Abstracts tagged "clinical trial"

Abstract Number: 1200 • ACR Convergence 2022
Vitamin D and Marine n-3 Fatty Acid Supplementation for Prevention of Autoimmune Disease in the VITAL Randomized Controlled Trial: Outcomes over 7 Years
Karen Costenbader¹, Nancy R Cook², I-Min Lee², Jill Hahn³, Joseph Walter¹, Vadim Bubes¹, Gregory Kotler¹, Nicole Yang¹, Sonia Friedman¹, Erik K Alexander¹ and JoAnn E Manson², ¹Brigham and Women's Hospital, Boston, MA, ²Harvard TH Chan School of Public Health, Brigham and Women's Hospital, Boston, MA, ³Brigham and Womens' Hospital, Boston, MA
Background/Purpose: Strong biologic rationale supports potential effects of both vitamin D and of marine omega-3 (n3) fatty acids for autoimmune disease prevention. Within the randomized…
Abstract Number: 1584 • ACR Convergence 2022
Colchicine or Prednisone for the Treatment of Acute Calcium Pyrophosphate Deposition Arthritis: A Multicenter Randomized Controlled Trial
Tristan Pascart¹, Pierre Robinet², Sebastien Ottaviani³, Remi Leroy⁴, Nicolas Segaud⁵, Aurore Pacaud², Hélène Luraschi², Thibault Rabin², Agathe Grandjean², Xavier Deplanque⁶, Pierre Maciejasz⁶, Fabien Visade², Alexandre Mackowiak², Nicolas Baclet⁶, Antoine Lefebvre², Jean-François Budzik², Thomas Bardin⁷, Pascal Richette⁸, Laurène Norberciak², Vincent Ducoulombier² and Eric Houvenagel¹, ¹Groupement Hospitalier de l'Institut Catholique de Lille, Lomme, France, ²Hôpital Saint-Philibert, Lomme, France, ³Hopital Bichat-Claude Bernard, Paris, France, ⁴Centre Hospitalier de Dunkerque, Dunkerque, France, ⁵Centre Hospitalier d'Armentières, Armentières, France, ⁶Hôpital Saint-Vincent-de-Paul, Lille, France, ⁷Hôpital Lariboisiere, Paris, France, ⁸Department of Rheumatology, Hôpital Lariboisière, Assistance Publique-Hôpitaux de Paris, Paris, France
Background/Purpose: Treatment of acute CPP arthritis mainly relies on expert opinion, as there are no trials that assessed the efficacy of anti-inflammatory drugs, despite the…
Abstract Number: 1891 • ACR Convergence 2022
Osteoarthritis of the Knee, Inflammation, and the Effect of Adalimumab: A Randomized Placebo-Controlled Trial
Walter P Maksymowych¹, Louis Bessette², Robert G Lambert³, Amanda Carapellucci⁴ and Tom Appleton⁵, ¹Department of Medicine, University of Alberta, Edmonton, AB, Canada, ²Centre de l'Ostoporose et de Rhumatologie de Québec, Québec, QC, Canada, ³University of Alberta, Edmonton, AB, Canada, ⁴CARE Arthritis LTD, Edmonton, AB, Canada, ⁵The University of Western Ontario, London, ON, Canada
Background/Purpose: Recent RCTs demonstrated that TNFα inhibition has no effect on pain and MRI-detected synovitis or bone marrow lesions in patients with erosive hand OA.…
Abstract Number: 2031 • ACR Convergence 2022
Efficacy and Safety of Telitacicept in Primary Sjögren’s Syndrome: A Randomized, Double-blind, Placebo-controlled, Phase 2 Trial
Dong Xu¹, Shangzhu Zhang¹, Cibo Huang², Chenghui Huang³, Li Qin⁴, Xiaomei Li⁵, Meiqing Chen⁶, Xiumei Liu⁷, Yi Liu⁸, Zhijun Li⁹, Jiankang Hu¹⁰, Chunde Bao¹¹, wei Wei¹², Jing Tian¹³, Xinwang Duan¹⁴, Jianmin Fang¹⁵ and Xiaofeng Zeng¹⁶, ¹Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China, ²Beijing Hospital, Beijing, China, ³The Second Affiliated Hospital of Guangzhou Medical University, Guangzhou, China, ⁴Huzhou Third Municipal Hospital, Huzhou, China, ⁵Anhui Provincial Hospital, Hefei, China, ⁶The First Affiliated Hospital of Xiamen University, Xiamen, China, ⁷The First Hospital of Shanxi Medical University, Taiyuan, China, ⁸West China Hospital of Sichuan University, Chengdu, China, ⁹The First Affiliated Hospital of Bengbu Medical College, Bengbu, China, ¹⁰Jiangxi Pingxiang People’s Hospital, Shanghai, China, ¹¹Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine, Shanghai, China, ¹²Tianjin Medical University General Hospital, Tianjin, China, ¹³Second Xiangya Hospital of Central South University, Changsha, China, ¹⁴The Second Affiliated Hospital of Nanchang University, Nanchang, China, ¹⁵Shanghai Tongji Hospital, Shanghai, China, ¹⁶Department of Rheumatology, Peking Union Medical College Hospital (PUMCH), Chinese Academy of Medical Sciences National Clinical Research Center for Dermatologic and Immunologic Diseases (NCRC-DID), Beijing, China
Background/Purpose: To evaluate the efficacy and safety of telitacicept in adult patients with primary Sjögren’s syndrome (pSS) in a phase II randomized double-blind placebo-controlled trial.Methods:…
Abstract Number: 2145 • ACR Convergence 2022
Efficacy and Safety of Risankizumab for Active Psoriatic Arthritis: 100-Week Results from the KEEPsAKE 1 and KEEPsAKE 2 Trials
Lars Erik¹, Kim Papp², Douglas White³, Cecilia Asnal⁴, Wenjing Lu⁵, Ahmed Soliman⁵, Byron Padilla⁶, Michael Chen⁵ and Andrew Ostor⁷, ¹Bispebjerg-Frederiksberg Hospital, Vedbæk, Denmark, ²K Papp Clinical Research and Probity Medical Research, Waterloo, ON, Canada, ³Rheumatology Department, Waikato Hospital, and Waikato Clinical School, University of Auckland, Hamilton, New Zealand, ⁴Hospital Alemán, Buenos Aires, Argentina, ⁵AbbVie, Inc., North Chicago, IL, ⁶AbbVie, Inc., Waukegan, IL, ⁷Cabrini Hospital, Monash University & Emeritus Research, Melbourne, Australia
Background/Purpose: PsA is a chronic, systemic inflammatory disease with a variety of clinical manifestations including arthritis, enthesitis, and dactylitis and is associated with skin and…
Abstract Number: 0139 • ACR Convergence 2022
A Clinical Study Designed to Support a Demonstration of Interchangeability Between AVT02 and Reference Adalimumab (Humira®)
Steven Feldman¹, Heimo stroissnig², Richard Kay³, Joanna Sobierska⁴, Roshan Dias⁴, Eric Guenzi⁵, Hendrik Otto², Halimuniyazi Haliduola², Abid Sattar⁶, Ruth Ruffieux⁴, Matjaz Steijger⁴ and Fausto Berti⁴, ¹Wake Forest School of Medicine, Winston-Salem, NC, ²Alvotech, Jülich, Germany, ³RK Statistics, Bakewell, United Kingdom, ⁴Alvotech, Zürich, Switzerland, ⁵UGA Biopharma, Bonn, Germany, ⁶Alvotech, London, United Kingdom
Background/Purpose: To support a demonstration of interchangeability of proposed biosimilar AVT02 and Humira® (reference adalimumab).Methods: Participants with chronic plaque psoriasis were selected for the study…
Abstract Number: 0312 • ACR Convergence 2022
Dose-dependent Suppression of T Cell-Dependent Antibody Response in Healthy Volunteers by KPL-404, an Anti-CD40 Monoclonal Antibody, Supports Phase 2 Study in Patients with Rheumatoid Arthritis
Lara Pupim¹, Gerd Burmester², Fang Fang¹, Alan Kivitz³, Moses Njenga¹, Costantino Pitzalis⁴, Jay Chatfield¹, Anastassia Papandrikopoulou¹, Manoj Samant¹, Steve Schmitz¹, Madeline Spiers¹, Eben Tessari¹, John Ziemniak¹ and John F. Paolini⁵, ¹Kiniksa, Lexington, MA, ²Charité University Medicine Berlin, Berlin, Germany, ³Department of Rheumatology, Altoona Center for Clinical Research, Duncansville, PA, ⁴Queen Mary University of London, London, United Kingdom, ⁵Kiniksa Pharmaceuticals, Lexington, MA
Background/Purpose: An unmet need remains in patients with failure and/or inadequate response (IR) to biological disease-modifying antirheumatic drugs (bDMARD-IR) and/or Janus kinase inhibitors (JAKi-IR). The…
Abstract Number: 0480 • ACR Convergence 2022
Treatment of Giant Cell Arteritis Patients with Ultra-short Glucocorticoids and Tocilizumab: Role of Imaging in a Prospective Study
Francesco Muratore¹, Giulia Cassone², Chiara Marvisi³, ELENA GALLI¹, Luigi Boiardi¹, GIULIA BESUTTI¹, Lucia Spaggiari¹, MASSIMILIANO CASALI¹, Pamela Mancuso¹, Annibale Versari¹, Paolo Giorgi Rossi¹ and Carlo Salvarani⁴, ¹Azienda Unità Sanitaria Locale-IRCCS di Reggio Emilia, Reggio Emilia, Italy, ²Università di Modena e Reggio Emilia, Modena, Italy, ³Università di Modena e Reggio Emilia and National Institute of Arthritis & Musculoskeletal & Skin Diseases, National Institutes of Health, Bethesda, MD, ⁴Azienda Unità Sanitaria Locale-IRCCS di Reggio Emilia, Università di Modena e Reggio Emilia, Reggio Emilia, Italy
Background/Purpose: To evaluate the clinical and functional/morphological imaging response in a series of active large vessel (LV)-GCA patients treated with tocilizumab (TCZ) monotherapy after ultra-short-term…
Abstract Number: 0935 • ACR Convergence 2022
Targeted Synovial Tissue RNA-Seq Coupled with Artificial Intelligence Accurately Predicts Early Rheumatoid Arthritis Patients Likely to Respond to CsDMARDs, Enriching CsDMARDs Response Rates and Enabling Early Identification of Patients Requiring Subsequent Biological Therapy
Giorgio CASABURI, Tyler O'Malley, Todd Holscher and Ming-Chou Lee, Exagen, Inc., Vista, CA
Background/Purpose: Rheumatoid arthritis (RA) is a chronic, inflammatory, systemic autoimmune disease, affecting the joints with varying severity. RA affects approximately 0.5/1% of adults in the…
Abstract Number: 1359 • ACR Convergence 2022
Usability and Acceptability of a Digital Behavioral Therapy for the Management of Fibromyalgia
Nelson Mitchell¹, Yifei Dai², Michael Rosenbluth³, Allison Kraus¹, Maggie Avila¹, Aabha Morey¹, Michael Gendreau⁴, Nicolette Vega¹, Zunera Ghalib¹ and Brian Keefe⁵, ¹Swing Therapeutics, San Francisco, ²Swing Therapeutics, Gainesville, FL, ³Swing Therapeutics, San Francisco, CA, ⁴GENDREAU CONSULTING, LLC, Poway, CA, ⁵Swing Therapeutics, New York, NY
Background/Purpose: Cognitive behavioral therapy (CBT) is considered a gold-standard treatment with demonstrated level 1A evidence for management of fibromyalgia (FM). Acceptance and Commitment Therapy (ACT),…
Abstract Number: 1599 • ACR Convergence 2022
Bimekizumab Treatment in Patients with Active Psoriatic Arthritis and Inadequate Response to Tumor Necrosis Factor Inhibitors: 16-Week Efficacy and Safety from a Phase 3, Randomized, Double-Blind, Placebo-Controlled Study
Joseph Merola¹, Robert Landewé², Iain B McInnes³, Philip J Mease⁴, Christopher Ritchlin⁵, Yoshiya Tanaka⁶, Akihiko Asahina⁷, Frank Behrens⁸, Dafna Gladman⁹, Laure Gossec¹⁰, Richard Warren¹¹, Barbara Ink¹², Deepak Assudani¹², Rajan Bajracharya¹², Jason Coarse¹³ and Laura Coates¹⁴, ¹Harvard Medical School, Brigham and Women's Hospital, Boston, MA, ²Amsterdam University Medical Center, Meerssen, Netherlands, ³Institute of Infection, Immunity and Inflammation, College of Medical, Veterinary and Life Sciences, University of Glasgow, Glasgow, Scotland, United Kingdom, ⁴Swedish Medical Center/Providence St. Joseph Health, Seattle, WA, ⁵Allergy, Immunology and Rheumatology Division, University of Rochester Medical School, Canandaigua, NY, ⁶University of Occupational and Environmental Health, Kitakyusyu Fukuoka, Japan, ⁷Department of Dermatology, The Jikei University School of Medicine, Tokyo, Japan, ⁸Rheumatology University Hospital & Fraunhofer Institute Translational Medicine and Pharmacology, Goethe-University Frankfurt, Frankfurt Am Main, Germany, ⁹Toronto Western Hospital, Schroeder Arthritis Institute, Toronto, ON, Canada, ¹⁰Sorbonne Université, Paris, France, ¹¹The University of Manchester, Manchester, United Kingdom, ¹²UCB Pharma, Slough, United Kingdom, ¹³UCB Pharma, Raleigh, NC, USA, Raleigh, NC, ¹⁴Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK, Oxford, England, United Kingdom
Background/Purpose: Bimekizumab (BKZ) is a monoclonal IgG1 antibody that selectively inhibits IL-17F in addition to IL-17A. The phase 3 BE COMPLETE study assessed the efficacy…
Abstract Number: 1893 • ACR Convergence 2022
Antihistamine Use and Structural Progression of Knee OA: A Post-Hoc Analysis of Two Phase 3 Clinical Trials
Asger Bihlet¹, Claire Miller¹, Inger Byrjalsen¹, Morten Karsdal², Jeppe Andersen¹, Tharaknath Rao³ and Matthew Baker⁴, ¹NBCD, Copenhagen, Denmark, ²Nordic Bioscience, Herlev, Denmark, ³Mobility Bio, San Diego, CA, ⁴Mobility Bio, San Diego
Background/Purpose: Prior studies indicate that mast cells are involved in chronic inflammation and that their activity in the synovium may contribute to structural progression of…
Abstract Number: 2054 • ACR Convergence 2022
Towards a Novel Clinician-Reported Outcome Measure for SLE – Outcomes of an International Consensus Process
Kathryn Connelly¹, Laura Eades², Rachel Koelmeyer³, Darshini Ayton³, Vera Golder², Rangi Kandane-Rathnayake², Kate Gregory-Wong³, Hussein Al-Mossawi⁴, Jeanette Andersen⁵, Cynthia Aranow⁶, Laurent Arnaud⁷, Anca Askanase⁸, Subhashis Banerjee⁹, Catherine Barbey¹⁰, Hermine Brunner¹¹, Joy Buie¹², Laurie Burke¹³, Alain Cornet¹⁴, Karen Costenbader¹⁵, Maria Dall'Era¹⁶, Khadija Dantata¹⁷, Nikolay Delev⁹, Ann Eldred¹⁸, Alan Friedman¹⁹, Richard Furie²⁰, Sandra Garces²¹, Dennis Grasela²², Heath Guay²³, Oliver Guenther²⁴, Maria Juarez²⁵, Shelly Kafka²⁶, Kenneth Kalunian²⁷, Elaine Karis²⁸, Youmna Lahoud²⁹, Catharina Lindholm³⁰, Jeffrey Lockman³¹, Charlotte Lupton³², Justine Maller³³, Ashley Marion³⁴, Patrick Marquis³⁵, Joan Merrill³⁶, Thomas Morel³⁷, Marta Mosca³⁸, Yulia Pincus³⁹, Samantha Pomponi⁴⁰, Guillermo Pons-Estel⁴¹, Jorge Ross Terres³³, Cailin Sibley⁴², Maria Silk⁴³, Sanjeev Roy⁴⁴, Lee S Simon⁴⁵, Alessandro Sorrentino⁴⁶, Christian Stach⁴⁷, George Stojan⁴⁸, Ying Sun²⁴, Yoshiya Tanaka⁴⁹, Erik Thomas⁵⁰, Ronald van Vollenhoven⁵¹, Cristina Vazquez Mateo⁵⁰, Edward M Vital⁵², Victoria Werth⁵³, Eric Zollars²⁸, Qing Zuraw⁵⁴ and Eric Morand⁵⁵, ¹Monash Health, Camberwell, Australia, ²Monash University, Clayton, Australia, ³Monash University, Melbourne, Australia, ⁴AstraZeneca, Bucks, United Kingdom, ⁵Lupus Europe, Lupus DK, EULAR PARE, ERN ReCONNECT, Brussels, Belgium, ⁶Feinstein Institutes for Medical Research, Manhasset, NY, ⁷Hautepierre Hospital, University Hospital of Strasbourg, Rheumatology, Strasbourg, France, ⁸Columbia University Medical Center, New York, NY, ⁹Bristol Myers Squibb, Princeton, NJ, ¹⁰Biogen, Baar, Switzerland, ¹¹Division of Rheumatology, Cincinnati Children's Hospital Medical Center, University of Cincinnati, Department of Pediatrics, Cincinnati, OH, ¹²Lupus Foundation of America, Charleston, SC, ¹³LORA Group, Royal Oak, MD, ¹⁴Lupus Europe, Brussels, Belgium, ¹⁵Brigham and Women's Hospital, Boston, MA, ¹⁶University of California, Division of Rheumatology, San Francisco, CA, ¹⁷Lupus Foundation of America, Richmond Hill, GA, ¹⁸AbbVie, Inc., Lake Bluff, IL, ¹⁹AbbVie, Inc., Libertyville, IL, ²⁰Northwell Health, Great Neck, NY, ²¹Amgen, Inc., Almada, Portugal, ²²Bristol Myers Squibb, Lawrencevile, NJ, ²³AbbVie, Inc., Worcester, MA, ²⁴Merck KGaA, Darmstadt, Germany, ²⁵UCB Pharma, Slough, United Kingdom, ²⁶AbbVie, Inc., Norristown, PA, ²⁷University of California San Diego, La Jolla, CA, ²⁸Amgen, Inc., Thousand Oaks, CA, ²⁹Biogen International GmbH, Milton, MA, ³⁰AstraZeneca, Gothenburg, Sweden, ³¹Bristol-Myers Squibb, New York, NY, ³²AstraZeneca, Cambridge, United Kingdom, ³³Genentech, San Francisco, CA, ³⁴Lupus Foundation of America, Washington, DC, ³⁵Modus Outcomes, Cambridge, MA, ³⁶Oklahoma Medical Research Foundation, Oklahoma City, OK, ³⁷UCB Pharma, Brussels, Belgium, ³⁸University of Pisa, Pisa, Italy, ³⁹Janssen, Flemington, NJ, ⁴⁰Bristol Myers Squibb, Lawrence Township, NJ, ⁴¹Centro Regional de Enfermedades Autoinmunes y Reumáticas, Rosario, Argentina, ⁴²Janssen Research & Development, San Diego, CA, ⁴³Eli Lilly, Carmel, IN, ⁴⁴Global Clinical Development, Ares Trading SA, an affiliate of Merck KGaA, Darmstadt, Germany,⁴⁵SDG LLC, West Newton, MA,⁴⁶AstraZeneca, Sollentuna, Sweden, ⁴⁷UCB Pharma, Monheim, ⁴⁸UCB Pharma, Baltimore, MD, ⁴⁹University of Occupational and Environmental Health, Kitakyusyu Fukuoka, Japan, ⁵⁰EMD Serono, an affiliate of Merck KGaA, Darmstadt, Germany, ⁵¹Amsterdam University Medical Centers, Amsterdam, Netherlands, ⁵²Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, United Kingdom, ⁵³University of Pennsylvania and Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA, ⁵⁴Janssen Research and Development, LLC, Spring House, PA, ⁵⁵Monash University, Victoria; Department of Rheumatology, Monash Health, Melbourne, Australia
Background/Purpose: Most late-phase randomised controlled trials (RCTs) of novel drugs for systemic lupus erythematosus (SLE) have failed to meet their primary endpoint or shown contradictory…
Abstract Number: 2146 • ACR Convergence 2022
Efficacy of Upadacitinib in Patients with Psoriatic Arthritis and Prior Exposure to Anti-TNF Therapy in the SELECT-PsA 2 Trial Through 2 Years
Philip J Mease¹, Rodrigo Luppino Assad², Shigeyoshi Tsuji³, Pascal Richette⁴, Arathi Setty⁵, Erin McDearmon-Blondell⁶, Tianming Gao⁵, Sandra Ciecinski⁶ and Filip Van den bosch⁷, ¹Swedish Medical Center/Providence St. Joseph Health, Seattle, WA, ²Department of Internal Medicine, Ribeirão Preto Medical School, University of São Paulo, São Paulo, Brazil, ³Department of Orthopaedics and Rheumatology, Nippon Life Hospital, Osaka, Japan, ⁴Department of Rheumatology, Hôpital Lariboisière, Assistance Publique-Hôpitaux de Paris, Paris, France, ⁵AbbVie, Inc., North Chicago, IL, ⁶AbbVie, Inc., Mettawa, IL, ⁷Department of Internal Medicine and Paediatrics, Ghent University and VIB Centre for Inflammation Research, Ghent, Belgium
Background/Purpose: Patients with psoriatic arthritis (PsA) who experience anti-TNF failure and switch to another TNF inhibitor as second- or third-line therapy typically show poorer responses…
Abstract Number: L07 • ACR Convergence 2021
Depletion of KLRG1+ T Cells in a First-in-human Clinical Trial of ABC008 in Inclusion Body Myositis (IBM)
Niti Goel¹, Dulce Soler-Ferran², Monette Coutreau², Jorge Escobar³, Kate Courtemanche², Merrilee Needham⁴ and Steven Greenberg⁵, ¹Abcuro, Inc.; Duke University, Durham, NC, ²Abcuro, Inc., Newton, MA, ³Abcuro, Inc., Hayward, CA, ⁴Perron Institute, Murdoch University, Perth, Australia, ⁵Brigham and Women's Hospital, Harvard Medical School, Boston, MA
Background/Purpose: Inclusion body myositis (IBM), a relentlessly progressive autoimmune skeletal muscle disease, has no effective available pharmacological therapy. A prominent feature of IBM on microscopy…

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