Abstracts tagged "Randomized Trial"

Abstract Number: 0986 • ACR Convergence 2020
BIIB059, a Humanized Monoclonal Antibody Targeting Blood Dendritic Cell Antigen 2 on Plasmacytoid Dendritic Cells, Shows Dose-Related Efficacy in a Phase 2 Study in Participants with Active Cutaneous Lupus Erythematosus
Victoria Werth¹, Richard Furie², Juanita Romero-Díaz³, Sandra Navarra⁴, Kenneth Kalunian⁵, Ronald van Vollenhoven⁶, Filippa Nyberg⁷, Benjamin Kaffenberger⁸, Saira Sheikh⁹, Goran Radunovic¹⁰, Xiaobi Huang¹¹, Hua Carroll¹², Francois Gaudreault¹², Adam Meyers¹¹, Catherine Barbey¹³, Cristina Musselli¹¹ and Nathalie Franchimont¹¹, ¹University of Pennsylvania and the Michael J. Crescenz VA Medical Center, Philadelphia, PA, ²Zucker School of Medicine at Hofstra/Northwell, Great Neck, NY, ³Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran, Mexico City, Mexico, ⁴University of Santo Tomas, Manila, Philippines, ⁵University of California San Diego, La Jolla, CA, ⁶Department of Rheumatology, Amsterdam Rheumatology and Immunology Center, Amsterdam, Netherlands, ⁷Karolinska University Hospital, Stockholm, Sweden, ⁸Ohio State University, Columbus, OH, ⁹Division of Rheumatology, Allergy and Immunology, University of North Carolina, Chapel Hill, NC, ¹⁰Institute of Rheumatology, University of Belgrade, Belgrade, Serbia, ¹¹Biogen, Cambridge, MA, ¹²Biogen, Cambridge, ¹³Biogen, Baar, Switzerland
Background/Purpose: No approved targeted therapies have been developed for cutaneous lupus erythematosus (CLE), a disfiguring autoimmune disease that severely impairs quality of life.1 BIIB059 is…
Abstract Number: 1633 • ACR Convergence 2020
A Randomized, Double-Blind, Placebo-Controlled Study of Anakinra in Pediatric and Adult Patients with Still’s Disease
Laura Schanberg¹, Peter Nigrovic², Ashley Cooper³, Winn Chatham⁴, Shoghik Akoghlanian⁵, Namrata Singh⁶, C. Egla Rabinovich⁷, Akaluck Thatayatikom⁸, Alysha Taxter⁹, Jonathan Hausmann¹⁰, Milan Zdravkovic¹¹, Sven Ohlman¹¹, Henrik Andersson¹¹, Susanna Cederholm¹¹, Gunilla Huledal¹¹, Rayfel Schneider¹² and Fabrizio De Benedetti¹³, ¹Duke University Medical Center, Durham, NC, ²Division of Rheumatology, Inflammation and Immunity, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA; Division of Immunology, Boston Children's Hospital, Harvard Medical School, Boston, MA, USA, Boston, ³Children's Mercy Kansas City, Kansas City, MO, ⁴University of Alabama at Birmingham, Birmingham, AL, ⁵Nationwide Children’s Hospital, Columbus, ⁶University of Washington, Bellevue, WA, ⁷Duke University Hospital, Durham, NC, ⁸Department of Pediatrics, University of Florida, Gainesville, FL, ⁹Wake Forest Baptist Medical Center, Winston-Salem, ¹⁰Boston Children's Hospital / Beth Israel Deaconess Medical Center, Cambridge, MA, ¹¹Sobi, Stockholm, Sweden, ¹²University of Toronto, The Hospital for Sick Children, Toronto, Canada, ¹³Division of Rheumatology, Laboratory of Immuno-Rheumatology, IRCCS Ospedale Pediatrico Bambino Gesù, Rome, Italy, Rome, Italy
Background/Purpose: Still’s disease, including both systemic juvenile idiopathic arthritis (SJIA) and adult-onset Still’s disease (AOSD), is a rare systemic auto-inflammatory disorder associated with an activated…
Abstract Number: 0228 • ACR Convergence 2020
Impact of Upadacitinib or Adalimumab as Initial Therapy on the Achievement of 48-Week Treatment Goals in Patients with Rheumatoid Arthritis and Inadequate Response to Methotrexate: Post Hoc Analysis of a Phase 3 Study
Eduardo Mysler¹, Yoshiya Tanaka², Arthur Kavanaugh³, Daniel Aletaha⁴, Peter Taylor⁵, In-Ho Song⁶, Tim Shaw⁶, Yanna Song⁷, Ryan DeMasi⁶, Mira Ali⁶ and Roy Fleischmann⁸, ¹Organización Medica de Investigación, Buenos Aires, Argentina, ²The First Department of Internal Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan, ³Division of Rheumatology, Allergy, & Immunology, University of California San Diego Medical School, San Diego, CA, ⁴Division of Rheumatology, Department of Medicine III, Medical University of Vienna,, Vienna, Austria, ⁵Botnar Research Centre, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, United Kingdom, ⁶AbbVie Inc., North Chicago, IL, ⁷AbbVie Inc., North Chicago,, IL, ⁸Southwestern Medical Center, Metroplex Clinical Research Center, Dallas, TX
Background/Purpose: In the randomized, double-blinded, Phase 3 SELECT-COMPARE study, upadacitinib (UPA) + MTX demonstrated greater clinical and functional responses vs adalimumab (ADA) + MTX in…
Abstract Number: 0987 • ACR Convergence 2020
Efficacy and Safety of Iberdomide in Patients with Active Systemic Lupus Erythematosus: 24-Week Results of a Phase 2, Randomized, Placebo-Controlled Study
Joan Merrill¹, Victoria Werth², Richard Furie³, Ronald van Vollenhoven⁴, Milan Petronijevic⁵, Benito Velasco Zamora⁶, Maria Majdan⁷, Fedra Irazoque-Palazuelos⁸, Michael Weiswasser⁹, Shimon Korish⁹, Peter Schafer⁹, Zhaohui Liu⁹, Allison Gaudy⁹, Nataliya Agafonova⁹ and Nikolay Delev⁹, ¹Oklahoma Medical Research Foundation, Oklahoma City, OK, ²University of Pennsylvania and the Michael J. Crescenz VA Medical Center, Philadelphia, PA, ³Zucker School of Medicine at Hofstra/Northwell, Great Neck, NY, ⁴Amsterdam University Medical Centers, Amsterdam, Netherlands, ⁵Military Medical Academy, Belgrade, Serbia, ⁶Instituto CER S.A., Buenos Aires, Argentina, ⁷Medical University of Lublin and Samodzielny Publicnzy Szpital Kliniczny Nr 4 w Lublinie, Lublin, Poland, ⁸Centro de Investigación y Tratamiento Reumatológico S.C, Miguel Hidalgo, Mexico, ⁹Bristol Myers Squibb, Princeton
Background/Purpose: Iberdomide is a high-affinity cereblon ligand that promotes ubiquitination and proteasomal degradation of Ikaros (IKZF1) and Aiolos (IKZF3), transcription factors linked to the genetic…
Abstract Number: 1842 • ACR Convergence 2020
Repository Corticotropin Injection (Acthar® Gel) for Persistently Active Systemic Lupus Erythematosus: Post Hoc Analyses of Patient-Reported Outcomes from a Phase 4, Multicenter, Randomized, Double-blind, Placebo-Controlled Trial
Anca Askanase¹, George Wan², Mary Panaccio², Enxu Zhao², Julie Zhu², Roman Bilyk² and Richard Furie³, ¹Columbia University College of Physicians and Surgeons, New York, NY, ²Mallinckrodt Pharmaceuticals, Bedminster, NJ, ³Zucker School of Medicine at Hofstra/Northwell, Great Neck, NY
Background/Purpose: Repository corticotropin injection (RCI, Mallinckrodt Pharmaceuticals) is a naturally sourced complex mixture of adrenocorticotropic hormone analogs and other pituitary peptides approved for the treatment…
Abstract Number: 0369 • ACR Convergence 2020
Effect of Upadacitinib on Reducing Pain in Patients with Active Ankylosing Spondylitis and Inadequate Response to Nonsteroidal Anti-inflammatory Drugs
Atul Deodhar¹, Xenofon Baraliakos², Iain McInnes³, Kurt de Vlam⁴, Louis Bessette⁵, Anna Maniccia⁶, Ralph Lippe⁷, Christopher Saffore⁶, Tianming Gao⁶, In-Ho Song⁶ and Andrew Östör⁸, ¹Oregon Health & Science University, Portland, OR, ²Rheumazentrum Ruhrgebiet-Ruhr-University Bochum, Herne, Germany, ³Institute of Infection, Immunity, and Inflammation, University of Glasgow, Glasgow, United Kingdom, ⁴Department of Rheumatology, University of Leuven, Belgium, Leuven, Belgium, ⁵Laval University, Quebec, Canada, ⁶AbbVie Inc., North Chicago, IL, ⁷AbbVie Deutschland GmbH & Co. KG, Wiesbaden, Germany, ⁸Cabrini Medical Center, Monash University, Malvern, Victoria, Australia
Background/Purpose: Pain is a debilitating symptom of ankylosing spondylitis (AS) and negatively impacts patient (pt) lives. Upadacitinib (UPA), a Janus kinase (JAK) inhibitor engineered for…
Abstract Number: 0989 • ACR Convergence 2020
Withdrawal of MMF Is Safe in Quiescent Renal and Non-Renal SLE: Results from a Multi-Center Randomized Trial
Eliza Chakravarty¹, Tammy Utset², Diane Kamen³, Gabriel Contreras⁴, W. Joseph McCune⁵, Kenneth Kalunian⁶, Cynthia Aranow⁷, Megan Clowse⁸, Elena Massarotti⁹, Ellen Goldmuntz¹⁰, Jessica Springer¹⁰, Lynette Keyes-Elstein¹¹, Bill Barry¹¹, Ashley Pinckney¹¹ and Judith James¹², ¹Oklahoma Medical Research Foundation, Oklahoma City, OK, ²University of Chicago, Chicago, IN, ³Medical University of South Carolina, Charleston, SC, ⁴University of Miami Miller School of Medicine, Miami, ⁵University of Michigan, Ann Arbor, MI, ⁶University of California San Diego, La Jolla, CA, ⁷Feinstein Institutes for Medical Research, Manhasset, NY, ⁸Duke University, Chapel Hill, NC, ⁹Brigham and Women's hospital, Boston, MA, ¹⁰NIH/NIAID, Rockville, MD, ¹¹Rho, Durham, NC, ¹²Oklahoma Medical Research Foundation, Oklahoma City
Background/Purpose: Mycophenolate Mofetil (MMF) is standard of care therapy for long term treatment of lupus nephritis and other manifestations of SLE. However, it is associated…
Abstract Number: 1843 • ACR Convergence 2020
Integrated Efficacy of the AURORA 1 and AURA-LV Trials Confirms Voclosporin Rapid Proteinurea Reduction in the Presence of Low-Dose Steroids
Ellen M Ginzler¹, Joshua Kaplan², Laura Lisk³, Ray Federico⁴, Neil Solomons⁵ and Robert Huizinga⁵, ¹SUNY Downstate Health Sciences University, Brooklyn, ²Rutgers University, New Brunswick, NJ, ³Aurinia Pharmaceuticals Inc., Victoria, BC, Canada, ⁴Aurinia Pharmaceuticals, Inc., Victoria, Canada, ⁵Aurinia Pharmaceuticals, Victoria, BC, Canada
Background/Purpose: Voclosporin (VCS) is a novel calcineurin inhibitor (CNI) with a favorable metabolic profile and a consistent predictable dose response potentially eliminating the need for…
Abstract Number: 0675 • ACR Convergence 2020
AR882, a Potent and Selective Uricosuric Agent, Significantly Reduced Serum Urate Levels Following Multiple Ascending Once-Daily Doses in Healthy Subject Volunteers
Zancong Shen¹, Elizabeth Polvent², Vijay Hingorani², Andrea Clouser-Roche², Chris Mikelatis², Rongzi Yan², Shunqi Yan² and Li-Tain Yeh², ¹Arthrosi therapeutics, Laguna Hills, CA, ²Arthrosi Therapeutics Inc, Laguna Hills, CA
Background/Purpose: AR882 is a potent and selective uric acid transporter 1 (URAT1) inhibitor under development for the treatment of hyperuricemia or gout. AR882 exhibited linear…
Abstract Number: 1146 • ACR Convergence 2020
Pilot Study of an Internet-Based Pain Coping Skills Training Program for Patients with Systemic Lupus Erythematosus
Kelli Allen¹, Tyler Beuchamp², Rebecca Cleveland³, Kimberlea Grimm¹, David Hu¹, Katie Huffman¹, Frances Keefe⁴, Julie Norfleet¹, Christine Rini⁵, Andres Santana¹, Shruti Saxena Beem⁶ and Saira Sheikh⁷, ¹University of North Carolina at Chapel Hill, Chapel HIll, NC, ²Medical College of Georgia, Augusta, GA, ³University of North Carolina, Chapel Hill, NC, ⁴Duke University Medical Center, Durham, NC, ⁵Northwestern University, Chicago, IL, ⁶University of North Carolina at Chapel Hill, Chapel Hill, ⁷University of North Carolina Thurston Arthritis Research Center, Chapel Hill
Background/Purpose: Patients with Systemic Lupus Erythematosus (SLE) have increased symptoms of fatigue, chronic pain, depression and anxiety, which are associated with negative impacts on quality…
Abstract Number: 2001 • ACR Convergence 2020
Adverse Effects of Low Dose Methotrexate: Adjudicated Hematologic Outcomes in a Large Randomized Double-blind Placebo-controlled Trial
Kathleen Vanni¹, Nancy Berliner¹, Nina Paynter², Robert Glynn², Jean MacFadyen¹, Joshua Colls¹, Fengxin Lu¹, Chang Xu², Paul Ridker¹ and Daniel H Solomon¹, ¹Brigham and Women's Hospital, Boston, MA, ²Brigham and Women's Hospital, Boston
Background/Purpose: Low dose methotrexate (LD-MTX), a cornerstone in the treatment of rheumatoid arthritis, is associated with a moderately increased risk of anemia and leukopenia, but…

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