter, Randomized, Double-blind, Placebo-controlled 3-year TULIP Extension Study
Kenneth C. Kalunian¹, Richard A. Furie², Eric F. Morand³, Ian N. Bruce⁴, Susan Manzi⁵, Yoshiya Tanaka⁶, Kevin Winthrop⁷, Gabriel Abreu⁸, Ihor Hupka⁹, Lijin Zhang¹⁰, Shanti Werther¹¹, Micki Hultquist¹², Raj Tummala¹⁰ and Catharina Lindholm¹¹, ¹UC San Diego, La Jolla, CA, ²Northwell Health, Great Neck, NY, ³Monash University, Melbourne, Australia, ⁴The University of Manchester, Manchester, United Kingdom, ⁵Allegheny Health Network, Pittsburgh, PA, ⁶University of Occupational and Environmental Health, Kitakyusyu Fukuoka, Japan, ⁷Oregon Health & Science University, Portland, OR, ⁸AstraZeneca, Mölndal, Sweden, ⁹AstraZeneca, Warsaw, Poland, ¹⁰AstraZeneca, Gaithersburg, MD, ¹¹AstraZeneca, Gothenburg, Sweden, ¹²AstraZeneca, Bethesda, MD
Background/Purpose: Anifrolumab is a fully human IgG1 κ monoclonal antibody that binds to the type I IFN receptor and inhibits type I IFN signaling.1 In…

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