Abstracts tagged "clinical trial"

Abstract Number: 0819 • ACR Convergence 2023
Regression to the Mean for Physical Function and Quality of Life in Trials for Symptomatic Knee Osteoarthritis
Martin Englund and Aleksandra Turkiewicz, Lund University, Lund, Sweden
Background/Purpose: Improvement in pain reported in clinical trials for osteoarthritis (OA) is typically strongly depending on the regression-to-the-mean phenomenon. Regression to the mean has been…
Abstract Number: 1318 • ACR Convergence 2023
Abatacept Modulates Both Global and Citrulline Specific T Cell Signatures: Results from Inhibition of Co-Simulation in Rheumatoid Arthritis Phase IV Trial
Ravi Kumar Sharma¹, Aysin Tulunay Virlan², Louise Bennett³, John Cole³, Sam McAllister², Sara Turcinov⁴, Samantha Miller³, Fraser Morton³, Ashley Gilmour³, Sean Kerrigan³, Anatoly Dubnovitsky¹, Leonid Padyukov⁵, Caron Paterson³, William Kwok⁶, René Toes⁷, Lars Klareskog⁸, Arthur Pratt⁹, John Isaacs¹⁰, Sean Connolly¹¹, Duncan Porter³, Stefan Siebert¹², Iain McInnes³, Vivianne Malmström⁸ and Carl Goodyear³, ¹Division of Rheumatology, Department of Medicine Solna, Center for Molecular Medicine, Karolinska University Hospital, Karolinska Institutet, Stockholm, Sweden, ²University of Glasgow - School of Infection & Immunity, Glasgow, United Kingdom, ³University of Glasgow, Glasgow, United Kingdom, ⁴Division of Rheumatology, Department of Medicine Solna, Center for Molecular Medicine, Karolinska Institutet. Theme of Inflammation and Ageing, Medical Unit Gastro, Derma, Rheuma, Karolinska University Hospital, Stockholm, Sweden, ⁵Karolinska Institutet, Solna, Sweden, ⁶Benaroya Research Institute at Virginia Mason, Seattle, WA, ⁷Leiden University Medical Center, Leiden, Netherlands, ⁸Karolinska Institutet, Stockholm, Sweden, ⁹Immunity and Inflammation Theme, Translational and Clinical Research Institute, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, United Kingdom, ¹⁰Translational and Clinical Research Institute, Newcastle University and Musculoskeletal Unit, Newcastle Hospitals, Newcastle upon Tyne, Newcastle upon Tyne, United Kingdom, ¹¹Bristol Myers Squibb, Princeton, NJ, ¹²School of Infection and Immunity, University of Glasgow, Glasgow, United Kingdom
Background/Purpose: Clinical outcomes in Rheumatoid arthritis (RA) have improved with the introduction of biological and targeted synthetic disease modifying anti-rheumatic drugs (b & tsDMARDs). Abatacept…
Abstract Number: 1438 • ACR Convergence 2023
Efficacy of Guselkumab in Early-Onset and Late-Onset Psoriatic Arthritis: Post Hoc Pooled Analyses of Two Phase 3 Randomized Controlled Trials in Patients with Active PsA
Enrique Soriano¹, Mitsumasa Kishimoto², Emmanouil Rampakakis³, Francois Nantel⁴, May Shawi⁵, Frederic Lavie⁶, Philip J. Mease⁷ and Dafna Gladman⁸, ¹Rheumatology Section, Internal Medicine Services, Hospital Italiano de Buenos Aires, and University Institute Hospital Italiano de Buenos Aires, Buenos Aires, Argentina, ²Kyorin University School of Medicine, Yokohoma, Japan, ³McGill University, Department of Pediatrics / JSS Medical Research, Scientific Affairs, Montreal, QC, Canada, ⁴Nantel Medsci Consult, Consultant, Montreal, QC, Canada, ⁵Immunology, Janssen Research & Development, LLC, Titusville, NJ, ⁶The Janssen Pharmaceutical Companies of Johnson & Johnson, Paris, France, ⁷Swedish Medical Center/Providence St. Joseph Health and University of Washington School of Medicine, Seattle, WA, ⁸Schroeder Arthritis Institute, Krembil Research Institute, Toronto Western Hospital, Department of Medicine, University of Toronto, Toronto, ON, Canada
Background/Purpose: Late-onset PsA may be associated with elevated acute phase reactants, higher joint count, and erosive disease at diagnosis1,2. Given potential phenotype differences and increasing…
Abstract Number: 1677 • ACR Convergence 2023
Two-week Break in Methotrexate Treatment and COVID-19 Vaccine Response. Results of the Vaccine Response on off Methotrexate (VROOM) Study, an Open Label, Prospective, Two-arm Parallel-group, Multi-center, Superiority, Randomized Controlled Trial
Abhishek Abhishek¹, Nicholas Peckham², Corinna Pade³, Joseph Gibbons³, Lucy Cureton², Anne Francis², Vicki Barber², Jennifer Williams², duncan Appelbe², lucy Eldridge², patrick Julier², daniel Altmann⁴, James Bluett⁵, Tim Brooks⁶, Laura Coates², ines Rombach⁷, Amanda Semper⁶, Ashley Otter⁶, Ana Valdes¹, Jonathan Nguyen-Van-Tam¹, Hywel Williams¹, Aine McKnight³, Rosemary Boyton⁴ and jonathan Cook², ¹University of Nottingham, Nottingham, United Kingdom, ²University of Oxford, Oxford, United Kingdom, ³Queen Mary University of London, London, United Kingdom, ⁴Imperial College London, London, United Kingdom, ⁵University of Manchester, Manchester, United Kingdom, ⁶UK Health Security Agency, Porton Down, United Kingdom, ⁷University of Sheffield, Sheffield, United Kingdom
Background/Purpose: Immunosuppressive treatments inhibit vaccine-induced immunity. We evaluated if a two-week interruption of methotrexate treatment immediately after COVID-19 booster improved antibody response against spike protein…
Abstract Number: 2111 • ACR Convergence 2023
Self-reported Methotrexate Adherence Underestimates Biochemical Adherence: Results from the Methotrexate Use Improvement in Rheumatoid Arthritis Using Biomarker Feedback Trial
James Bluett¹, Kimme Hyrich², Brian Keevil³, Patty Doran⁴ and Anne Barton⁵, ¹University of Manchester, Manchester, United Kingdom, ²Versus Arthritis Centre for Epidemiology, Centre for Musculoskeletal Research, The University of Manchester, Manchester, United Kingdom, ³Department of Clinical Biochemistry, Manchester University NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester, United Kingdom, ⁴School of Social Sciences, The University of Manchester, Manchester, United Kingdom, ⁵Versus Arthritis Centre for Genetics and Genomics, Centre for Musculoskeletal Research, The University of Manchester, Manchester, United Kingdom
Background/Purpose: Methotrexate (MTX) adherence is suboptimal and is associated with disease flare, DAS-28 response, radiographic damage and healthcare costs. Adherence can be measured using self-reported…
Abstract Number: 2333 • ACR Convergence 2023
Dapirolizumab Pegol Impacts Important Immunologic Pathways in SLE: Pharmacodynamic Analysis of B Cell and Type I Interferon Pathways from a Phase 2b Trial
Ioana Cutcutache¹, Alex Powlesland¹, Andrew Skelton¹, Yunyun Sun¹, Matthew Page¹, George Stojan², Peter Lipsky³, Ania Skowera¹ and Christian Stach⁴, ¹UCB Pharma, Slough, United Kingdom, ²UCB, Baltimore, MD, ³AMPEL BioSolutions, Charlottesville, VA, ⁴UCB Pharma, Monheim am Rheim, Germany
Background/Purpose: The pivotal role of CD40-CD40L interactions in systemic lupus erythematosus (SLE) pathogenesis stems from the orchestration of a range of immune and inflammatory responses…
Abstract Number: 2576 • ACR Convergence 2023
Rapid Onset of Response in Adult Dermatomyositis Patients Receiving Anti-interferon β (PF-06823859): Results of a Phase 2, Double-blind, Randomized, Placebo-Controlled Study
Rohit Aggarwal¹, Elena Peeva², Aaron Mangold³, Abigail Sloan² and Myron Chu², ¹University of Pittsburgh, Pittsburgh, PA, ²Pfizer, Cambridge, MA, ³Mayo Clinic, Scottsdale, AZ
Background/Purpose: Interferon (IFN) dysregulation is a key feature in the pathogenesis of Dermatomyositis (DM). PF-06823859 is a potent, selective, humanized IgG1 neutralizing antibody directed against…
Abstract Number: 0183 • ACR Convergence 2023
Barriers and Facilitators to Recruiting Underrepresented Participants for Clinical Trials: Insights from the Lupus Clinical Investigators Network (LuCIN)
Tessa Englund¹, Christine Lee², Julie Hsieh², Richardae Araojo², Julia Mariano¹, Emily McCormick³, Stacie Bell⁴, Albert Roy⁵ and Saira Sheikh¹, ¹University of North Carolina at Chapel Hill, Chapel Hill, NC, ²U.S. Food and Drug Administration, Silver Spring, MD, ³Thurston Arthritis Research Center, Chapel Hill, NC, ⁴Lupus Therapeutics, Lakewood, CO, ⁵Lupus Research Alliance, New York, NY
Background/Purpose: Despite greater prevalence of lupus among diverse, racial and ethnic minority populations, marked gaps exist between populations affected by lupus and those enrolled in…
Abstract Number: 0519 • ACR Convergence 2023
Long-Term Safety and Efficacy of Bimekizumab in Patients with Active Ankylosing Spondylitis: 5-Year Results from a Phase 2b Study and Its Open-Label Extension
Atul Deodhar¹, Victoria Navarro-Compán², Denis Poddubnyy³, Lianne Gensler⁴, Sofia Ramiro⁵, Tetsuya Tomita⁶, Helena Marzo-Ortega⁷, Carmen Fleurinck⁸, Thomas Vaux⁹, Ute Massow¹⁰, Désirée van der Heijde⁵ and Xenofon Baraliakos¹¹, ¹Division of Arthritis and Rheumatic Disease, Oregon Health & Science University, Portland, OR, ²Department of Rheumatology, La Paz University Hospital, IdiPaz, Madrid, Spain, ³Department of Gastroenterology, Infectious Diseases and Rheumatology, Charité – Universitätsmedizin Berlin, Berlin, Germany, ⁴University of California San Francisco, Department of Medicine, Division of Rheumatology, San Francisco, CA, ⁵Department of Rheumatology, Leiden University Medical Center, Leiden, Netherlands, ⁶Graduate School of Health Science, Morinomiya University of Medical Science, Osaka, Japan, ⁷NIHR Leeds Biomedical Research Centre, Leeds Teaching Hospitals NHS Trust and Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, United Kingdom, ⁸UCB Pharma, Oosterzele, Belgium, ⁹UCB Pharma, Slough, United Kingdom, ¹⁰UCB Pharma, Monheim am Rhein, Germany, ¹¹Rheumazentrum Ruhrgebiet Herne, Ruhr-University Bochum, Herne, Germany
Background/Purpose: Bimekizumab (BKZ), a monoclonal IgG1 antibody, selectively inhibits IL-17F in addition to IL17A. BKZ has demonstrated clinical efficacy and safety up to 3 years…
Abstract Number: 0820 • ACR Convergence 2023
Radiographic and Pain Outcomes from a Phase 3 Extension Study Evaluating the Safety and Efficacy of Lorecivivint in Subjects with Severe Osteoarthritis of the Knee (OA-07): 36 Month Single Blind and Placebo Crossover Phase Results
Yusuf Yazici¹, Christopher Swearingen², Victor Lopez³, Jon Britt⁴, Sarah Kennedy⁵, Jeyanesh Tambiah² and Timothy McAlindon⁶, ¹NYU Grossman School of Medicine, La Jolla, CA, ²Biosplice Therapeutics, Inc., San Diego, CA, ³Biosplice Therapeutics, Inc., Santa Clarita, CA, ⁴Biosplice Therapeutics, Inc., Los Angeles, CA, ⁵Biosplice Therapeutics, Inc., Superior, CO, ⁶Tufts Medical Center, Arlington, MA
Background/Purpose: Knee osteoarthritis (OA) has unmet need for safe, efficacious symptom and disease-modifying treatments. Lorecivivint (LOR), an intra-articular (IA) CLK/DYRK inhibitor thought to modulate Wnt…
Abstract Number: 1323 • ACR Convergence 2023
Distinct Treatment Responses in Patients with Rheumatoid Arthritis Receiving Filgotinib 200 Mg over 12 Months: A Post Hoc Analysis of FINCH 1
Peter C. Taylor¹, Yoshiya Tanaka², Emily Aiello³, Thomas P.A. Debray⁴, Chris Watson⁵, Kristina Harris⁶ and Gerd Burmester⁷, ¹Nuffield Department of Orthopedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, United Kingdom, ²University of Occupational and Environmental Health, Kitakyushu, Japan, ³Real-world Analytics, Cytel, Toronto, ON, Canada, ⁴Biostatistics, Galapagos NV, Mechelen, Belgium, ⁵Medical Affairs, Galapagos Biotech Ltd., Cambridge, United Kingdom, ⁶Medical Safety, Galapagos NV, Mechelen, Belgium, ⁷Charité – Universitätsmedizin Berlin, Department of Rheumatology and Clinical Immunology, Berlin, Germany
Background/Purpose: FINCH 1 (NCT02889796) was a Phase 3 randomized controlled trial evaluating filgotinib (FIL) in patients with rheumatoid arthritis and an inadequate response to methotrexate…
Abstract Number: 1440 • ACR Convergence 2023
Removal of Methotrexate in Patients with Active Psoriatic Arthritis with Newly Induced Ustekinumab Treatment Leads to a Delayed Response in DAPSA and DAS28 Within the First 16 Weeks
Michaela Koehm¹, Ann Christina Foldenauer², Tanja Rossmanith², Herbert Kellner³, Uta Kiltz⁴, Arnd Kleyer⁵, Gerd Burmester⁶, David Kofler⁷, Jan Brandt-Juergens⁸, Raoul Bergner⁹ and Frank Behrens¹⁰, ¹University Hospital Frankfurt, Frankfurt, Germany, ²Fraunhofer Institute for Translational Medicine and Pharmacology ITMP, Fraunhofer Cluster of Excellence Immune Mediated Diseases CIMD, Frankfurt, Germany, ³Hospital Neuwittelsbach, Center for Rheumatology and Gastroenterology, Munich, Germany, ⁴Rheumazentrum Ruhrgebiet, Herne, Germany, ⁵University Hospital Erlangen, Erlangen, Germany, ⁶Charité – Universitätsmedizin Berlin, Department of Rheumatology and Clinical Immunology, Berlin, Germany, ⁷University of Cologne, Cologne, Germany, ⁸rheumatologische Schwerpunktpraxis, Berlin, Germany, ⁹Municipal Hospital Ludwigshafen, Department of Internal Medicine A, Nephrology and Rheumatology, Ludwigshafen, Germany, ¹⁰Goethe-University & Fraunhofer ITMP, Frankfurt, Germany
Background/Purpose: Methotrexate (MTX) is often used as first-line DMARD therapy in active psoriatic arthritis (PsA). The value of MTX in combination with different bDMARDs is…
Abstract Number: 1687 • ACR Convergence 2023
Sex of the Patient Affects Response to Advanced Therapies in Psoriatic Arthritis: Meta-analysis of Data from Randomized Controlled Trials
Lihi Eder¹, Sivakami Mylvaganam², Jordi Pardo Pardo³, Jennifer Petkovic⁴, Vibeke Strand⁵, Philip J. Mease⁶ and Keith Colaco⁷, ¹Women’s College Research Institute, Division of Rheumatology, University of Toronto, Toronto, ON, Canada, ²Department of Biochemistry, University of Toronto, Toronto, ON, Canada, ³Cochrane Musculoskeletal, University of Ottawa, Ottawa, ON, Canada, ⁴Cochrane Equity Methods Group, University of Ottawa, Ottawa, ON, Canada, ⁵Stanford University, Portola Valley, CA, ⁶Swedish Medical Center/Providence St. Joseph Health and University of Washington School of Medicine, Seattle, WA, ⁷Women’s College Research Institute / Department of Health and Society, University of Toronto, Toronto, ON, Canada
Background/Purpose: Limited information exists on participation and study outcomes by sex in randomized controlled trials (RCTs) among patients with psoriatic arthritis (PsA). Through a systematic…
Abstract Number: 2143 • ACR Convergence 2023
Efficacy of Filgotinib in Patients with Rheumatoid Arthritis: Week 156 Results from a Long-term Extension Study
Maya Buch¹, Daniel Aletaha², Roberto F. Caporali³, Bernard G. Combe⁴, Hendrik Schulze-Koops⁵, Jacques-Eric Gottenberg⁶, Yoshiya Tanaka⁷, Ricardo Blanco⁸, Tsutomu Takeuchi⁹, Edmund V. Ekoka Omoruyi¹⁰, Katrien Van Beneden¹¹, Vijay Rajendran¹², Chris Watson¹³, Francesco De Leonardis¹⁴ and Paul Emery¹⁵, ¹University of Manchester and NIHR Manchester Biomedical Research Centre, Manchester, United Kingdom, ²Division of Rheumatology, Department of Medicine III, Medical University of Vienna, Vienna, Austria, Wien, Austria, ³Department of Clinical Sciences and Community Health, University of Milan, and Department of Rheumatology and Medical Sciences, ASST Gaetano Pini-CTO, Milano, Italy, ⁴Department of Rheumatology, Montpellier University, Montpellier, France, ⁵Division of Rheumatology and Clinical Immunology, Department of Internal Medicine IV, Ludwig-Maximilians–University Munich, Munich, Germany, ⁶Rheumatology Department, Strasbourg University Hospital, Strasbourg, France, ⁷University of Occupational and Environmental Health, Kitakyushu, Japan, ⁸Hospital Universitario Marqués de Valdecilla, IDIVAL, Santander, Spain, ⁹Keio University School of Medicine and Saitama Medical University, Tokyo, Japan, ¹⁰Biostatistics, Galapagos NV, Mechelen, Belgium, ¹¹Medical Safety, Galapagos NV, Mechelen, Belgium, ¹²Clinical Research, Galapagos NV, Mechelen, Belgium, ¹³Medical Affairs, Galapagos Biotech Ltd., Cambridge, United Kingdom, ¹⁴Medical Affairs, Galapagos GmbH, Basel, Switzerland, ¹⁵Leeds 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: In the treatment of RA, JAK inhibitors are a valuable option to meet remission or low disease activity (LDA) treatment targets following an inadequate…
Abstract Number: 2334 • ACR Convergence 2023
Remission Attainment in Patients with Systemic Lupus Erythematosus Treated with Anifrolumab Compared with Placebo over a 4-Year Period
Ronald van Vollenhoven¹, Eric Morand², Richard A. Furie³, Kenneth Kalunian⁴, Raj Tummala⁵, Gabriel Abreu⁶, Hussein Al-Mossawi⁷ and Catharina Lindholm⁶, ¹Amsterdam University Medical Centers, Amsterdam, Netherlands, ²Monash University, Centre for Inflammatory Diseases, Melbourne, Australia, ³Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Great Neck, NY, ⁴University of California San Diego, La Jolla, CA, ⁵BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD, ⁶BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden, ⁷BioPharmaceuticals R&D, AstraZeneca, Cambridge, United Kingdom
Background/Purpose: In patients with SLE, remission is an established therapeutic goal associated with reduced damage accrual and flares, and improved health-related quality of life.1 Here,…

All abstracts accepted to ACR Convergence are under media embargo once the ACR has notified presenters of their abstract’s acceptance. They may be presented at other meetings or published as manuscripts after this time but should not be discussed in non-scholarly venues or outlets. The following embargo policies are strictly enforced by the ACR.

Accepted abstracts are made available to the public online in advance of the meeting and are published in a special online supplement of our scientific journal, Arthritis & Rheumatology. Information contained in those abstracts may not be released until the abstracts appear online. In an exception to the media embargo, academic institutions, private organizations, and companies with products whose value may be influenced by information contained in an abstract may issue a press release to coincide with the availability of an ACR abstract on the ACR website. However, the ACR continues to require that information that goes beyond that contained in the abstract (e.g., discussion of the abstract done as part of editorial news coverage) is under media embargo until 10:00 AM CT on October 25. Journalists with access to embargoed information cannot release articles or editorial news coverage before this time. Editorial news coverage is considered original articles/videos developed by employed journalists to report facts, commentary, and subject matter expert quotes in a narrative form using a variety of sources (e.g., research, announcements, press releases, events, etc.).

Violation of this policy may result in the abstract being withdrawn from the meeting and other measures deemed appropriate. Authors are responsible for notifying colleagues, institutions, communications firms, and all other stakeholders related to the development or promotion of the abstract about this policy. If you have questions about the ACR abstract embargo policy, please contact ACR abstracts staff at [email protected].