Abstracts tagged "clinical trial"

Abstract Number: 1583 • ACR Convergence 2022
Race and Disease Severity Predict Reduced Response to Treat-to-Target Urate Lowering Therapy in Gout: Post-hoc Analysis of a Multicenter, Randomized, Double-Blind, Non-Inferiority Trial
Lindsay Helget¹, James O'Dell¹, Jeff Newcomb¹, Maria Androsenko², Mary Brophy², Anne Davis-Karim³, Bryant England¹, Ryan Ferguson², Michael Pillinger⁴, Tuhina Neogi⁵, Paul Palevsky⁶, Hongsheng Wu² and Ted Mikuls⁷, ¹University of Nebraska Medical Center, Omaha, NE, ²VA Boston Cooperative Studies Program Coordinating Center, Boston, MA, ³VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center, Albuquerque, NM, ⁴NYU Grossman School of Medicine, New York, NY, ⁵Boston University School of Medicine, Boston, MA, ⁶University of Pittsburgh School of Medicine, Pittsburgh, Pittsburgh, ⁷Division of Rheumatology, University of Nebraska Medical Center, Omaha, NE
Background/Purpose: The ACR recommends a treat-to-target strategy in the management of gout, involving titration of urate lowering therapy (ULT) to a serum urate (SU) goal…
Abstract Number: 1862 • ACR Convergence 2022
Lenabasum Reduces IFNγ and pIRF3 in Dermatomyositis Skin: Biomarker Results from a Double-Blind Phase 3 International Randomized Controlled Trial
Thomas Vazquez¹, Meena Sharma¹, Rui Feng², DeAnna Diaz³, Nilesh Kodali¹, Josh Dan³, Madison Grinnell³, Emily Keyes³, Grant Sprow³, Barbara White⁴ and Victoria Werth³, ¹Philadelphia VAMC, Philadelphia, PA, USA and Department of Dermatology, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, ²University of Pennsylvania, Philadelphia, ³Philadelphia VAMC, Philadelphia, PA, USA and Department of Dermatology, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, ⁴Corbus Pharmaceuticals, Pleasanton, CA
Background/Purpose: Dermatomyositis (DM) is an autoimmune connective tissue disease that primarily affects the skin and lung; few effective treatment options are available. Lenabasum is a…
Abstract Number: 2016 • ACR Convergence 2022
Safety and Efficacy Associated with Long-Term Low Dose Glucocorticoids in Rheumatoid Arthritis: A Systematic Review and Meta-Analysis of Randomized Placebo-Controlled Trials
Andriko Palmowski¹, Sabrina Mai Nielsen², Zhivana Boyadzhieva³, Abelina Schneider³, Anne Pankow³, Linda Hartman⁴, Jose Pereira da Silva⁵, John Kirwan⁶, Siegfried Wassenberg⁷, Christian Dejaco⁸, Robin Christensen⁹, Maarten Boers¹⁰ and Frank Buttgereit¹¹, ¹Department of Rheumatology and Clinical Immunology, Charité – Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany, ²The Parker Institute, Section for Biostatistics and Evidence-Based Research, Bispebjerg-Frederiksberg Hospital, Frederiksberg, Denmark, ³Charité-Universitätsmedizin Berlin, Berlin, Germany, ⁴Amsterdam University Medical Centers, Vrije Universiteit, Amsterdam, Netherlands, ⁵University of Coimbra, Rheumatology, Columbia, Portugal, ⁶University of Bristol, Bristol, United Kingdom, ⁷Rheumazentrum Ratingen, Ratingen, Germany, ⁸Department of Rheumatology, Hospital of Brunico (SABES-ASDAA), Brunico, Italy, and Department of Rheumatology and Immunology, Medical University of Graz, Graz, Austria, ⁹Musculoskeletal Statistics Unit, The Parker Institute, Copenhagen, Denmark, ¹⁰Amsterdam UMC, Vrije Universiteit, Amsterdam, Netherlands, ¹¹Charité Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin / DRFZ Berlin, Berlin, Germany
Background/Purpose: There is ongoing controversy about the safety and efficacy of long-term low dose glucocorticoids (GCs) in rheumatoid arthritis (RA). Our aim was to study…
Abstract Number: 2143 • ACR Convergence 2022
Effect of Upadacitinib and Adalimumab on Residual Pain Among Patients with Psoriatic Arthritis Whose Inflammation Was Attenuated After Three and Six Months of Treatment
Louis Bessette¹, Georg Pongratz², Luca Navarini³, Rodrigo Garcia Salinas⁴, Tianming Gao⁵, Marie-Claude Laliberté⁶, Ralph Lippe⁷ and Philip J Mease⁸, ¹Centre de l'Ostoporose et de Rhumatologie de Québec, Québec, QC, Canada, ²Asklepios Clinic Bad Abbach, University of Regensburg, Regensburg, Germany, ³Rheumatology, Immunology, and Clinical Medicine, Department of Medicine, Campus Bio-Medico University of Rome, Rome, Italy, ⁴Hospital Italiano de La Plata, La Plata, Argentina, ⁵AbbVie, Inc., North Chicago, IL, ⁶AbbVie, Québec, QC, Canada, ⁷AbbVie, Inc, Wiesbaden, Germany, ⁸Swedish Medical Center/Providence St. Joseph Health, Seattle, WA
Background/Purpose: Managing pain, a predominant symptom of psoriatic arthritis (PsA), is a priority for patients and healthcare providers. Upadacitinib (UPA), a Janus kinase (JAK) inhibitor,…
Abstract Number: 0090 • ACR Convergence 2022
Lack of Racial and Ethnic Diversity in Clinical Trials of Psoriatic Arthritis
Niti Goel, TrialSpark, Duke University, Durham, NC
Background/Purpose: Participant diversity in clinical trials of therapeutics in rheumatology is important to evaluate to better understand how individuals of different races and ethnicities might…
Abstract Number: 0310 • ACR Convergence 2022
Higher Baseline Circulating CD4+CXCR5+PD-1hi Follicular Helper T Cells Predict Therapeutic Efficacy of Abatacept in Moderate to Severe Rheumatoid Arthritis
TING WANG, Natalia V. Giltiay, Christian Lood and Bobby Kwanghoon Han, Division of Rheumatology, University of Washington, Seattle, WA
Background/Purpose: Activation of T cells plays a key role in the pathogenesis of rheumatoid arthritis (RA), which is characterized by inflammation of the synovial tissue…
Abstract Number: 0470 • ACR Convergence 2022
Long-term Efficacy of Tocilizumab Monotherapy After Ultra-short Glucocorticoid Administration to Treat Giant Cell Arteritis – One Year Follow-up of the GUSTO Trial
Lisa Christ¹, Luca Seitz², Godehard Scholz¹, Lukas Buetikofer³, Florian Kollert¹, Stephan Reichenbach⁴ and Peter Villiger⁵, ¹Department of Rheumatology and Immunology, University of Bern, Inselspital, Bern, Switzerland, ²Department of Rheumatology and Immunology, University of Bern, Inselspital, Switzerland, ³CTU Bern, University of Bern, Bern, Switzerland, ⁴University of Bern, Institute for Social and Preventive Medicine, Bern, Switzerland, ⁵Medical Center Monbijou, Rheumatology and Immunology, Bern, Switzerland
Background/Purpose: Two randomised controlled trials (RCT) [1, 2] demonstrated a glucocorticoid (GC)-sparing effect of tocilizumab (TCZ) of at least 50% in the treatment of giant…
Abstract Number: 0918 • ACR Convergence 2022
Efficacy and Safety of Filgotinib in Patients with Inadequate Response to Methotrexate, with 4 or < 4 Poor Prognostic Factors: A Post Hoc Analysis of the FINCH 1 Study
BERNARD COMBE¹, Yoshiya Tanaka², Maya Buch³, Gerd Burmester⁴, Beatrix Bartok⁵, Alena Pechonkina⁶, Ling Han⁶, Kahaku Emoto⁷, Shungo Kano⁷, Thijs Hendrikx⁸ and Daniel Aletaha⁹, ¹Montpellier University, Montpellier, France, ²University of Occupational and Environmental Health, Kitakyusyu Fukuoka, Japan, ³University of Manchester and NIHR Manchester Biomedical Research Centre, Manchester, United Kingdom, ⁴Charité University Medicine Berlin, Berlin, Germany, ⁵Gilead Sciences, Inc., La Jolla, CA, ⁶Gilead Sciences, Foster City, CA, ⁷Gilead Sciences, K.K., Tokyo, Japan, ⁸GLPG, Leiden, Netherlands, ⁹Medical University Vienna, Wien, Austria
Background/Purpose: Patients (pts) with rheumatoid arthritis (RA) and poor prognostic factors1 (PPF) are at risk for progression without adequate treatment. Filgotinib (FIL) is a once…
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…

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