Abstracts tagged "clinical trial"

Abstract Number: 1225 • ACR Convergence 2021
Baseline Extracellular Matrix Biomarkers Predict Abatacept Treatment Response in MTX-Naive, ACPA+ Patients with Early RA
Paul Emery¹, Yoshiya Tanaka², Vivian Bykerk³, Clifton Bingham⁴, Tom WJ Huizinga⁵, Gustavo Citera⁶, Chun Wu⁷, Sarah Hu⁷, Peter Schafer⁷, Jinqi Liu⁷, Sean Connolly⁷, Robert Wong⁸ and Roy Fleischmann⁹, ¹Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds and Leeds NIHR Biomedical Research Centre, Leeds, United Kingdom, ²University of Occupational and Environmental Health, Kitakyushu, Japan, ³Division of Rheumatology, Hospital for Special Surgery, New York City, NY, ⁴Johns Hopkins University, Baltimore, MD, ⁵Leiden University Medical Center, Leiden, Netherlands, ⁶Instituto de Rehabilitación Psicofísica, Buenos Aires, Argentina, ⁷Bristol Myers Squibb, Princeton, NJ, ⁸Bristol Myers Squibb, Basking Ridge, NJ, ⁹Metroplex Clinical Research Center and University of Texas Southwestern Medical Center, Dallas, TX
Background/Purpose: Predictive biomarkers reflecting RA processes and treatment (tmt) efficacy are urgently needed to inform medical options. Markers of bone remodeling and extracellular matrix (ECM)…
Abstract Number: 1345 • ACR Convergence 2021
Long-Term Safety and Effectiveness of Upadacitinib in Patients with Psoriatic Arthritis: Results at 56 Weeks from the SELECT-PsA 1 Study
Iain McInnes¹, Koji Kato², Marina Magrey³, Joseph Merola⁴, Mitsumasa Kishimoto⁵, Cesar Pacheco Tena⁶, Derek Haaland⁷, Liang Chen⁸, Yuanyuan Duan⁹, Patrick Zueger¹⁰, Jianzhong Liu¹¹, Ralph Lippe¹², Aileen Pangan¹¹ and Frank Behrens¹³, ¹University of Glasgow, School of Medicine, Glasgow, Scotland, United Kingdom, ²AbbVie Inc, Shinagawa- Ku, Japan, ³Case Western Reserve University, MetroHealth Medical Center, Cleveland, OH, USA, Richfield, OH, ⁴Harvard Medical School, Brigham and Women’s Hospital, Boston, MA, ⁵Department of Nephrology and Rheumatology, Kyorin University School of Medicine, Yokohama, Japan, ⁶Facultad de Medicina, Universidad Autonoma de Chihuahua, Chihuahua, Mexico, ⁷McMaster University, Hamilton, Ontario and The Waterside Clinic, Oro Medonte, ON, Canada, ⁸AbbVie Inc., North Chicago, ⁹AbbVie Inc, North Chicago, ¹⁰AbbVie Inc., Mettawa, IL, ¹¹AbbVie Inc., North Chicago, IL, ¹²AbbVie Deutschland GmbH & Co. KG, Berlin, Germany, ¹³Rheumatology & Fraunhofer Institute for Translational Medicine and Pharmacology ITMP, Fraunhofer Cluster Immune-Mediated Diseases (CIMD), Fraunhofer Cluster Immune-Mediated Diseases (CIMD), Frankfurt/Main, Germany
Background/Purpose: In the SELECT-PsA 1 study, through 24 weeks (wks), once daily upadacitinib 15 mg (UPA15) and 30 mg (UPA30) showed improvements in musculoskeletal symptoms,…
Abstract Number: 1691 • ACR Convergence 2021
Long-Term Safety Profile of Upadacitinib in Patients with Rheumatoid Arthritis, Psoriatic Arthritis, or Ankylosing Spondylitis
Gerd Burmester¹, Stanley Cohen², Kevin Winthrop³, Peter Nash⁴, Andrea Rubbert-Roth⁵, Atul Deodhar³, Ori Elkayam⁶, Eduardo Mysler⁷, Yoshiya Tanaka⁸, Jianzhong Liu⁹, Ana Paula Lacerda⁹, Bosny Pierre-Louis⁹, Tim Shaw¹⁰ and Philip Mease¹¹, ¹Charité University Medicine Berlin, Berlin, Germany, ²Metroplex Clinical Research Center, Dallas, TX, ³Oregon Health & Science University, Portland, OR, ⁴Griffith University, Brisbane, Australia, ⁵Kantonspital St Gallen, St.Gallen, Switzerland, ⁶Tel Aviv Sourasky Medical Center, Tel Aviv, Israel, ⁷Organización Medica de Investigación, Rheumatology, Buenos Aires, Argentina, ⁸University of Occupational and Environmental Health, Kitakyushu, Japan, ⁹AbbVie Inc., North Chicago, IL, ¹⁰AbbVie Inc., North Chicago, ¹¹Swedish Medical Center/Providence St. Joseph Health and University of Washington, Seattle, WA
Background/Purpose: The efficacy and safety of the oral Janus kinase inhibitor, upadacitinib (UPA), has been evaluated for several rheumatic diseases. The objective of this analysis…
Abstract Number: 1748 • ACR Convergence 2021
The Peroxisome Proliferator-Activated Receptor-γ (PPAR) Agonist Pioglitazone Improves Vascular and Metabolic Dysfunction in Patients with Systemic Lupus Erythematosus (SLE)
Sarfaraz Hasni¹, Yenealem Temesgen-Oyelakin², Michael Davis³, Sarthak Gupta⁴, Elaine Poncio⁵, Mohammad Naqi¹, Xinghao Wang⁶, Christopher Oliveira⁷, Dillon Claybaugh¹, Amit Dey¹, Shajia Lu¹, Philip Carlucci⁸, Zerai Manna¹, Yinghui Shi¹, Isabel Ochoa⁵, Donald Thomas⁹, Theo Heller¹⁰, Massimo Gadina¹¹, Jun Chu⁴, Monica Purmalek¹, Xiaobai Li¹², Martin Playford¹³, Nehal Mehta¹³ and Mariana Kaplan¹, ¹National Institutes of Health, Bethesda, MD, ²National Institutes of Health (NIH), Bethesda, MD, ³NIAMS, Bethesda, MD, ⁴National Institutes of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Institutes of Health (NIH), Bethesda, MD, ⁵NIH/NIAMS, Bethesda, MD, ⁶NIAMS/NIH, Bethesda, MD, ⁷National Institutes of Health (NIH), Vienna, VA, ⁸New York University School of Medicine, New York, NY, ⁹Arthritis and Pain Associates of Prince George's County, Silver Spring, MD, ¹⁰NIDDK/National Institutes of Health, Bethesda, MD, ¹¹National Institute of Arthritis and Musculoskeletal and Skin Diseases, Bethesda, MD, ¹²Clinical Center, National Institutes of Health, Bethesda, MD, ¹³NHLBI/National Institutes of Health, Bethesda, MD
Background/Purpose: Premature cardiovascular events in SLE are associated with significant mortality and morbidity with no effective treatments described to date. Both immune dysregulation characteristics of…
Abstract Number: 1807 • ACR Convergence 2021
Relationships Between Fatigue and Hemoglobin/C-Reactive Protein Levels and Associations Between Fatigue and Clinical Response in Patients with Active Psoriatic Arthritis: Results from Two Randomized Controlled Trials of Guselkumab (TREMFYA®)
Proton Rahman¹, Philip Mease², Atul Deodhar³, Laure Gossec⁴, Arthur Kavanaugh⁵, Soumya Chakravarty⁶, Alexa Kollmeier⁷, Yan Liu⁸, Xiwu Lin⁸, May Shawi⁹ and Chenglong Han⁸, ¹Department of Medicine, Eastern Health and Memorial University of Newfoundland, St John's, NL, Canada, ²Swedish Medical Center/Providence St. Joseph Health and University of Washington, Seattle, WA, ³Oregon Health & Science University, Portland, OR, ⁴Sorbonne Université; APHP, Rheumatology Department, Pitié-Salpêtrière Hospital, Paris, France, ⁵University of California San Diego, La Jolla, CA, ⁶Janssen Scientific Affairs, LLC and Drexel University College of Medicine, Horsham, PA, ⁷Janssen Research & Development, LLC, La Jolla, CA, ⁸Janssen Research & Development, LLC, Spring House, PA, ⁹Janssen Immunology Global Commercial Strategy Organization, Toronto, ON, Canada
Background/Purpose: Fatigue is a key patient (pt)-reported symptom of psoriatic arthritis (PsA).1,2 Utilizing data from the Phase 3 DISCOVER-1 (D1) and -2 (D2) studies, these…
Abstract Number: 0477 • ACR Convergence 2021
TNX-102 SL (Sublingual Cyclobenzaprine) for the Treatment of Fibromyalgia in the RELIEF Study: Positive Results of a Phase 3 Randomized, Double-Blind, Placebo-Controlled Multicenter Efficacy and Safety Trial
Gregory Sullivan¹, Mary Kelley², Annabelle Iserson¹, Perry Peters², Ashild Peters², Candace Flint¹, Judy Gendreau³, Herb Harris¹, Ben Vaughn⁴ and Seth Lederman⁵, ¹Tonix Pharmaceuticals, Inc., Chatham, NJ, ²Tonix Pharmaceuticals, Inc., San Diego, CA, ³Gendreau Consulting, LLC, Poway, CA, ⁴Rho, Inc., Cary, NC, ⁵Tonix Pharmaceuticals, Inc., South Dartmouth, MA
Background/Purpose: Fibromyalgia (FM) is characterized by chronic widespread pain, fatigue, and nonrestorative sleep, a symptom constellation suggestive of a pathological disturbance in central pain processing…
Abstract Number: 1230 • ACR Convergence 2021
Impact of Serologic Status on Clinical Responses to Upadacitinib or Abatacept in Patients with Rheumatoid Arthritis and Prior Inadequate Response to Biologic DMARDs: Sub-Group Analysis from the Phase 3 SELECT-CHOICE Study
Andrea Rubbert-Roth¹, Jeffrey Sparks², Arnaud Constantin³, Ricardo Xavier⁴, Yanna Song⁵, Jessica Suboticki⁵ and Roy Fleischmann⁶, ¹Kantonspital St Gallen, St.Gallen, Switzerland, ²Brigham and Women’s Hospital and Harvard Medical School, Boston, MA, ³Toulouse University Hospital, Toulouse Cedex 9, France, ⁴Departamento de Reumatologia, Hospital de Clínicas de Porto Alegre, Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil, ⁵AbbVie Inc., North Chicago, IL, ⁶University of Texas Southwestern Medical Center, Metroplex Clinical Research Center, Dallas, TX
Background/Purpose: In patients with RA who had a prior inadequate response or intolerance to biologic DMARDs, the oral Janus kinase inhibitor, upadacitinib (UPA), demonstrated superiority…
Abstract Number: 1350 • ACR Convergence 2021
Sustained Improvement in Physical Function, Disease Impact and Health-Related Quality of Life in Patients with Psoriatic Arthritis Treated with Bimekizumab: 3-Year Results from a Phase 2b Open-Label Extension Study
Laure Gossec¹, Akihiko Asahina², Alice Gottlieb³, Laura Coates⁴, Barbara Ink⁵, Deepak Assudani⁶, Jason Coarse⁷, Scarlett Hellot⁸, Jason Eells⁶ and Philip Mease⁹, ¹Sorbonne Université and Hôpital Pitié-Salpêtrière, Paris, France, ²Department of Dermatology, The Jikei University School of Medicine, Tokyo, Japan, ³Icahn School of Medicine at Mount Sinai, New York, NY, ⁴Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, United Kingdom, ⁵UCB Celltech, Slough, UK, Slough, United Kingdom, ⁶UCB Pharma, Slough, United Kingdom, ⁷UCB Pharma, Raleigh, NC, ⁸UCB Pharma, Colombes, France, ⁹Swedish Medical Center/Providence St. Joseph Health and University of Washington, Seattle, WA
Background/Purpose: Bimekizumab (BKZ) is a monoclonal IgG1 antibody that selectively inhibits both interleukin (IL)-17F and IL-17A, and has demonstrated clinical improvements in joint and skin…
Abstract Number: 1692 • ACR Convergence 2021
Long-Term Efficacy and Safety of Upadacitinib in Patients with Rheumatoid Arthritis: 3-year Results from the SELECT-EARLY Study
Ronald F van Vollenhoven¹, Tsutomu Takeuchi², Jacob Aelion³, Nilmo Chavez⁴, Pablo Mannucci⁵, Atul Singhal⁶, Jerzy Swierkot⁷, Alan Friedman⁸, Nasser Khan⁸, Yihan Li⁹, Xianwei Bu⁹, Justin Klaff⁸ and Vibeke Strand¹⁰, ¹Amsterdam University Medical Centers, Department of Rheumatology and Clinical Immunology, Rheumatology and Immunology Center ARC, Amsterdam, Netherlands, ²Div. Rheumatology, Keio University, Tokyo, Japan, ³Arthritis Clinic and West Tennessee Research Institute, Jackson, TN, ⁴Instituto Guatemalteco de Seguridad Social, Ciudad de Guatemala, Guatemala, ⁵Aprillus Asistencia e Investigación, Buenos Aires, Argentina, ⁶Southwest Rheumatology Research LLC, Dallas, TX, ⁷Department of Rheumatology and Internal Medicine, Wroclaw Medical University, Wroclaw, Poland, ⁸AbbVie Inc., North Chicago, IL, ⁹AbbVie Inc., North Chicago, ¹⁰Stanford University School of Medicine, Portola Valley, CA
Background/Purpose: Upadacitinib (UPA), an oral Janus kinase inhibitor, demonstrated significant improvements in signs, symptoms, and structural inhibition as monotherapy (mono) vs methotrexate (MTX) in MTX-naïve…
Abstract Number: 1750 • ACR Convergence 2021
Itolizumab, a Novel anti-CD6 Therapy, in Systemic Lupus Erythematosus Patients: Interim Safety Results from the Phase 1b EQUALISE Dose-escalation Study
Kenneth Kalunian¹, Richard Furie², Jai Radhakrishnan³, Vandana Mathur⁴, Krishna Polu⁴, Stephen Connelly⁴, Joel Rothman⁴, Cherie Ng⁴, Leslie Chinn⁵, Maple Fung⁶, Dolca Thomas⁷ and Chaim Putterman⁸, ¹UC San Diego, La Jolla, CA, ²Zucker School of Medicine at Hofstra/Northwell, Great Neck, NY, ³Columbia University, New York, NY, ⁴Equillium, Inc., La Jolla, CA, ⁵Equillium, Inc., South San Francisco, CA, ⁶Equillium, Inc., San Diego, CA, ⁷Equillium, Inc., Brooklyn, NY, ⁸Albert Einstein College of Medicine, Bronx, NY
Background/Purpose: CD6, a co-stimulatory receptor predominantly expressed on T cells, promotes CD4+ T cell proliferation and differentiation into Th1/Th17 cells. The CD6 ligand, activated leukocyte…
Abstract Number: 1816 • ACR Convergence 2021
Treatment of Non-biologic-DMARD-IR PsA Patients with Upadacitinib or Adalimumab Results in the Modulation of Distinct Functional Pathways: Proteomics Analysis of a Phase 3 Study
Thierry Sornasse¹, Jaclyn Anderson², Koji Kato³, Apinya Lertratanakul⁴, Christopher Ritchlin⁵ and Iain McInnes⁶, ¹AbbVie Inc, Redwood City, CA, ²AbbVie Inc, Gurnee, IL, ³AbbVie Inc, Shinagawa- Ku, Japan, ⁴AbbVie Inc., North Chicago, IL, ⁵Division of Allergy, Immunology, and Rheumatology, School of Medicine and Dentistry, University of Rochester Medical Center, Rochester, NY, ⁶University of Glasgow, School of Medicine, Glasgow, Scotland, United Kingdom
Background/Purpose: Treatment of non-biologic-DMARD-IR (DMARD-IR) PsA patients with upadacitinib (UPA) at 15 mg QD, an oral JAK1 selective inhibitor, resulted in improvement in musculoskeletal symptoms,…
Abstract Number: 0488 • ACR Convergence 2021
Efficacy and Safety of Brepocitinib (Tyrosine Kinase 2/Janus Kinase 1 Inhibitor) for the Treatment of Active Psoriatic Arthritis: Results from a Phase 2b Randomized Controlled Trial
Philip Mease¹, Philip S Helliwell², Paula Silwinska-Stanczyk³, Malgorzata Miakisz⁴, Andrew Ostor⁵, Elena Peeva⁶, Michael Vincent⁶, Vanja Sikirica⁷, Randall Winnette⁸, Ruolun Qiu⁶, Gang Li⁷, Gang Feng⁶, Jean Beebe⁶ and David Martin⁶, ¹Swedish Medical Center/Providence St. Joseph Health and University of Washington, Seattle, WA, ²Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, United Kingdom, ³REUMATIKA – Centrum Reumatologii NZOZ, Warsaw, Poland, ⁴Twoja Przychodnia Centrum Medyczne Nowa Sol, Nowa Sol, Poland, ⁵Monash University, Cabrini Hospital & Emeritus Research, Melbourne, Australia, ⁶Pfizer Inc, Cambridge, MA, ⁷Pfizer Inc, Collegeville, PA, ⁸Pfizer Inc, New York, NY
Background/Purpose: Brepocitinib is a small-molecule tyrosine kinase 2/Janus kinase 1 inhibitor that has shown promising results in an oral formulation for plaque psoriasis and alopecia…
Abstract Number: 1234 • ACR Convergence 2021
Routine Assessment of Patient Index Data 3 (RAPID3) in Patients with Rheumatoid Arthritis Treated with Long-Term Upadacitinib Therapy
Martin Bergman¹, Maya Buch², Yoshiya Tanaka³, Gustavo Citera⁴, Sami Bahlas⁵, Ernest Wong⁶, Yanna Song⁷, Namita Tundia⁷, Jessica Suboticki⁷ and Vibeke Strand⁸, ¹Martin Jan Bergman, MD, Ridley Park, PA, ²University of Leeds, Leeds, United Kingdom, ³University of Occupational and Environmental Health, Kitakyushu, Japan, ⁴Instituto de Rehabilitación Psicofísica, Buenos Aires, Argentina, ⁵Medicine, King Abdulaziz University, Jeddah, Saudi Arabia, ⁶Rheumatology, Queen Alexandra Hospital, Portsmouth, United Kingdom, ⁷AbbVie Inc., North Chicago, IL, ⁸Stanford University School of Medicine, Portola Valley, CA
Background/Purpose: Routine Assessment of Patient Index Data 3 (RAPID3) is a pooled index of 3 patient-reported measures: patient global assessment, pain, and physical function. RAPID3…
Abstract Number: 1363 • ACR Convergence 2021
Identification of PsA Phenotypes with Machine Learning Analytics Using Data from a Phase 3 Clinical Trial Program of Guselkumab in a Bio-naïve Population of Patients with PsA
Pascal Richette¹, Marijn Vis², Sarah Ohrndorf³, William Tillett⁴, Marlies Neuhold⁵, Michel van Speybroeck⁶, Elke Theander⁷, Wim Noel⁸, May Shawi⁹, Alexa Kollmeier¹⁰ and Alen Zabotti¹¹, ¹Lariboisiere Hospital, Paris, France, ²Erasmus MC, Badhoevedorp, Netherlands, ³Charité University Medicine Berlin, Berlin, Germany, ⁴Royal National Hospital for Rheumatic Diseases, Bath, United Kingdom, ⁵Janssen-Cilag, Zug, Switzerland, ⁶Janssen Pharmaceutica, Belgium, Belgium, ⁷Janssen Cilag, Lund, Sweden, ⁸Janssen Pharmaceutica, Vilvoorde, Belgium, ⁹Janssen Immunology Global Commercial Strategy Organization, Toronto, ON, Canada, ¹⁰Janssen Research & Development, LLC, La Jolla, CA, ¹¹University of Udine, Udine, Italy
Background/Purpose: Psoriatic arthritis (PsA) is mainly described based on the individual domains or clinical components of the disease.1,2 The aim of this post hoc analysis…
Abstract Number: 1694 • ACR Convergence 2021
Sustainability of Response to Upadacitinib Among Patients with Active Rheumatoid Arthritis Refractory to Biological Disease-Modifying Anti-Rheumatic Drugs
Ronald van Vollenhoven¹, Stephen Hall², Alvin Wells³, Sebastian Meerwein⁴, Yanna Song⁵, Jessica Suboticki⁵ and Roy Fleischmann⁶, ¹Department of Rheumatology and Clinical Immunology, Amsterdam University Medical Center, Amsterdam Rheumatology Center, Amsterdam, Netherlands, ²Emeritus Research and Monash University, Melbourne, Australia, Melbourne, Australia, ³Rheumatology and Immunotherapy Center, Franklin, WI, ⁴AbbVie Deutschland GmbH & Co. KG, Ludwigshafen, Germany, ⁵AbbVie Inc., North Chicago, IL, ⁶Metroplex Clinical Research Center and University of Texas Southwestern Medical Center, Dallas, TX
Background/Purpose: Sustained clinical remission (REM) is the primary treatment goal for patients with rheumatoid arthritis (RA), with low disease activity (LDA) being an appropriate target…

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Accepted abstracts are made available to the public online in advance of the meeting and are published in a special online supplement of Arthritis & Rheumatology. Information contained in those abstracts may not be released until the abstracts appear online. 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 a scientific presentation or presentation of additional new information that will be available at the time of the meeting) is under embargo until Saturday, November 11, 2023.

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