Abstracts tagged "clinical trials"

Abstract Number: 028 • 2020 Pediatric Rheumatology Symposium
A Randomized, Double-blind, Placebo-controlled Study of Anakinra in Pediatric and Adult Patients with Still’s Disease
Laura Schanberg¹, Peter Nigrovic ², Ashley Cooper ³, Winn Chatham ⁴, Shoghik Akoghlanian ⁵, Namrata Singh ⁶, C. Egla Rabinovich ⁷, Akaluck Thatayatikom ⁸, Alysha Taxter ⁹, Jonathan Hausmann ¹⁰, Milan Zdravkovic ¹¹, Sven Ohlman ¹¹, Henrik Andersson ¹¹, Susanna Cederholm ¹², Gunilla Huledal ¹¹, Rayfel Schneider ¹³ and Fabrizio De Benedetti ¹⁴, ¹Duke Children's Hospital & Health Center, Durham, North Carolina, ²Boston Children's Hospital, Boston, Massachusetts, ³Children's Mercy Kansas City, Kansas City, ⁴University of Alabama at Birmingham, Birmingham, ⁵Nationwide Children's Hospital, Columbus, ⁶University of Iowa Hospitals and Clinics, Iowa, Iowa, ⁷Duke University Hospital, Durham, ⁸University of Florida, Gainesville, ⁹Wake Forest Baptist Medical Center, Winston-Salem, ¹⁰Division of Immunology, Boston Children's Hospital; Rheumatology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, ¹¹Sobi, Stockholm, Sweden, ¹²Stockholm, Sweden, ¹³The Hospital for Sick Children, Toronto, Canada, ¹⁴Division of Rheumatology, IRCCS Ospedale Pediatrico Bambino Gesu', Rome, Italy
Background/Purpose: Adult-onset Still’s disease (AOSD) and systemic juvenile idiopathic arthritis (SJIA) are rare systemic disorders of auto-inflammatory nature. There is a growing understanding that SJIA…
Abstract Number: L18 • 2019 ACR/ARP Annual Meeting
A Human Recombinant Fusion Protein Targeting B Lymphocyte Stimulator (BlyS) and a Proliferation-Inducing Ligand (APRIL), Telitacicept (RC18), in Systemic Lupus Erythematosus (SLE): Results of a Phase 2b Study
Di Wu¹, Jing Li ², Dong Xu ², Wenxiang Wang ³, Lin Li ⁴, Jianmin Fang ³ and Fengchun Zhang ⁵, ¹Peking Union Medical College Hospital, Beijing, Beijing, China (People's Republic), ²Department of Rheumatology and Clinical Immunology Peking Union Medical College Hospital, Beijing, China (People's Republic), ³RemeGen, Ltd., Yantai, China (People's Republic), ⁴RemeGen, Ltd., Beijing, China (People's Republic), ⁵Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China (People's Republic)
Background/Purpose: Telitacicept, also named RC18, is a novel recombinant fusion protein constructed with the extracellular domain of the human transmembrane activator and calcium modulator and…
Abstract Number: L21 • 2019 ACR/ARP Annual Meeting
Secukinumab 150 mg Significantly Improved Signs and Symptoms of Non-radiographic Axial Spondyloarthritis: Results from a Phase 3 Double-blind, Randomized, Placebo-controlled Study
Atul Deodhar¹, Ricardo Blanco ², Eva Dokoupilova ³, Marleen van de Sande ⁴, Stephen Hall ⁵, Anna Wiksten ⁶, Brian Porter ⁷, Hanno Richards ⁶, Sibylle Haemmerle ⁶ and Jürgen Braun ⁸, ¹Oregon Health & Science University, Portland, OR, ²Division of Rheumatology, Hospital Universitario Marqués de Valdecilla, Santander, Spain, ³MEDICAL PLUS s.r.o., Uherske Hradiste; University of Veterinary and Pharmaceutical sciences, Faculty of Pharmacy, Department of Pharmaceutics, Brno, Czech Republic, ⁴Amsterdam Rheumatology and immunology Center, Department of Rheumatology and Clinical Immunology, Amsterdam UMC /University of Amsterdam, Amsterdam, Netherlands, ⁵Monash University, Melbourne, Australia, ⁶Novartis Pharma AG, Basel, Switzerland, ⁷Novartis Pharmaceuticals Corporation, East Hanover, NJ, ⁸Rheumazentrum Ruhrgebiet/Ruhr University, Herne, Germany
Background/Purpose: Non-radiographic axial spondyloarthritis (nr-axSpA) and ankylosing spondylitis (AS) are considered part of the spectrum of axSpA. Patients (pts) are classified as nr-axSpA due to…
Abstract Number: 930 • 2019 ACR/ARP Annual Meeting
Neurostimulation for Treatment of Drug Refractory Rheumatoid Arthritis: A First-in-Human Study Using a Novel Vagus Nerve Stimulator
Norman Gaylis¹, David Sikes ², Alan Kivitz ³, Diane Horowitz ⁴, Charles Peterfy ⁵, Yaakov Levine ⁶, David Chernoff ⁶ and Mark Genovese ⁷, ¹Arthritis and Rheumatic Disease Specialties, Aventura, FL, ²Florida Medical Clinic, Land O Lakes, FL, ³Altoona Center for Clinical Research, Duncansville, PA, ⁴Northwell Health, Manhasset, NY, ⁵Spire Sciences Inc, Boca Raton, ⁶SetPoint Medical, Valencia, CA, ⁷Stanford University, Stanford, CA
Background/Purpose: The inflammatory reflex is an endogenous neuroimmune circuit that helps regulate innate and adaptive immunity (Annu. Rev. Immunol. 2012; 30:313). Activation of this reflex by…
Abstract Number: 1694 • 2019 ACR/ARP Annual Meeting
Pharmacogenetics and Pharmacodynamics of Response to Apremilast in a Phase 3 Clinical Study in Subjects with Active Behçet’s Disease
Joseph Maranville¹, Irina Medvedeva ¹, Robert Yang ¹, Mindy Chen ², Lorraine (Ruoying) Fang ², Sandra Collazo ³, Shannon McCue ³, Marla Hochfeld ³ and Peter Schafer ³, ¹Celgene Corporation, Cambridge, MA, ²Celgene Corporation, Berkeley Heights, NJ, ³Celgene Corporation, Summit, NJ
Background/Purpose: This was an exploratory analysis of genetic polymorphisms, plasma biomarkers, and blood leukocytes with clinical response in the phase 3 clinical study CC-10004-BCT-002 (NCT02307513).Methods:…
Abstract Number: 937 • 2019 ACR/ARP Annual Meeting
Dual Neutralization of IL-17A and IL-17F with Bimekizumab in Patients with Active Ankylosing Spondylitis: 48-Week Efficacy and Safety Results from a Phase 2b, Randomized, Blinded, Placebo-Controlled, Dose-Ranging Study
Désirée van der Heijde¹, Lianne Gensler ², Atul Deodhar ³, Xenofon Baraliakos ⁴, Denis Poddubnyy ⁵, Alan Kivitz ⁶, Marga Oortgiesen ⁷, Dominique Baeten ⁸, Nadine Goldammer ⁹, Jason Coarse ⁷, MK Farmer ⁷ and Maxime Dougados ¹⁰, ¹Leiden University Medical Center, Leiden, Netherlands, ²University San Francisco California, San Francisco, CA, ³Oregon Health & Science University, Portland, OR, ⁴Rheumazentrum Ruhrgebiet-Ruhr-University Bochum, Herne, Germany, Herne, Germany, ⁵Charité - Universitätsmedizin Berlin and German Rheumatism Research Centre, Berlin, Germany, Berlin, Germany, ⁶Altoona Center for Clinical Research, Duncansville, PA, ⁷UCB Pharma, Raleigh, NC, USA, Raleigh, NC, ⁸UCB Pharma, Brussels, Belgium, Brussels, ⁹UCB Pharma, Monheim, Germany, Monheim, Germany, ¹⁰Cochin Hospital, Paris, France
Background/Purpose: The monoclonal antibody bimekizumab potently and selectively neutralizes both IL-17A and IL-17F. We report the 48-week efficacy and safety of bimekizumab in patients (pts)…
Abstract Number: 1697 • 2019 ACR/ARP Annual Meeting
Efficacy of Apremilast for Oral Ulcers Associated with Active Behçet’s Syndrome over 64 Weeks: Long-term Results from the Japanese Subgroup in a Phase III Study
Mitsuhiro Takeno¹, Yoshiya Tanaka ², Hajime Kono ³, Shoji Sugii ⁴, Mitsumasa Kishimoto ⁵, Sue Cheng ⁶, Shannon McCue ⁷, Mindy Chen ⁸, Maria Paris ⁶ and Hiroaki Dobashi ⁹, ¹Nippon Medical School, Tokyo, Japan, ²University of Occupational and Environmental Health Japan, Kitakyushu, Japan, ³Teikyo University School of Medicine, Tokyo, Japan, ⁴Department of Rheumatic Diseases, Tokyo Metropoitan Tama Medica Center, Fuchu, Japan, ⁵Immuno-Rheumatology Center, St. Luke’s International Hospital, Tokyo, Japan, ⁶Celgene Corporation, Summit, ⁷Celgene Corporation, Summit, NJ, ⁸Celgene Corporation, Berkeley Heights, NJ, ⁹Kagawa University, Kagawa, Japan
Background/Purpose: Behçet’s syndrome is a chronic, multi-system, variable vessel vasculitis characterized by painful, recurrent oral ulcers (OU) that can be disabling and may impair quality…
Abstract Number: 940 • 2019 ACR/ARP Annual Meeting
Response to Placebo in Randomized Clinical Trials with Biologics in Non-renal, Non-neuropsychiatric Systemic Lupus Erythematosus: A Systematic Review and Pooled Analysis
Konstantinos Tselios¹, Laura Wakani ², Dafna Gladman ³, Jiandong Su ⁴ and Murray Urowitz ⁴, ¹University Health Network, University of Toronto, Toronto, Canada, ²University Health Network, Toronto, Canada, ³Toronto Western Hospital, Toronto, Canada, Toronto, ON, Canada, ⁴University Health Network, University of Toronto, Toronto, ON, Canada
Background/Purpose: Most randomized controlled trials (RCTs) with biologic medicines in systemic lupus erythematosus (SLE) failed to reach their respective end-points with the rates of the…
Abstract Number: 1760 • 2019 ACR/ARP Annual Meeting
Six-week Treatment with Low-dose Prednisolone in Patients with Painful Hand Osteoarthritis (HOPE): Results from a Randomised Double-blind Placebo-controlled Trial
Féline Kroon¹, Marion Kortekaas ¹, Annelies Boonen ², Stephan Böhringer ³, Monique Reijnierse ¹, Frits R Rosendaal ³, Naghmeh Riyazi ⁴, Mirian Starmans ⁵, Franktien Turkstra ⁶, Jende van Zeben ⁷, CF Allaart ⁸ and Margreet Kloppenburg ³, ¹Leiden University Medical Center, Leiden, Netherlands, ²Maastricht University Medical Center, Maastricht, Netherlands, ³Leiden University Medical Center, Leiden, Zuid-Holland, Netherlands, ⁴Haga Hospital, The Hague, Netherlands, ⁵Zuyderland Medical Center, Heerlen, Netherlands, ⁶Amsterdam Rheumatology and immunology Center | Reade, Amsterdam, Netherlands, ⁷Sint Franciscus Vlietland Groep, Rotterdam, Netherlands, ⁸Department of Rheumatology, Leiden University Medical Center, Leiden, The Netherlands, Leiden, Netherlands
Background/Purpose: Hand osteoarthritis (OA) is a prevalent joint disease with high disease-burden in need for effective therapeutic options. Studies have shown that synovial inflammation is…
Abstract Number: 941 • 2019 ACR/ARP Annual Meeting
Treatment of Lupus Nephritis with anti-CD20 Followed by Anti-BAFF: Impact on B Cell Reconstitution, B Cell Subsets, and Autoreactivity
Yemil Atisha Fregoso¹, Susan Malkiel ², Kristina Harris ³, Sai Kanaparthi ³, Margie Byron ⁴, Linna Ding ⁵, Dawn Smilek ⁶, David Wofsy ⁷, Maria Dall'Era ⁸, Cynthia Aranow ¹ and Betty Diamond ⁹, ¹Feinstein Institute for Medical Research, Manhasset, NY, ²Feinstein Institute for Medical Research, Manhasset, ³Immune Tolerance Network, Bethesda, ⁴Rho Federal Systems, Inc., Chapel Hill, NC, ⁵National Institute of Allergy and Infectious Diseases, Bethesda, MD, ⁶Immune Tolerance Network, San Francisco, CA, ⁷UCSF, San Francisco, ⁸University of California, San Francisco, San Francisco, CA, ⁹Feinstein Institutes for Medical Research, Manhasset
Background/Purpose: Despite the relevance of B cells in lupus, two clinical trials of anti-CD20 failed to meet primary endpoints in patients with lupus and lupus…
Abstract Number: 2174 • 2019 ACR/ARP Annual Meeting
Test-Retest Reliability and Validity of a Mobile Health Application to Automate the 30 Seconds Chair Stand Test – Preliminary Data to Create a Contemporary Instrument for Randomized Clinical Trials
Lucas Dantas¹, Matthew Harkey ², André Dantas ³, Lori Lyn Price ⁴, Jeffrey Driban ⁵ and Timothy McAlindon ¹, ¹Tufts Medical Center, Boston, MA, ²Tufts Medical Center, University of Massachusetts Medical School, Boston, MA, ³CI&T, Tokyo, Japan, ⁴Tufts Medical Center, Tufts University, Boston, MA, ⁵Tufts Medical Center, Boston
Background/Purpose: Contemporary technologies offer potential solutions to improve and automate data collection of randomized clinical trials by transitioning assessments from the clinic to the real-world.…
Abstract Number: 946 • 2019 ACR/ARP Annual Meeting
Improvements in Disease Activity and Quality of Life for up to 64 Weeks in Patients with Behçet’s Syndrome: Results from a Phase III Study
Gulen Hatemi¹, Alfred Mahr ², Mitsuhiro Takeno ³, Doyoung Kim ⁴, Melike Melikoglu ⁵, Sue Cheng ⁶, Shannon McCue ⁷, Maria Paris ⁶, Mindy Chen ⁸ and Yusuf Yazici ⁹, ¹Istanbul University-Cerrahpasa, Cerrahpasa Medical Faculty, Department of Internal Medicine, Division of Rheumatology, Istanbul University-Cerrahpasa, Behcet's Disease Research Center, Istanbul, Turkey, Istanbul, Turkey, ²Hospital Saint-Louis, University Paris Diderot, Paris, France, ³Nippon Medical School, Tokyo, Japan, ⁴Yonsei University College of Medicine and Severance Hospital, Seoul, Republic of Korea, ⁵Istanbul University-Cerrahpasa, Cerrahpasa Medical Faculty, Department of Internal Medicine, Division of Rheumatology, Istanbul University – Cerrahpasa, Behçet’s Disease Research Center, Istanbul, Turkey, Istanbul, Turkey, ⁶Celgene Corporation, Summit, ⁷Celgene Corporation, Summit, NJ, ⁸Celgene Corporation, Berkeley Heights, NJ, ⁹New York University School of Medicine, New York
Background/Purpose: Behçet’s syndrome is a chronic, multi-system inflammatory disorder characterized by painful, recurrent oral ulcers (OU) that can impair quality of life (QoL). Apremilast (APR),…
Abstract Number: 2710 • 2019 ACR/ARP Annual Meeting
Sarilumab, a Human Monoclonal Antibody to the Interleukin-6 Receptor, in Polyarticular-course Juvenile Idiopathic Arthritis: A 12-week, Multinational, Open-label, Dose-finding Study
Fabrizio De Benedetti¹, Inmaculada Calvo Penadés ², Nadina Rubio-Pérez ³, Alexey Maschan ⁴, Pierre Quartier ⁵, Zbigniew Żuber ⁶, Marina Stanislav ⁷, Raul Barria ⁸, Daniel Clemente ⁹, Gabriel Vega-Cornejo ¹⁰, Nancy Liu ¹¹, Christine Xu ¹¹, Angeliki Giannelou ¹², Bolanle Akinlade ¹² and Lydie Baret-Cormel ¹³, ¹Bambino Gesù Children’s Hospital, Rome, Italy, ²Hospital Univ. La Fe, Valencia, Spain, ³University Hospital Dr. José Eleuterio González, Monterrey, Mexico, ⁴Center for Pediatric Hematology, Oncology and Immunology, Moscow, Russia, ⁵Necker Hospital, Paris, France, ⁶Andrzej Frycz Modrzewski Krakow University, Kraków, Poland, ⁷V.A. Nasonova Research Rheumatology Institute, Moscow, Russia, ⁸Bioreuma, Concepción, Chile, ⁹Hospital Infantil Universitario Niño Jesús, Madrid, Spain, ¹⁰CREA de Guadalajara, Jalisco, Mexico, ¹¹Sanofi, Bridgewater, NJ, ¹²Regeneron, New York, NY, ¹³Sanofi, Chilly-Mazarin, France
Background/Purpose: Sarilumab blocks interleukin-6 (IL-6) from binding to membrane and soluble IL-6 receptor-α. Sarilumab is approved for adults with rheumatoid arthritis (RA) and is being…
Abstract Number: 1144 • 2019 ACR/ARP Annual Meeting
Understanding Clinical Trials Participation Among Individuals of African Descent with Lupus Through the Lens of Critical Race Theory: A Qualitative Analysis
Candace Feldman¹, Jessica Williams ¹, Courtnie Phillip ¹, Corine Sinnette ¹, Karen Mancera-Cuevas ², Patricia Canessa ³, Gina Curry ⁴, Maryann Mason ² and Rosalind Ramsey-Goldman ², ¹Brigham and Women's Hospital, Boston, MA, ²Northwestern University, Chicago, IL, ³IPHA, Chicago, IL, ⁴University of Chicago, Chicago, IL
Background/Purpose: Despite a disproportionate burden of lupus and poorer outcomes among individuals of African descent (hereafter “black”) compared to white individuals, black individuals are underrepresented…
Abstract Number: 2771 • 2019 ACR/ARP Annual Meeting
A Phase I, Randomized, Double-blind, Placebo-controlled, Single Center, Single-dose Escalation to Investigate the Safety, Tolerability, and Pharmacodynamics of Subcutaneously Administered DEN-181 in Adult Patients with ACPA+ Rheumatoid Arthritis on Stable Methotrexate
Amee Sonigra ¹, Hendrik Nel ², Nishta Ramnoruth ², Meghna Talekar ², Joanne Tesiram ³, Frederik Stuurman ⁴, Lavinia Proctor ⁵, Helen Roberts ⁶, Robin Thurmond ⁷, Phillip Vecchio ³, Ian Gourley ⁸, Mark Rigby ⁹, Nathan Felix ¹⁰, Stephane Becart ¹¹, Kim Campbell ¹² and Ranjeny Thomas², ¹Princess Alexandra Hospital, Woolloongabba, Queensland, Australia, ²University of Queensland, Woolloongabba, Australia, ³Princess Alexandra Hospital, Woolloongabba, Australia, ⁴Centre for Human Drug Research, Leiden, Netherlands, ⁵Dendright, Woolloongabba, Australia, ⁶Dendright, Woolloongabba, Queensland, Australia, ⁷Janssen Research & Development, La Jolla, CA, ⁸Janssen Research & Development, Springhouse, ⁹Janssen Research & Development, La Jolla, ¹⁰Janssen R&D, Spring House, PA, ¹¹Janssen R&D, La Jolla, CA, ¹²Janssen Research & Development, LLC, Spring House, PA
Background/Purpose: Antigen-specific immunological tolerance strategies leverage the natural process of antigen presentation by dendritic cells (DCs) to regulate pathogenic T cells and B cells. We…

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