Abstracts tagged "clinical trial"

Abstract Number: L11 • ACR Convergence 2020
Tofacitinib for the Treatment of Adult Patients with Ankylosing Spondylitis: Primary Analysis of a Phase 3, Randomized, Double-blind, Placebo-controlled Study
Atul Deodhar¹, Paula Sliwinska-Stanczyk², Huji Xu³, Xenofon Baraliakos⁴, Lianne Gensler⁵, Dona Fleishaker⁶, Lisy Wang⁶, Joseph Wu⁶, Sujatha Menon⁶, Cunshan Wang⁶, Oluwaseyi Dina⁷, Lara Fallon⁸, Keith S Kanik⁶ and Désirée van der Heijde⁹, ¹Oregon Health & Science University, Portland, OR, ²Reumatika Centrum Reumatologii, Warszawa, Poland, ³Shanghai Changzheng Hospital, Shanghai, China (People's Republic), ⁴Rheumazentrum Ruhrgebiet, Ruhr-University Bochum, Bochum, Germany, ⁵University of California San Francisco, San Francisco, CA, ⁶Pfizer Inc, Groton, CT, ⁷Pfizer Inc, New York, NY, ⁸Pfizer Inc, Montreal, QC, Canada, ⁹Leiden University Medical Center, Leiden, Netherlands
Background/Purpose: Tofacitinib is an oral JAK inhibitor that is being investigated for the treatment of adult patients (pts) with AS.Methods: This Phase 3, randomized, double-blind…
Abstract Number: 0213 • ACR Convergence 2020
Sustainability of Response to Upadacitinib as Monotherapy or in Combination Among Patients with Rheumatoid Arthritis and Prior Inadequate Response to Conventional Synthetic DMARDs
Arthur Kavanaugh¹, Maya Buch², Bernard Combe³, Louis Bessette⁴, In-Ho Song⁵, Yanna Song⁶, Jessica Suboticki⁵ and Peter Nash⁷, ¹Division of Rheumatology, Allergy, & Immunology, University of California San Diego Medical School, San Diego, CA, ²Centre of Musculoskeletal Research, School of Biological Sciences, University of Manchester, Manchester, United Kingdom, ³University of Montpellier, Montpellier, France, ⁴Laval University, Quebec, Canada, ⁵AbbVie Inc., North Chicago, IL, ⁶AbbVie Inc., North Chicago,, IL, ⁷School of Medicine Griffith University, Brisbane, Queensland, Australia
Background/Purpose: To assess long-term sustainability of responses to upadacitinib (UPA), a JAK inhibitor, with or without background csDMARD(s) in patients (pts) with rheumatoid arthritis (RA).Methods:…
Abstract Number: 0361 • ACR Convergence 2020
Response to Treatment with Ixekizumab in Patients with Active Non-Radiographic Axial Spondyloarthritis Based on HLA-B27 Status and Disease Duration
Victoria Navarro-Compán¹, Jose Maldonado-Cocco², Proton Rahman³, Andris Kronbergs⁴, David Sandoval⁴, So Young Park⁴, Theresa Hunter⁴ and Marina Magrey⁵, ¹Hospital Universitario La Paz IdiPaz, Madrid, Pais Vasco, Spain, ²University of Buenos Aires School of Medicine, Buenos Aires, Argentina, ³Memorial University of Newfoundland, Department of Medicine, St John's, Canada, ⁴Eli Lilly and Company, Indianapolis, ⁵Case Western Reserve University School of Medicine, Cleveland, OH
Background/Purpose: In this analysis, we evaluate the efficacy of ixekizumab at week 16 in patients with non-radiographic axial spondyloarthritis (nr-axSpA) with or without baseline HLA-B27…
Abstract Number: 0717 • ACR Convergence 2020
Predictors of Clinical Remission in Children with Extended Oligoarticular Arthritis, Enthesitis-related Arthritis, or Psoriatic Arthritis Treated with Etanercept in the CLIPPER Studies
Jelena Vojinovic¹, Vyacheslav Chasnyk¹, Joke Dehoorne¹, Violeta Panaviene¹, Jonathan Akikusa², Tadej Avcin¹, Jeffrey Chaitow¹, Bernard Lauwerys¹, Jordi Antón¹, Inmaculada Penades¹, Berit Flato¹, Alina Boteanu³, Hans-Iko Huppertz¹, Juan Jaller¹, Daniela Graham⁴, Cecilia Borlenghi⁵, Bonnie Vlahos⁶, Chuanbo Zang⁶ and Nicolino Ruperto², ¹Paediatric Rheumatology International Trials Organisation (PRINTO), Genoa, Italy, ²PRINTO, Istituto Giannina Gaslini, Genova, Italy, ³Hospital Universitario Ramón y Cajal, Madrid, Spain, ⁴Pfizer, Groton, PA, ⁵Pfizer, New York, NY, ⁶Pfizer, Collegeville, PA
Background/Purpose: CLIPPER is an ongoing, 8-year, phase 3b, multicenter, open-label study of the safety and efficacy of etanercept in the treatment of juvenile idiopathic arthritis…
Abstract Number: 0900 • ACR Convergence 2020
Achievement of Low Disease Activity According to BASDAI with Ixekizumab in Patients with Axial Spondyloarthritis: 16-Week Results from the COAST Trials
Denis Poddubnyy¹, Xavier Juanola², Clément Prati³, Hagen Russ⁴, Yves Schymura⁴, Soyi Liu-Leage⁵, Mani Haschemi Nassab⁴ and Jean Dudler⁶, ¹Charité – Universitätsmedizin Berlin, Berlin, Germany, ²Rheumatology Service, University Hospital Bellvitge, IDIBELL, Barcelona, Spain, Barcelona, Spain, ³Service de Rhumatologie, Hôpital Jean-Minjoz , Besançon, France, Besançon, France, ⁴Eli Lilly and Company, Indianapolis, Indiana, USA, Indianapolis, IN, ⁵Eli Lilly and Company, Indianapolis, IN, ⁶Department of Rheumatology, HFR Fribourg - Hospital Cantonal, Fribourg, Switzerland, Fribourg, Switzerland
Background/Purpose: The efficacy of ixekizumab (IXE), a selective interleukin-17A antagonist, was assessed in patients (pts) with axial SpA (axSpA) in three Phase 3, randomized, double-blind,…
Abstract Number: 1231 • ACR Convergence 2020
Radiographic Outcomes in Patients with Rheumatoid Arthritis Receiving Upadacitinib as Monotherapy or in Combination with Methotrexate: Results at 2 Years
Charles Peterfy¹, Vibeke Strand², Mark Genovese³, Alan Friedman⁴, Jeffrey Enejosa⁴, Stephen Hall⁵, Eduardo Mysler⁶, Patrick Durez⁷, Xenofon Baraliakos⁸, Tim Shaw⁴, Yanna Song⁹, Yihan Li⁴ and In-Ho Song⁴, ¹Spire Sciences, Inc., Boca Raton, FL, ²Division of Immunology/Rheumatology, Stanford University, Palo Alto, CA, ³Stanford University Medical Center, Palo Alto, CA, ⁴AbbVie Inc., North Chicago, IL, ⁵Cabrini Medical Centre, Monash University and Emeritus Research, Malvern, Victoria, Australia, ⁶Organización Medica de Investigación, Buenos Aires, Argentina, ⁷Division of Rheumatology, Cliniques Universitaires Saint-Luc, Bruxelles, Belgium, ⁸Rheumazentrum Ruhrgebiet-Ruhr-University Bochum, Herne, Germany, ⁹AbbVie Inc., North Chicago,, IL
Background/Purpose: For patients with rheumatoid arthritis (RA), long‑term prevention of structural joint damage is a key treatment goal.1 In the SELECT-EARLY and SELECT-COMPARE trials, upadacitinib…
Abstract Number: 1744 • ACR Convergence 2020
The STAtins to Prevent Rheumatoid Arthritis (STAPRA) Trial: Clinical Results and Subsequent Qualitative Study, a Mixed Method Evaluation
Laurette van Boheemen¹, Marieke ter Wee², Samina Turk³, Marian van Beers³, Wouter Bos³, Diane Marsman⁴, Ed Griep⁵, Mirian Starmans⁶, Calin Popa⁷, Alper van Sijl³, Bart Seppen³, Maarten Boers⁸, Mike Nurmohamed⁹ and Dirkjan van Schaardenburg⁸, ¹Amsterdam Rheumatology and immunology Center | Reade, Amste, Netherlands, ²Amsterdam Rheumatology and Immunology Center, location Amsterdam UMC, VUmc, Amsterdam, Netherlands, ³Amsterdam Rheumatology and immunology Center | Reade, Amsterdam, Netherlands, ⁴Sint Maartenskliniek, Nijmegen, Netherlands, ⁵Antonius Ziekenhuis, Sneek, Netherlands, ⁶Zuyderland MC, Heerlen, Netherlands, ⁷Radboudumc, Nijmegen, Netherlands, ⁸Amsterdam Rheumatology and immunology Center | Reade and Amsterdam UMC, Amsterdam, Netherlands, ⁹Amsterdam Rheumatology and immunology Center, location Reade and Amsterdam UMC, VU medical center, Amsterdam, Netherlands
Background/Purpose: Persons at high risk of developing rheumatoid arthritis (RA) may benefit from a low-risk pharmacological intervention aimed at primary prevention. Previous studies demonstrated disease-modifying…
Abstract Number: 2028 • ACR Convergence 2020
Predictors of Maintaining Inactive Disease After Etanercept Withdrawal, and Regaining Inactive Disease Status After Flare and Retreatment, in Adults with Non-radiographic Axial Spondyloarthritis: Results from RE-EMBARK
Filip Van den Bosch¹, James Cheng-Chung Wei², Francisco Blanco³, Pamela Selema⁴, Daniela Graham⁵, Edmund Arthur⁶, Vassilis Tsekouras⁷, Bonnie Vlahos⁴, Chuanbo Zang⁴, Atul Deodhar⁸ and Peter Nash⁹, ¹Ghent University Hospital, Ghent, Belgium, ²Chung Shan Medical University Hospital, Taichung, Taiwan (Republic of China), ³INIBIC-Complejo Hospitalario Universitario A Coruña, A Coruna, Spain, ⁴Pfizer, Collegeville, PA, ⁵Pfizer, Groton, PA, ⁶Pfizer, Peapack, NJ, ⁷Pfizer, Nicosia, Cyprus, ⁸Oregon Health & Science University, Portland, OR, ⁹School of Medicine Griffith University, Brisbane, Queensland, Australia
Background/Purpose: RE-EMBARK was a phase 4, multicenter, open-label, 3-period study that evaluated etanercept (ETN) withdrawal and retreatment in adult patients with non-radiographic axial spondyloarthritis (nr-axSpA)…
Abstract Number: 0048 • ACR Convergence 2020
Determinants of Participation in Clinical Trials Among Patients with Lupus in the United States
Onengiya Harry¹, Carl Langefeld², Miranda Marion³, Trent Younts³, Lori Crosby⁴, Mara Vitolins³ and Avani Modi⁴, ¹Wake Forest School of Medicine, Clemmons, NC, ²Wake Forest School of Medicine, Winston Salem, NC, ³Wake Forest School of Medicine, Winston-Salem, ⁴Cincinnati Children's Hospital Medical Center, Cincinnati
Background/Purpose: Patient and family participation in research is critical to improving health outcomes, and identifying factors that contribute to participation or lack of participation in…
Abstract Number: 0214 • ACR Convergence 2020
Sustainability of Response Between Upadacitinib and Adalimumab Among Patients with Rheumatoid Arthritis and Prior Inadequate Response to Methotrexate
Peter Nash¹, Arthur Kavanaugh², Maya Buch³, Bernard Combe⁴, Louis Bessette⁵, In-Ho Song⁶, Yanna Song⁷, Jessica Suboticki⁶ and Roy Fleischmann⁸, ¹School of Medicine Griffith University, Brisbane, Queensland, Australia, ²Division of Rheumatology, Allergy, & Immunology, University of California San Diego Medical School, San Diego, CA, ³Centre of Musculoskeletal Research, School of Biological Sciences, University of Manchester, Manchester, United Kingdom, ⁴University of Montpellier, Montpellier, France, ⁵Laval University, Quebec, Canada, ⁶AbbVie Inc., North Chicago, IL, ⁷AbbVie Inc., North Chicago,, IL, ⁸Southwestern Medical Center, Metroplex Clinical Research Center, Dallas, TX
Background/Purpose: The primary treatment goal for patients(pts) with rheumatoid arthritis(RA) is a state of sustained clinical remission(REM) or low disease activity(LDA).1,2 We assess long-term sustainability…
Abstract Number: 0384 • ACR Convergence 2020
Serum Neutrophil Count Predicts Progression of Interstitial Lung Disease and Mortality in Patients with Systemic Sclerosis Related Interstitial Lung Disease
Nancy Wareing¹, Ning Li², Elizabeth Volkmann³, Marka Lyons⁴, Michael Roth², Donald Tashkin² and Shervin Assassi¹, ¹University of Texas Houston McGovern Medical School, Division of Rheumatology and Clinical Immunogenetics, Houston, TX, ²University of California, Los Angeles, Los Angeles, ³University of California, Los Angeles, Los Angeles, CA, ⁴University of Texas Houston, McGovern Medical School, Division of Rheumatology and Clinical Immunogenetics, Houston, TX
Background/Purpose: Systemic sclerosis (SSc) patients have a prominent neutrophil gene expression signature. However, investigations into the pathophysiologic role of neutrophils in SSc are lacking. This…
Abstract Number: 0798 • ACR Convergence 2020
A Randomized, Double-blind Phase 3 Study Comparing the Efficacy, Safety and Immunogenicity of PF-06410293 (Abrilada™), an Adalimumab (ADL) Biosimilar, and Reference ADL (Humira®) in Patients with Moderate to Severe Active RA: Results from Weeks 52-92
Roy Fleischmann¹, Daniel Alvarez², Amy Bock³, Carol Cronenberger⁴, Ivana Vranic⁵, Wuyan Zhang⁶ and Rieke Alten⁷, ¹Southwestern Medical Center, Metroplex Clinical Research Center, Dallas, TX, ²Pfizer, Collegeville, PA, ³Pfizer, Cambridge, MA, ⁴Pfizer, Collegeville, ⁵Pfizer, Tadworth, United Kingdom, ⁶Pfizer, New York, ⁷Schlosspark-Klinik, Universitätsmedizin, Berlin, Germany
Background/Purpose: To evaluate the long-term safety, immunogenicity (IG), and efficacy of the adalimumab (ADL) biosimilar, PF-06410293 (ADL-PF), in patients (pts) with moderate to severe active…
Abstract Number: 0935 • ACR Convergence 2020
Efficacy and Safety Results from a Phase 2, Randomized, Double-Blind Trial of BIIB059, an Anti-Blood Dendritic Cell Antigen 2 Antibody, in SLE
Richard Furie¹, Ronald van Vollenhoven², Kenneth Kalunian³, Sandra Navarra⁴, Juanita Romero-Díaz⁵, Victoria Werth⁶, Xiaobi Huang⁷, Hua Carroll⁸, Adam Meyers⁷, Cristina Musselli⁷, Catherine Barbey⁹ and Nathalie Franchimont⁷, ¹Zucker School of Medicine at Hofstra/Northwell, Great Neck, NY, ²Department of Rheumatology, Amsterdam Rheumatology and Immunology Center, Amsterdam, Netherlands, ³University of California San Diego, La Jolla, CA, ⁴University of Santo Tomas, Manila, Philippines, ⁵Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran, Mexico City, Mexico, ⁶University of Pennsylvania and the Michael J. Crescenz VA Medical Center, Philadelphia, PA, ⁷Biogen, Cambridge, MA, ⁸Biogen, Cambridge, ⁹Biogen, Baar, Switzerland
Background/Purpose: Type I interferons (IFN-I), inflammatory mediators principally produced by plasmacytoid dendritic cells (pDCs), components of the innate immune system, have been implicated in the…
Abstract Number: 1233 • ACR Convergence 2020
Use of Multi-Biomarker Disease Activity Scores to Compare Biosimilar Adalimumab-afzb (PF-06410293) with EU-Sourced Reference Adalimumab in a Phase 3, Randomized, Double-Blind Trial in Patients with Active RA
Jonathan Kay¹, Amy Bock², Noriko Iikuni³, Wuyan Zhang⁴ and Daniel Alvarez⁵, ¹University of Massachusetts Medical School, Worcester, MA, ²Pfizer, Cambridge, MA, ³Pfizer, New York, NY, ⁴Pfizer, New York, ⁵Pfizer, Collegeville, PA
Background/Purpose: Traditional efficacy endpoints of disease activity (DA) in studies of anti-rheumatic drugs can be confounded by subjective (patient-/physician-reported) assessments, comorbidities, and pre-existing joint damage.…
Abstract Number: 1745 • ACR Convergence 2020
A Novel Method for Predicting 1-Year Retention of Abatacept Using Machine Learning Techniques
Rieke Alten¹, Claire Behar², Christine Boileau², Pierre Merckaert², Ebenezer Afari², Virginie Vannier-Moreau³, Sean Connolly³, Yedid Elbez², Pierre-Antoine Juge⁴ and Karissa Lozenski³, ¹Schlosspark-Klinik, Universitätsmedizin, Berlin, Germany, ²Excelya, Boulogne-Billancourt, France, ³Bristol-Myers Squibb Company, Princeton, NJ, ⁴Université de Paris, Service de Rhumatologie Hôpital Bichat-Claude Bernard, AP-HP, Paris, France
Background/Purpose: In the ACTION (NCT02109666) study, using multivariable Cox proportional hazards regression models, patient (pt) global assessment of pain, country, reason for stopping last biologic,…

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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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