Abstracts tagged "clinical trial"

Abstract Number: L13 • ACR Convergence 2021
Efficacy and Safety of Subcutaneous Belimumab (BEL) and Rituximab (RTX) Sequential Therapy in Patients with Systemic Lupus Erythematosus: The Phase 3, Randomized, Placebo-Controlled BLISS-BELIEVE Study
Cynthia Aranow¹, Cornelia Allaart², Zahir Amoura³, Ian N Bruce⁴, Patricia Cagnoli⁵, Richard Furie¹, Paul Peter Tak⁶, Murray Urowitz⁷, Ronald van Vollenhoven⁸, Kenneth L Clark⁶, Mark Daniels⁹, Norma Lynn Fox¹⁰, Yun Irene Gregan¹⁰, James Groark¹¹, Robert B Henderson⁹, Mary Oldham⁹, Don Shanahan⁹, Andre van Maurik⁹, David A Roth¹⁰ and YK Onno Teng², ¹Feinstein Institutes for Medical Research, Northwell Health, Great Neck, NY, ²Leiden University Medical Center, Leiden, Netherlands, ³Centre National de reference pour le Lupus, Service de Medecine Interne 2, Institut E3M, Hopital Pitié-Salpétrière, Paris, France, ⁴NIHR Manchester Biomedical Research Centre, Manchester University Hospitals NHS Trust and Centre for Musculoskeletal Research, University of Manchester, Manchester Academic Health Science Centre, Manchester, United Kingdom, ⁵University of Michigan Medical Center, Ann Arbor, MI, ⁶GlaxoSmithKline (At the time of the author's contribution to this study), Stevenage, United Kingdom, ⁷Toronto Western Hospital, University of Toronto, Lupus Clinic, Toronto, ON, Canada, ⁸Amsterdam University Medical Center, Amsterdam Rheumatology Center, Amsterdam, Netherlands, ⁹GlaxoSmithKline, Stevenage, United Kingdom, ¹⁰GlaxoSmithKline, Collegeville, PA, ¹¹GlaxoSmithKline (At the time of the author's contribution to this study), Collegeville, PA
Background/Purpose: Disease control remains an unmet need in SLE. The rationale for sequential BEL and RTX therapy in SLE was previously published.1 This study evaluated…
Abstract Number: L20 • ACR Convergence 2021
Efficacy of Emapalumab, an Anti-IFNγ Antibody in Patients with Macrophage Activation Syndrome (MAS) Complicating Systemic Juvenile Idiopathic Arthritis (sJIA) Who Had Failed High-Dose Glucocorticoids (GCs)
Fabrizio De Benedetti¹, Alexei Grom², Paul Brogan³, Claudia Bracaglia¹, Manuela Pardeo¹, Giulia Marucci¹, Despina Eleftheriou³, Charalampia Papadopoulou³, Pierre Quartier⁴, Jordi Antón⁵, Rikke Frederiksen⁶, Veronica Asnaghi⁶ and Cristina De Min⁶, ¹Bambino Gesù Children's Hospital IRCCS, Rome, Italy, ²Cincinnati Children’s Hospital, Division of Rheumatology, Cincinnati, OH, ³UCL Institute of Child Health, and Great Ormond Street Hospital NHS Foundation Trust, London, United Kingdom, ⁴Université de Paris, IMAGINE Institute, RAISE reference centre, Pediatric Immuno-Hematology and Rheumatology Unit, Necker Hospital, Assistance Publique-Hôpitaux de Paris, Paris, France, ⁵Hospital Sant Joan de Déu, Division of Pediatric Rheumatology, University of Barcelona, Barcelona, Spain, ⁶Swedish Orphan Biovitrum AG (Sobi), Basel, Switzerland
Background/Purpose: MAS is a life-threatening complication of rheumatic diseases, occurring most frequently in sJIA. The mainstay of MAS treatment is high dose GCs; however, GCs…
Abstract Number: 1391 • ACR Convergence 2021
Rituximab Is Superior to Placebo in Polymyalgia Rheumatica Patients: A Double Blind Randomized Controlled Proof of Principle Trial
Diane Marsman¹, Nathan den Broeder², Frank van den Hoogen³, Alfons den Broeder¹ and Aatke van der Maas⁴, ¹Sint Maartenskliniek, Nijmegen, Gelderland, Netherlands, ²Radboud University Medical Centre, Nijmegen, Gelderland, Netherlands, ³Sint Maartenskliniek, Ubbergen, Gelderland, Netherlands, ⁴St Maartenskliniek, Nijmegen, Gelderland, Netherlands
Background/Purpose: Corticosteroids remain the cornerstone of polymyalgia rheumatica treatment, but their use has several disadvantages such as long treatment duration and glucocorticoid-related adverse events.1,2 Data…
Abstract Number: 1696 • ACR Convergence 2021
Clinical Outcomes up to Week 48 of Ongoing Filgotinib RA Long-term Extension Trial of Biologic DMARD Inadequate Responders Initially on Filgotinib or Placebo in a Phase 3 Trial
Maya Buch¹, Tsutomu Takeuchi², Vijay Rajendran³, Jacques-Eric Gottenberg⁴, Alena Pechonkina⁵, YingMeei Tan⁶, Qi Gong⁵, Katrien Van Beneden⁷ and Roberto Caporali⁸, ¹University of Leeds, Leeds, United Kingdom, ²Div. Rheumatology, Keio University, Tokyo, Japan, ³Galapagos NV, Mechelen, Belgium, ⁴National Reference Center for Rare East South-West Autoimmune Systemic Diseases RESO, Strasbourg University Hospitals, Strasbourg, France, ⁵Gilead Sciences, Inc., Foster City, CA, ⁶Gilead Sciences, Inc, San Diego, CA, ⁷Galapagos, NV, Mechelen, Belgium, ⁸Policlinico S. Matteo University, Pavia, Italy
Background/Purpose: The preferential Janus kinase-1 inhibitor filgotinib (FIL) is approved to treat RA in Europe and Japan. We assessed FIL efficacy and safety in patients…
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: 0496 • ACR Convergence 2021
Safety and Efficacy of Rituximab for Systemic Sclerosis: A Double-Blind, Parallel-Group Comparison, Investigators Initiated Confirmatory Randomized Clinical Trial (DESIRES Study)
Satoshi Ebata¹, Ayumi Yoshizaki¹, Koji Oba², Kosuke Kashiwabara³, Keiko Ueda³, Yukari Umemura⁴, Takeyuki Watadani⁵, Takemichi Fukasawa¹, Shunsuke Miura¹, Asako Yoshizaki-Ogawa¹, Yoshihide Asano¹, Naoko Okiyama⁶, Masanari Kodera⁷, Minoru Hasegawa⁸ and Shinichi Sato¹, ¹Department of Dermatology, The University of Tokyo, Graduate School of Medicine, Tokyo, Japan, ²Department of Biostatistics, School of Public Health, Graduate School of Medicine, and Interfaculty Initiative in Information Studies, The University of Tokyo, Tokyo, Japan, ³Clinical Research Support Center, The Tokyo University Hospital, Tokyo, Japan, ⁴Biostatistics Section, Department of Data Science, Center for Clinical Sciences, National Center for Global Health and Medicine, Tokyo, Japan, ⁵Department of Diagnostic Radiology, The University of Tokyo, Graduate School of Medicine, Tokyo, Japan., Tokyo, Japan, ⁶Department of Dermatology, Faculty of Medicine, University of Tsukuba, Ibaraki, Japan., Ibaraki, Japan, ⁷Department of Dermatology, Japan Community Health Care Organization Chukyo Hospital, Aichi, Japan., Aichi, Japan, ⁸Department of Dermatology, Division of Medicine, Faculty of Medical Sciences, University of Fukui, Fukui, Japan., Fukui, Japan
Background/Purpose: Systemic sclerosis (SSc) is a systemic autoimmune disease belonging to collagen diseases, characterized by fibrosis of various organs including the skin and lungs, and…
Abstract Number: 1237 • ACR Convergence 2021
Predictors of Response: Baseline Characteristics and Early Treatment Responses Associated with Achievement of Remission and Low Disease Activity Among Upadacitinib-Treated Patients with Rheumatoid Arthritis
Arthur Kavanaugh¹, Zoltan Szekanecz², Edward Keystone³, Andrea Rubbert-Roth⁴, Stephen Hall⁵, Ricardo Xavier⁶, Joaquim Pereira⁷, In-Ho Song⁸, Naomi Martin⁹, Yanna Song⁸, Samuel Anyanwu⁸ and Peter Nash¹⁰, ¹Division of Rheumatology, Allergy and Immunology, Department of Medicine, University of California San Diego, La Jolla, CA, ²Division of Rheumatology, Faculty of Medicine, University of Debrecen, Debrecen, Hungary, ³Keystone Consulting Enterprises Inc., Toronto, ON, Canada, ⁴Kantonspital St Gallen, St.Gallen, Switzerland, ⁵Emeritus Research and Monash University, Melbourne, Australia, Melbourne, Australia, ⁶Departamento de Reumatologia, Hospital de Clínicas de Porto Alegre, Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil, ⁷Hospital de Santa Maria, Centro Hospitalar Universitário Lisboa Norte and Instituto de Medicina Molecular, Faculdade de Medicina, Universidade de Lisboa, Lisbon Academic Medical Centre, Lisbon, Portugal, ⁸AbbVie Inc., North Chicago, IL, ⁹AbbVie Inc., Saint-Laurent, QC, Canada, ¹⁰Griffith University, Brisbane, Australia
Background/Purpose: Early prediction of response to treatment with upadacitinib (UPA) 15 mg once daily (QD) could help optimize therapy in patients (pts) with RA.1-4 The…
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: 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: 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…

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