Abstracts tagged "clinical trial"

Abstract Number: 0603 • ACR Convergence 2021
Barriers and Potential Solutions in the Recruitment and Retention of Older Patients in Clinical Trials – Lessons Learned from Six Large Multi-center Randomized Controlled Trials
Thomas Buttgereit¹, Andriko Palmowski¹, Noah Forsat¹, Maarten Boers², Miles Witham³, Nicolas Rodondi⁴, Elisavet Moutzouri⁴, Antonio Jesus Quesada Navidad⁵, Arnoud van’t Hof⁶, Bart van der Worp⁷, Laura Coll-Planas⁸, Marieke Voshaar⁹, Maarten de Wit¹⁰, Jose Pereira da Silva¹¹, Sven Stegemann¹², Johannes Bijlsma¹³, Marcus Koeller¹⁴, Simon Mooijaart¹⁵, Patricia Kearney¹⁶ and Frank Buttgereit¹, ¹Charité – Universitätsmedizin Berlin, Berlin, Germany, ²Amsterdam UMC, Vrije Universiteit, Amsterdam, Netherlands, ³AGE Research Group, NIHR Newcastle Biomedical Research Centre, Translational and Clinical Research Institute, Newcastle University and Newcastle upon Tyne Hospitals Trust, Newcastle, United Kingdom, ⁴Department of General Internal Medicine, Inselspital, Bern University Hospital, Bern, Switzerland, ⁵CNIC – Spanish National Center for Cardiovascular Research, Madrid, ⁶Cardiology Department, Maastricht UMC, Maastricht, Netherlands, ⁷Department of Neurology and Neurosurgery, Brain Center, University Medical Center Utrecht, Utrecht, Netherlands, ⁸Fundació Salut i Envelliment, Universitat Autònoma de Barcelona, Barcelona, Spain, ⁹Department Psychology, Health and Technology, University of Twente, Twente, Netherlands, ¹⁰EULAR Patient Research Partner, Zaltbommel, Netherlands, ¹¹University of Coimbra | UC · Clínica Universitária de Reumatologia. Faculty of Medicine, Columbia, Portugal, ¹²TU Graz, Institute for Process and Particle Engineering, Graz, Australia, ¹³Department of Rheumatology and Clinical Immunology, University Medical Centre Utrecht, Utrecht, Netherlands, ¹⁴Faculty of Geriatric Medicine, Medical University of Vienna, Vienna, Austria, ¹⁵Department of Gerontology and Geriatrics, Leiden University Medical Center, Leiden, The Netherlands; Institute for Evidence-based Medicine in Old Age | IEMO, Leiden, Netherlands, ¹⁶School of Epidemiology and Public Health, University College Cork, Cork, Ireland
Background/Purpose: Older people remain underrepresented in clinical trials, and evidence generated in younger populations cannot always be generalized to older patients.We aimed to identify key…
Abstract Number: 1241 • ACR Convergence 2021
Comparison of the Effects of Upadacitinib Monotherapy with MTX on Protein Biomarkers in MTX-Naïve and MTX-Inadequate Responders in Patients with Active Rheumatoid Arthritis: Results from the SELECT-EARLY and SELECT‑MONOTHERAPY Phase 3 Studies
Thierry Sornasse¹, Heidi Camp², Fang Cai³, Justin Klaff² and Iain McInnes⁴, ¹AbbVie Inc, Redwood City, CA, ²AbbVie Inc., North Chicago, IL, ³AbbVie, Redwood City, CA, ⁴University of Glasgow, School of Medicine, Glasgow, Scotland, United Kingdom
Background/Purpose: In MTX-naïve patients (SELECT-EARLY/M13-545 Phase 3 study) UPA 15 mg QD monotherapy (UPA Mono) demonstrated significant and clinically meaningful improvements in RA signs and…
Abstract Number: 1425 • ACR Convergence 2021
Voclosporin for Lupus Nephritis: Interim Analysis of the AURORA 2 Extension Study
Amit Saxena¹, Christopher Mela² and Antonia Coeshall³, ¹NYU School of Medicine, New York, NY, ²Aurinia Pharmaceuticals Inc., Victoria, BC, Canada, ³Aurinia Pharmaceuticals Inc., Rockville
Background/Purpose: Voclosporin, a novel calcineurin inhibitor (CNI), has been tested successfully in 2 pivotal trials in adult patients with lupus nephritis (LN). Previously reported results…
Abstract Number: 1700 • ACR Convergence 2021
Pharmacokinetic Boosting to Enable Once-Daily Reduced Dose Tofacitinib
Céleste van der Togt¹, Lise Verhoef², Nathan den Broeder³, Rob ter Heine³, Bart van den Bemt⁴ and Alfons den Broeder⁵, ¹Sint Maartenskliniek, Ubbergen, Gelderland, Netherlands, ²Sint Maartenskliniek, Nijmegen, Netherlands, ³Radboud University Medical Centre, Nijmegen, Gelderland, Netherlands, ⁴Sint Maartenskliniek; Radboud University Medical Center, Ubbergen, Netherlands, ⁵Sint Maartenskliniek, Nijmegen, Gelderland, Netherlands
Background/Purpose: Tofacitinib is an effective, yet costly, drug for treatment of RA and PsA. Tofacitinib is metabolized mainly by the cytochrome P450-enzyme CYP3A4, and the…
Abstract Number: 1765 • ACR Convergence 2021
Should SLE Patients Entering Clinical Trials Be Required to Have at Least One BILAG A and/or Two BILAG B Domain Scores?
Ewa Olech¹, Faizi Hussain² and Joan Merrill³, ¹IQVIA, Las Vegas, NV, ²IQVIA, Redding, United Kingdom, ³Oklahoma Medical Research Foundation, Oklahoma City, OK
Background/Purpose: High placebo response rates have challenged interpretation of clinical trial results in SLE and may have contributed to failure of some effective treatments. One…
Abstract Number: 1856 • ACR Convergence 2021
Serum IFN Score Predicts Long Term Outcome in Limited Cutaneous SSc
Ranjitha Karanth¹, Giuseppina Abignano², Vishal Kakkar², Rebecca Ross², Christopher Denton³ and Francesco Del Galdo², ¹Leeds Institute of Rheumatic and Musculoskeletal Medicine, LTHT, Leeds, United Kingdom, ²University of Leeds, Leeds, United Kingdom, ³University College London Division of Medicine, Centre for Rheumatology and Connective Tissue Diseases, London, United Kingdom
Background/Purpose: Limited cutaneous systemic sclerosis (lcSSc) carries a highly variable prognosis and to date there are no stratification tools to predict clinical outcomes. Evidence suggests…
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…

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