Abstracts tagged "clinical trial"

Abstract Number: 2501 • ACR Convergence 2023
Selection of Indicators Reporting Response Rate in Pharmaceutical Trials for Systemic Lupus Erythematosus: Preference and Relative Sensitivity
Jingru Tian¹, Shuntong Kang², Dingyao Zhang³ and Qianjin Lu⁴, ¹Institute of Dermatology, Chinese Academy of Medical Sciences and Peking Union Medical College, Nanjing, China, ²Department of Dermatology, Hunan Key Laboratory of Medical Epigenomics, The Second Xiangya Hospital, Central South University, Nanjing, China, ³Graduate Program in Biological and Biomedical Sciences, Yale University, New Haven, CT, ⁴Hospital for Skin Diseases, Institute of Dermatology, Chinese Academy of Medical Sciences and Peking Union Medical College, Changsha, China
Background/Purpose: Systemic lupus erythematosus (SLE) is a common multisystem autoimmune disease with chronic inflammation. Many efficacy evaluation indicators of randomized clinical trials (RCTs) for SLE…
Abstract Number: 0450 • ACR Convergence 2023
Baricitinib versus TNF-inhibitors in Patients with Active Rheumatoid Arthritis After Failure of CsDMARDs: A Pragmatic, Multicenter, Real-Life Study in a Treat-to-Target Setting
Martinus Van de Laar¹, Martijn Oude Voshaar¹, Peter ten Klooster¹, Danyta Tedjo² and celine van de laar³, ¹University of Twente, Hengelo (OV), Netherlands, ²TiH @ University of Twente, Hengelo (OV), Netherlands, ³Erasmus School of Health Policy and Management, Erasmus University, Rotterdam, Netherlands
Background/Purpose: The EULAR guidelines for Rheumatoid Arthritis (RA) patients advise to use a strategy aiming at a predefined target of disease activity (T2T). If this…
Abstract Number: 0780 • ACR Convergence 2023
Assessing Differential Effects of DMARDs on Psoriasis Area and Severity Index and Patient Global Assessment in Subgroups of Patients with Active PsA Treated over 52-weeks with Secukinumab in a Non-Interventional Trial (AQUILA) Using a Multistage Clustering Approach
Michaela Koehm¹, Maximilian Klippstein², Sabine Kugler³, Sina Mackay³, Daniel Schulz³, Asmir Vodencarevic⁴, Guillaume Wendt⁴, Daniel Peterlik⁴, Uta Kiltz⁵, Jan Brandt-Juergens⁶ and Frank Behrens⁷, ¹University Hospital Frankfurt, Frankfurt, Germany, ²Fraunhofer Institute for Translational Medicine and Pharmacology ITMP, Fraunhofer Cluster of Excellence Immune Mediated Diseases CIMD, Frankfurt, Germany, ³Fraunhofer Institute for Intelligent Analysis and Information Systems IAIS, Fraunhofer Cluster of Excellence Immune Mediated Diseases CIMD, Sankt Augustin, Germany, ⁴Novartis Pharma GmbH, Nürnberg, Germany, ⁵Rheumazentrum Ruhrgebiet, Herne, Germany, ⁶rheumatologische Schwerpunktpraxis, Berlin, Germany, ⁷Goethe-University & Fraunhofer ITMP, Frankfurt, Germany
Background/Purpose: Individualized treatment strategies are of high importance in the treatment of patients with active psoriatic arthritis (PsA), a heterogeneous immune-mediated disease. IL-17 inhibition has…
Abstract Number: 1191 • ACR Convergence 2023
A Phase 1b, Randomized, Double-Blind, Placebo-Controlled, Multiple-Dosing, Ascending-Dose Study Evaluating the Safety, Tolerability and Pharmacokinetics of XG004 Applied Topically in Participants with Osteoarthritis of the Knee
Guang-Liang Jiang¹ and Feng Xu², ¹Xgene Pharmaceutical Inc., Lexington, MA, ²Xgene Pharmaceutical Inc., Altos Hills, CA
Background/Purpose: Globally osteoarthritis affects about 302 million patients, knee osteoarthritis accounts for 263 million and ranks the highest in disability and pain compared to OA…
Abstract Number: 1433 • ACR Convergence 2023
Bimekizumab Impact on Core Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) Domains for Patients with Psoriatic Arthritis: 52-Week Results from Four Phase 3 Studies
Joseph Merola¹, Philip J. Mease², Atul Deodhar³, Barbara Ink⁴, Carmen Fleurinck⁵, Rajan Bajracharya⁴, Jason Coarse⁶ and Laura Coates⁷, ¹Harvard Medical School, Brigham and Women's Hospital, Newton, MA, ²Swedish Medical Center/Providence St. Joseph Health and University of Washington School of Medicine, Seattle, WA, ³Division of Arthritis and Rheumatic Disease, Oregon Health & Science University, Portland, OR, ⁴UCB Pharma, Slough, United Kingdom, ⁵UCB Pharma, Oosterzele, Belgium, ⁶UCB Pharma, Morrisville, NC, ⁷University of Oxford, Oxford, United Kingdom
Background/Purpose: The Group for Research and Assessment of Psoriasis and PsA (GRAPPA) domain‑based treatment recommendations for PsA focus on six key domains: peripheral arthritis, axial…
Abstract Number: 1612 • ACR Convergence 2023
Design and Validation of a Comparator for Randomized Controlled Trials of a Digital Cognitive Behavioral Therapy
Michael Gendreau¹, Yifei Dai², Michael Rosenbluth³, David Williams⁴ and Daniel Clauw⁵, ¹Gendreau Consulting, LLC, Poway, CA, ²Swing Therapeutics, Gainesville, FL, ³Swing Therapeutics, San Francisco, CA, ⁴Chronic Pain and Fatigue Research Center, Department of Anesthesiology, University of Michigan, Ann Arbor, MI, ⁵Department of Anesthesiology, University of Michigan, Ann Arbor, MI
Background/Purpose: The use of a control arm (comparator) in randomized controlled trials (RCTs) is considered the gold standard for trial conduct and interpretation. Choosing an…
Abstract Number: 2024 • ACR Convergence 2023
Patient-Reported Outcomes in Patients with Lupus Nephritis: A Post Hoc Analysis of Control Arm Data from Two Completed Phase III Randomized Clinical Trials
Christophe T. Tchakoute¹, Huiyan (Ashley) Mao², Gene Wallenstein¹, Jorge Ross Terres¹, Seitaro Yoshida¹ and Lisa Lindsay¹, ¹Genentech, Inc., South San Francisco, CA, ²Hoffmann-La Roche Ltd, Mississauga, ON, Canada
Background/Purpose: Lupus nephritis (LN) is a severe and common (50%) organ-threatening manifestation of systemic lupus erythematosus and is associated with a high risk of progression…
Abstract Number: 2256 • ACR Convergence 2023
The Impact of Clinical Trial Metrics in Psoriatic Arthritis
Maxine Yarnall and Kara Murray, Spherix Global Insights, Exton, PA
Background/Purpose: Rheumatologists have access to a plethora of advanced biologic and small molecule agents for the treatment of psoriatic arthritis (PsA). Prior to FDA approval,…
Abstract Number: 2539 • ACR Convergence 2023
Baseline IL-10 Levels as a Predictive Biomarker for Achieving Clinical Response with Abatacept in ACPA+ Patients with Early RA
Jinqi Liu¹, Yicong Li², Kai Fu¹, Chun Wu¹, Peter Schafer³, Sean Connolly¹, Ian M. Catlett⁴, Michael Maldonado¹, Robert Wong⁵, Paul Emery⁶, Yoshiya Tanaka⁷, Vivian Bykerk⁸, Clifton Bingham⁹, Thomas Huizinga¹⁰ and Roy Fleischmann¹¹, ¹Bristol Myers Squibb, Princeton, NJ, ²Parexel International, Durham, NC, ³Bristol Myers Squibb, Belle Mead, NJ, ⁴Bristol Myers Squibb, Pennington, NJ, ⁵Bristol Myers Squibb (at the time of analysis), Princeton, NJ, ⁶Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, and NIHR Leeds Biomedical Research Centre, Leeds Teaching Hospitals NHS Trust, Leeds, United Kingdom, ⁷University of Occupational and Environmental Health, Kitakyushu, Japan, ⁸Department of Rheumatology, Hospital for Special Surgery, New York, NY, ⁹Division of Rheumatology, Department of Medicine, Johns Hopkins University, Baltimore, MD, ¹⁰Leiden University Medical Center, Leiden, Netherlands, ¹¹Division of Rheumatology, University of Texas Southwestern Medical Center, Metroplex Clinical Research Center, Dallas, TX
Background/Purpose: A key target of RA treatment is to achieve early and sustained remission in order to ensure lower levels of long-term structural joint damage…
Abstract Number: 0451 • ACR Convergence 2023
Long-term Clinical Profile of Filgotinib in Patients with Rheumatoid Arthritis by Cardiovascular Risk Factors: A Post Hoc Subgroup Analysis
Maya Buch¹, Jose A Gomez-Puerta², Gerd Burmester³, Bernard G. Combe⁴, Vijay Rajendran⁵, Pieter-Jan Stiers⁶, Paul Van Hoek⁷, Katrien Van Beneden⁷, Jacques-Eric Gottenberg⁸, Yoshiya Tanaka⁹, Daniel Aletaha¹⁰, René Westhovens¹¹ and Roberto F. Caporali¹², ¹University of Manchester and NIHR Manchester Biomedical Research Centre, Manchester, United Kingdom, ²Department of Rheumatology, Hospital Clinic of Barcelona, Barcelona, Spain, ³Charité – Universitätsmedizin Berlin, Department of Rheumatology and Clinical Immunology, Berlin, Germany, ⁴Department of Rheumatology, Montpellier University, Montpellier, France, ⁵Clinical Research, Galapagos NV, Mechelen, Belgium, ⁶Biostatistics, Galapagos NV, Mechelen, Belgium, ⁷Medical Safety, Galapagos NV, Mechelen, Belgium, ⁸Rheumatology Department, Strasbourg University Hospital, Strasbourg, France, ⁹University of Occupational and Environmental Health, Kitakyushu, Japan, ¹⁰Division of Rheumatology, Department of Medicine III, Medical University of Vienna, Vienna, Austria, Wien, Austria, ¹¹Department of Rheumatology, KU Leuven, Skeletal Biology and Engineering Research Center, Leuven, Belgium, ¹²Department of Clinical Sciences and Community Health, University of Milan, and Department of Rheumatology and Medical Sciences, ASST Gaetano Pini-CTO, Milano, Italy
Background/Purpose: Filgotinib (FIL) is an oral Janus kinase 1 preferential inhibitor for the treatment of moderate to severe active RA. A previous pooled analysis reported…
Abstract Number: 0782 • ACR Convergence 2023
Comparison of Dual-immunosuppressive Therapy with a Voclosporin-based, Triple-immunosuppressive Regimen for Lupus Nephritis in the ALMS and AURORA 1 Studies
Maria Dall'Era¹, Ernie Yap², Matt Truman², Lucy Hodge² and Neil Solomons³, ¹University of California San Francisco, San Francisco, CA, ²Aurinia Pharmaceuticals Inc., Edmonton, AB, Canada, ³Neil Solomons Consulting Inc., Victoria, BC, Canada
Background/Purpose: Dual-immunosuppressive regimens consisting of high-dose glucocorticoids and higher doses ( >2 g/day) of mycophenolate mofetil (MMF) are still frequently used for the initial management…
Abstract Number: 1197 • ACR Convergence 2023
Efficacy and Safety of a Single Intra-Articular Injection of MM-II, a Novel Suspension of Large, Empty, Multilamellar Liposomes, in People with Painful Knee OA: Results of a 26-Week, Phase 2b, Placebo-Controlled, Double-Blind, Randomized Trial
Schnitzer Thomas¹, Helene Rovsing², Edith Lau³, Sidsel Boll⁴, Ballari Brahmachari⁵, Richard Chou⁶, Tarini Joshi⁵, Roni Wechsler⁷, Siu-Long Yao⁵, Sveta Weiner⁵, Asger Bihlet⁸ and Philip Conaghan⁹, ¹Northwestern University Feinberg School of Medicine, Chicago, IL, ²Sanos Clinic, Gandrup, Denmark, ³Hong Kong Center for Clinical Research, Hong Kong, China, ⁴Sanos Clinic, Vejle, Denmark, ⁵Sun Pharmaceutical Industries, Inc., Princeton, NJ, ⁶Jacobs School of Medicine and Biomedical Sciences, University of Buffalo, Buffalo, NY, ⁷Moebius Medical, Tel Aviv, Israel, ⁸NBCD, Soeborg, Denmark, ⁹University of Leeds, Leeds, United Kingdom
Background/Purpose: Safe and effective therapies are needed for OA pain. MM-II, a novel suspension of large, empty, multilamellar liposomes composed of dimyristoylphosphatidylcholine and dipalmitoylphosphatidylcholine, effectively…
Abstract Number: 1434 • ACR Convergence 2023
Long-Term Efficacy and Safety of Risankizumab for Active Psoriatic Arthritis: 148-Week Results from the KEEPsAKE 2 Trial
Andrew Östör¹, Filip Van den Bosch², Kim A Papp³, Cecilia Asnal⁴, Ricardo Blanco⁵, Jacob Aelion⁶, Vassilis Stakias⁷, Thomas Iyile⁷, Kyle Carter⁷, Ahmed Soliman⁷, Leonidas Drogaris⁷, Michael Chen⁷, Byron Padilla⁷ and Alan Kivitz⁸, ¹Monash University & Emeritus Research; Australian National University, Melbourne, Australia, ²Department of Internal Medicine and Pediatrics, Ghent University and VIB Center for Inflammation Research, Ghent, Belgium, ³Alliance Clinical Research and Probity Medical Research, Waterloo, and University of Toronto, Toronto, ON, Canada, ⁴Hospital Alemán, Buenos Aires, Argentina, ⁵Rheumatology Department, Immunopathology Group, Hospital Universitario Marqués de Valdecilla-IDIVAL, Santander, Spain, ⁶West Tennessee Research Institute, Jackson, TN, ⁷AbbVie, Inc., North Chicago, IL, ⁸Altoona Center for Clinical Research, Duncansville, PA
Background/Purpose: PsA is a chronic systemic inflammatory disease that affects 30% of patients diagnosed with psoriasis, with a clinical burden that includes dactylitis, enthesitis, cutaneous…
Abstract Number: 1614 • ACR Convergence 2023
Therapy Combining Millimeter Wave-based Neuromodulation with Coaching for the Improvement in Quality of Life of Patients with Fibromyalgia: A Prospective, Multicenter, Randomized, Controlled Trial
Caroline Maindet¹, Anne Dumolard², Mélanie Veloso², Mario Barmaki³, Rodrigue Deleens⁴, Raphaël Gonon-Demoulian⁵, Alberta Lorenzi-Pernot⁶, Mireille Michel-Cherqui⁷, Alain Serrie⁸, Stanislas Velliet⁹ and Jean-Luc Bosson², ¹University Hospital Grenoble Alpes, Grenoble, France, ²Grenoble Alpes University Hospital, Grenoble, France, ³Médipôle Lyon Villeurbanne, Lyon, France, ⁴Rouen University Hospital, Rouen, France, ⁵Montpellier University Hospital, Montpellier, France, ⁶Neurology private practice, Mornant, France, ⁷Foch hospital, Suresnes, France, ⁸Paris University Hospital, Paris, Guinea, ⁹Valenciennes hospital, Valenciennes, France
Background/Purpose: Fibromyalgia is a chronic syndrome with symptoms of moderate to severe intensity, including diffuse pain, fatigue, sleep disturbance, and cognitive impairment. While first-line recommendation…
Abstract Number: 2055 • ACR Convergence 2023
A Randomized Controlled Trial of Two Hepatitis a Vaccine Doses Among Adolescents with Juvenile Idiopathic Arthritis and Crohn’s Disease on Immunosuppressive Therapy: A Pilot Study
Racheal Githumbi¹, Susan Kuhn¹, Carla Osiowy², Jennifer DeBruyn¹, Marvin Fritzler¹, Nicole Johnson¹, Otto G Vanderkooi¹ and Heinrike Schmeling¹, ¹University of Calgary, Calgary, AB, Canada, ²National Microbiology Laboratory, Public Health Agency of Canada, Winnepig, MB, Canada
Background/Purpose: Juvenile idiopathic arthritis (JIA) and Crohn's disease (CD) are now controlled using immunosuppressive medications. However, disease control comes at the risk of increased infection.…

All abstracts accepted to PRYSM 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 6:00 PM CT on March 18. 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].