Abstracts tagged "Randomized Trial"

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: 2144 • ACR Convergence 2023
Pharmacodynamic Effects of Nipocalimab in Patients with Moderate to Severe Active Rheumatoid Arthritis (RA): Results from the Multicenter, Randomized, Double-blinded, Placebo-controlled Phase 2A IRIS-RA Study
Rohit Panchakshari¹, Matthew Loza², Thomas Huizinga³, Georg Schett⁴, Keying Ma², Jocelyn H. Leu², Sophia G. Liva², Fowzia Ibrahim⁵, Bei Zhou⁶, Qingmin Wang², Ricardo Rojo Cella², Chetan S. Karyekar², Kaiyin Fei², Carolyn Cuff⁷ and Sheng Gao², ¹Janssen Research & Development, LLC, La Jolla, CA, ²Janssen Research & Development, LLC, Spring House, PA, ³Leiden University Medical Center, Leiden, Netherlands, ⁴Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen, Germany, ⁵Janssen Research & Development, LLC, High Wycombe, United Kingdom, ⁶Janssen Research & Development, LLC, Chesterbrook, PA, ⁷Janssen Research & Development, LLC, Cambridge, MA
Background/Purpose: Nipocalimab is a fully human, immunoglobulin G (IgG) 1 monoclonal antibody that blocks the neonatal crystallizable fragment receptor (FcRn), thereby lowering IgG levels. RA…
Abstract Number: 0406 • ACR Convergence 2023
Obesity Is a Risk Factor for Poor Response to Treatment in Early Rheumatoid Arthritis – a NORD-STAR Spin-Off Study
Violetta Dubovyk¹, Gerdur Maria Grondal², Bjorn Gudbjornsson³, Espen A Haavardsholm⁴, Marte Schrumpf Heiberg⁴, Merete Hetland⁵, Kim Hørslev-Petersen⁶, Meliha Kapetanovic⁷, Alf Kastbom⁸, John Lampa⁹, Kristina Lend¹⁰, Dan Nordstrom¹¹, Michael Nurmohamed¹², Milad Rizk¹³, Annika Söderbergh¹⁴, Till Uhlig¹⁵, Mikkel Østergaard¹⁶, Ronald van Vollenhoven¹², Anna Rudin¹⁷ and Cristina Maglio¹⁸, ¹University of Gothenburg, Gothenburg, Sweden, ²Department for Rheumatology, Landspitali University Hospital, Reykjavik, Iceland, ³Centre for Rheumatology Research, University Hospital, Reykjavik, Iceland, ⁴Diakonhjemmet Hospital, Oslo, Norway, ⁵Copenhagen Center for Arthritis Research, Rigshospitalet, Copenhagen, Denmark, ⁶University of Southern Denmark, Odense, Denmark, ⁷Lund University and Skåne University Hospital, Lund, Sweden, ⁸Linköping University, Linköping, Sweden, ⁹Stockholm County, Hãsselby, Sweden, ¹⁰Amsterdam UMC, Karolinska Institute, Stockholm, Sweden, ¹¹Helsinki University Hospital, Helsinki, Finland, ¹²Amsterdam University Medical Centers, Amsterdam, Netherlands, ¹³Västmanlands Hospital Västerås, Västerås, Sweden, ¹⁴Örebro University Hospital, Örebro, Sweden, ¹⁵Center for Treatment of Rheumatic and Musculoskeletal Diseases (REMEDY), Diakonhjemmet Hospital, Oslo, Norway, ¹⁶Copenhagen Center for Arthritis Research, Center for Rheumatology and Spine Diseases, Centre for Head and Orthopaedics, Rigshospitalet; University of Copenhagen, Copenhagen, Denmark, ¹⁷Department of Rheumatology and Inflammation Research, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden, ¹⁸Institute of Medicine, University of Gothenburg, Gothenburg, Sweden
Background/Purpose: Several therapeutic options are currently available to treat rheumatoid arthritis (RA); however, the response to treatment is highly variable, and not all patients achieve…
Abstract Number: 0839 • ACR Convergence 2023
Efficacy and Safety of Nipocalimab in Patients with Moderate to Severe Active Rheumatoid Arthritis (RA): The Multicenter, Randomized, Double-blinded, Placebo-controlled Phase 2a IRIS-RA Study
Peter C. Taylor¹, Georg Schett², Fowzia Ibrahim³, Bei Zhou⁴, Jocelyn H. Leu⁵, Sophia G. Liva⁵, Qingmin Wang⁵, Ricardo Rojo Cella⁵, Chetan S. Karyekar⁵ and Kaiyin Fei⁵, ¹Nuffield Department of Orthopedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, United Kingdom, ²Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen, Germany, ³Janssen Research & Development, LLC, High Wycombe, United Kingdom, ⁴Janssen Research & Development, LLC, Chesterbrook, PA, ⁵Janssen Research & Development, LLC, Spring House, PA
Background/Purpose: RA is a chronic inflammatory disease associated with autoantibodies. Despite the use of targeted therapies, up to half of patients fail to achieve remission…
Abstract Number: 1634 • ACR Convergence 2023
Iscalimab (CFZ533) in Patients with Sjögren’s Disease: Week 24 Efficacy and Safety Results of a Randomized, Placebo-controlled, Phase 2b Dose-ranging Study
Benjamin A Fisher¹, Xavier Mariette², Athena S Papas³, Thomas Grader-Beck⁴, Hendrika Bootsma⁵, Wan-Fai Ng⁶, Paul Van Daele⁷, Stephanie Finzel⁸, Sergio Elgueta⁹, Josef Hermann¹⁰, Sara McCoy¹¹, Arthur Bookman¹², Monika Sopala¹³, Wen-Lin Luo¹⁴, Cornelia Scheurer¹³ and Wolfgang Hueber¹³, ¹University of Birmingham, Birmingham, United Kingdom, ²Université Paris-Saclay, Le Kremlin-Bicêtre, France, ³Division of Oral Medicine, Tufts School of Dental Medicine, Boston, MA, ⁴Division of Rheumatology, Johns Hopkins School of Medicine, Baltimore, MD, ⁵Department of Rheumatology, University Medical Centre Groningen, Groningen, Netherlands, ⁶NIHR Newcastle Clinical Research Facility, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, United Kingdom, ⁷Department of internal medicine, Erasmus MC, Rotterdam, Netherlands, ⁸Department of Rheumatology and Clinical Immunology, University Medical Center Freiburg, University of Freiburg, Freiburg, Germany, ⁹Clinical Research Chile SpA, Biomedical Research Centre, Valdivia, Chile, ¹⁰Division of Rheumatology and Immunology, Department of Internal Medicine, Medical University Graz, Graz, Austria, ¹¹University of Wisconsin School of Medicine and Public Health, Middleton, WI, ¹²Toronto Western Hospital, Toronto, ON, Canada, ¹³Novartis Pharma AG, Basel, Switzerland, ¹⁴Novartis Pharmaceuticals Corporation, East Hanover, NJ
Background/Purpose: Sjögren's disease (SjD) is an autoimmune disease affecting secretory glands and other organs with no approved systemic treatments. Iscalimab (CFZ533) is a mAb directed…
Abstract Number: 2151 • ACR Convergence 2023
Effects of Methotrexate on Blood Pressure in Rheumatoid Arthritis: A Randomized Controlled Trial
Sara Tommasi¹, Richard Woodman¹, Michael Wiese², Michael Shanahan¹ and Arduino Mangoni¹, ¹Flinders University, Adelaide, Australia, ²University of South Australia, Adelaide, Australia
Background/Purpose: Treatment with methotrexate (MTX) has been shown to be associated with lower cardiovascular risk and lower blood pressure (BP) compared with other disease modifying…
Abstract Number: 0439 • ACR Convergence 2023
Humoral Immune Response to 13 Valent-conjugate and 23-valent Polysaccharide Pneumococcal Vaccines in RA Patients Treated with Abatacept: Results of the Open Randomized Controlled Trial VACINA (Vaccination Against Pneumococcal in Naïve Abatacept Rheumatoid Arthritis Patients)
JACQUES MOREL¹, Olivier Brocq², Cécile Gaujoux Viala³, Arnaud Constantin⁴, Slim Lassoued⁵, Emanuelle Dernis⁶, Christophe Richez⁷, Cedric Lukas⁸, Claire Daien⁹ and Claire Duflos¹⁰, ¹Protocole thérapeutique immuno-rhumatologie, Montpellier, France, ²Hospital of Princesse Grâce de Monaco, Monaco, Monaco, ³IDESP Univ Montpellier, INSERM, Rheumatology, CHU Nîmes, Montpellier, France, ⁴Teaching hospital Purpan, and University of Paul Sabatier, Toulouse, France, ⁵Hospital of Jean-Rougié, Cahors, France, ⁶CH Le Mans, Le Mans, France, ⁷Université de Bordeaux, Bordeaux, France, ⁸CHU Montpellier, Montpellier, France, ⁹University Hospital, Montpellier, France, ¹⁰CHU and University of Montpellier, Montpellier, France
Background/Purpose: To prevent infections, EULAR recommends to vaccinate RA patients against streptococcal pneumoniae. PCV13 is a T- cell dependent vaccine whereas PPSV23 induces a T-independent…
Abstract Number: 0840 • ACR Convergence 2023
Head-to-Head Comparison of TLL-018 and Tofacitinib in Patients with Active Rheumatoid Arthritis: Final Results from a Phase IIa Study
Xiaofeng Zeng¹, chanyuan wu², Jiankang Hu³, SHENGYUN LIU⁴, Zhenyu Jiang⁵, Jingyang Li⁶, Xiaoxia Wang⁷, Ju Liu⁸, Chaofan Yuan⁹, Guang Yang¹⁰ and Chris Liang¹⁰, ¹Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China, ²Department of Rheumatology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China, ³Pingxiang People’s Hospital, PingXiang, China, ⁴The First Affiliated Hospital Of Zhengzhou University, Zhengzhou, China, ⁵The First Hospital of Jilin University, Changchun, China, ⁶Zhuzhou Central Hospital, Zhuzhou, China, ⁷Second Hospital of Shanxi Medical University, Taiyuan, China, ⁸Jiujiang No. 1 People’s Hospital, JiuJiang, China, ⁹Hangzhou Highlightll Pharmaceutical Co., Ltd, Beijing, China, ¹⁰Hangzhou Highlightll Pharmaceutical Co., Ltd, HangZhou, China
Background/Purpose: None of the currently approved treatments for rheumatoid arthritis (RA) can achieve ACR50 in >50% of the patients, and 5 – 20% of the…
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…

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