Abstracts tagged "clinical trial"

Abstract Number: 1433 • ACR Convergence 2023
Bimekizumab Impact on Core Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) Domains for Patients with Psoriatic Arthritis: 52-Week Results from Four Phase 3 Studies
Joseph Merola¹, Philip J. Mease², Atul Deodhar³, Barbara Ink⁴, Carmen Fleurinck⁵, Rajan Bajracharya⁴, Jason Coarse⁶ and Laura Coates⁷, ¹Harvard Medical School, Brigham and Women's Hospital, Newton, MA, ²Swedish Medical Center/Providence St. Joseph Health and University of Washington School of Medicine, Seattle, WA, ³Division of Arthritis and Rheumatic Disease, Oregon Health & Science University, Portland, OR, ⁴UCB Pharma, Slough, United Kingdom, ⁵UCB Pharma, Oosterzele, Belgium, ⁶UCB Pharma, Morrisville, NC, ⁷University of Oxford, Oxford, United Kingdom
Background/Purpose: The Group for Research and Assessment of Psoriasis and PsA (GRAPPA) domain‑based treatment recommendations for PsA focus on six key domains: peripheral arthritis, axial…
Abstract Number: 1612 • ACR Convergence 2023
Design and Validation of a Comparator for Randomized Controlled Trials of a Digital Cognitive Behavioral Therapy
Michael Gendreau¹, Yifei Dai², Michael Rosenbluth³, David Williams⁴ and Daniel Clauw⁵, ¹Gendreau Consulting, LLC, Poway, CA, ²Swing Therapeutics, Gainesville, FL, ³Swing Therapeutics, San Francisco, CA, ⁴Chronic Pain and Fatigue Research Center, Department of Anesthesiology, University of Michigan, Ann Arbor, MI, ⁵Department of Anesthesiology, University of Michigan, Ann Arbor, MI
Background/Purpose: The use of a control arm (comparator) in randomized controlled trials (RCTs) is considered the gold standard for trial conduct and interpretation. Choosing an…
Abstract Number: 2024 • ACR Convergence 2023
Patient-Reported Outcomes in Patients with Lupus Nephritis: A Post Hoc Analysis of Control Arm Data from Two Completed Phase III Randomized Clinical Trials
Christophe T. Tchakoute¹, Huiyan (Ashley) Mao², Gene Wallenstein¹, Jorge Ross Terres¹, Seitaro Yoshida¹ and Lisa Lindsay¹, ¹Genentech, Inc., South San Francisco, CA, ²Hoffmann-La Roche Ltd, Mississauga, ON, Canada
Background/Purpose: Lupus nephritis (LN) is a severe and common (50%) organ-threatening manifestation of systemic lupus erythematosus and is associated with a high risk of progression…
Abstract Number: 2256 • ACR Convergence 2023
The Impact of Clinical Trial Metrics in Psoriatic Arthritis
Maxine Yarnall and Kara Murray, Spherix Global Insights, Exton, PA
Background/Purpose: Rheumatologists have access to a plethora of advanced biologic and small molecule agents for the treatment of psoriatic arthritis (PsA). Prior to FDA approval,…
Abstract Number: 2539 • ACR Convergence 2023
Baseline IL-10 Levels as a Predictive Biomarker for Achieving Clinical Response with Abatacept in ACPA+ Patients with Early RA
Jinqi Liu¹, Yicong Li², Kai Fu¹, Chun Wu¹, Peter Schafer³, Sean Connolly¹, Ian M. Catlett⁴, Michael Maldonado¹, Robert Wong⁵, Paul Emery⁶, Yoshiya Tanaka⁷, Vivian Bykerk⁸, Clifton Bingham⁹, Thomas Huizinga¹⁰ and Roy Fleischmann¹¹, ¹Bristol Myers Squibb, Princeton, NJ, ²Parexel International, Durham, NC, ³Bristol Myers Squibb, Belle Mead, NJ, ⁴Bristol Myers Squibb, Pennington, NJ, ⁵Bristol Myers Squibb (at the time of analysis), Princeton, NJ, ⁶Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, and NIHR Leeds Biomedical Research Centre, Leeds Teaching Hospitals NHS Trust, Leeds, United Kingdom, ⁷University of Occupational and Environmental Health, Kitakyushu, Japan, ⁸Department of Rheumatology, Hospital for Special Surgery, New York, NY, ⁹Division of Rheumatology, Department of Medicine, Johns Hopkins University, Baltimore, MD, ¹⁰Leiden University Medical Center, Leiden, Netherlands, ¹¹Division of Rheumatology, University of Texas Southwestern Medical Center, Metroplex Clinical Research Center, Dallas, TX
Background/Purpose: A key target of RA treatment is to achieve early and sustained remission in order to ensure lower levels of long-term structural joint damage…
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: 0782 • ACR Convergence 2023
Comparison of Dual-immunosuppressive Therapy with a Voclosporin-based, Triple-immunosuppressive Regimen for Lupus Nephritis in the ALMS and AURORA 1 Studies
Maria Dall'Era¹, Ernie Yap², Matt Truman², Lucy Hodge² and Neil Solomons³, ¹University of California San Francisco, San Francisco, CA, ²Aurinia Pharmaceuticals Inc., Edmonton, AB, Canada, ³Neil Solomons Consulting Inc., Victoria, BC, Canada
Background/Purpose: Dual-immunosuppressive regimens consisting of high-dose glucocorticoids and higher doses ( >2 g/day) of mycophenolate mofetil (MMF) are still frequently used for the initial management…
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: 1434 • ACR Convergence 2023
Long-Term Efficacy and Safety of Risankizumab for Active Psoriatic Arthritis: 148-Week Results from the KEEPsAKE 2 Trial
Andrew Östör¹, Filip Van den Bosch², Kim A Papp³, Cecilia Asnal⁴, Ricardo Blanco⁵, Jacob Aelion⁶, Vassilis Stakias⁷, Thomas Iyile⁷, Kyle Carter⁷, Ahmed Soliman⁷, Leonidas Drogaris⁷, Michael Chen⁷, Byron Padilla⁷ and Alan Kivitz⁸, ¹Monash University & Emeritus Research; Australian National University, Melbourne, Australia, ²Department of Internal Medicine and Pediatrics, Ghent University and VIB Center for Inflammation Research, Ghent, Belgium, ³Alliance Clinical Research and Probity Medical Research, Waterloo, and University of Toronto, Toronto, ON, Canada, ⁴Hospital Alemán, Buenos Aires, Argentina, ⁵Rheumatology Department, Immunopathology Group, Hospital Universitario Marqués de Valdecilla-IDIVAL, Santander, Spain, ⁶West Tennessee Research Institute, Jackson, TN, ⁷AbbVie, Inc., North Chicago, IL, ⁸Altoona Center for Clinical Research, Duncansville, PA
Background/Purpose: PsA is a chronic systemic inflammatory disease that affects 30% of patients diagnosed with psoriasis, with a clinical burden that includes dactylitis, enthesitis, cutaneous…
Abstract Number: 1614 • ACR Convergence 2023
Therapy Combining Millimeter Wave-based Neuromodulation with Coaching for the Improvement in Quality of Life of Patients with Fibromyalgia: A Prospective, Multicenter, Randomized, Controlled Trial
Caroline Maindet¹, Anne Dumolard², Mélanie Veloso², Mario Barmaki³, Rodrigue Deleens⁴, Raphaël Gonon-Demoulian⁵, Alberta Lorenzi-Pernot⁶, Mireille Michel-Cherqui⁷, Alain Serrie⁸, Stanislas Velliet⁹ and Jean-Luc Bosson², ¹University Hospital Grenoble Alpes, Grenoble, France, ²Grenoble Alpes University Hospital, Grenoble, France, ³Médipôle Lyon Villeurbanne, Lyon, France, ⁴Rouen University Hospital, Rouen, France, ⁵Montpellier University Hospital, Montpellier, France, ⁶Neurology private practice, Mornant, France, ⁷Foch hospital, Suresnes, France, ⁸Paris University Hospital, Paris, Guinea, ⁹Valenciennes hospital, Valenciennes, France
Background/Purpose: Fibromyalgia is a chronic syndrome with symptoms of moderate to severe intensity, including diffuse pain, fatigue, sleep disturbance, and cognitive impairment. While first-line recommendation…
Abstract Number: 2055 • ACR Convergence 2023
A Randomized Controlled Trial of Two Hepatitis a Vaccine Doses Among Adolescents with Juvenile Idiopathic Arthritis and Crohn’s Disease on Immunosuppressive Therapy: A Pilot Study
Racheal Githumbi¹, Susan Kuhn¹, Carla Osiowy², Jennifer DeBruyn¹, Marvin Fritzler¹, Nicole Johnson¹, Otto G Vanderkooi¹ and Heinrike Schmeling¹, ¹University of Calgary, Calgary, AB, Canada, ²National Microbiology Laboratory, Public Health Agency of Canada, Winnepig, MB, Canada
Background/Purpose: Juvenile idiopathic arthritis (JIA) and Crohn's disease (CD) are now controlled using immunosuppressive medications. However, disease control comes at the risk of increased infection.…
Abstract Number: 2326 • ACR Convergence 2023
Efficacy and Safety of Voclosporin in Patients with Proteinuria > 2 G/g
Emily Littlejohn¹, Salem Almaani², Vanessa Birardi³, Ernie Yap⁴ and Christopher Collins⁵, ¹Cleveland Clinic, Cleveland, OH, ²Ohio State University Medical Center, Columbus, OH, ³Aurinia Pharmaceuticals Inc, Edmonton, AB, Canada, ⁴Aurinia Pharmaceuticals Inc., Edmonton, AB, Canada, ⁵Formerly Aurinia Pharmaceuticals Inc., Copenhagen, Denmark
Background/Purpose: Proteinuria is the most common manifestation of lupus nephritis and is a mediator of progressive kidney damage. Early reductions in urine protein creatinine ratio…
Abstract Number: 2545 • ACR Convergence 2023
Efficacy and Safety of Intravenous Secukinumab for the Treatment of Active Axial Spondyloarthritis: Results from a Randomized, Double-Blind, Phase 3 Study
Atul Deodhar¹, Jerzy Supronik², Alan Kivitz³, Guillermo Valenzuela⁴, Karen Kapur⁵, Susanne Rohrer⁶, Eva Dokoupilova⁷, Hanno Richards⁶ and Karel Pavelka⁸, ¹Division of Arthritis and Rheumatic Disease, Oregon Health & Science University, Portland, OR, ²OsteoMedic sc A Racewicz J Supronik, Bialystok, Poland, ³Altoona Center for Clinical Research, Duncansville, PA, ⁴Integral Rheumatology & Immunology Specialists, Plantation, FL, ⁵Novartis Pharmaceuticals Corporation, East Hanover, NJ, ⁶Novartis Pharma AG, Basel, Switzerland, ⁷Masaryk University, Faculty of Pharmacy, Department of Pharmaceutical Technology; MEDICAL PLUS sro, Brno, Czech Republic, ⁸Institut of Rheumatology and Department of Rheumatology, First Faculty of Medicine, Charles University, Praha, Czech Republic
Background/Purpose: While subcutaneous secukinumab (SEC) is approved for the treatment of axial spondyloarthritis (axSpA), some patients may benefit more from intravenous (IV) administration. This study…
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: 0817 • ACR Convergence 2023
Comparative Effectiveness of Yoga and Strengthening Exercise for Treating Knee OsteoArthritis: A Randomised Controlled Trial (YOGA Trial)
Bedru Abafita¹, Ambrish Singh¹, Dawn Aitken¹, Steffany Moonaz², Andrew J Palmer¹, Leigh Blizzard¹, Changhai Ding¹, Stan Drummen¹, Graeme Jones³, Kim Bennell⁴ and Benny Samuel Antony¹, ¹Menzies Institute for Medical Research, University of Tasmania, Hobart, Australia, ²Department of Clinical and Health Services Research, Southern California University of Health Sciences, Whittier, CA, ³Menzies Institute for Medical Research, University of Tasmania, Melbourne, Australia, ⁴University of Melbourne, Melbourne, Australia
Background/Purpose: There is uncertainty about the best type of exercise to optimise outcomes for people with knee osteoarthritis (OA). Strengthening exercise is commonly recommended. However,…

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