Abstracts tagged "clinical trial"

Abstract Number: 0183 • ACR Convergence 2021
Efficacy and Safety of Risankizumab for Active Psoriatic Arthritis: 24-Week Results from the Phase 3, Randomized, Double-blind Clinical Trial for CsDMARD-IR and Bio-IR Patients
Merav Lidar¹, Jacob Aelion², Gareth Scott Tarr³, Kim Papp⁴, Lisa Barcomb⁵, Ahmed M. Soliman⁵, Wenjing Lu⁶, Ann Eldred⁵ and Andrew Ostor⁷, ¹Chaim Sheba Medical Center, Ramat Gan, Israel, ²Arthritis Clinic and West Tennessee Research Institute, Jackson, TN, ³Winelands Medical Research Centre and the Institute of Orthopaedics and Rheumatology (IOR), Winelands Medi-Clinic Orthopaedic Hospital, Stellenbosch, South Africa, ⁴K Papp Clinical Research and Probity Medical Research, Waterloo, ON, Canada, ⁵Abbvie Inc., North Chicago, IL, ⁶AbbVie Inc., North Chicago, ⁷Monash University, Cabrini Hospital, and Emertius Research, Malvern, Australia
Background/Purpose: Risankizumab (RZB) is a humanized immunoglobulin G1 monoclonal antibody that specifically inhibits interleukin 23 by binding to its p19 subunit. RZB is being investigated…
Abstract Number: 0665 • ACR Convergence 2021
Pegloticase Treatment for Uncontrolled Gout in Kidney Transplanted Patients: Results of an On-going Multicenter, Open-Label, Efficacy and Safety Study
Abdul Abdellatif¹, Lin Zhao², Paul M. Peloso³, Katya Cherny², Brad Marder², John D. Scandling⁴ and Kenneth Saag⁵, ¹Kidney Hypertension Transplant Clinic Clear Lake Specialties, Webster, TX, ²Horizon Therapeutics plc, Deerfield, IL, ³Horizon Therapeutics plc, Gurnee, IL, ⁴Stanford Medicine, Department of Nephrology, Stanford, CA, ⁵University of Alabama at Birmingham, Birmingham, AL
Background/Purpose: Gout in kidney transplant (KT) recipients can be severe and particularly challenging to manage. Pegloticase (pegylated recombinant uricase) rapidly metabolizes urate and is a…
Abstract Number: 1244 • ACR Convergence 2021
Mindfulness-Based Stress Reduction (MBSR) to Improve Patient-Related Outcomes (PROs) in Patients with Rheumatoid Arthritis in Clinical Remission but Elevated Negative PROs: A Pragmatic Pilot Study
Marie-Claude Beaulieu¹, Isabelle Gaboury², Patricia L Dobkin³, Nathalie Carrier⁴, France Gervais⁵, Françoise Gendron⁶, Pasquale Roberge⁷, PIERRE DAGENAIS⁷, Sophie Roux⁷ and Gilles Boire¹, ¹Universite de Sherbrooke, Sherbrooke, QC, Canada, ²University of Sherbrooke, Sherbrooke, QC, Canada, ³McGill University, Montréal, QC, Canada, ⁴CIUSSS de l'Estrie - CHUS, Sherbrooke, QC, Canada, ⁵NA, Rimouski, QC, Canada, ⁶NA, Sherbrooke, QC, Canada, ⁷Université de Sherbrooke, Sherbrooke, QC, Canada
Background/Purpose: Many patients with controlled rheumatoid arthritis (RA) continue to report high levels of disease activity (PGA), as well as other disturbing patient-related outcomes (PROs),…
Abstract Number: 1443 • ACR Convergence 2021
Long-term Effectiveness of Ultra-Low Doses of Rituximab in Rheumatoid Arthritis
Nathan den Broeder¹, Lise Verhoef², Yael De Man³, Marc Kok⁴, Rogier Thurlings⁵, Wilfred van der Weele⁶, Bart van den Bemt⁷, Frank van den Hoogen⁸, Aatke van der Maas⁹ and Alfons den Broeder¹⁰, ¹Radboud University Medical Centre, Nijmegen, Gelderland, Netherlands, ²Sint Maartenskliniek, Nijmegen, Netherlands, ³Ziekenhuisgroep Twente (Hospital Group Twente), Borne, Netherlands, ⁴Maasstad Hospital, Rotterdam, Netherlands, ⁵Radboud University Medical Centre, Nijmegen, Netherlands, ⁶Reade, Amsterdam, Netherlands, ⁷Sint Maartenskliniek; Radboud University Medical Center, Ubbergen, Netherlands, ⁸Sint Maartenskliniek, Ubbergen, Gelderland, Netherlands, ⁹St Maartenskliniek, Nijmegen, Gelderland, Netherlands, ¹⁰Sint Maartenskliniek, Nijmegen, Gelderland, Netherlands
Background/Purpose: The optimal rituximab (RTX) dose for the treatment of rheumatoid arthritis remains unclear. RTX treatment of 1000mg per 6 months and 2000mg per 6…
Abstract Number: 1703 • ACR Convergence 2021
AP1189: A Novel Oral Biased Melanocortin Agonist with Anti-inflammatory and Pro-resolving Effect for the Treatment of Rheumatoid Arthritis
Thomas Jonassen¹, Thierry Duvauchelle¹, Birgitte Telmer², Irene Sandholdt², Thomas Boesen¹ and Ellen-Margrethe Hauge³, ¹SynAct Pharma, Holte, Denmark, ²CroxxMed, Hørsholm, Denmark, ³Aarhus University Hospital, Aarhus, Denmark
Background/Purpose: Melanocortin (MC) type 1 and type 3 receptor stimulation is associated with anti-inflammation and promotion of inflammatory resolution. AP1189 is a biased MC type…
Abstract Number: 1770 • ACR Convergence 2021
Interim Analysis of Cohort 1 in the Mesenchymal Stromal Cell Trial in Systemic Lupus Erythematosis: Safety and Data Management During the Pandemic
Gary Gilkeson¹, Diane Kamen¹, S Sam Lim², Rosalind Ramsey-Goldman³, Kenneth Kalunian⁴, Saira Sheikh⁵, Mariko Ishimori⁶ and Daniel Wallace⁷, ¹Medical University of South Carolina, Charleston, SC, ²Department of Medicine, Division of Rheumatology, Emory University School of Medicine, Atlanta, GA, ³Northwestern University, Chicago, IL, ⁴UC San Diego, La Jolla, CA, ⁵University of North Carolina Thurston Arthritis Research Center, and Department of Medicine, Division of Rheumatology, Allergy and Immunology, University of North Carolina at Chapel Hill School of Medicine, Chapel Hill, NC, ⁶Cedars-Sinai Health System, Los Angeles, CA, ⁷Attune Health, Beverly Hills, CA
Background/Purpose: There is heightened interest in the use of mesenchymal stromal cells (MSCs) for the treatment of autoimmune diseases. There are a number of reports…
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…

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