Abstracts tagged "clinical trial"

Abstract Number: 0003 • ACR Convergence 2024
CLN-978, a CD19-directed T Cell Engager (TCE), Leads to Rapid and Deep B Cell Depletion and Has Broad Potential for Development in Autoimmune Diseases
Máire F. Quigley¹, Jennifer S. Michaelson¹, Jeffrey Jones¹, Farrukh T. Awan², Geoffrey P. Shouse³, Yue Zhang¹, Todd Shearer¹, Judy Inumerable¹, Irina M. Shapiro¹, Patrick A. Baeuerle¹ and Stephen Wax¹, ¹Cullinan Therapeutics, Inc., Cambridge, ²UT Southwestern Medical Center, Dallas, ³City of Hope Comprehensive Cancer Center, Duarte
Background/Purpose: CD19-directed CAR T cell therapy has been reported to induce profound B cell depletion and deep clinical responses, including drug-free remission, in patients with…
Abstract Number: 0500 • ACR Convergence 2024
An Update on the Integrated Safety Analysis of Filgotinib in Patients with Moderate to Severe Active Rheumatoid Arthritis over a Median of 4.3 Years
Kevin Winthrop¹, Daniel Aletaha², Roberto Caporali³, Yoshiya Tanaka⁴, Tsutomu Takeuchi⁵, Vikas Modgill⁶, Edmund V. Ekoka Omoruyi⁷, Dick de Vries⁸, Katrien Van Beneden⁹, Jacques-Eric Gottenberg¹⁰ and Gerd Burmester¹¹, ¹School of Medicine, Oregon Health and Science University, Portland, OR, ²Department of Medicine III, Division of Rheumatology, Medical University of Vienna, Wien, Austria, ³Department of Clinical Sciences and Community Health, University of Milan, and Department of Rheumatology and Medical Sciences, ASST Gaetano Pini-CTO, Milan, Italy, ⁴Department of Internal Medicine, University of Occupational and Environmental Health, Kitakyushu, Fukuoka, Japan, ⁵Department of Internal Medicine, Keio University, Tokyo, Tokyo, Japan, ⁶Medical Safety, Galapagos NV, Mechelen, Belgium, ⁷Biostatistics, Galapagos NV, Mechelen, Belgium, ⁸Clinical Development, Galapagos BV, Leiden, Netherlands, ⁹Medical Affairs, Galapagos NV, Mechelen, Belgium, ¹⁰Rheumatology Department, Strasbourg University Hospital,, Strasbourg, France, ¹¹Department of Rheumatology and Clinical Immunology, Charité – Universitätsmedizin Berlin, Berlin, Germany
Background/Purpose: The oral Janus kinase 1-preferential inhibitor filgotinib (FIL) is approved at doses of 100 mg (FIL100) and 200 mg (FIL200) for the treatment of…
Abstract Number: 0658 • ACR Convergence 2024
Zetomipzomib (KZR-616), a First-in-Class Selective Immunoproteasome Inhibitor, Demonstrated Improvements in SLE/LN Disease Measures and Biomarkers in Patients with Highly Active SLE or Nephrotic Range Proteinuria in the Open-label Phase 1b/2 MISSION Study
Richard Furie¹, Amit Saxena², Samir Parikh³, Richard Leff⁴, Lucas Bohnett⁵, Kathryn Ray⁶, Brian Tuch⁴, Janet Anderl⁴, Jennifer Whang⁴ and Kiruthi Palaniswamy⁷, ¹Northwell Health, Manhasset, NY, ²NYU School of Medicine, New York, NY, ³Ohio State University, Columbus, OH, ⁴Kezar Life Sciences, South San Francisco, CA, ⁵Kezar Life Sciences, El Cajon, ⁶Kezar Life Sciences, Mill Valley, CA, ⁷Kezar Life Sciences, Inc, South San Francisco, CA
Background/Purpose: Zetomipzomib is a selective inhibitor of the immunoproteasome with anti-inflammatory and immunomodulatory potential without evidence of immunosuppression to date. The MISSION study (NCT03393013), a…
Abstract Number: 0792 • ACR Convergence 2024
Radiographic and Pain Outcomes from a Phase 3 Trial (OA-07) Evaluating the Efficacy and Safety of Repeat Lorecivivint Injections over 3 Years in Subjects with Knee OA
Yusuf Yazici¹, Jeyanesh Tambiah², Christopher Swearingen³ and Timothy McAlindon⁴, ¹NYU Grossman School of Medicine, La Jolla, CA, ²Biosplice Therapeutics Inc., San Diego, CA, ³Biosplice Therapeutics, Inc, San Diego, CA, ⁴University of Massachusets, Worchester, MA
Background/Purpose: Knee OA has unmet need for safe and efficacious symptom and disease-modifying treatments. Lorecivivint (LOR), an intra-articular (IA) CLK/DYRK inhibitor thought to modulate inflammatory…
Abstract Number: 1367 • ACR Convergence 2024
Maintained Improvement of Disease Activity and Patient-reported Outcomes (PROs) with Filgotinib in Patients with Rheumatoid Arthritis (RA) in the Real World: Up to 2-year Interim Data from FILOSOPHY
James Galloway¹, Jérôme Avouac², Gerd Burmester³, Roberto Caporali⁴, Thomas P.A. Debray⁵, Katrien Van Beneden⁶, Neil Betteridge⁷, Susana Romero Yuste⁸, Monia Zignani⁵, Patrick Verschueren⁹ and Karen Bevers¹⁰, ¹Centre for Rheumatic Diseases, King's College London, London, United Kingdom, ²Rheumatology A Department, Hôpital Cochin, AP-HP Centre - Université Paris Cité, Paris, France, ³Department of Rheumatology and Clinical Immunology, Charité – Universitätsmedizin Berlin, Berlin, Germany, ⁴Department of Clinical Sciences and Community Health, University of Milan, and Department of Rheumatology and Medical Sciences, ASST Gaetano Pini-CTO, Milan, Italy, ⁵Alfasigma S.p.A., Bologna, Italy, ⁶Medical Affairs, Galapagos NV, Mechelen, Belgium, ⁷Neil Betteridge Associates, Lonodn, United Kingdom, ⁸Department of Rheumatology, University Hospital Complex of Pontevedra, Pontevedra, Spain, ⁹Department of Rheumatology, University Hospital Leuven and KU Leuven, Leuven, Belgium, ¹⁰Department of Rheumatology, Sint Maartenskliniek, Nijmegen, Netherlands
Background/Purpose: FILOSOPHY (NCT04871919) and PARROTFISH (NCT05323591) are ongoing, prospective, observational Phase 4 studies of filgotinib in patients with RA. This interim analysis evaluated effectiveness and…
Abstract Number: 1473 • ACR Convergence 2024
Patient-Reported Symptoms Improved with Stringent Control of Swollen Joints in Patients with Psoriatic Arthritis: Results from Two Phase 3 Studies of Bimekizumab
M. Elaine Husni¹, Philip Mease², Dafna Gladman³, Barbara Ink⁴, Jérémy Lambert⁵, Patrick Healy⁶ and Laure Gossec⁷, ¹Cleveland Clinic, Cleveland, OH, ²Swedish Medical Center/Providence St. Joseph Health; University of Washington School of Medicine, Seattle, WA, ³University of Toronto, Toronto Western Hospital, Toronto, ON, Canada, ⁴UCB Pharma, Slough, United Kingdom, ⁵UCB Pharma, Colombes, France, ⁶UCB Pharma, Morrisville, NC, ⁷Sorbonne Université, Paris, France
Background/Purpose: PsA is characterized by joint and skin inflammation, and associated with debilitating symptoms of pain and fatigue.1 Previous research has shown that pain and…
Abstract Number: 1745 • ACR Convergence 2024
Use of Statins and Its Association with Major Adverse Cardiovascular Outcomes with Tofacitinib versus TNF Inhibitors in a Risk-Enriched Population of Patients with Rheumatoid Arthritis
Jon Giles¹, christina Charles-Schoeman², Maya H. Buch³, Maxime Dougados⁴, Zoltan Szekanecz⁵, Ted Mikuls⁶, Steven R Ytterberg⁷, Gary G Koch⁸, Kenneth Kwok⁹, Mary Jane Cadatal¹⁰, Sujatha Menon¹¹, Yan Chen¹², Annette M Diehl¹², Jose L Rivas¹³, Arne Yndestad¹⁴ and Deepak L Bhatt¹⁵, ¹Cedars Sinai Medical Center, Los Angeles, CA, ²UCLA Medical Center, Santa Monica, CA, ³Division of Musculoskeletal & Dermatological Sciences, University of Manchester, and NIHR Manchester Biomedical Research Centre, Manchester, United Kingdom, ⁴Université de Paris; Department of Rheumatology, Hôpital Cochin; Assistance Publique-Hôpitaux de Paris; and INSERM (U1153): Clinical Epidemiology and Biostatistics, PRES Sorbonne Paris-Cité, Paris, France, ⁵Department of Rheumatology, Faculty of Medicine, University of Debrecen, Debrecen, Hungary, ⁶University of Nebraska Medical Center, Omaha, NE, ⁷Division of Rheumatology, Mayo Clinic, Rochester, MN, ⁸Department of Biostatistics, University of North Carolina at Chapel Hill, Chapel Hill, NC, ⁹Pfizer Inc, New York, NY, ¹⁰Pfizer Inc, Manila, Philippines, ¹¹Pfizer Inc, Groton, CT, ¹²Pfizer Inc, Collegeville, PA, ¹³Pfizer SLU, Madrid, Spain, ¹⁴Pfizer Inc, Oslo, Norway, ¹⁵Mount Sinai Fuster Heart Hospital, Icahn School of Medicine at Mount Sinai, New York, NY
Background/Purpose: ORAL Surveillance (NCT02092467; a post-authorization safety study of tofacitinib 5 and 10 mg twice daily [BID] vs TNF inhibitors [TNFi]) found higher incidence of…
Abstract Number: 2056 • ACR Convergence 2024
Deucravacitinib Treatment Did Not Impact Immune Response to SARS-CoV-2 Vaccines and Infection in Patients with Plaque Psoriasis: Results from the Phase 3 POETYK Long-Term Extension Trial
Kevin Winthrop¹, Joseph Merola², Akimichi Morita³, Diamant Thaçi⁴, Jianzhong Zhang⁵, Aditi Basu Ba⁶, Ian M. Catlett⁷, John Schwarz⁶ and Yi Luo⁶, ¹School of Medicine, Oregon Health and Science University, Portland, OR, ²UT Southwestern Medical Center, Newton, MA, ³Department of Geriatric and Environmental Dermatology, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan, ⁴Institute and Comprehensive Center for Inflammation Medicine, University of Lübeck, Lübeck, Schleswig-Holstein, Germany, ⁵Department of Dermatology, Peking University People’s Hospital, Beijing, China, ⁶Bristol Myers Squibb, Princeton, ⁷Bristol Myers Squibb, Princeton, NJ
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: 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…
Abstract Number: 2583 • ACR Convergence 2024
Apremilast Reduces Axial Inflammation in Patients with Psoriatic Arthritis as Assessed by CANDEN MRI Scoring: Results from a Phase 4 Study
Mikkel Ostergaard¹, Walter Maksymowych², Robert Lambert², Mikael Boesen³, Guillermo J. Valenzuela⁴, Michael R. Bubb⁵, Olga Kubassova⁶, Xenofon Baraliakos⁷, Carlo Selmi⁸, Stephen Colgan⁹, Yuri Klyachkin¹⁰, Cynthia Deignan¹¹, Zhenwei Zhou¹¹ and Philip Mease¹², ¹Department of Clinical Medicine, University of Copenhagen and Center for Rheumatology, Copenhagen Center for Arthritis Research, Glostrup, Denmark, ²University of Alberta, Edmonton, AB, Canada, ³Copenhagen University Hospital, Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark, ⁴Guillermo Valenzuela MD PA/ IRIS Rheumatology, Plantation, FL, ⁵University of Florida, Gainesville, FL, ⁶Image Analysis Group, Philadelphia, PA, ⁷Rheumazentrum Ruhrgebiet Herne, Ruhr-University Bochum, Herne, Germany, ⁸Department of Biomedical Sciences, Humanitas University, Rozzano, Italy, ⁹Amgen, Halton Hills, ON, Canada, ¹⁰Amgen, Lexington, KY, ¹¹Amgen Inc., Thousand Oaks, CA, ¹²Swedish Medical Center/Providence St. Joseph Health; University of Washington School of Medicine, Seattle, WA
Background/Purpose: Apremilast is an oral phosphodiesterase-4 inhibitor with a unique immunomodulatory mechanism of action and is approved for the treatment of psoriatic arthritis (PsA). Although…
Abstract Number: 0018 • ACR Convergence 2024
Preclinical Analysisof CB-010, an Allogeneic anti-CD19CAR-T Cell Therapywith a PD-1 Knockout, for the Treatment of Patients with Refractory Systemic Lupus Erythematosus (SLE)
Elizabeth Garner, George Kwong, Tristan W Fowler, Heinrich Kufeldt, Brian Kerfs, Julie Kim, Art Aviles, Lynne Alexander, Franco Davi, Chris Holland, Jean-Yves Maziere, Ashraf Garrett, Mara Bryan, Linh Chu, Sarbani Bhaduri, Michele Gerber, Elaine Alambra, Justin Skoble, Tom Kochy, Tonia Nesheiwat, Socorro Portella, Enrique Zudaire and Steven B Kanner, Caribou Biosciences, Berkeley, CA
Background/Purpose: Autologous CD19-directed CAR-T cell therapy has been shown to eradicate aberrant B cells leading to durable clinical responses in SLE patients (Müller 2024; Wang 2024). However, autologous CAR-T cell…
Abstract Number: 0502 • ACR Convergence 2024
Similar Efficacy, PK, Safety, and Immunogenicity of Tocilizumab Biosimilar (CT-P47) and Reference Tocilizumab in Patients with Moderate-to-Severe Active Rheumatoid Arthritis: Week 52 Results from the Phase III Single Transition Study
Gerd Burmester¹, Jakub Trefler², Artur Racewicz³, Janusz Jaworski⁴, Agnieszka Zielińska⁵, Marek Krogulec⁶, Sławomir Jeka⁷, Rafał Wojciechowski⁸, Katarzyna Kolossa⁹, Anna Dudek¹⁰, Magdalena Krajewska-Włodarczyk¹¹, Paweł Hrycaj¹², Piotr Adrian Klimiuk¹³, SungHyun Kim¹⁴, JeeHye Suh¹⁴, GoEun Yang¹⁴, Yunah Kim¹⁴, YooBin Jung¹⁴, JiWoo Hong¹⁴ and Josef Smolen¹⁵, ¹Department of Rheumatology and Clinical Immunology, Charité – Universitätsmedizin Berlin, Berlin, Germany, ²REUMA RESEARCH, Wrocław, Poland, ³Zdrowie Osteo-Medic, Warszawa, Poland, ⁴Reumatika-Centrum Reumatologii, Warszawa, Poland, ⁵MICS Centrum Medyczne Warszawa, Warszawa, Poland, ⁶NZOZ Lecznica MAK - MED, Nadarzyn, Poland, ⁷MICS Centrum Medyczne, Polska, Poland, ⁸Department of Rheumatology and Systemic Connective Tissue Diseases, University Hospital No. 2, Bydgoszcz, PL, Bydgoszcz, Poland, ⁹MICS Centrum Medyczne Bydgoszcz, Bydgoszcz, Poland, ¹⁰Centrum Medyczne Amed, Warszawa, Poland, ¹¹University of Warmia and Mazury, Clinic of Rheumatology, Olsztyn, Poland, ¹²Prywatna Praktyka Lekarska Prof. dr hab. med. Paweł, Poznań, Poland, ¹³Medical University of Bialystok and Inter Clinic Piotr Adrian Klimiuk, Department of Rheumatology and Internal Diseases, Białystok, Poland, ¹⁴Celltrion, Inc., Incheon, Republic of Korea, ¹⁵Medical University of Vienna, Vienna, Austria
Background/Purpose: The therapeutic equivalence of CT-P47 (a proposed biosimilar to reference tocilizumab [ref-tocilizumab]) was demonstrated in patients with moderate to severe RA through disease activity…
Abstract Number: 0659 • ACR Convergence 2024
Obinutuzumab Benefits Patients with Active Lupus Nephritis Irrespective of Baseline Proteinuria Severity: A Post Hoc Analysis of a Phase II Trial
Richard Furie¹, Jorge A. Ross Terres², Elsa Martins³, Imran Hassan⁴, Thomas Schindler³, Jay Garg⁵, William F. Pendergraft III⁶, Ana Malvar⁷ and Brad Rovin⁸, ¹Northwell Health, Manhasset, NY, ²Genentech, Inc,, San Francisco, ³F. Hoffmann-La Roche Ltd, Basel, Switzerland, ⁴Hoffmann-La Roche Ltd, Mississauga, Canada, ⁵Genentech, Inc., South San Francisco, CA, ⁶Genentech, Inc., Chapel Hill, NC, ⁷Organización Médica de Investigación, Buenos Aires, Argentina, ⁸The Ohio State University, Columbus, OH
Background/Purpose: Lupus nephritis (LN) is the most common severe organ-threatening manifestation of systemic lupus erythematosus (SLE). The randomized, placebo-controlled, Phase II NOBILITY trial (NCT02550652) demonstrated…
Abstract Number: 0823 • ACR Convergence 2024
A Randomized, Double-Blind, Placebo-Controlled Trial of Abatacept for the Treatment of Relapsing, Non-Severe, Granulomatosis with Polyangiitis
Carol Langford¹, Nader Khalidi², Jason Springer³, Marcia Friedman⁴, Bernhard Hellmich⁵, Christian Pagnoux⁶, Natasha Dehghan⁷, Ora Singer⁸, Curry Koening⁹, Yih Chang Lin¹⁰, Paul Monach¹¹, Larry Moreland¹², Aurore Fifi-Mah¹³, Oliver Flossmann¹⁴, Lindsy Forbess¹⁵, Peter Lanyon¹⁶, Eamonn Molloy¹⁷, Ulrich Specks¹⁸, Robert Spiera¹⁹, Elaine Yacyshyn²⁰, Carol McAlear²¹, Cristina Burroughs¹⁰, Rachel Jones²², Rennie Rhee²¹, Rula A. Hajj-Ali²³, Kenneth Warrington¹⁸, David Cuthbertson¹⁰, Jeffrey Krischer¹⁰, David Jayne²² and Peter Merkel²¹, and the Vasculitis Clinical Research Consortium and the European Vasculitis Society, ¹Cleveland Clinic, Moreland Hills, OH, ²McMaster University, Hamilton, ON, Canada, ³Vanderbilt University Medical Center, Franklin, TN, ⁴Oregon Health and Science University, Portland, OR, ⁵Medius Kliniken, Kirchheim unter Teck, Germany, ⁶Mount Sinai Hospital, Toronto, ON, Canada, ⁷University of British Columbia - Vancouver, Vancouver, BC, Canada, ⁸University of Michigan, Huntington Woods, MI, ⁹University of Texas Dell Medical School, Austin, TX, ¹⁰University of South Florida, Tampa, FL, ¹¹VA Boston Healthcare System, Boston, MA, ¹²University of Colorado, Denver, CO, ¹³University of Calgary, Calgary, AB, Canada, ¹⁴Royal Berkshire Hospital, Reading, United Kingdom, ¹⁵Cedars-Sinai Medical Center, Los Angeles, CA, ¹⁶University of Nottingham, Nottingham, United Kingdom, ¹⁷St Vincent's University Hospital, Dublin, Ireland, ¹⁸Mayo Clinic, Rochester, MN, ¹⁹Scleroderma, Vasculitis, and Myositis Center, Hospital for Special Surgery, Weill Cornell Medical College, New York, NY, ²⁰University of Alberta, Edmonton, AB, Canada, ²¹University of Pennsylvania, Philadelphia, PA, ²²University of Cambridge, Cambridge, United Kingdom, ²³Cleveland Clinic, Cleveland, OH
Background/Purpose: Granulomatosis with polyangiitis (GPA) is a small-vessel vasculitis associated with frequent relapses. Following encouraging results from an open-label study, a randomized, double-blind, placebo-controlled trial…
Abstract Number: 1376 • ACR Convergence 2024
Comparison of the Efficacy of DMARDs in Phase 3 Trials of Different Populations Used in FDA Approvals for Rheumatoid Arthritis Since 2010
Catherine Emanuel¹ and Ajay Aggarwal², ¹Aclaris Therapeutics Inc., St Louis, MO, ²Aclaris Therapeutics, Inc., Wellesley, MA
Background/Purpose: Varying mechanisms of action are required to address the needs of rheumatoid arthritis patients with different levels of severity. Since 2010, all new FDA…

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