Abstracts tagged "clinical trial"

Abstract Number: 0774 • ACR Convergence 2024
A Multicenter, Randomized, Controlled Trial to Evaluate the Effects of Low-dose Glucocorticoids Compared to Stopping Glucocorticoids to Maintain Remission of Granulomatosis with Polyangiitis: The TAPIR Trial
Peter Merkel¹, Christian Pagnoux², Nader Khalidi³, Ulrich Specks⁴, Curry Koening⁵, Carol Langford⁶, Larry Moreland⁷, Paul Monach⁸, Jason Springer⁹, Shubhasree Banerjee¹, Simon Carette¹⁰, Rennie Rhee¹, Medha Soowamber¹¹, Kenneth Warrington⁴, Renee Borchin¹², Cristina Burroughs¹³, Carol McAlear¹, David Cuthbertson¹³ and Jeffrey Krischer¹³, ¹University of Pennsylvania, Philadelphia, PA, ²Mount Sinai Hospital, Toronto, ON, Canada, ³McMaster University, Hamilton, ON, Canada, ⁴Mayo Clinic, Rochester, MN, ⁵University of Texas Dell Medical School, Austin, TX, ⁶Cleveland Clinic, Moreland Hills, OH, ⁷University of Colorado, Denver, CO, ⁸VA Boston Healthcare System, Boston, MA, ⁹Vanderbilt University Medical Center, Franklin, TN, ¹⁰Mount Sinai Hosptial, Toronto, ON, Canada, ¹¹University of Toronto, Toronto, ON, Canada, ¹²University of South Florida, Tampa, ¹³University of South Florida, Tampa, FL
Background/Purpose: Use of low-dose glucocorticoids to maintain remission in patients with granulomatosis with polyangiitis (GPA) remains controversial. Additionally, there is no consensus on how to…
Abstract Number: 1194 • ACR Convergence 2024
Treatment Effect of Lorecivivint Across Multiple Trials in Patients with Knee OA: A Meta-analysis
Christopher Swearingen¹, Jeyanesh Tambiah² and Yusuf Yazici³, ¹Biosplice Therapeutics, Inc, San Diego, CA, ²Biosplice Therapeutics Inc., San Diego, CA, ³NYU Grossman School of Medicine, La Jolla, CA
Background/Purpose: Lorecivivint (LOR), an intra-articular (IA) CLK/DYRK inhibitor thought to modulate inflammatory and Wnt pathways has previously appeared safe, improved patient-reported outcomes (PROs) compared with…
Abstract Number: 1467 • ACR Convergence 2024
Time to First Clinically Meaningful Efficacy Responses in Musculoskeletal and Patient Reported Outcomes in Patients with Active Psoriatic Arthritis Treated with Risankizumab: A Post Hoc Analysis of the Phase 3 KEEPsAKE 1 and KEEPsAKE 2 Trials
William Tillett¹, Simona Rednic², Kristi Mizelle³, Christopher Ritchlin⁴, Saakshi Khattri⁵, Linyu Shi⁶, Brenton Bialik⁶, Thomas Iyile⁷ and Arthur Kavanaugh⁸, ¹Royal National Hospital of Rheumatic Diseases; Department of Life Sciences, Centre for Therapeutic Innovation, University of Bath, Bath, United Kingdom, ²Department of Rheumatology, "Iuliu Hațieganu" University of Medicine and Pharmacy and County Emergency Hospital, Cluj-Napoca, Romania, ³Tidewater Physicians Multispecialty Group (TPMG) Rheumatology, Newport News, VA, ⁴Department of Medicine, Allergy, Immunology, and Rheumatology Division, University of Rochester Medical School, Canandaigua, NY, ⁵Mount Sinai Medical Center, New York, NY, ⁶AbbVie Inc., North Chicago, IL, ⁷AbbVie Inc., hyattsville, MD, ⁸University of California San Diego, La Jolla, CA
Background/Purpose: The phase 3 KEEPsAKE 1 and KEEPsAKE 2 randomized double-blind clinical trials demonstrate that risankizumab (RZB) provides a high level of durable improvement in…
Abstract Number: 1677 • ACR Convergence 2024
Safety and Efficacy of FNS007, a Non-T Cell Receptor Contacting Peptide, for Patients with Active Rheumatoid Arthritis: A Randomized, Double-blind, Placebo-controlled, Proof-of-concept Trial
Ru Li¹, Xing Sun¹, Suping Niu², Xiaolin Sun¹, Guimin Zheng³, Meilu Liu³, Jiyang Lv⁴, Gengmin Zhou⁴, Gang Yuan⁵, Yujin Ye⁵, Shuang Wang⁵, Pingfei Fang⁶, Qi Tang⁶, Jin Kang⁶, Xiaoyue Li⁷, Chao Sun⁷, Song Zhang⁷, Yongjun Mei⁷, Jian Wang⁷, He Su⁷, Lijing Huang⁸, Chenhui Li⁸, Chao Liu⁸, Fengxiao Zhang³, Qingwen Wang⁴, Niansheng Yang⁵, Fen Li⁶, Linjie Chen⁷, Yi Fang² and Zhanguo Li⁹, ¹Department of Rheumatology and Immunology, Peking University People’s Hospital, Beijing, China, ²Clinical Trial Institution, Peking University People’s Hospital, Beijing, China, ³Department of Rheumatology and Immunology, Hebei General Hospital, Shijiazhuang, Hebei, China (People's Republic), ⁴Department of Rheumatism and Immunology, Peking University Shenzhen Hospital, Shenzhen, Guangdong, China (People's Republic), ⁵Department of Rheumatology, First Affiliated Hospital, Sun Yat-sen University, Guangzhou, Guangdong, China (People's Republic), ⁶Department of Rheumatology and Immunology, the Second Xiangya Hospital of Central South University, Changsha, Hunan, China (People's Republic), ⁷Department of Rheumatology, The First Affiliated Hospital of Bengbu Medical College, Bengbu, China, ⁸Hebei Fitness Biotechnology Limited Company, Shijiazhuang, Hebei, China (People's Republic), ⁹Peking univeristy people's hospital, Beijing, China
Background/Purpose: Long-term drug-free remission is an unmet need for the management of rheumatoid arthritis (RA), which might be achieved by restoring antigen-specific immune tolerance. Autoantigenic…
Abstract Number: 2019 • ACR Convergence 2024
Safety and Efficacy of SEL-212 in the US and ex-US Subgroups: Results from the Phase 3 DISSOLVE Studies
Michael Pillinger¹, Alan Kivitz², Atul Singhal³, Anand Patel⁴, Rehan Azeem⁵, Aletta Falk⁶, Bhavisha Desai⁷, Hugues Santin-Janin⁸ and Herbert Baraf⁹, ¹New York University Grossman School of Medicine, New York,, NY, ²Altoona Center for Clinical Research, Duncansville, PA, ³Southwest Arthritis Research Group, Mesquite, TX, ⁴Conquest Research, Winter Park, FL, ⁵Sobi Inc., Waltham, MA, ⁶Sobi, Stockholm, Sweden, ⁷Sobi, Glastonbury, CT, ⁸Sobi, BETTENDORF (68560), France, ⁹Center for Rheumatology and Bone Research, Wheaton, MD
Background/Purpose: The DISSOLVE Phase 3 study program investigated the efficacy and safety of SEL-212, a novel, once-monthly, two-component infusion therapy consisting of pegadricase (SEL-037, a…
Abstract Number: 2286 • ACR Convergence 2024
Certolizumab Inhibits Radiographic Progression Even in RA Patients with High Rheumatoid Factor Levels: A Pooled, Post-Hoc Analysis of Two Phase 3 Trials
Josef Smolen¹, Gerd Burmester², Yoshiya Tanaka³, Tsutomu Takeuchi⁴, Jeffrey Curtis⁵, Ted Mikuls⁶, Clementina López Medina⁷, Peter C. Taylor⁸, Nicola Tilt⁹, Bernard Lauwerys¹⁰, Baran Ufuktepe¹¹ and Thomas Huizinga¹², ¹Medical University of Vienna, Vienna, Austria, ²Department of Rheumatology and Clinical Immunology, Charité – Universitätsmedizin Berlin, Berlin, Germany, ³Department of Internal Medicine, University of Occupational and Environmental Health, Kitakyushu, Fukuoka, Japan, ⁴Department of Internal Medicine, Keio University, Tokyo, Tokyo, Japan, ⁵The University of Alabama at Birmingham, Birmingham, AL, ⁶University of Nebraska Medical Center, Omaha, NE, ⁷Reina Sofia University Hospital, Cordoba, Spain, ⁸University of Oxford, Oxford, United Kingdom, ⁹UCB Pharma, Slough, United Kingdom, ¹⁰UCB Pharma, Brussels, Belgium, ¹¹UCB Pharma, Istanbul, Turkey, ¹²Department of Rheumatology, Leiden University, Leiden, Netherlands
Background/Purpose: In patients (pts) with rheumatoid arthritis (RA), including those treated with disease-modifying antirheumatic drugs, high rheumatoid factor (RF) levels are a poor prognostic factor,…
Abstract Number: 2527 • ACR Convergence 2024
Efficacy and Safety of Nipocalimab, an Anti-FcRn Monoclonal Antibody, in Primary Sjogren’s Disease: Results from a Phase 2, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study (DAHLIAS)
Jacques-Eric Gottenberg¹, Kathy Sivils², Kim Campbell³, Jada Idokogi³, Kim Lo³, Sophia G. Liva³, Jonathan Shelton⁴, Harman Dhatt⁵, Jonathan J. Hubbard³ and Ghaith Noaiseh⁶, ¹Rheumatology Department, Strasbourg University Hospital,, Strasbourg, France, ²Johnson & Johnson Innovative Medicine, Edmond, OK, ³Janssen Research & Development, LLC, a Johnson & Johnson Company, Spring House, PA, ⁴Janssen Scientific Affairs, LLC, San Diego, CA, USA, San Diego, ⁵Janssen Global Services, LLC, a Johnson & Johnson Company, Raritan, NJ, USA, Raritan, NJ, ⁶University of Kansas Medical Center, Kansas City, KS
Background/Purpose: Sjögren’s disease (SjD) is a chronic, systemic autoimmune disease characterized by the presence of specific autoantibodies (AAb) and lymphocytic infiltration of exocrine glandular tissues.…
Abstract Number: 0405 • ACR Convergence 2024
Olokizumab, a Monoclonal Antibody Against IL-6, in Polyarticular-course Juvenile Idiopathic Arthritis (pcJIA): Results of 24 Weeks of the Phase 2 Open-label Clinical Trial
Ekaterina Alexeeva¹, Tatiana Dvoryakovskaya², Elena Zholobova³, Elizaveta Krekhova⁴, Rinat Raupov⁵, Daria Bukhanova⁶, Alina Egorova⁶, Sofia Kuzkina⁶, Mikhail Samsonov⁶, Irina Nikishina⁷ and Mikhail Kostik⁵, ¹National Medical Research Center of Children's Health, Sechenov First Moscow State Medical University of the Ministry of Health of the Russian Federation, Moscow, Russia, ²National Medical Research Center of Children's Health, Moscow, Russia, ³Sechenov First Moscow State Medical University of the Ministry of Health of the Russian Federation, Moscow, Russia, ⁴National Medical Research Centre for Children's Health, Moscow, Russia, ⁵Saint-Petersburg State Pediatric Medical University, Saint Petersburg, Russia, ⁶R-Pharm, Moscow, Russia, ⁷V. A. Nasonova Research Institute of Rheumatology, Moscow, Russia
Background/Purpose: Olokizumab (OKZ) is a direct interleukin-6 inhibitor for treatment of rheumatoid arthritis and is being investigated in the open-label Phase 2 trial in adolescents…
Abstract Number: 0610 • ACR Convergence 2024
Clinical Evaluation on IFI44L Gene Methylation Detection for Diagnosis of Systemic Lupus Erythematosus by Methylation Sensitive High Resolution Melting (MS-HRM)
Xiaoping hong and liancheng lin, The Second Clinical Medical College of Jinan University, Shenzhen, China (People's Republic)
Background/Purpose: To evaluate the clinical effectiveness of IFI44L gene methylation detection for the diagnosis of Systemic Lupus Erythematosus (SLE) by MS-HRM, to determine the relative…
Abstract Number: 0775 • ACR Convergence 2024
A Phase 3, Randomized, Double-Blind, Multicenter, Placebo-Controlled Study of Inebilizumab in IgG4-Related Disease (MITIGATE): Primary Efficacy and Safety Findings
John Stone¹, Emma Culver², Arezou Khosroshahi³, Wen Zhang⁴, Emanuel Della Torre⁵, Kazuichi Okazaki⁶, Yoshiya Tanaka⁷, Matthias Löhr⁸, Nicolas Schleinitz⁹, Lingli Dong¹⁰, Hisanori Umehara¹¹, Marco Lanzillotta¹², Zachary Wallace¹³, Mikael Ebbo¹⁴, George Webster¹⁵, Ferran Martinez Valle¹⁶, Manu Nayar¹⁷, Vinciane Rebours¹⁸, Cory Perugino¹⁹, Xinxin Dong²⁰, Yanping Wu²⁰, Nishi Rampal²⁰ and Daniel Cimbora²⁰, ¹Massachusetts General Hospital , Harvard Medical School, Concord, MA, ²John Radcliffe Hospital, and Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom, ³Emory University, Atlanta, GA, ⁴Peking Union Medical College Hospital, Dong Cheng Qu, China (People's Republic), ⁵Ospedale San Raffaele, Milan, Italy, ⁶University of Occupational and Environmental Health, Osaka, Japan, ⁷Department of Internal Medicine, University of Occupational and Environmental Health, Kitakyushu, Fukuoka, Japan, ⁸Karolinska Institutet, Stockholm, Sweden, ⁹Aix Marseille university, AP-HM, Marseille, France, ¹⁰Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China (People's Republic), ¹¹Department of Rheumatology and Immunology, Nagahama City Hospital,, Nagahama, Shiga 526-0043, Japan, Japan, ¹²IRCCS Ospedale San Raffaele, Milano, Italy, ¹³Massachusetts General Hospital, Newton, MA, ¹⁴Aix-Marseille Université, Marseille, France, ¹⁵University College Hospital London, London, United Kingdom, ¹⁶Vall d’Hebron Hospital, Barcelona, Spain, ¹⁷Freeman Hospital, Newcastle Upon Tyne, United Kingdom, ¹⁸Beaujon Hospital, Université Paris-Cité, France, ¹⁹Massachusetts General Hospital, Boston, MA, ²⁰Amgen Inc., Thousand Oaks, CA
Background/Purpose: IgG4-related disease (IgG4-RD) is a rare, systemic, fibroinflammatory disease characterized by unpredictable and recurring flares, leading to organ damage and decreased quality of life.…
Abstract Number: 1211 • ACR Convergence 2024
An Evaluation of the Efficacy, Pharmacokinetics and Safety, of the Transient Receptor Potential Vanilloid 1 (TRPV1) Agonist RTX-GRT7039 – a Placebo-controlled Study in Patients with Osteoarthritis Knee Pain
Thor Ostenfeld¹, Stefan Ivanicius¹, Roman Stancik² and Philip G Conaghan³, ¹Grunenthal GmbH, Aachen, Germany, ²National Institute of Rheumatic Diseases, Piestany, Slovenia, ³Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, and NIHR Leeds Biomedical Research Centre, Leeds Teaching Hospitals NHS Trust, Leeds, United Kingdom
Background/Purpose: The transient receptor potential vanilloid 1 (TRPV1) is a critical driver of osteoarthritis (OA) pain. RTX-GRT7039 is an investigational medicinal product containing the active…
Abstract Number: 1468 • ACR Convergence 2024
Efficacy of bDMARDs in Early versus Established Disease in Axial Spondyloarthritis: A Meta-Analysis of Randomized Trials
Diego Benavent¹, Victoria Navarro Compán², Dafne Capelusnik³ and Sofia Ramiro⁴, ¹Rheumatology Department, Hospital Universitari de Bellvitge, Barcelona, Spain, CAMBRILS, Spain, ²La Paz University Hospital, Hospital La Paz Institute for Health Research (IdiPAZ), Madrid, Spain, ³Tel Aviv Sourasky Medical Center, Ramat Gan, Israel, ⁴Leiden University Medical Center, Bunde, Netherlands
Background/Purpose: The ASAS consensus definition of ‘early axial spondyloarthritis (axSpA)’ (axial symptoms ≤ 2 years) was expert-based given the scarcity of evidence1. We conducted a…
Abstract Number: 1731 • ACR Convergence 2024
Baricitinib in the Treatment of Adult Idiopathic Inflammatory Myopathy: A Randomized, Treatment Delayed-Start Clinical Trial
hector Chinoy¹, Ashma Krishan¹, Yvonne Sylvestre¹, James Lilleker², Patrick Gordon³, Sarah Tansley⁴, Athiveeraramapandian Prabu⁵, Aamir Aslam⁶, Andrew Snedden⁷ and Janine Lamb⁸, ¹The University of Manchester, Manchester, United Kingdom, ²Northern Care Alliance NHS Trust, Salford, United Kingdom, ³nhs, London, United Kingdom, ⁴University of Bath, Bath, United Kingdom, ⁵Sandwell and West Birmingham Hospitals NHS Trust, Birmingham, United Kingdom, ⁶Leeds Teaching Hospitals NHS Trust, Leeds, United Kingdom, ⁷Northern Care Alliance NHS Foundation Trust, Salford, United Kingdom, ⁸University of Manchester, UK, Manchester, United Kingdom
Background/Purpose: The aim of the study was to assess the effects of baricitinib, a JAK1/2 inhibitor, following 24 weeks of active treatment on disease activity…
Abstract Number: 2020 • ACR Convergence 2024
Prediction of the Response of Patients with Chronic Uncontrolled Gout to Pegloticase
Peter Lipsky¹ and anthony yeo², ¹AMPEL BioSolutions, Charlottesville, VA, ²Independent consultant, Ann arbor, MI
Background/Purpose: Pegloticase is a pegylated recombinant uricase approved for treatment of chronic uncontrolled gout. Because of the development of anti-drug antibodies (ADA), persistent urate lowering…
Abstract Number: 2294 • ACR Convergence 2024
Pharmacodynamic Effects of Nipocalimab on Disease Biomarkers in Patients with Moderate-to-Severe Active Sjögren’s Disease: Results from a Multicenter, Randomized, Double-blinded, Placebo-controlled Phase 2 Study
Kathy Sivils¹, Steven Leonardo², He Li³, Keying Ma⁴, Matthew J. Loza⁵, Jonathan J. Hubbard⁴, Kim Campbell⁴ and Sheng Gao⁴, ¹Johnson & Johnson Innovative Medicine, Edmond, OK, ²Janssen Research & Development, LLC, a Johnson & Johnson Company, Cambridge, MA, ³Janssen Research & Development, LLC, Therapeutics Discovery, Spring House, PA, ⁴Janssen Research & Development, LLC, a Johnson & Johnson Company, Spring House, PA, ⁵Janssen Research & Development, LLC, a Johnson & Johnson company, Spring House, PA, USA, Spring House, PA
Background/Purpose: Nipocalimab is a fully human, immunoglobulin G (IgG) 1 monoclonal antibody that selectively binds to the IgG-binding site of the neonatal crystallizable fragment receptor…

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