Abstracts tagged "clinical trial"

Abstract Number: 1752 • ACR Convergence 2021
Efficacy of Voclosporin in Recent Onset Lupus Nephritis
Meggan Mackay¹, Matt Truman², Nicole England², Vanessa Birardi³ and Paola Mina-Osorio⁴, ¹Feinstein Institutes for Medical Research, Manhasset, NY, ²Aurinia Pharmaceuticals Inc., Victoria, BC, Canada, ³Aurinia Pharmaceuticals Inc, Rockville, MD, ⁴Aurinia Pharmaceuticals Inc., New York, NY
Background/Purpose: Voclosporin is a novel calcineurin inhibitor recently approved for the treatment of adults with active lupus nephritis (LN) in combination with background immunosuppressive therapy.…
Abstract Number: 1823 • ACR Convergence 2021
Efficacy of Upadacitinib in Patients with Active Psoriatic Arthritis and a Low or High Swollen Joint Count: A Subgroup Analysis of 2 Phase 3 Studies
Laure Gossec¹, Dafna Gladman², Erin McDearmon-Blondell³, Philipp Sewerin⁴, Christopher Ritchlin⁵, Dai Feng⁶, Apinya Lertratanakul⁷, Roberto Ranza⁸, Lai-Shan Tam⁹, Antonio Marchesoni¹⁰, Laura Coates¹¹ and Peter Nash¹², ¹Sorbonne Université; APHP, Rheumatology Department, Pitié-Salpêtrière Hospital, Paris, France, ²Schroeder Arthritis Institute, Krembil Research Institute, Toronto Western Hospital, Toronto, ON, Canada, ³AbbVie Inc., Elmhurst, IL, ⁴Department and Hiller Research Unit of Rheumatology, Heinrich Heine University Duesseldorf, Duesseldorf, Germany, ⁵Division of Allergy, Immunology, and Rheumatology, School of Medicine and Dentistry, University of Rochester Medical Center, Rochester, NY, ⁶AbbVie Inc., East Brunswick, NJ, ⁷AbbVie Inc., North Chicago, IL, ⁸Hospital de Clinicas, Universidade Federal de Uberlândia, Uberlandia, MG, Brazil, ⁹Department of Medicine & Therapeutics, The Prince of Wales Hospital, The Chinese University of Hong Kong, Hong Kong, China (People's Republic), ¹⁰Dipartimento di Reumatologia, ASST Gaetano Pini-CTO, Milano, Italy, ¹¹Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, United Kingdom, ¹²Griffith University, Brisbane, Australia
Background/Purpose: Although most patients with psoriatic arthritis (PsA) enrolled in clinical trials have polyarticular arthritis, patients in clinical practice may present with oligoarthritis. Data on…
Abstract Number: 0497 • ACR Convergence 2021
Efficacy in Patient Subgroups in the INCREASE Trial, a Phase III Trial to Evaluate Inhaled Treprostinil in Patients with Pulmonary Hypertension Due to Parenchymal Lung Disease
Victor Tapson¹, Steven Nathan², Reda Girgis³, James Runo⁴, Remzi Bag⁵, Arunabh Talwar⁶, Peter Smith⁷, Lisa Edwards⁷, Christine Park⁷ and Aaron Waxman⁸, ¹Cedars-Sinai, Los Angeles, CA, ²Inova Fairfax, Falls Church, VA, ³Michigan State University, Lansing, MI, ⁴University of Wisconsin, Madison, WI, ⁵University of Chicago, Chicago, IL, ⁶Hofstra Northwell School of Medicine, Hempstead, NY, ⁷United Therapeutics Corporation, Durham, NC, ⁸Brigham and Women's Hospital, Boston, MA
Background/Purpose: INCREASE was a 16-week trial evaluating the safety and efficacy of inhaled treprostinil (iTRE) in patients with pulmonary hypertension associated with interstitial lung disease…
Abstract Number: 1240 • ACR Convergence 2021
Biomarker Driven Dissection of Inflammation Modulatory Effects of Upadacitinib versus Abatacept in Patients with Active Rheumatoid Arthritis Refractory to Biologic DMARDs
Fang Cai¹, Thierry Sornasse², Feng Hong³, Heidi Camp⁴, Koji Kato⁵ and Iain McInnes⁶, ¹AbbVie, Redwood City, CA, ²AbbVie Inc, Redwood City, CA, ³AbbVie, Worcester, MA, ⁴AbbVie Inc., North Chicago, IL, ⁵AbbVie Inc, Shinagawa- Ku, Japan, ⁶University of Glasgow, School of Medicine, Glasgow, Scotland, United Kingdom
Background/Purpose: In patients with active rheumatoid arthritis (RA) refractory to biologic DMARDs (bDMARD-IR), a phase 3, double-blind and active-controlled study (SELECT-CHOICE) demonstrated that upadacitinib (UPA)…
Abstract Number: 1396 • ACR Convergence 2021
Baricitinib in Relapsing Giant Cell Arteritis: A Prospective Open-Label Single-Institution Study
Matthew Koster¹, Cynthia Crowson², Rachel Giblon¹, Ali Duarte-Garcia¹, Jane Jaquith¹, Cornelia M. Weyand¹ and Kenneth Warrington³, ¹Mayo Clinic, Rochester, MN, ²Mayo Clinic, Eyota, MN, ³Mayo Clinic, Rochester, Minnesota
Background/Purpose: Pre-clinical giant cell arteritis (GCA) mouse models have demonstrated effective suppression of arterial wall lesional T-cells through inhibition of Janus kinase 3 (JAK3) and…
Abstract Number: 1697 • ACR Convergence 2021
Clinical Outcomes up to Week 48 of Filgotinib Treatment in an Ongoing Long-term Extension Trial of RA Patients with Inadequate Response to MTX Initially Treated with Filgotinib or Adalimumab During the Phase 3 Parent Trial
Bernard Combe¹, Yoshiya Tanaka², Paul Emery³, Alena Pechonkina⁴, Albert Kuo⁴, Qi Gong⁴, Katrien Van Beneden⁵, Vijay Rajendran⁶ and Hendrik Schulze-Koops⁷, ¹CHU Montpellier Montpellier University, Montpellier, France, ²University of Occupational and Environmental Health, Kitakyushu, Japan, ³Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds and Leeds NIHR Biomedical Research Centre, Leeds, United Kingdom, ⁴Gilead Sciences, Inc., Foster City, CA, ⁵Galapagos, NV, Mechelen, Belgium, ⁶Galapagos NV, Mechelen, Belgium, ⁷Division of Rheumatology and Clinical Immunology, Department of Internal Medicine IV, University of Munich, Munich, Germany
Background/Purpose: The preferential Janus kinase (JAK)-1 inhibitor filgotinib (FIL) is approved for treatment of moderately to severely active RA in Europe and Japan. We assessed…
Abstract Number: 1755 • ACR Convergence 2021
Increasing Participation of Underrepresented Groups in Lupus Clinical Trials: Insights from Qualitative Interviews with Patients and Physicians
Saira Sheikh¹, Maria Naylor², Becky Lane², Jennifer Sacks², Janine Gaiha-Rohrbach² and Cherie Butts², ¹University of North Carolina Thurston Arthritis Research Center, and Department of Medicine, Division of Rheumatology, Allergy and Immunology, University of North Carolina at Chapel Hill School of Medicine, Chapel Hill, NC, ²Biogen, Cambridge, MA
Background/Purpose: Systemic lupus erythematosus disproportionately affects Black/African American (AA) and Latino/a populations.1 Challenges to engage and include these populations in clinical trials (CTs) can be…
Abstract Number: 1834 • ACR Convergence 2021
To What Extent Do Clinical Features of PsA Predict Achievement of Minimal Disease Activity at Week 24: A Post Hoc Analysis of the Phase III Clinical Trial Program of Guselkumab in a Bio-naïve Patient Population
Marijn Vis¹, Pascal Richette², Ramirez Julio³, Marlies Neuhold⁴, Robert Wapenaar⁵, Elke Theander⁶, Wim Noel⁷, May Shawi⁸, Alexa Kollmeier⁹ and William Tillett¹⁰, ¹Erasmus MC, Badhoevedorp, Netherlands, ²Lariboisiere Hospital, Paris, France, ³Hospital Universitari Clinic, Barcelona, Spain, ⁴Janssen-Cilag, Zug, Switzerland, ⁵Janssen-Cilag BV, Breda, Netherlands, ⁶Janssen Cilag, Lund, Sweden, ⁷Janssen Pharmaceutica, Vilvoorde, Belgium, ⁸Janssen Immunology Global Commercial Strategy Organization, Toronto, ON, Canada, ⁹Janssen Research & Development, LLC, La Jolla, CA, ¹⁰Royal National Hospital for Rheumatic Diseases, Bath, United Kingdom
Background/Purpose: Guselkumab (GUS), a human monoclonal antibody targeting the interleukin-23p19-subunit, has demonstrated efficacy across joint and skin endpoints at Week 24 (W24) in the Phase…
Abstract Number: 0112 • ACR Convergence 2021
A Randomized Trial Showing No Differences in Patient Satisfaction with Telemedicine Delivered by Phone or Video During COVID-19 in Rheumatology and Other Medical Specialty Clinics
Maria I. Danila¹, Dongmei Sun², Lesley Jackson¹, Gary Cutter¹, Elizabeth Jackson¹, Eric Ford¹, Erin DeLaney¹, Amy Mudano¹, Jeffrey Foster¹, Giovanna Rosas¹, Jeffrey Curtis³ and Kenneth Saag¹, ¹University of Alabama at Birmingham, Birmingham, AL, ²Division of Clinical Immunology and Rheumatology, The University of Alabama at Birmingham, Birmingham, AL, ³Division of Clinical Immunology and Rheumatology, Department of Medicine, Department of Epidemiology, University of Alabama at Birmingham, Birmingham, AL
Background/Purpose: The COVID-19 pandemic has led to a significant shift to home-based telemedicine including video and phone-only visits in many medical specialties. However, patients may…
Abstract Number: 0603 • ACR Convergence 2021
Barriers and Potential Solutions in the Recruitment and Retention of Older Patients in Clinical Trials – Lessons Learned from Six Large Multi-center Randomized Controlled Trials
Thomas Buttgereit¹, Andriko Palmowski¹, Noah Forsat¹, Maarten Boers², Miles Witham³, Nicolas Rodondi⁴, Elisavet Moutzouri⁴, Antonio Jesus Quesada Navidad⁵, Arnoud van’t Hof⁶, Bart van der Worp⁷, Laura Coll-Planas⁸, Marieke Voshaar⁹, Maarten de Wit¹⁰, Jose Pereira da Silva¹¹, Sven Stegemann¹², Johannes Bijlsma¹³, Marcus Koeller¹⁴, Simon Mooijaart¹⁵, Patricia Kearney¹⁶ and Frank Buttgereit¹, ¹Charité – Universitätsmedizin Berlin, Berlin, Germany, ²Amsterdam UMC, Vrije Universiteit, Amsterdam, Netherlands, ³AGE Research Group, NIHR Newcastle Biomedical Research Centre, Translational and Clinical Research Institute, Newcastle University and Newcastle upon Tyne Hospitals Trust, Newcastle, United Kingdom, ⁴Department of General Internal Medicine, Inselspital, Bern University Hospital, Bern, Switzerland, ⁵CNIC – Spanish National Center for Cardiovascular Research, Madrid, ⁶Cardiology Department, Maastricht UMC, Maastricht, Netherlands, ⁷Department of Neurology and Neurosurgery, Brain Center, University Medical Center Utrecht, Utrecht, Netherlands, ⁸Fundació Salut i Envelliment, Universitat Autònoma de Barcelona, Barcelona, Spain, ⁹Department Psychology, Health and Technology, University of Twente, Twente, Netherlands, ¹⁰EULAR Patient Research Partner, Zaltbommel, Netherlands, ¹¹University of Coimbra | UC · Clínica Universitária de Reumatologia. Faculty of Medicine, Columbia, Portugal, ¹²TU Graz, Institute for Process and Particle Engineering, Graz, Australia, ¹³Department of Rheumatology and Clinical Immunology, University Medical Centre Utrecht, Utrecht, Netherlands, ¹⁴Faculty of Geriatric Medicine, Medical University of Vienna, Vienna, Austria, ¹⁵Department of Gerontology and Geriatrics, Leiden University Medical Center, Leiden, The Netherlands; Institute for Evidence-based Medicine in Old Age | IEMO, Leiden, Netherlands, ¹⁶School of Epidemiology and Public Health, University College Cork, Cork, Ireland
Background/Purpose: Older people remain underrepresented in clinical trials, and evidence generated in younger populations cannot always be generalized to older patients.We aimed to identify key…
Abstract Number: 1241 • ACR Convergence 2021
Comparison of the Effects of Upadacitinib Monotherapy with MTX on Protein Biomarkers in MTX-Naïve and MTX-Inadequate Responders in Patients with Active Rheumatoid Arthritis: Results from the SELECT-EARLY and SELECT‑MONOTHERAPY Phase 3 Studies
Thierry Sornasse¹, Heidi Camp², Fang Cai³, Justin Klaff² and Iain McInnes⁴, ¹AbbVie Inc, Redwood City, CA, ²AbbVie Inc., North Chicago, IL, ³AbbVie, Redwood City, CA, ⁴University of Glasgow, School of Medicine, Glasgow, Scotland, United Kingdom
Background/Purpose: In MTX-naïve patients (SELECT-EARLY/M13-545 Phase 3 study) UPA 15 mg QD monotherapy (UPA Mono) demonstrated significant and clinically meaningful improvements in RA signs and…
Abstract Number: 1425 • ACR Convergence 2021
Voclosporin for Lupus Nephritis: Interim Analysis of the AURORA 2 Extension Study
Amit Saxena¹, Christopher Mela² and Antonia Coeshall³, ¹NYU School of Medicine, New York, NY, ²Aurinia Pharmaceuticals Inc., Victoria, BC, Canada, ³Aurinia Pharmaceuticals Inc., Rockville
Background/Purpose: Voclosporin, a novel calcineurin inhibitor (CNI), has been tested successfully in 2 pivotal trials in adult patients with lupus nephritis (LN). Previously reported results…
Abstract Number: 1700 • ACR Convergence 2021
Pharmacokinetic Boosting to Enable Once-Daily Reduced Dose Tofacitinib
Céleste van der Togt¹, Lise Verhoef², Nathan den Broeder³, Rob ter Heine³, Bart van den Bemt⁴ and Alfons den Broeder⁵, ¹Sint Maartenskliniek, Ubbergen, Gelderland, Netherlands, ²Sint Maartenskliniek, Nijmegen, Netherlands, ³Radboud University Medical Centre, Nijmegen, Gelderland, Netherlands, ⁴Sint Maartenskliniek; Radboud University Medical Center, Ubbergen, Netherlands, ⁵Sint Maartenskliniek, Nijmegen, Gelderland, Netherlands
Background/Purpose: Tofacitinib is an effective, yet costly, drug for treatment of RA and PsA. Tofacitinib is metabolized mainly by the cytochrome P450-enzyme CYP3A4, and the…
Abstract Number: 1765 • ACR Convergence 2021
Should SLE Patients Entering Clinical Trials Be Required to Have at Least One BILAG A and/or Two BILAG B Domain Scores?
Ewa Olech¹, Faizi Hussain² and Joan Merrill³, ¹IQVIA, Las Vegas, NV, ²IQVIA, Redding, United Kingdom, ³Oklahoma Medical Research Foundation, Oklahoma City, OK
Background/Purpose: High placebo response rates have challenged interpretation of clinical trial results in SLE and may have contributed to failure of some effective treatments. One…
Abstract Number: 1856 • ACR Convergence 2021
Serum IFN Score Predicts Long Term Outcome in Limited Cutaneous SSc
Ranjitha Karanth¹, Giuseppina Abignano², Vishal Kakkar², Rebecca Ross², Christopher Denton³ and Francesco Del Galdo², ¹Leeds Institute of Rheumatic and Musculoskeletal Medicine, LTHT, Leeds, United Kingdom, ²University of Leeds, Leeds, United Kingdom, ³University College London Division of Medicine, Centre for Rheumatology and Connective Tissue Diseases, London, United Kingdom
Background/Purpose: Limited cutaneous systemic sclerosis (lcSSc) carries a highly variable prognosis and to date there are no stratification tools to predict clinical outcomes. Evidence suggests…

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