Abstracts tagged "Randomized Trial"

Abstract Number: L08 • ACR Convergence 2024
A Phase 2b, Randomized, Double-blind, Placebo-controlled, Dose-ranging and Parallel-group Study to Evaluate the Safety and Efficacy of XG005 in Subjects with Painful Osteoarthritis of the Knee
Limin Ren¹, Wenjie Zheng², Zhenpeng Guan³, Yang Zhang⁴, Zeyu Huang⁵, Tong Li⁶, Yuwei Peng⁷, Qiuli Wu⁸, Wei Gou⁹, Wei Zhao¹⁰, Pengyan Qiao¹¹, Xiaoli Pan¹² and Guang-Liang Jiang¹³, ¹Peking University, People’s Hospital, Rheumatology and Immunology Department, Beijing, China, ²Yantai Yuhuangding Hospital of Qingdao University, Department of Orthopedics, Yantai, China, ³Peking University, Shougang Hospital, Department of Orthopedics, Beijing, China, ⁴Division of Orthopaedic Surgery, Nanfang Hospital, Southern Medical University, Guangzhou, China, ⁵West China Hospital of Sichuan University, Department of Orthopedics, Chengdu, China, ⁶Xiangya Hospital of Central South University, Rheumatology and Immunology Department, Changsha, China, ⁷PingXiang People’s Hospital, Rheumatology and Immunology Department, Pingxiang, China, ⁸Tianjin Medical University General Hospital, Department of Orthopedics, Tianjin, China, ⁹Hebei Petrochina Central Hospital, Rheumatology and Immunology Department, Langfang, China, ¹⁰Central Hospital Affiliated to Shenyang Medical College, Department of Orthopedics, Shenyang, China, ¹¹Shanxi Bethune Hospital, Shanxi Academy of Medical Sciences, Third Hospital of Shanxi Medical University, Tongji Shanxi Hospital, Rheumatology and Immunology Department, Taiyuan, China, ¹²Affiliated Hospital of Zunyi Medical University, Rheumatology and Immunology Department, Zunyi, China, ¹³Xgene Pharmaceutical, Lexington, MA
Background/Purpose: Osteoarthritis (OA) affects 595 million people globally; cases are projected to increase 49-95% for various joints by 2050 as populations age (GBD 2023). OA…
Abstract Number: L14 • ACR Convergence 2024
A Withdrawal Study of Colchicine in Behçet Syndrome
Basak Sirin¹, Sinem Nihal Esatoglu², Hasan Yazıcı³ and Gulen Hatemi⁴, ¹Istanbul University- Cerrahpaşa, Cerrahpaşa Medical Faculty, Department of Internal Medicine, Istanbul, Turkey, ²Istanbul University- Cerrahpaşa, Cerrahpaşa Medical Faculty, Department of Internal Medicine, Division of Rheumatology, Istanbul,Türkiye/Istanbul University- Cerrahpaşa, Behcet's Disease Research Center, Istanbul, Turkey, ³Academic Hospital, Istanbul, Turkey, ⁴Istanbul University- Cerrahpaşa, Cerrahpaşa Medical Faculty, Department of Internal Medicine, Division of Rheumatology, Istanbul,Türkiye/Istanbul University- Cerrahpaşa, Behcet's Disease Research Center, Istanbul,Türkiye, Istanbul, Turkey
Background/Purpose: Previous randomized controlled studies reported conflicting results regarding the effectiveness of colchicine on oral ulcers in Behçet syndrome (BS). A randomized drug discontinuation design…
Abstract Number: L15 • ACR Convergence 2024
LEVI-04, a Novel neurotrophin-3 Inhibitor, Substantially Improves Pain and Function Without Deleterious Effects on Joint Structure in People with Knee Osteoarthritis: A Randomized Controlled Phase II Trial
Philip Conaghan¹, Ali Guermazi², Nathaniel Katz³, Asger Bihlet⁴, Dror Rom⁵, Michael Perkins⁶, Bernadette Hughes⁶, Claire Herholdt⁶, Iwona Bombelka⁶ and Simon Westbrook⁶, ¹University of Leeds, Leeds, United Kingdom, ²Boston University, West Roxbury, MA, ³Rin Sof Innovation, Ltd, Boston, MA, ⁴NBCD A/S, Soeborg, Denmark, ⁵Prosoft Clinical, Chesterbrook, ⁶Levicept Ltd, Ramsgate, United Kingdom
Background/Purpose: There is an urgent need for new therapies to treat OA. Excess neurotrophins (NT) are implicated in OA and other painful conditions. Previous OA…
Abstract Number: L16 • ACR Convergence 2024
Dapirolizumab Pegol Demonstrated Significant Improvement in Systemic Lupus Erythematosus Disease Activity: Efficacy and Safety Results of a Phase 3 Trial
Megan Clowse¹, David Isenberg², Joan Merrill³, Thomas Dörner⁴, Michelle Petri⁵, Edward Vital⁶, Eric Morand⁷, Teri Jimenez⁸, Stephen Brookes⁹, Janine Gaiha-Rohrbach¹⁰, Christophe Martin¹¹, Annette Nelde¹² and Christian Stach¹³, ¹Division of Rheumatology and Immunology, Duke University, Durham, NC, ²Department of Ageing, Rheumatology and Regenerative Medicine, Division of Medicine, University College London, London, United Kingdom, ³Oklahoma Medical Research Foundation, Oklahoma City, OK, ⁴Department of Medicine/Rheumatology and Clinical Immunology, Charité Universitätsmedizin Berlin, Berlin, Germany, ⁵Johns Hopkins University School of Medicine, Baltimore, MD, ⁶Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds and NIHR Leeds Biomedical Research Centre, Leeds Teaching Hospitals NHS Trust, Leeds, United Kingdom, ⁷Centre for Inflammatory Diseases, Monash University, Melbourne, Australia, ⁸UCB, Raleigh, NC, ⁹Biogen, Maidenhead, United Kingdom, ¹⁰Biogen, Cambridge, MA, ¹¹UCB, Slough, United Kingdom, ¹²Biogen, Baar, Switzerland, ¹³UCB, Monheim am Rhein, Germany
Background/Purpose: Dapirolizumab pegol (DZP) is a novel, polyethylene glycol (PEG)-conjugated antigen-binding (Fab') fragment, lacking an Fc domain, that inhibits CD40L signaling. By binding to CD40L,…
Abstract Number: 0217 • ACR Convergence 2024
Understanding Treatment Goals and Factors Influencing Decisions About Clinical Trial Participation in Lupus Patients from Diverse Backgrounds
Joy Buie¹, Safoah Agyemang¹ and Joan Merrill², ¹Lupus Foundation of America, Washington, DC, ²Oklahoma Medical Research Foundation, Oklahoma City 73104, OK
Background/Purpose: With many emerging treatments in development for lupus, clinical trial recruitment has become increasingly difficult. Growing appreciation of patient input into trial design may be of …
Abstract Number: 1131 • ACR Convergence 2024
Zasocitinib (TAK-279), a Selective Oral Tyrosine Kinase 2 Inhibitor, Reduces Body Surface Area Involvement in a Phase 2b Trial in Moderate-to-Severe Plaque Psoriasis
Vivian Laquer¹, Leon Kircik², Neil Sadick³, Jamie Weisman⁴, Yiwei Zhao⁵, Jessamyn Blau⁵, Wenwen Zhang⁶, Jonathan Uy⁵, Warren Winkelman⁶ and Melinda Gooderham⁷, ¹First OC Dermatology Research, Fountain Valley, CA, ²Icahn School of Medicine at Mount Sinai, New York, NY, ³Weill Cornell Medical College, New York, NY, ⁴Piedmont Atlanta, Atlanta, GA, ⁵Takeda Development Center Americas, Inc., Cambridge, MA, ⁶Takeda Development Center Americas, Inc., Cambridge, ⁷SKiN Centre for Dermatology and Probity Medical Research, Peterborough, ON, Canada
Background/Purpose: Zasocitinib (TAK-279) is a highly selective, allosteric, oral inhibitor of tyrosine kinase 2 (TYK2). TYK2 mediates signaling from cytokines involved in the pathogenesis of…
Abstract Number: 1542 • ACR Convergence 2024
Efficacy and Safety Results from a Phase 2 Trial of Daxdilimab in Patients with Systemic Lupus Erythematosus
Arezou Khosroshahi¹, Sarah Welsh², Liangwei Wang², David Larson² and Nisha Jain², ¹Emory University, Atlanta, GA, ²Amgen, Inc., Rockville, MD
Background/Purpose: SLE, an autoimmune disease affecting multiple organ systems, is characterized by periods of flares and remission. Type I interferon secreted at high levels by…
Abstract Number: 1735 • ACR Convergence 2024
High-Intensity Interval Training Outperforms Moderate Exercise in Aerobic Capacity for Recent-Onset Idiopathic Inflammatory Myopathies: A Randomized Controlled Trial
Kristofer Andreasson¹, Cecilia Leijding¹, Maryam Dastmalchi², Antonella Notarnicola³, Stefano Gastaldello¹, Heléne Sandlund², Daniel Andersson⁴, Ingrid Lundberg⁵ and Helene Alexanderson², ¹Karolinska Institutet, Stockholm, Sweden, ²Karolinska University hospital, Stockholm, Sweden, ³Karolinska University Hospital and Karolinska Institutet, Stockholm, Stockholms Lan, Sweden, ⁴Karolinska Institutet, Solna, Sweden, ⁵Karolinska Universitetssjukhuset, Karolinska Institutet, Stockholm, Sweden
Background/Purpose: Exercise is a recognized adjunctive therapy for patients with idiopathic inflammatory myopathies (IIM), enhancing physical capacity and reducing inflammation. Hitherto, moderate-to-intensive exercise has been…
Abstract Number: 2353 • ACR Convergence 2024
Effects of Guselkumab on cDAPSA Disease Activity State and Its Association with Long-Term Radiographic Progression in a Cohort of Patients with Moderately-Highly Active Psoriatic Arthritis: Post Hoc Analyses of Phase 3 Randomized Controlled Studies
Philip Mease¹, Alice Gottlieb², Iain McInnes³, Natalie J. Shiff⁴, Toby Thomas⁵, Emmanouil Rampakakis⁶, Francois Nantel⁷, Frederic Lavie⁸ and Proton Rahman⁹, ¹Swedish Medical Center/Providence St. Joseph Health; University of Washington School of Medicine, Seattle, WA, ²Icahn School of Medicine at Mount Sinai, Department of Dermatology, Seattle, WA, ³University of Glasgow, College of Medical Veterinary and Life Sciences, Glasgow, United Kingdom, ⁴Janssen Scientific Affairs, LLC / University of Saskatchewan, Adjunct, Community Health and Epidemiology, Horsham, PA, ⁵Janssen Pharmaceuticals, Horsham, PA, ⁶McGill University, Department of Pediatrics / Scientific Affairs, JSS Medical Research Inc., Montreal, QC, Canada, ⁷Nantel MedSci Consult, Montreal, QC, Canada, ⁸Janssen Cilag Global Medical Affairs, Immunology Global Medical Affairs, Issy les Moulineaux, France, ⁹Memorial University of Newfoundland, Faculty of Medicine, Division of Rheumatology, St. John's, Canada
Background/Purpose: In the Phase 3 DISCOVER (D)-1 and -2 studies, guselkumab (GUS; IL-23p19-subunit inhibitor) 100 mg every 4 weeks (Q4W) or Q8W significantly improved joint…
Abstract Number: 2686 • ACR Convergence 2024
Dose Escalation Safety Study of Brentuximab Vedotin for Diffuse Cutaneous Systemic Sclerosis:Clinical Results and Mechanistic Analysis of Skin and Peripheral Blood Mononuclear Cells
David Fox¹, Laura Cooney², Lia Stelzig³, Robert Lafyatis⁴, Johann Gudjonsson⁵, Lam Tsoi⁶, Maureen Mayes⁷, Ankoor Shah⁸, Suzanne Kafaja⁹, William Barry³, Ellen Goldmuntz¹⁰, Dawn Smilek¹¹ and Dinesh Khanna⁶, ¹University of Michigan, Dexter, MI, ²University of Michigan and Immune Tolerance Network, Ann Arbor, MI, ³Rho, Durham, NC, ⁴Division of Rheumatology and Clinical Immunology, University of Pittsburgh, Pittsburgh, PA, ⁵Department of Dermatology, University of Michigan, Ann Arbor, MI, ⁶University of Michigan, Ann Arbor, MI, ⁷UTHealth Houston Division of Rheumatology, Houston, TX, ⁸Duke University, Durham, NC, ⁹Division of Rheumatology, University of California, Los Angeles, Los Angeles, CA, ¹⁰Division of Allergy, Immunology, and Transplantation, National Institute of Allergy and Infectious Diseases, Rockville, MD, ¹¹Immune Tolerance Network, UCSF, San Francisco, CA
Background/Purpose: Brentuximab vedotin (ADCETRIS®) is a drug antibody conjugate targeting CD30 approved for treatment of Hodgkin’s lymphoma (HL) and other hematologic malignancies. Association of CD30…
Abstract Number: 0290 • ACR Convergence 2024
Deucravacitinib Long-term Efficacy Through 4 Years in Week 16 Placebo Crossover Patients in the Phase 3 POETYK PSO-1, PSO-2, and LTE Program
Mark Lebwohl¹, Richard Warren², Shinichi Imafuku³, Jerry Bagel⁴, April W. Armstrong⁵, Thierry Passeron⁶, Subhashis Banerjee⁷, Renata M. Kisa⁸, Matthew J. Colombo⁷, Thomas Scharnitz⁸, Kim Hoyt⁸, Diamant Thaçi⁹ and Andrew Blauvelt¹⁰, ¹Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, NY, ²Dermatology Centre, Northern Care Alliance NHS Foundation Trust and NIHR Manchester Biomedical Research Centre, Manchester University NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester, United Kingdom, ³Fukuoka University Hospital Faculty of Medicine, Fukuoka, Japan, ⁴Psoriasis Treatment Center of New Jersey, East Windsor, ⁵University of California Los Angeles, Los Angeles, ⁶Université Côte d’Azur, University Hospital of Nice, Nice, France, ⁷Bristol Myers Squibb, Princeton, NJ, ⁸Bristol Myers Squibb, Princeton, ⁹Institute and Comprehensive Center for Inflammation Medicine, University of Lübeck, Lübeck, Schleswig-Holstein, Germany, ¹⁰Oregon Medical Research Center, Portland, OR
Background/Purpose: Deucravacitinib, an oral, selective, allosteric tyrosine kinase 2 inhibitor, is approved in the US, EU, and other countries for treatment of adults with moderate…
Abstract Number: 1137 • ACR Convergence 2024
Deucravacitinib, an Oral,Selective,Allosteric Tyrosine Kinase 2 Inhibitor, in Patients WithModerate to Severe Scalp Psoriasis: Efficacy and Safety Results of a Phase 3b/4, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Trial (PSORIATYK SCALP)
Kristina Callis Duffin¹, Christopher E. M. Griffiths², Matthias Hoffmann³, Andrew Blauvelt⁴, Eugene Balagula⁵, Andrew Napoli⁵, Ying-Ming Jou⁵, Rachel Dyme⁵, Virginia Hala⁵, andreas pinter⁶ and Mark Lebwohl⁷, ¹University of Utah, Salt Lake City, ²Dermatology Centre, University of Manchester, Manchester, and King’s College Hospital and King’s College London, London, United Kingdom, ³Private Practice, Witten, Germany, ⁴Oregon Medical Research Center, Portland, OR, ⁵Bristol Myers Squibb, Princeton, ⁶University Hospital of the Goethe University, Frankfurt am Main, Frankfurt, Germany, ⁷Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, NY
Background/Purpose: Deucravacitinib, an oral, selective, allosteric tyrosine kinase 2 (TYK2) inhibitor, is approved in the US, EU, and other countries for treatment of adults with…
Abstract Number: 1552 • ACR Convergence 2024
Kinetics of Mucocutaneous and Musculoskeletal Responses to Deucravacitinibin Patients with Active SLE in the Phase 2 PAISLEY Trial
Ronald Van Vollenhoven¹, Joseph Merola², Kathryn H. Dao³, Piotr Leszczynski⁴, Marilyn Pike⁵, Samantha Pomponi⁶, Coburn Hobar⁶, Matthew J. Colombo⁶, Ravi Koti⁶, Subhashis Banerjee⁶, Thomas Wegman⁷ and Eric Morand⁸, ¹Department of Rheumatology and Clinical Immunology, Amsterdam University Medical Centers, Amsterdam, Netherlands, ²UT Southwestern Medical Center, Newton, MA, ³Department of Internal Medicine, Division of Rheumatology, The University of Texas Southwestern Medical Center, Dallas, ⁴Department of Internal Medicine, Poznań University of Medical Sciences, Poznań, Poland, ⁵Rheumatology, MedPharm Consulting, Inc., Raleigh, NC, ⁶Bristol Myers Squibb, Princeton, NJ, ⁷Bristol Myers Squibb, Beaver Falls, PA, ⁸School of Clinical Sciences, Monash University, Melbourne, Victoria, Australia
Background/Purpose: Deucravacitinib is a first-in-class, oral, selective, allosteric tyrosine kinase 2 (TYK2) inhibitor approved in multiple countries for the treatment of moderate to severe plaque…
Abstract Number: 1988 • ACR Convergence 2024
A Randomized, Open-Label Study on the Effect of Nipocalimab on Vaccine Responses in Healthy Participants
Marta Cossu¹, Carolina Bobadilla Mendez², Amanda Jackson³, Eugene Myshkin⁴, Grace Liu⁵, Edwin Lam⁶, Ulf H. Beier², Kathleen Weisel², Brittney Scott², Jocelyn H. Leu⁶, Sheng Gao² and Dessislava Dimitrova², ¹Janssen Pharmaceutical Research and Development, a Johnson & Johnson company, Leiden, Netherlands, ²Janssen Research & Development, LLC, a Johnson & Johnson company, Spring House, PA, ³Janssen Research & Development, LLC, La Jolla, CA, ⁴Janssen Research & Development, LLC, a Johnson & Johnson company, Cambridge, MA, ⁵Janssen Research & Development, LLC, a Johnson & Johnson company, Raritan, NJ, ⁶Janssen Research & Development, LLC, a Johnson & Johnson company, Spring House, PA, PA
Background/Purpose: Nipocalimab is a human IgG1 monoclonal antibody targeting the neonatal Fc receptor (FcRn) that selectively reduces IgG levels without impacting antigen presentation, T- and…
Abstract Number: 2355 • ACR Convergence 2024
Efficacy of Risankizumab Across Distinct PsA Phenotypes Identified with Machine Learning Analytics Using Data from Biologic DMARD-Naive Patients in Two Phase 3 Clinical Trials
Laure Gossec¹, Andra Balanescu², Maria Antonietta D'Agostino³, Alexis Ogdie⁴, Philipp Sewerin⁵, Yu Deng⁶, Linyu Shi⁶, Yoshiyuki Sugimoto⁷, Sheng Zhong⁶, Yunzhao Xing⁶, Ralph Lippe⁶ and Mitsumasa Kishimoto⁸, ¹Sorbonne Université, Paris, France, ²UNIVERSITY OF MEDICINE AND PHARMACY CAROL DAVILA, Bucharest, Romania, ³Versailles-Saint-Quentin University (INSERM U1173, Laboratoire d’Excellence INFLAMEX); University Hospital Ambroise Paré, Versailles, France, ⁴Department of Medicine, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, ⁵Rheumazentrum Ruhrgebiet, Ruhr University Bochum, Bochum, Germany, ⁶AbbVie Inc., North Chicago, IL, ⁷AbbVie GK, Tokyo, Tokyo, Japan, ⁸Department of Nephrology and Rheumatology, Kyorin University School of Medicine, Tokyo, Japan
Background/Purpose: Risankizumab (RZB), an IL-23 p19 inhibitor, is well tolerated and provides long-term efficacy through 100 weeks in adults with PsA, demonstrated by the phase…

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