Abstracts tagged "clinical trial"

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,…
Abstract Number: 2035 • ACR Convergence 2020
Exploring Stratification Strategies for Early Diffuse Systemic Sclerosis Clinical Trial Design
Robyn Domsic¹, Shiyao Gao², Maureen Laffoon², Steven Wisniewski³, Robert Lafyatis⁴, Virginia Steen⁵ and Thomas Medsger⁶, ¹University of Pittsburgh School of Medicine, Pittsburgh, PA, ²University of Pittsburgh, Pittsburgh, PA, ³University of Pittsburgh Graduate School of Public Health, Pittsburgh, PA, ⁴University of Pittsburgh, Arlington, MA, ⁵Division of Rheumatology, Department of Medicine, MedStar Georgetown University Hospital, Washington, DC, ⁶University of Pittsburgh School of Medicine, Verona, PA
Background/Purpose: Clinical trials in early diffuse systemic sclerosis (SSc) using the modified Rodnan skin score (mRSS) as the primary outcome have been largely negative. This…
Abstract Number: 0107 • ACR Convergence 2020
Effects of Abaloparatide on Modeling and Remodeling Based Bone Formation
David W Dempster¹, Hua Zhou¹, Sudhaker D Rao², Chris Recknor³, Paul D Miller⁴, Benjamin Z Leder⁵, Miriam Annett⁶, Michael S Ominsky⁶ and Bruce H Mitlak⁶, ¹Regional Bone Center, Helen Hayes Hospital, West Haverstraw, NY, West Haverstraw, NY, ²Bone & Mineral Research Laboratory, Henry Ford Health System, Detroit, MI, Detroit, MI, ³United Osteoporosis Centers, Gainesville, GA, Gainesville, GA, ⁴Colorado Center for Bone Research, Lakewood, CO, Lakewood, CO, ⁵Mass General Hospital, Harvard Medical School, Boston, MA, Boston, MA, ⁶Radius Health, Inc., Waltham, MA, Waltham, MA
Background/Purpose: To evaluate abaloparatide-induced changes in the bone formation indices of mineralizing surface (MS), bone formation rate (BFR) and mineral apposition rate (MAR); and to…

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