Abstracts tagged "clinical trial"

Abstract Number: 0526 • ACR Convergence 2024
Comparing Immunogenicity and Safety Following Transition from Reference Rituximab to Biosimilar Rituximab (DRL_RI) in Patients with Rheumatoid Arthritis: A Randomized, Double-blind, Phase 3 Study
Narendra Maharaj¹, Dharma rao Uppada², Naveen Reddy MAREDDY¹, Pramod Reddy Pundra¹, Anastas Batalov³, Delina Ivanova⁴, nedyalka staykova⁵, Asta Baranauskaite⁶ and Laila Hassan⁷, ¹Clinical Development - Biologics, Dr. Reddy’s Laboratories Ltd., Bachupally, Hyderabad 500090, India, Hyderabad, India, ²Clinical Development - Biologics, Dr. Reddy’s Laboratories Ltd., Bachupally, Hyderabad 500090, India, Hyderabad, ³Medical University of Plovdiv, Medical Faculty, University Hospital "Kaspela", Clinic of Rheumatology, Plovdiv 4000, Bulgaria, Plovdiv, Bulgaria, ⁴Diagnostic and Consulting Center Aleksandrovska EOOD Sofia 1431, Bulgaria, Sofia, Bulgaria, ⁵Outpatient Clinic for Specialized Medical Help – Medical Center Kuchuk Paris OOD; Plovdiv 4004, Bulgaria, plovdiv, Bulgaria, ⁶Hospital of Lithuanian University of Health Sciences Kauno Klinikos, LT-50161, Lithuania, Kaunas, Lithuania, ⁷11914 Astoria Blvd. Ste. 330, Houston TX 77089 United States, Houston, TX
Background/Purpose: To assess immunogenicity and safety in patients with active rheumatoid arthritis (RA) transitioning from US-Rituximab (RP) or EU-Rituximab (RMP) to DRL_RI (proposed rituximab biosimilar),…
Abstract Number: 0670 • ACR Convergence 2024
A Randomized, Open-Label, Phase III Trial Comparing Efficacy and Safety of Intravenous Cyclophosphamide, Mycophenolate Mofetil, or Tacrolimus as Induction Therapy in Lupus Nephritis
Alekhya Amudalapalli, Ashlesha Shukla, Abhichandra Maddineni, Sandeep Nagar, Sudhish Gadde, Harish BV, Rashmi Ranjan Sahoo and Pradeepta Sekhar Patro, IMS and SUM Hospital, Bhubaneswar, India
Background/Purpose: The optimal treatment for lupus nephritis is challenging due to its heterogeneity and the lack of prognostic factors favoring one immunosuppressive drug over another.…
Abstract Number: 1030 • ACR Convergence 2024
Diversity in Axial Spondyloarthritis Drug Trials: Examining Enrollment by Sex, Race, Ethnicity and Geographic Region
Mathieu Choufani¹, Wissam Ghusn² and Joerg Ermann³, ¹Division of Rheumatology, Inflammation, and Immunity, Brigham and Women's Hospital, Boston, MA, ²Department of Internal Medicine, Boston Medical Center, Boston, MA, ³Division of Rheumatology, Inflammation and Immunity, Brigham and Women's Hospital and Harvard Medical School, Boston, MA
Background/Purpose: While axial spondyloarthritis (AxSpA) was historically perceived as a "white man's disease", it is now appreciated as a condition that can affect individuals of…
Abstract Number: 1392 • ACR Convergence 2024
Safety and Efficacy of Upadacitinib (UPA) in Japanese Patients with Rheumatoid Arthritis (RA) and Inadequate Response to Conventional Synthetic DMARDs: Results Through 5 Years from the SELECT-SUNRISE Study
Hideto Kameda¹, Tsutomu Takeuchi², Kunihiro Yamaoka³, Motohiro Oribe⁴, Mitsuhiro Kawano⁵, Masayuki Yokoyama⁶, Yuko Konishi⁶, Sumi Chonan⁶, Sara Penn⁷, Heidi S Camp⁷ and Yoshiya Tanaka⁸, ¹Toho University, Tokyo, Japan, ²Department of Internal Medicine, Keio University, Tokyo, Tokyo, Japan, ³Kitasato University School of Medicine, Kanagawa, Japan, ⁴Oribe Clinic of Rheumatism and Medicine, Oita, Japan, ⁵Kanazawa Medical University, Ishikawa, Japan, ⁶AbbVie GK, Tokyo, Japan, ⁷AbbVie, North Chicago, IL, ⁸Department of Internal Medicine, University of Occupational and Environmental Health, Kitakyushu, Fukuoka, Japan
Background/Purpose: To evaluate the efficacy and safety of UPA in Japanese RA patients (pts) up to 5 yrs in a long term extension (LTE) of…
Abstract Number: 1494 • ACR Convergence 2024
Trajectories of Disease Evolution upon Treatment Initiation in Systemic Lupus Erythematosus: Pooled Results from Three Randomized Clinical Trials of Belimumab
Ioannis Parodis¹, Julius Lindblom², Alexandre Tsoi³, Dionysis Nikolopoulos⁴ and Lorenzo Beretta⁵, ¹Karolinska Institutet, Karolinska University Hospital; Örebro University, Solna, Sweden, ²Karolinska Institutet, Stockholm, Sweden, ³Karolinska Institute, Stockholm, Sweden, ⁴Karolinska Institutet and Karolinska University Hospital, Division of Rheumatology, Department of Medicine Solna, Stockholm, Sweden, ⁵Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di MIlano, Milan, Milan, Italy
Background/Purpose: The efficacy of belimumab in treating SLE has been demonstrated in several phase 3 randomized clinical trials (RCTs). These trials showed belimumab efficacy on…
Abstract Number: 1759 • ACR Convergence 2024
Predictors of Radiographic Spinal Progression in Patients with Axial Spondyloarthritis Receiving IL-17A Inhibitor or TNF Inhibitor Therapy over 2 Years: A Post Hoc Analysis of a Phase IIIb Study
Denis Poddubnyy¹, Juergen Braun², Pedro M Machado³, Victoria Navarro Compán⁴, Lianne S Gensler⁵, Kay Geert Hermann⁶, Erhard Quebe-Fehling⁷, Christelle C Pieterse⁸, Aimee Readie⁹, Corine Gaillez⁷ and Xenofon Baraliakos¹⁰, ¹Charite-Universitatsmedizin Berlin, Berlin, Germany, ²Rheuma Praxis, Ruhr-University Bochum, Berlin, Germany, ³Department of Neuromuscular Diseases and Centre for Rheumatology, University College London, London, United Kingdom, ⁴La Paz University Hospital, Hospital La Paz Institute for Health Research (IdiPAZ), Madrid, Spain, ⁵Department of Medicine/Rheumatology, University of California, San Francisco, San Francisco, CA, ⁶Charite Medical School, Berlin, Germany, ⁷Novartis Pharma AG, Basel, Switzerland, ⁸Syneos Health, Amsterdam, Netherlands, ⁹Novartis Pharmaceuticals Corporation, East Hanover, NJ, ¹⁰Rheumazentrum Ruhrgebiet Herne, and Ruhr-University Bochum, Bochum, Germany
Background/Purpose: Previous studies have identified predictors of radiographic spinal progression in patients with axial spondyloarthritis (axSpA). In this post hoc analysis of the SURPASS study…
Abstract Number: 2102 • ACR Convergence 2024
Unraveling Knee Osteoarthritis Subtypes: Differential Effect of Oral Salmon Calcitonin Treatment
Monica Hannani¹, Peder Frederiksen², Morten Karsdal², Asger Reinstrup Bihlet³, Jaume Bacardit⁴, Anne-Christine Bay-Jensen² and Christian Thudium², ¹Nordic Bioscience & University of Copenhagen, Herlev, Denmark, ²Nordic Bioscience, Herlev, Denmark, ³NBCD A/S, Soeborg, Denmark, ⁴School of Computing, Newcastle University, Newcastle upon Tyne, United Kingdom
Background/Purpose: Osteoarthritis (OA) patients are to this day left without effective treatment options. Despite different etiologies, trials designs do not account for the substantial heterogeneity…
Abstract Number: 2370 • ACR Convergence 2024
Redefining Clinical Trial Inclusion Criteria Using Quality of Life in Cutaneous Lupus Erythematosus
Daniella Faden¹, lillian Xie², Caroline Stone¹, Lais Lopes Almeida Gomes¹, Ahmed Eldaboush¹, Cristina Ricco², Rui Feng² and Victoria Werth³, ¹University of Pennsylvania, Philadelphia, PA, ²University of Pennsylvania, Philadelphia, ³University of Pennsylvania, Wynnewood, PA
Background/Purpose: Regulatory guidance on endpoint measures for disease activity in cutaneous lupus erythematosus (CLE) patients is essential to improve therapies. CLE profoundly impacts quality of…
Abstract Number: 0200 • ACR Convergence 2024
Evaluating the Effectiveness of Educational Initiatives on Recruiting Underrepresented Participants into SLE Clinical Trials
Maria Bacalao¹, Marie Maitre² and Shivani Kottur³, ¹UT Southwestern, Dallas, TX, ²Parkland Hospital, Dallas, TX, ³UT Southwestern Medical Center, Dallas, TX
Background/Purpose: Healthcare disparities in SLE clinical trials are well known, with minoritized individuals facing more significant SLE morbidity and mortality, while being underrepresented in randomized…
Abstract Number: 0533 • ACR Convergence 2024
Using Adalimumab Serum Concentration to Choose a Subsequent DMARD in Rheumatoid Arthritis Patients Failing Adalimumab Treatment (ADDORA-switch): Results of a Blinded Randomized Test Treatment Trial
Maike Wientjes¹, Sadaf Atiqi², Gertjan Wolbink³, Michael Nurmohamed⁴, Maarten Boers⁵, Femke Hooijberg², Theo Rispens⁶, Annick De Vries⁶, Floris Loeff⁶, Ronald Van Vollenhoven⁷, Sofia Ramiro⁸, Noortje van Herwaarden⁹, Bart van den Bemt¹⁰ and Alfons den Broeder¹, ¹Sint Maartenskliniek, Ubbergen, Netherlands, ²Reade, Amsterdam, Netherlands, ³Reade and Sanquin Diagnostic Services, Amsterdam, Netherlands, ⁴Reade and Amsterdam UMC, Kortenhoef, Netherlands, ⁵Amsterdam UMC, Vrije Universiteit, Amersfoort, Netherlands, ⁶Sanquin Diagnostic Services, Amsterdam, Netherlands, ⁷Department of Rheumatology and Clinical Immunology, Amsterdam University Medical Centers, Amsterdam, Netherlands, ⁸Leiden University Medical Center, Bunde, Netherlands, ⁹Sint Maartenskliniek, Nijmegen, Netherlands, ¹⁰Sint Maartenskliniek / Radboudumc, Ubbergen, Netherlands
Background/Purpose: Adalimumab is an effective and safe treatment for RA, however a substantial proportion of RA patients discontinue its use due to inefficacy. Upon failure,…
Abstract Number: 0671 • ACR Convergence 2024
Effect of Litifilimab on Cutaneous Lupus Erythematosus Disease Area and Severity Index–Activity (CLASI-A) Subcomponents and Physician Global Assessment–Skin (PGA–Skin) in Patients with Cutaneous Lupus Erythematosus (CLE) in a Phase 2 Study
Victoria Werth¹, Joseph F. Merola², Qianyun Li³, Weihong Yang³ and Catherine Barbey⁴, ¹Hospital of the University of Pennsylvania, Philadelphia, PA, ²UT Southwestern Medical Center, Dallas, TX, ³Biogen, Cambridge, MA, ⁴Biogen, Baar, Switzerland
Background/Purpose: In the randomized, placebo-controlled Phase 2 LILAC study of litifilimab (NCT02847598), Part B (participants with active CLE with/without SLE) met its primary endpoint of…
Abstract Number: 1039 • ACR Convergence 2024
Through the LuCIN Lens: Defining Barriers and Forging Solutions for Lupus Clinical Trials in North America
Brandon Jackson¹, Maria Dall'Era², Saira Sheikh³, Xueting Zhang⁴, Taylor Irons⁵, Jennifer Meriwether⁶, Maya Merrell¹ and Stacie Bell⁷, ¹Lupus Research Alliance / Lupus Therapeutics, Miami, FL, ²UCSF, Corte Madera, CA, ³University of North Carolina at Chapel Hill, Chapel Hill, NC, ⁴Weill Cornell, New York, NY, ⁵Lupus Research Alliance / Lupus Therapeutics, Houston, ⁶Lupus Research Alliance / Lupus Therapeutics, New York, NY, ⁷Lupus Therapeutics, Lakewood, CO
Background/Purpose: Lupus Therapeutics (LT), the clinical affiliate of the Lupus Research Alliance, oversees the Lupus Clinical Investigators Network (LuCIN), a network of premier research sites…
Abstract Number: 1393 • ACR Convergence 2024
Relationship Between Disease Activity and Adverse Events in Rheumatoid Arthritis: An Integrated Post Hoc Analysis of Upadacitinib Phase 3 Trials
Roy Fleischmann¹, Zoltán Szekanecz², Eduardo Mysler³, Kevin Winthrop⁴, Kunihiro Yamaoka⁵, Kirsten Famulla⁶, Yanna Song⁷, Birgit Kovacs⁷, Sander Strengholt⁸ and Gerd Burmester⁹, ¹Metroplex Clinical Research Center and University of Texas Southwestern Medical Center, Dallas, TX, ²University of Debrecen, Debrecen, Hungary, ³Organizacion Medica de Investigacion, Buenos Aires, AR, Buenos Aires, Argentina, ⁴School of Medicine, Oregon Health and Science University, Portland, OR, ⁵Kitasato University School of Medicine, Sagamihara, Japan, ⁶AbbVie Deutschland GmbH & Co. KG, Immunology, North Chicago, ⁷AbbVie, North Chicago, IL, ⁸AbbVie Inc., North Chicago, IL, ⁹Department of Rheumatology and Clinical Immunology, Charité – Universitätsmedizin Berlin, Berlin, Germany
Background/Purpose: Patients with RA are at a heightened risk of developing significant adverse events (AEs) such as MACE, VTE, and serious infectious events (SIE). Limited…
Abstract Number: 1531 • ACR Convergence 2024
Prospective mRNA SARS-CoV-2 Additional Vaccination in Systemic Autoimmune Disease Patients on Immunosuppressive Medications in a Randomized Controlled Trial
Meggan Mackay¹, Catriona Wagner², Ashley Pinckney³, Jeffrey Cohen⁴, Zachary Wallace⁵, Arezou Khosroshahi⁶, Jeffrey Sparks⁷, Sandra Lord⁸, Amit Saxena⁹, Roberto Caricchio¹⁰, Alfred Kim¹¹, Diane Kamen¹², Fotios Koumpouras¹³, Anca Askanase¹⁴, Kenneth Smith¹⁵, Joel Guthridge¹⁵, Susan Macwana¹⁶, Sean McCarthy¹⁷, Matthew Sherman¹⁸, Sanaz Daneshfar Hamrah¹⁹, Maria Veri¹⁹, Kate York²⁰, Sarah Walker²¹, Sandeep Narpala²², Robin Carroll²², Bob Lin²², Leonid Serebryanny²², Adrian McDermott²³, William Barry²¹, Ellen Goldmuntz²⁴, James McNamara²⁵, Sara Tedeschi²⁶, Amit Bar-Or²⁷, Dinesh Khanna²⁸, ACV01 Clinical Study Team¹⁵ and Judith James¹⁵, ¹Feinstein Institutes for Medical Research, Manhasset, NY, ²Oklahoma Medical Research Foundation, Santa Cruz, CA, ³Rho, St Louis Park, NC, ⁴Neurologic Institute, Cleveland Clinic, Cleveland, OH, USA, Cleveland, OH, ⁵Massachusetts General Hospital, Newton, MA, ⁶Emory University, Atlanta, GA, ⁷Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA, Boston, MA, ⁸Center for Interventional Immunology, Benaroya Research Institute, Seattle, WA., Seattle, WA, ⁹NYU School of Medicine, New York, NY, ¹⁰University of Massachusetts Chan Medical School, Worcester, MA, ¹¹Washington University School of Medicine, Division of Rheumatology, Department of Medicine, St Louis, MO, ¹²Medical University of South Carolina, Charleston, SC, ¹³Yale School of Medicine, New Haven, CT, ¹⁴Columbia University Medical Center, New York, NY, ¹⁵Oklahoma Medical Research Foundation, Oklahoma City, OK, ¹⁶Oklahoma Medical Research Foundation, Oklahoma City, ¹⁷DAIT/NIAID/NIH, Rockville, MD, ¹⁸DAIT/NIAID/NIH, Washington, DC, ¹⁹Division of Allergy, Immunology, and Transplantation, NIH/NIAID, Bethesda, MD, USA., Bethesda, MD, ²⁰Rho Federal Systems Division, Durham, NC, USA., Durham, NC, ²¹Rho, Durham, NC, ²²Vaccine Research Center, NIH/NIAID, Bethesda, MD, USA, Bethesda, MD, ²³Vaccine Research Center, NIH/NIAID, Bethesda, MD, ²⁴NIAID/ NIH, Washington, DC, ²⁵NIH, Bethesda, MD, ²⁶Brigham and Women's Hospital, Boston, MA, ²⁷Department of Neurology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, USA, Philadelphia, PA, ²⁸Division of Rheumatology, Department of Internal Medicine, University of Michigan, Ann Arbor, Michigan, USA, Ann Arbor, MI
Background/Purpose: Autoimmune disease patients treated with mycophenolate mofetil/mycophenolic acid (MMF/MPA), methotrexate (MTX), or B cell-depleting therapies (BCDT) exhibit reduced humoral responses following primary two-dose COVID-19…
Abstract Number: 1760 • ACR Convergence 2024
A Phase 2 Multicenter, Randomized, Double-Blinded, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of a Mitogen-activated Protein Kinase-Activated Protein Kinase 2 (MK2) Inhibitor in Active Ankylosing Spondylitis
Walter Maksymowych¹, Robert Lambert¹, Paula Śliwinska-Stańczyk², Piotr Adrian Klimiuk³, Anusha Yeshokumar⁴, Elizabeth Cerullo⁴, Rebecca Kepich⁴, Chahin Pachai⁴ and Steven Greenberg⁴, ¹University of Alberta, Edmonton, AB, Canada, ²Centrum Medyczne ReumaPark, Warsaw, Poland, ³Medical University of Bialystok and Inter Clinic Piotr Adrian Klimiuk, Department of Rheumatology and Internal Diseases, Białystok, Poland, ⁴Bristol Myers Squibb, Princeton, NJ
Background/Purpose: CC-99677 (also known as BMS-986371) is a novel, orally bioavailable, small-molecule covalent inhibitor of mitogen-activated protein (MAP) kinase-activated protein kinase 2 (MK2). The MK2…

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