Abstracts tagged "clinical trial"

Abstract Number: 1874 • ACR Convergence 2021
Using 18F-fluorodeoxyglucose Positron Emission Tomography to Standardize Clinical Trial Recruitment in Takayasu’s Arteritis
Kaitlin Quinn¹, Hugh Alessi², Emily Rose³, Mark A. Ahlman⁴, Christopher Redmond⁴, Yiming Luo⁴, Ertugrul Cagri bolek⁵, Carol Langford⁶, Cristina Ponte⁷, Peter Merkel⁸ and Peter Grayson⁹, ¹National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Institutes of Health (NIH), Washington, DC, ²National Institutes of Health, Bethesda, Maryland, ³Case Western, Cleveland Heights, OH, ⁴National Institutes of Health, Bethesda, MD, ⁵Vasculitis Translational Research Program, NIAMS, NIH, US, Lanham, MD, ⁶Cleveland Clinic, Moreland Hills, OH, ⁷Hospital de Santa Maria, Lisbon, Portugal, ⁸University of Pennsylvania, Philadelphia, PA, ⁹National Institutes of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Institutes of Health (NIH), Bethesda, MD
Background/Purpose: Disease activity assessment can be challenging in Takayasu’s arteritis (TAK), which can lead to difficulty in determining eligibility for enrollment into randomized clinical trials…
Abstract Number: 0185 • ACR Convergence 2021
Phase 1 Study Results of GS-5718, an Oral IRAK4-Inhibitor: Pharmacodynamics of Single and Multiple Doses of GS-5718 in Healthy Subjects
Silke Roedder¹, Emily Wendt², Chad Burris², Jonathan Nazareon², Grace Park³, Phil Pangilinan², Gianna Huang², Anubhav Mathur², James Taylor², Andrew Billin² and Franziska Matzkies⁴, ¹Gilead Sciences, Menlo Park, CA, ²Gilead Sciences, Foster City, CA, ³Gilead Sciences, Seattle, WA, ⁴Gilead Sciences, Inc., Foster City, CA
Background/Purpose: Adaptive and innate immune pathways are involved in inflammation and pathogenesis of autoimmune diseases including Rheumatoid Arthritis (RA) and Lupus Erythematosus (LE). Immune complexes…
Abstract Number: 0675 • ACR Convergence 2021
Urate-lowering Therapy for Prevention of Gout: Prespecified Analyses from the CKD-FIX Trial
Anushree Tiku¹, Neil Boudville², Fiona Brown³, Alan Cass⁴, Phiilip Clarke⁵, Richard Day⁶, Janak de Zoysa⁷, Bettina Douglas⁸, Randall Faull⁹, David Harris¹⁰, Carmel Hawley¹¹, Graham Jones⁶, John Kanellis³, Elaine Pascoe¹¹, Suetonia Palmer¹², Vlado Perkovic¹³, Gopala Rangan¹⁰, Donna Reidlinger¹¹, Laura Robison¹¹, Robert Walker¹⁴, Giles Walters¹⁵, David Johnson¹¹, Sunil Badve¹³ and Nicola Dalbeth⁷, ¹The George Institute of Australia, Sydney, Australia, ²University of Western Australia, Perth, Australia, ³Monash University, Melbourne, Australia, ⁴Menzies School of Health Research, Darwin, Australia, ⁵University of Oxford, Oxford, United Kingdom, ⁶University of New South Wales, Sydney, Australia, ⁷University of Auckland, Auckland, New Zealand, ⁸Princess Alexandra Hospital, Brisbane, Australia, ⁹University of Adelaide, Adelaide, Australia, ¹⁰University of Sydney, Sydney, Australia, ¹¹University of Queensland, Brisbane, Australia, ¹²University of Otago, Christchurch, New Zealand, ¹³The George Institute for Global Health, Sydney, Australia, ¹⁴University of Otago, Dunedin, New Zealand, ¹⁵The Canberra Hospital, Canberra, Australia
Background/Purpose: The CKD-FIX randomized controlled trial showed that allopurinol did not slow decline of estimated glomerular filtration rate (eGFR) over 104 weeks in patients with…
Abstract Number: 1258 • ACR Convergence 2021
Measurement of Specific Organ Domains in Lupus Randomised Controlled Trials
Kathryn Connelly¹, Jeevan Vettivel², Vera Golder², Rangi Kandane-Rathnayake² and Eric Morand³, ¹Monash University, Camberwell, Australia, ²Monash University, Clayton, Australia, ³Monash University, Melbourne, Australia
Background/Purpose: Randomised controlled trials (RCTs) in SLE typically adopt composite responder definitions as primary efficacy endpoints, however outcomes within individual organ domains are also important…
Abstract Number: 1459 • ACR Convergence 2021
Attainment of the Lupus Low Disease Activity State in Response to Anifrolumab in 2 Phase 3 Trials
Eric Morand¹, Gabriel Abreu², Richard Furie³ and Raj Tummala⁴, ¹Monash University, Melbourne, Australia, ²BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden, ³Zucker School of Medicine at Hofstra/Northwell Health, Great Neck, NY, ⁴BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD
Background/Purpose: The Lupus Low Disease Activity State (LLDAS), a treat-to-target (T2T) endpoint for SLE, is prospectively validated as protective from flares and damage accrual.1 LLDAS…
Abstract Number: 1708 • ACR Convergence 2021
The Efficacy and Safety of Piclidenoson vs Methotrexate in Early Rheumatoid Arthritis: Phase 3 Randomized, Double-blind, Placebo-controlled Study
Tatiana Reitblat¹, Alexandra Gurman- Balbir², Zivit Harpaz³, Motti Farbstein³, Michael Silverman³, William Kerns³ and Pnina Fishman³, ¹Barzilai Medical Center, Ashkelon, Israel, ²Rambam Medical Center, Haifa, Israel, ³Can-Fite BioPharma, Petah Tikva, Israel
Background/Purpose: Piclidenoson, a highly selective A3 adenosine receptor (A3AR) agonist, demonstrated safety and efficacy in phase 2 clinical studies in rheumatoid arthritis (RA) and psoriasis.…
Abstract Number: 1771 • ACR Convergence 2021
First-in-Human Safety, Pharmacokinetic and Pharmacodynamic Study of Escalating Single- and Multiple-Doses of BMS-986256, a Novel, Potent, Oral Inhibitor of TLR7 and TLR8
Melanie Harrison¹, Manoj Chiney¹, Diane Shevell², Lixian Dong³, Michelle Dawes¹ and Ihab Girgis³, ¹Bristol Myers Squibb, Lawrenceville, NJ, ²Bristol Myers Squibb, Lawrenceville, ³Bristol Myers Squibb, Princeton, NJ
Background/Purpose: Toll-like receptor (TLR)7 and TLR8 are endosomal receptors that are normally activated by pathogen-associated RNA. They are also activated by self-RNA as part of…
Abstract Number: 1900 • ACR Convergence 2021
Urate Lowering Therapy in the Treatment of Gout: A Multicenter, Randomized, Double-blind Comparison of Allopurinol and Febuxostat Using a Treat-to-Target Strategy
James O'Dell¹, Tuhina Neogi², Michael Pillinger³, Paul Palevsky⁴, Jeff Newcomb¹, Mary Brophy⁵, Hongsheng Wu⁵, Annie Davis-Karim⁶, Ryan Ferguson⁵, David Pittman⁶, Robert Terkeltaub⁷, Amy Cannella¹, Bryant England¹, Lindsay Helget¹, Ted Mikuls¹ and Tomas Taylor⁸, ¹University of Nebraska Medical Center, Omaha, NE, ²Boston University School of Medicine, Boston, MA, ³New York University Grossman School of Medicine, New York,, NY, ⁴Pittsburgh University, Pittsburgh, PA, ⁵Boston VA, Boston, MA, ⁶Albuquerque VA, Albuquerque, NM, ⁷VA/UCSD, San Diego, CA, ⁸White River Junction VA, White River Junction, VT
Background/Purpose: Urate lowering therapy (ULT) is a cornerstone treatment in the management of gout. A paucity of data exists about the relative efficacy and safety…
Abstract Number: 0196 • ACR Convergence 2021
A Single Center, Double Blind, Randomized, Placebo-Controlled Trial of Anakinra in Adult Patients with Features of Cytokine Storm Syndrome in COVID-19
Lesley Jackson¹, Randy Cron¹, Nitasha Khullar², Christopher Chapleau³, Dongmei Sun⁴ and Winn Chatham¹, ¹University of Alabama at Birmingham, Birmingham, AL, ²University of Alabama Birmingham, Birmingham, AL, ³UAB Pharmacy, University of Alabama at Birmingham, Birmingham, AL, ⁴Division of Clinical Immunology and Rheumatology, The University of Alabama at Birmingham, Birmingham, AL
Background/Purpose: Some patients with COVID-19 develop respiratory distress and cytokine storm syndrome (CSS) which is characterized by hyperinflammation and may progress to multi-organ failure. Anakinra…
Abstract Number: 0726 • ACR Convergence 2021
Joint Safety of Tanezumab versus NSAIDs; A Combined Assessment of Benefit and Harm
Robert Fountaine¹, Robert Dworkin², Anne Hickman¹, Glenn Pixton³, Ed Whalen⁴, Christine West¹ and Kenneth Verburg¹, ¹Pfizer Inc., Groton, CT, ²University of Rochester, Rochester, NY, ³Pfizer Inc., Morrisville, NC, ⁴Pfizer Inc., New York, NY
Background/Purpose: Tanezumab, a monoclonal antibody against nerve growth factor, is in development for the relief of signs and symptoms of moderate to severe osteoarthritis (OA)…
Abstract Number: 1273 • ACR Convergence 2021
A 12-week Aerobic Exercise Training Program in Women with Systemic Lupus Erythematosus (SLE) Improves Fatigue, Mitochondrial Dysfunction and Associated Interferon Gene Signature
Sarfaraz Hasni¹, Marquis Chapman², Rebekah Feng¹, Anam Ahmad¹, Sarthak Gupta³, Mohammad Naqi¹, Adam Munday¹, Shajia Lu¹, Massimo Gadina², Zerai Manna¹, Xiaobai Li⁴, Yinghui Shi¹, Kalyani Mishra-Thakur¹, Michael Davis⁵, Jun Chu³, Elaine Poncio⁶, Yenealem Temesgen-Oyelakin⁷, Jonathan Martinez¹, Zoe Morris¹, Isabel Ochoa⁶, Shuichiro Nakabo⁸, Bart Drinkard¹, Gayle McCrossin¹, Marybeth Stockman¹, Mariana Kaplan¹, Leorey Saligan¹, Randall Keyser⁹, Leighton Chan¹ and Lisa Chin¹, ¹National Institutes of Health, Bethesda, MD, ²National Institute of Arthritis and Musculoskeletal and Skin Diseases, Bethesda, MD, ³National Institutes of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Institutes of Health (NIH), Bethesda, MD, ⁴Clinical Center, National Institutes of Health, Bethesda, MD, ⁵NIAMS, Bethesda, MD, ⁶NIH/NIAMS, Bethesda, MD, ⁷National Institutes of Health (NIH), Bethesda, MD, ⁸NIAMS/NIH, Bethesda, MD, ⁹George Mason University, Bethesda
Background/Purpose: Fatigue in SLE patients is ubiquitous and is reported as one of the most debilitating symptoms. Yet mechanisms underlying the pathophysiology of SLE-related fatigue…
Abstract Number: 1502 • ACR Convergence 2021
Longitudinal Changes in B Cell Subsets in Patients in the Mesenchymal Stromal Cell Trial in Lupus: Analysis of the First Cohort
Diane Kamen¹, S Sam Lim², Scott Jenks³, Regina Bugrovosky³, Aisha Hill³, Chungwen Wei³, Cristina Drenkard³, Kenneth Kalunian⁴, Ummara Shah⁵, Mariko Ishimori⁶, Rosalind Ramsey-Goldman⁷, Saira Sheikh⁸, Mary Alison Mahieu⁷, Daniel Wallace⁹, Ellen Goldmuntz¹⁰ and Gary Gilkeson¹, ¹Medical University of South Carolina, Charleston, SC, ²Department of Medicine, Division of Rheumatology, Emory University School of Medicine, Atlanta, GA, ³Emory University, Atlanta, GA, ⁴UC San Diego, La Jolla, CA, ⁵University of Rochester, Rochester, NY, ⁶Cedars-Sinai Health System, Los Angeles, CA, ⁷Northwestern University, Chicago, IL, ⁸University of North Carolina, Chapel Hill, NC, ⁹Attune Health, Beverly Hills, CA, ¹⁰National Institutes of Health, Bethesda, MD
Background/Purpose: Recent advances allow expanded identification of B cell subtypes of pathogenic potential in lupus. Of particular interest are IgD- CD27- double negative (DN2) B…
Abstract Number: 1733 • ACR Convergence 2021
Classification of Patients with Systemic Lupus Erythematosus Enrolled in 2 Phase 3 Trials by EULAR/ACR 2019 Criteria
Martin Aringer¹, Ian N. Bruce², Richard Furie³, Eric Morand⁴, Emmanuelle Maho⁵, Catharina Lindholm⁶ and Raj Tummala⁷, ¹University Medical Center and Faculty of Medicine Carl Gustav Carus, TU Dresden, Dresden, Germany, ²University of Manchester and NIHR Manchester Biomedical Research Centre, Manchester University Hospitals NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester, United Kingdom, ³Zucker School of Medicine at Hofstra/Northwell Health, Great Neck, NY, ⁴Monash University, Melbourne, Australia, ⁵BioPharmaceuticals R&D, AstraZeneca, Cambridge, United Kingdom, ⁶BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden, ⁷BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD
Background/Purpose: The TULIP-1 and TULIP-2 trials of anifrolumab, an anti–type I IFN receptor mAb, enrolled autoantibody-positive (ANA, anti-dsDNA, and/or anti-Smith [anti-Sm]) patients, who fulfilled the…
Abstract Number: 1772 • ACR Convergence 2021
Autologous EBV-specific Cytotoxic T Cells in Systemic Lupus Erythematosus: An Innovative Phase I/IIa Clinical Trial
Antoine Enfrein¹, Beatrice Clemenceau², Soraya Saiagh³, Céline Bressollette⁴, Zahir Amoura⁵, Henri Vie² and Mohamed Hamidou¹, ¹Médecine interne, CHU de Nantes, Nantes, France, ²Inserm U1232, Université de Nantes, Nantes, France, ³Unité de Thérapie Cellulaire et Génique, CHU de Nantes, Nantes, France, ⁴Laboratoire de Virologie, CHU de Nantes, Nantes, France, ⁵Médecine interne, Hôpital Pitié Salpêtrière, AP-HP, Paris, France
Background/Purpose: Epstein-Barr Virus (EBV) has been suggested as a potential environmental factor in systemic lupus erythematosus (SLE) onset and disease activity. Here, we report the…
Abstract Number: 1940 • ACR Convergence 2021
Malignancies in Patients Aged ≥ 50 Years with RA and ≥ 1 Additional Cardiovascular Risk Factor: Results from a Phase 3b/4 Randomized Safety Study of Tofacitinib vs TNF Inhibitors
Jeffrey Curtis¹, Kunihiro Yamaoka², Yi-Hsing Chen³, Levent M Gunay⁴, Naonobu Sugiyama⁵, Carol A Connell⁶, Cunshan Wang⁶, Joseph Wu⁶, Sujatha Menon⁶, Ivana Vranic⁷ and Juan J Gomez-Reino⁸, ¹Division of Clinical Immunology and Rheumatology, Department of Medicine, Department of Epidemiology, University of Alabama at Birmingham, Birmingham, AL, ²School of Medicine, Department of Rheumatology and Infectious Diseases, Kitasato University, Sagamihara, Japan, ³Taichung Veterans General Hospital, Taichung, Taiwan (Republic of China), ⁴Pfizer Inc, Istanbul, Turkey, ⁵Pfizer Japan Inc, Tokyo, Japan, ⁶Pfizer Inc, Groton, CT, ⁷Pfizer Inc, Tadworth, Surrey, United Kingdom, ⁸Hospital Clínico Universitario, Santiago de Compostela, Spain
Background/Purpose: ORAL Surveillance (NCT02092467) was a post-authorization safety study to assess the relative risk of tofacitinib vs TNF inhibitors (TNFi), based on observed increases in…

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Accepted abstracts are made available to the public online in advance of the meeting and are published in a special online supplement of Arthritis & Rheumatology. Information contained in those abstracts may not be released until the abstracts appear online. Academic institutions, private organizations and companies with products whose value may be influenced by information contained in an abstract may issue a press release to coincide with the availability of an ACR abstract on the ACR website. However, the ACR continues to require that information that goes beyond that contained in the abstract (e.g., discussion of the abstract done as part a scientific presentation or presentation of additional new information that will be available at the time of the meeting) is under embargo until Saturday, November 11, 2023.

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