Abstracts tagged "Randomized Trial"

Abstract Number: 1636 • ACR Convergence 2023
Dazodalibep, a CD40L Antagonist, in Subjects with Sjögren’s Having Moderate-to-Severe Systemic Disease Activity: Full Crossover Results from a Phase 2, Randomized, Double-Blind, Placebo-Controlled, Proof of Concept Study
E. William St. Clair¹, Liangwei Wang², Ilias Alevizos², William A. Rees², Alan Baer³, Wan-Fai Ng⁴, Ghaith Noaiseh⁵ and Chiara Baldini⁶, ¹Duke University Medical Center, Durham, NC, ²Horizon Therapeutics, Rockville, MD, ³Johns Hopkins University School of Medicine, Baltimore, MD, ⁴NIHR Newcastle Clinical Research Facility, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, United Kingdom, ⁵University of Kansas Medical Center, Kansas City, KS, ⁶University of Pisa, Pisa, Italy
Background/Purpose: Dazodalibep (DAZ) is a non-antibody fusion protein that acts as a CD40L antagonist and blocks costimulatory signals between immune cells, including T cells, B…
Abstract Number: 2155 • ACR Convergence 2023
The Impact of Filgotinib on Disease Activity Outcomes with Concomitant Pain Control in the Phase 3 FINCH Studies
Peter C. Taylor¹, Arthur Kavanaugh², Peter Nash³, Janet Pope⁴, Georg Pongratz⁵, Bruno Fautrel⁶, Rieke Alten⁷, Ken Hasegawa⁸, Shangbang Rao⁹, Dick de Vries¹⁰, Pieter-Jan Stiers¹¹, Chris Watson¹² and René Westhovens¹³, ¹Nuffield Department of Orthopedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, United Kingdom, ²Division of Rheumatology, Allergy, and Immunology, University of California San Diego, La Jolla, CA, ³School of Medicine, Griffith University, Brisbane, Australia, ⁴University of Western Ontario, London, ON, Canada, ⁵Faculty of Medicine, Regensburg University, Regensburg, Germany, Regensburg, Germany, ⁶Sorbonne Université APHP, Paris, France, ⁷Department of Internal Medicine and Rheumatology, Schlosspark Klinik, University Medicine Berlin, Berlin, Germany, ⁸Global Medical Affairs Research, Gilead Sciences, Inc., Foster City, CA, ⁹Biostatistics, Gilead Sciences, Inc., Foster City, CA, ¹⁰Research and Development, Clinical Research, Galapagos BV, Leiden, Netherlands, ¹¹Biostatistics, Galapagos NV, Mechelen, Belgium, ¹²Medical Affairs, Galapagos Biotech Ltd., Cambridge, United Kingdom, ¹³Department of Rheumatology, KU Leuven, Skeletal Biology and Engineering Research Center, Leuven, Belgium
Background/Purpose: Patients (pts) with rheumatoid arthritis (RA) often experience substantial pain despite treatment, and consider pain control an important treatment outcome. This post hoc analysis…
Abstract Number: 0451 • ACR Convergence 2023
Long-term Clinical Profile of Filgotinib in Patients with Rheumatoid Arthritis by Cardiovascular Risk Factors: A Post Hoc Subgroup Analysis
Maya Buch¹, Jose A Gomez-Puerta², Gerd Burmester³, Bernard G. Combe⁴, Vijay Rajendran⁵, Pieter-Jan Stiers⁶, Paul Van Hoek⁷, Katrien Van Beneden⁷, Jacques-Eric Gottenberg⁸, Yoshiya Tanaka⁹, Daniel Aletaha¹⁰, René Westhovens¹¹ and Roberto F. Caporali¹², ¹University of Manchester and NIHR Manchester Biomedical Research Centre, Manchester, United Kingdom, ²Department of Rheumatology, Hospital Clinic of Barcelona, Barcelona, Spain, ³Charité – Universitätsmedizin Berlin, Department of Rheumatology and Clinical Immunology, Berlin, Germany, ⁴Department of Rheumatology, Montpellier University, Montpellier, France, ⁵Clinical Research, Galapagos NV, Mechelen, Belgium, ⁶Biostatistics, Galapagos NV, Mechelen, Belgium, ⁷Medical Safety, Galapagos NV, Mechelen, Belgium, ⁸Rheumatology Department, Strasbourg University Hospital, Strasbourg, France, ⁹University of Occupational and Environmental Health, Kitakyushu, Japan, ¹⁰Division of Rheumatology, Department of Medicine III, Medical University of Vienna, Vienna, Austria, Wien, Austria, ¹¹Department of Rheumatology, KU Leuven, Skeletal Biology and Engineering Research Center, Leuven, Belgium, ¹²Department of Clinical Sciences and Community Health, University of Milan, and Department of Rheumatology and Medical Sciences, ASST Gaetano Pini-CTO, Milano, Italy
Background/Purpose: Filgotinib (FIL) is an oral Janus kinase 1 preferential inhibitor for the treatment of moderate to severe active RA. A previous pooled analysis reported…
Abstract Number: 1005 • ACR Convergence 2023
Telemedicine for Rheumatology Care: A Randomized, Single-Blind, Parallel Group, Noninferiority Trial
Lesley E. Jackson¹, Jinoos Yazdany², Kiara Aaron¹, Sarah Goglin³, Mary Margaretten², David Chae⁴, Jeffrey Curtis¹, Diana Paez⁵, Gary Cutter¹, Kenneth Saag¹ and Maria I. ("Maio") Danila⁶, ¹University of Alabama at Birmingham, Birmingham, AL, ²University of California San Francisco, San Francisco, CA, ³University of California San Francisco, Burlingame, CA, ⁴Tulane University School of Public Health & Tropical Medicine, New Orleans, LA, ⁵University of California San Francisco, Department of Medicine/Rheumatology, San Francisco, CA, ⁶University of Alabama at Birmingham (UAB), Birmingham VA Medical Center, Birmingham, AL
Background/Purpose: In the wake of the COVID-19 pandemic, telemedicine rapidly became standard of care for people with rheumatic diseases. Observational data on effectiveness and acceptability…
Abstract Number: 1638 • ACR Convergence 2023
CD40L Inhibition with Dazodalibep Rapidly Reduces Blood Biomarkers of T and B Cell Costimulation in Subjects with Sjögren’s Having High Disease Activity or High Symptom Burden
Tuyet-Hang Pham¹, Michael A. Smith¹, Nannette Mittereder¹, William A. Rees², Ilias Alevizos², E. William St. Clair³ and Claire Emson¹, ¹Horizon Therapeutics plc, Rockville, MD, ²Horizon Therapeutics, Rockville, MD, ³Duke University Medical Center, Durham, NC
Background/Purpose: Dazodalibep (DAZ) is a non-antibody fusion protein that acts as a CD40L antagonist and blocks costimulatory signals between immune cells, including T cells, B…
Abstract Number: 2161 • ACR Convergence 2023
Pharmacokinetic and Safety Similarity of High- and Low-Concentration Formulations of Adalimumab Biosimilar ABP 501
Vincent Chow, Muhan Zhou, Daniel Mytych, Alexander Colbert, Mieke Jill Miller, Iwona Wala and Waldemar Radziszewski, Amgen, Inc., Thousand Oaks, CA
Background/Purpose: ABP 501 has been developed as a biosimilar for Humira® (adalimumab), a fully human monoclonal antibody targeting tumor necrosis factor alpha (TNFα). ABP 501…
Abstract Number: 0459 • ACR Convergence 2023
Upadacitinib Monotherapy versus Methotrexate in Patients with Rheumatoid Arthritis: Efficacy and Safety Through 5 Years in the SELECT-EARLY Randomized Controlled Trial
Ronald van Vollenhoven¹, Vibeke Strand², Tsutomu Takeuchi³, Nilmo Chávez⁴, Pablo Mannucci Walter⁵, Attul Singhal⁶, Jerzy Swierkot⁷, Nasser Khan⁸, Xianwei Bu⁹, Yihan Li⁹, Sara Penn⁹, Heidi Camp⁹ and Jacob Aelion¹⁰, ¹Amsterdam University Medical Centers, Amsterdam, Netherlands, ²Stanford University, Portola Valley, CA, ³Keio University School of Medicine and Saitama Medical University, Tokyo, Japan, ⁴Instituto Guatemalteco de Seguridad Social, Guatemala, Guatemala, ⁵Aprillus Asistencia e Investigación, Buenos Aires, Argentina, ⁶Southwest Rheumatology Research Group, Dallas, TX, ⁷Department of Rheumatology and Internal Medicine, Wrocław Medical Hospital, Wrocław, Poland, ⁸Pharmacovigilance and Patient Safety, AbbVie, Inc., North Chicago, IL, ⁹AbbVie, Inc., North Chicago, IL, ¹⁰West Tennessee Research Institute, Jackson, TN
Background/Purpose: To evaluate the efficacy and safety of upadacitinib (UPA) monotherapy vs MTX monotherapy over 5 yrs among MTX-naïve patients with moderately to severely active…
Abstract Number: 1020 • ACR Convergence 2023
An Increase in Safety Outcome Trials and the Issue of Informed Consent
Ayse Ozdede¹, Sinem Nihal Esatoglu² and Hasan Yazici³, ¹Istanbul University-Cerrahpasa, Cerrahpasa Medical School, Department of Internal Medicine, Division of Rheumatology, İstanbul, Turkey, ²Istanbul University-Cerrahpasa, Cerrahpasa Medical School, Department of Internal Medicine, Division of Rheumatology, Istanbul, Turkey, ³Academic Hospital, Istanbul, Turkey
Background/Purpose: The randomized controlled trial (RCT remains a most important research tool and a necessary document for drug licensing. Informed consent is an integral component…
Abstract Number: 1654 • ACR Convergence 2023
A Peer Health Coached Resilience-Based Energy Management Program Was Effective in Improving Fatigue and Other Outcomes in People with Systemic Sclerosis: Results of a Randomized Controlled Trial
Susan Murphy¹, Yen Chen², Mary Alore², Sheri Hicks², Adam Pape², Afton Hassett², Anna Kratz², Daniel Whibley², Alexandra Harper³, Suiyuan Huang², Gina Jay², Shannen Bolde² and Dinesh Khanna², ¹University of Michigan, Plymouth, MI, ²University of Michigan, Ann Arbor, MI, ³University of Michigan, Ypsilanti Charter Twp, MI
Background/Purpose: Systemic sclerosis (SSc), a rare autoimmune condition, has a high chronic symptom burden that can have dramatic, life-altering effects on function and quality of…
Abstract Number: 2169 • ACR Convergence 2023
Cost-utility of a Progressive Spacing of Tocilizumab or Abatacept in Patients with Rheumatoid Arthritis in Sustained Remission: A Medico-economic Analysis of the Towards the Lowest Efficacious Dose Trial
Joanna Kedra¹, Benjamin Granger², Lina El Houari³, Florence Tubach⁴ and Bruno Fautrel⁵, ¹Sorbonne Université, IPLESP, and Pitié-Salpêtrière Hospital, Paris, France, ²Sorbonne Université, INSERM, and Pitié Salpêtrière Hospital, Paris, France, ³Institut Pierre Louis d’Epidémiologie et de Santé Publique, Paris, France, ⁴Centre de pharmaco-épidémiologie de l'APHP, Paris, France, ⁵Sorbonne Université APHP, Paris, France
Background/Purpose: Biologic Disease Modifying Anti-Rheumatic Drugs (bDMARDs) progressive tapering is a real opportunity in people living with rheumatoid arthritis (RA) having achieved remission both from…
Abstract Number: 0480 • ACR Convergence 2023
Non-random Sampling in Rheumatology Randomized Controlled Trials: Evidence of Concerning Trial Conduct?
Victoria Le¹, Mats Junek², Mike Putman³, Maximilian Casey¹, Kenrick Manswell¹, Jay Goldsher¹, Elizabeth Nettleton¹, Desh Nepal¹ and Sanket Shah¹, ¹Medical College of Wisconsin, Milwaukee, WI, ²McMaster University, Hamilton, ON, Canada, ³Division of Rheumatology, Medical College of Wisconsin, Milwaukee, WI
Background/Purpose: Non-random sampling of baseline variables in randomized controlled trials (RCTs) may be due unintentional errors, stratified randomization strategies, or data fabrication. Prior studies have…
Abstract Number: 1197 • ACR Convergence 2023
Efficacy and Safety of a Single Intra-Articular Injection of MM-II, a Novel Suspension of Large, Empty, Multilamellar Liposomes, in People with Painful Knee OA: Results of a 26-Week, Phase 2b, Placebo-Controlled, Double-Blind, Randomized Trial
Schnitzer Thomas¹, Helene Rovsing², Edith Lau³, Sidsel Boll⁴, Ballari Brahmachari⁵, Richard Chou⁶, Tarini Joshi⁵, Roni Wechsler⁷, Siu-Long Yao⁵, Sveta Weiner⁵, Asger Bihlet⁸ and Philip Conaghan⁹, ¹Northwestern University Feinberg School of Medicine, Chicago, IL, ²Sanos Clinic, Gandrup, Denmark, ³Hong Kong Center for Clinical Research, Hong Kong, China, ⁴Sanos Clinic, Vejle, Denmark, ⁵Sun Pharmaceutical Industries, Inc., Princeton, NJ, ⁶Jacobs School of Medicine and Biomedical Sciences, University of Buffalo, Buffalo, NY, ⁷Moebius Medical, Tel Aviv, Israel, ⁸NBCD, Soeborg, Denmark, ⁹University of Leeds, Leeds, United Kingdom
Background/Purpose: Safe and effective therapies are needed for OA pain. MM-II, a novel suspension of large, empty, multilamellar liposomes composed of dimyristoylphosphatidylcholine and dipalmitoylphosphatidylcholine, effectively…
Abstract Number: 1677 • ACR Convergence 2023
Two-week Break in Methotrexate Treatment and COVID-19 Vaccine Response. Results of the Vaccine Response on off Methotrexate (VROOM) Study, an Open Label, Prospective, Two-arm Parallel-group, Multi-center, Superiority, Randomized Controlled Trial
Abhishek Abhishek¹, Nicholas Peckham², Corinna Pade³, Joseph Gibbons³, Lucy Cureton², Anne Francis², Vicki Barber², Jennifer Williams², duncan Appelbe², lucy Eldridge², patrick Julier², daniel Altmann⁴, James Bluett⁵, Tim Brooks⁶, Laura Coates², ines Rombach⁷, Amanda Semper⁶, Ashley Otter⁶, Ana Valdes¹, Jonathan Nguyen-Van-Tam¹, Hywel Williams¹, Aine McKnight³, Rosemary Boyton⁴ and jonathan Cook², ¹University of Nottingham, Nottingham, United Kingdom, ²University of Oxford, Oxford, United Kingdom, ³Queen Mary University of London, London, United Kingdom, ⁴Imperial College London, London, United Kingdom, ⁵University of Manchester, Manchester, United Kingdom, ⁶UK Health Security Agency, Porton Down, United Kingdom, ⁷University of Sheffield, Sheffield, United Kingdom
Background/Purpose: Immunosuppressive treatments inhibit vaccine-induced immunity. We evaluated if a two-week interruption of methotrexate treatment immediately after COVID-19 booster improved antibody response against spike protein…
Abstract Number: 2229 • ACR Convergence 2023
Individual Entheseal Points Have Differential Frequency of Involvement and Impact on Patient Reported Outcomes in Patients with Active Psoriatic Arthritis: Pooled Analysis of Two Phase 3, Randomized, Double-Blind, Placebo-Controlled Studies
Laura Coates¹, Iain McInnes², Sibel Aydin³, Mitsumasa Kishimoto⁴, Philip J. Mease⁵, May Shawi⁶, Miriam Zimmermann⁷, Emmanouil Rampakakis⁸, Frederic Lavie⁹ and Dennis McGonagle¹⁰, ¹University of Oxford, Oxford, United Kingdom, ²University of Glasgow, Glasgow, United Kingdom, ³Department of Medicine, Ottawa Hospital Riverside Campus, Ottawa, ON, Canada, ⁴Kyorin University School of Medicine, Yokohoma, Japan, ⁵Swedish Medical Center/Providence St. Joseph Health and University of Washington School of Medicine, Seattle, WA, ⁶Immunology, Janssen Research & Development, LLC, Titusville, NJ, ⁷Immunology, Janssen Medical Affairs, LLC, Zug, Switzerland, ⁸McGill University, Department of Pediatrics / JSS Medical Research, Scientific Affairs, Montreal, QC, Canada, ⁹The Janssen Pharmaceutical Companies of Johnson & Johnson, Paris, France, ¹⁰Leeds Biomedical Research Centre, University of Leeds, Leeds, United Kingdom
Background/Purpose: In patients with mono/oligoarticular psoriatic arthritis (PsA), swelling or tenderness of specific joints can be associated with poorer patient-reported outcomes (PROs) and physician global…
Abstract Number: 0518 • ACR Convergence 2023
Tofacitinib Efficacy and Safety in Patients with Ankylosing Spondylitis by Baseline C-Reactive Protein Levels: A Post Hoc Analysis
Atul Deodhar¹, Xenofon Baraliakos², Marina Nighat Magrey³, Lianne Gensler⁴, Amit V. Thorat⁵, Surya Pemmaraju⁶, Mary Jane Cadatal⁷ and Peter Nash⁸, ¹Division of Arthritis and Rheumatic Disease, Oregon Health & Science University, Portland, OR, ²Rheumazentrum Ruhrgebiet Herne, Ruhr-University Bochum, Herne, Germany, ³Case Western Reserve University, University Hospitals, Cleveland, OH, ⁴University of California San Francisco, Department of Medicine, Division of Rheumatology, San Francisco, CA, ⁵Pfizer Australia, Sydney, Australia, ⁶Pfizer Inc., Chennai, Tamil Nadu, India, ⁷Pfizer Inc., Manila, Philippines, ⁸School of Medicine, Griffith University, Brisbane, Australia
Background/Purpose: Elevated baseline (BL) CRP levels can predict treatment response in patients (pts) with AS. Tofacitinib is a Janus kinase inhibitor for the treatment of…

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