Abstracts tagged "clinical trials"

Abstract Number: 1383 • 2019 ACR/ARP Annual Meeting
Glucocorticoid Tapering in Monthly 1-mg Decrements Does Not Result in Clinically Manifest Adrenal Insufficiency in Patients with Rheumatoid Arthritis: Learnings from a Phase 3/4 Study
Frank Buttgereit¹, J. Michael Nebesky ², Gerd Burmester ³, Corrado Bernasconi ², Markus R. John ² and Marc Y. Donath ⁴, ¹Charité-Universitätsmedizin Berlin, Berlin, Germany, ²F. Hoffmann-La Roche, Basel, Switzerland, ³Charité—University Medicine Berlin, Berlin, Germany, ⁴University Hospital Basel, Basel, Switzerland
Background/Purpose: Systemic glucocorticoids (GCs) are used to treat serious inflammatory diseases but are associated with adverse events. Guidelines recommend tapering GCs to the lowest possible…
Abstract Number: 865 • 2019 ACR/ARP Annual Meeting
Safety and Efficacy of Lenabasum at 21 Months in an Open-Label Extension of a Phase 2 Study in Diffuse Cutaneous Systemic Sclerosis Subjects
Robert Spiera¹, Laura Hummers ², Lorinda Chung ³, Tracy Frech ⁴, Robyn Domsic ⁵, Vivien Hsu ⁶, Daniel Furst ⁷, Jessica Gordon ¹, Madeline Myers ⁸, Robert W Simms ⁹, Elizabeth Lee ¹⁰, Scott Constantine ¹⁰, Nancy Dgetluck ¹⁰, Bradley Bloom ¹⁰ and Barbara White ¹⁰, ¹Hospital for Special Surgery, New York, NY, ²Johns Hopkins University School of Medicine, Division of Rheumatology, Baltimore, MD, USA, Baltimore, MD, ³Stanford, Palo Alto, Palo Alto, CA, ⁴Division of Rheumatology, University of Utah and Salt Lake VAMC, Salt Lake City, UT, ⁵University of Pittsburgh, Pittsburgh, PA, ⁶Rutgers- RWJ Medical School, SOUTH PLAINFIELD, NJ, ⁷University of California, Los Angeles, CA, ⁸University of Texas, Houston, Houston, TX, ⁹Boston University, Boston, MA, ¹⁰Corbus Pharmaceuticals, Norwood, MA
Background/Purpose: Lenabasum is a synthetic, non-immunosuppressive, selective cannabinoid receptor type 2 agonist that activates resolution of innate immune responses and limits fibrosis in animal models…
Abstract Number: 1475 • 2019 ACR/ARP Annual Meeting
Comparison of Different Remission Indices in Patients with Psoriatic Arthritis: A Post Hoc Analysis of Data from Phase 3 Tofacitinib Studies
Gustavo Citera¹, Emilce Schneeberger ², Peter Nash ³, Josef Smolen ⁴, Philip Mease ⁵, Enrique Soriano ⁶, Vesna Matulic ⁷, Claudia Helling ⁸, Annette Szumski ⁹, Rajiv Mundayat ¹⁰, Daniela Graham ¹¹ and Dario Ponce de Leon ¹², ¹Instituto de Rehabilitación Psicofísica, Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, ²Instituto de Rehabilitación Psicofísica, Buenos Aires, Argentina, ³University of Queensland, Brisbane, Queensland, Australia, ⁴Medical University of Vienna, Vienna, Austria, ⁵Swedish Medical Center/Providence St Joseph Health, and University of Washington, Seattle, WA, ⁶Rheumatology Section, Internal Medicine Service, Hospital Italiano de Buenos Aires, Argentina., Buenos Aires, Buenos Aires, Argentina, ⁷Pfizer Chile S.A., Santiago, Chile, ⁸Pfizer Inc, Buenos Aires, Argentina, ⁹Syneos Health, Princeton, NJ, ¹⁰Pfizer Inc, New York, NY, ¹¹Pfizer Inc, Groton, CT, ¹²Pfizer Inc, Lima, Peru
Background/Purpose: An international task force has agreed that remission or low disease activity (LDA) are key treatment targets for patients (pts) with PsA, and recommends…
Abstract Number: 929 • 2019 ACR/ARP Annual Meeting
Efficacy and Safety of Fenebrutinib, a BTK Inhibitor, Compared to Placebo in Rheumatoid Arthritis Patients with Active Disease Despite TNF Inhibitor Treatment: Randomized, Double Blind, Phase 2 Study
Stanley Cohen¹, Katie Tuckwell ², Rebecca Kunder ², Tamiko Katsumoto ³, Rui Zhao ², Alberto Berman ⁴, Nemanja Damjanov ⁵, Dmytro Fedkov ⁶, Slawomir Jeka ⁷ and Mark Genovese ³, ¹Metroplex Clinical Research Center, Dallas, TX, ²Genentech, Inc., South San Francisco, CA, ³Stanford University, Stanford, CA, ⁴Universidad Nacional de Tucuman and Centro Médico Privado de Reumatología, Tucuman, Argentina, ⁵Institute of Rheumatology, Belgrade University School of Medicine, Belgrade, Serbia, Belgrade, Serbia, ⁶Bohomolets National Medical University, Kyiv, Ukraine, ⁷University Hospital Bydgoszcz no 2, CM UMK, Bydgoszcz, Poland
Background/Purpose: Fenebrutinib (GDC-0853, FEN) is an orally administered, highly selective, non-covalent, and reversible small molecule inhibitor of Bruton’s Tyrosine Kinase (BTK).1 We report the efficacy…
Abstract Number: 1489 • 2019 ACR/ARP Annual Meeting
Impact of Apremilast on PsA Impact of Disease Core Components in Patients with a Limited Number of Active Joints: Results from a Real-World Study
Tim Jansen¹, Eric-Jan Kroot ², Arie van Vliet ³, Jan Pander ⁴ and Marijn Vis ⁵, ¹Viecuri MC, Venlo, Netherlands, ²Elkerliek, Helmond, Netherlands, ³Celgene, Utretcht, Netherlands, ⁴Celgene, Utrecht, Netherlands, ⁵ErasmusMC, Rotterdam, Netherlands
Background/Purpose: Recent data suggest that patients with moderately active psoriatic arthritis (PsA) and a limited number of active joints have a high likelihood of achieving…
Abstract Number: 686 • 2018 ACR/ARHP Annual Meeting
Five-Year Efficacy and Safety of Apremilast Treatment in Subjects with Psa: A Pooled Analysis of the 3 Phase III Studies
Arthur Kavanaugh¹, Dafna D Gladman², Christopher J. Edwards³, Georg Schett⁴, Benoit Guerette⁵, Nikolay Delev⁵, Lichen Teng⁵, Maria Paris⁵ and Philip J. Mease⁶, ¹University of California, San Diego, School of Medicine, La Jolla, CA, ²Krembil Research Institute, Toronto Western Hospital, Toronto, ON, Canada, ³University of Southampton, Southampton, United Kingdom, ⁴Friedrich-Alexander-Universität Erlangen, Nürnberg und Universitätsklinikum Erlangen, Erlangen, Germany, ⁵Celgene Corporation, Summit, NJ, ⁶Swedish Medical Center and University of Washington School of Medicine, Seattle, WA
Background/Purpose: Long-term apremilast (APR) efficacy and safety were evaluated for up to 5 yrs in adults with active PsA in the phase III PALACE 1-3…
Abstract Number: 2483 • 2018 ACR/ARHP Annual Meeting
Major Secular Trends of Patient Characteristics and Inclusion Criteria in RA Clinical Trials
Andreas Kerschbaumer¹, Bruno Bierbaumer², Josef S. Smolen³ and Daniel Aletaha⁴, ¹Department of Internal Medicine III, Division of Rheumatology, Medical University of Vienna, Vienna, Austria, ²Independent, Munich, Germany, ³Division of Rheumatology, Department of Medicine 3, Medical University of Vienna, Vienna, Austria, ⁴Department of Medicine III, Division of Rheumatology, Medical University of Vienna, Vienna, Austria
Background/Purpose: Rheumatoid arthritis (RA) is among the most intensively studied chronic inflammatory musculoskeletal diseases. Over the past two decades numerous new compounds have been tested…
Abstract Number: 838 • 2018 ACR/ARHP Annual Meeting
Efficacy and Safety of Combined Immunosuppressive Therapy with High-Dose Glucocorticoid, Tacrolimus, and Cyclophosphamide in Interstitial Lung Disease Accompanied By Anti-MDA5-Positive Dermatomyositis -a Multicenter Prospective Study –
Hideaki Tsuji¹, Ran Nakashima¹, Yoshitaka Imura², Masato Yagita², Hajime Yoshifuji¹, Shintaro Hirata³, Takaki Nojima³, Eiji Sugiyama⁴, Kazuhiro Hatta⁵, Yoshio Taguchi⁶, Masaki Katayama⁷, Shuji Akizuki¹, Kosaku Murakami¹, Motomu Hashimoto⁸, Masao Tanaka⁸, Koichiro Ohmura¹ and Tsuneyo Mimori⁹, ¹Department of Rheumatology and Clinical Immunology, Graduate School of Medicine, Kyoto University, Kyoto, Japan, ²Department of Clinical Immunology and Rheumatology, The Tazuke-Kofukai Medical Research Institute, Kitano Hospital, Osaka, Japan, ³Department of Clinical Immunology and Rheumatology, Hiroshima University Hospital, Hiroshima, Japan, ⁴Department of Clinical Immunology and Rheumatology, Department of Clinical Immunology and Rheumatology, Hiroshima University Hospital, Hiroshima, Japan, ⁵Department of General Medicine, Tenri Hospital, Tenri, Japan, ⁶Department of Respiratory Medicine, Tenri Hospital, Tenri, Japan, ⁷Department of Rheumatology and Clinical Immunology, Osaka Red Cross Hospital, Osaka, Japan, ⁸Department of Advanced Medicine for Rheumatic Diseases, Graduate School of Medicine, Kyoto University, Kyoto, Japan, ⁹Department of Rheumatology and Clinical Immunology, Department of Rheumatology and Clinical Immunology, Graduate School of Medicine, Kyoto University, Kyoto, Japan
Background/Purpose: Interstitial lung disease (ILD) accompanied by anti-melanoma differentiation-associated gene 5 (MDA5)-positive dermatomyositis (DM) is often rapidly progressive and associated with poor life prognosis in…
Abstract Number: 2528 • 2018 ACR/ARHP Annual Meeting
A Multicenter Study Assessing the Efficacy and Safety of Repository Corticotropin Injection in Patients with Rheumatoid Arthritis: Preliminary Interim Data from the Open-Label Treatment Period
Roy Fleischmann¹, Daniel E. Furst², Richard Brasington³, Erin Connolly-Strong⁴, Jingyu Liu⁴ and Matthew E. Barton⁴, ¹University of Texas Southwestern Medical Center, Dallas, TX, ²David Geffen School of Medicine at UCLA, Los Angeles, CA, ³Washington University School of Medicine, St. Louis, MO, ⁴Mallinckrodt ARD, Inc., Bedminster, NJ
Background/Purpose: Rheumatoid arthritis (RA) is an autoimmune disorder associated with chronic inflammation and commonly treated with disease-modifying anti-rheumatic drugs (DMARDs) and corticosteroids. Repository corticotropin injection…
Abstract Number: 963 • 2018 ACR/ARHP Annual Meeting
Long-Term Safety of Tofacitinib up to 9.5 Years: A Comprehensive Integrated Analysis of the RA Clinical Development Program
Stanley Cohen¹, Yoshiya Tanaka², Xavier Mariette³, Jeffrey R. Curtis⁴, Eun Bong Lee⁵, Peter Nash⁶, Kevin Winthrop⁷, Christina Charles-Schoeman⁸, Lisy Wang⁹, Connie Chen¹⁰, Kenneth Kwok¹⁰, Pinaki Biswas¹⁰, Andrea Shapiro¹¹, Ann Madsen¹⁰ and Jürgen Wollenhaupt¹², ¹Metroplex Clinical Research Center and University of Texas Southwestern Medical Center, Dallas, TX, ²University of Occupational and Environmental Health, Kitakyushu, Japan, ³Paris-Sud University, Le Kremlin Bicêtre, France, ⁴University of Alabama at Birmingham, Birmingham, AL, ⁵Seoul National University, Seoul, Korea, Republic of (South), ⁶University of Queensland, Brisbane, Australia, ⁷Oregon Health and Science University, Portland, OR, ⁸University of California, Los Angeles, CA, ⁹Pfizer Inc, Groton, CT, ¹⁰Pfizer Inc, New York, NY, ¹¹Pfizer Inc, Peapack, NJ, ¹²Schön-Klinik Hamburg-Eilbek Teaching Hospital of the University of Hamburg, Hamburg, Germany
Background/Purpose: Tofacitinib is an oral Janus kinase inhibitor for the treatment of RA. Here, we report the largest integrated safety analysis of tofacitinib to date…
Abstract Number: 2562 • 2018 ACR/ARHP Annual Meeting
Secukinumab Improves Grappa-Omeract Core Domains of Psoriatic Arthritis
Ana-Maria Orbai¹, Iain B. McInnes², Laura C. Coates³, M. Elaine Husni⁴, Dafna D Gladman⁵, Laure Gossec⁶, Luminita Pricop⁷, Olivier Chambenoit⁸, Xiangyi Meng⁸ and Philip J. Mease⁹, ¹Johns Hopkins University School of Medicine, Baltimore, MD, ²University of Glasgow, Glasgow, United Kingdom, ³Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, United Kingdom, ⁴Cleveland Clinic, Cleveland, OH, ⁵Toronto Western Research Institute and University of Toronto, Toronto, ON, Canada, ⁶Université Pierre et Marie Curie and Hôpital Pitié-Salpêtrière, Paris, France, ⁷Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA, East Hanover, NJ, ⁸Novartis Pharmaceuticals Corporation, East Hanover, NJ, ⁹Swedish Medical Center and University of Washington, Seattle, WA
Background/Purpose: Secukinumab, a fully human monoclonal antibody that selectively neutralizes IL-17A, has demonstrated efficacy for patients with psoriatic arthritis (PsA) in multiple phase 3 clinical…
Abstract Number: 964 • 2018 ACR/ARHP Annual Meeting
Psoriatic Arthritis Impact of Disease (PsAID12) Was Provisionally Endorsed at Omeract 2018 As Core Instrument to Measure Psoriatic Arthritis-Specific Health-Related Quality of Life in Randomized Controlled Trials and Longitudinal Observational Studies
Richard Holland¹, Robin Christensen², Niti Goel³, Pil Hoejgaard⁴, William Tillett⁵, Laure Gossec⁶, Maarten de Wit⁷, Neil McHugh⁸, Philip J. Mease⁹, Beverly Shea¹⁰, Ying Ying Leung¹¹, Dafna D Gladman¹², Christine Lindsay¹³, Laura C. Coates¹⁴, Alexis Ogdie¹⁵, Vibeke Strand¹⁶, Lara Fallon¹⁷, Julie Birt¹⁸, Kristina Callis Duffin¹⁹, Oliver FitzGerald²⁰, Peter Tugwell²¹, Dorcas Beaton^22,23 and Ana-Maria Orbai²⁴, ¹Royal Prince Alfred Hospital Medical Centre, Sydney, Australia, ²Musculoskeletal Statistics Unit, The Parker Institute, Bispebjerg and Frederiksberg, Denmark, ³Kezar Life Sciences; Duke University School of Medicine, Durham, NC, ⁴Center for Rheumatology and Spine Diseases - Gentofte, Rigshospitalet, Hellerup, Denmark, ⁵Royal National Hospital for Rheumatic Diseases and University of Bath, Bath, United Kingdom, ⁶Sorbonne Universités, Paris, France, ⁷EULAR standing committee of PARE, Zurich, Switzerland, ⁸Rheumatology, Royal National Hospital, Bath, Great Britain, ⁹Swedish Medical Center and University of Washington, Seattle, WA, ¹⁰School of Epidemiology, Public Health, and Preventive Medicine, Faculty of Medicine, University of Ottawa, and Ottawa Hospital Research Institute, Clinical Epidemiology Program, Ottawa, ON, Canada, ¹¹Singapore General Hospital, Singapore, Singapore, ¹²University of Toronto, Toronto Western Hospital, Toronto, ON, Canada, ¹³Medical Affairs, Amgen Inc, Thousand Oaks, CA, ¹⁴University of Oxford, Oxford, United Kingdom, ¹⁵Medicine/Rheumatology and Epidemiology, University of Pennsylvania, Philadelphia, PA, ¹⁶Stanford University School of Medicine, Palo Alto, CA, ¹⁷Pfizer Canada, Montreal, QC, Canada, ¹⁸Eli Lilly and Company, Indianapolis, IN, ¹⁹Department of Dermatology, University of Utah, Salt Lake City, UT, ²⁰Department of Rheumatology, St. Vincent’s University Hospital, UCD School of Medicine and Medical Sciences and Conway Institute of Biomolecular and Biomedical Research, University College Dublin, Dublin, Ireland, ²¹Center For Global Health, Institute of Population Hlth, Ottawa, ON, Canada, ²²University of Toronto, Musculoskeletal Health and Outcomes Research, St. Michael's Hospital and Institute for Work and Health, Toronto, ON, Canada, ²³University of Toronto, Department of Occupational Science and Occupational Therapy, Rehabilitation Sciences Institute, and the Institute for Health Policy Management and Evaluation, Toronto, ON, Canada, ²⁴Johns Hopkins University School of Medicine, Baltimore, MD
Background/Purpose: The GRAPPA-OMERACT PsA working group (WG) is using the OMERACT Filter 2.1 instrument selection algorithm1 to develop a Psoriatic Arthritis (PsA) core instrument set…
Abstract Number: 2563 • 2018 ACR/ARHP Annual Meeting
Efficacy and Safety of a Potent and Highly Selective Oral Tyrosine Kinase 2 Inhibitor, BMS-986165, in Patients with Moderate-to-Severe Plaque Psoriasis: A Phase II, Randomized, Placebo-Controlled Trial
Kim A Papp¹, Kenneth B. Gordon², Diamant Thaçi³, Akimichi Morita⁴, Melinda Gooderham⁵, Peter Foley^6,7,8, Ihab G. Girgis⁹, Sudeep Kundu⁹ and Subhashis Banerjee⁹, ¹Clinical Research and Probity Medical Research, Waterloo, ON, Canada, ²Medical College of Wisconsin, Milwaukee, WI, ³University of Luebeck, Luebeck, Germany, ⁴Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan, ⁵SKiN Centre for Dermatology, Queen’s University and Probity Medical Research, Peterborough, ON, Canada, ⁶The University of Melbourne, Melbourne, Australia, ⁷St Vincent’s Hospital Melbourne & Probity Medical Research, Melbourne, Australia, ⁸Skin & Cancer Foundation Inc, Melbourne, Australia, ⁹Bristol-Myers Squibb, Princeton, NJ
Background/Purpose: BMS-986165, a potent and highly selective oral tyrosine kinase 2 inhibitor, inhibits signal transducer and activator of transcription (STAT)-dependent signalling pathways of interleukin-23 and…
Abstract Number: 981 • 2018 ACR/ARHP Annual Meeting
New Consensus on an Updated Core Domain Set for Clinical Trials in Juvenile Idiopathic Arthritis
Esi Morgan¹, Alessandro Consolaro², Jane Munro³, Jennifer Horonjeff⁴, Brian M. Feldman⁵, Hayyah Clairman⁶, Clifton O. Bingham III⁷, Alessandra Alongi⁸, Vibeke Strand⁹, Marion A.J. van Rossum¹⁰, Richard Veselý¹¹, Hermine I. Brunner¹², Daniel Horton¹³, Daniel J Lovell¹⁴, Sarah Ringold¹⁵, Nicola Ruperto¹⁶, Suzanne Schrandt¹⁷, Natalie Jane Shiff¹⁸, Karine Toupin-April¹⁹ and Beverly Shea²⁰, ¹University of Cincinnati, Cincinnati, OH, ²Clinica Pediatrica - Reumatologia, Istituto Giannina Gaslini, Genova, Italy, ³Paediatric Rheumatology, Royal Children's Hospital, Victoria, Australia, ⁴Columbia University Medical Centre, New York, NY, ⁵Rheumatology, The Hospital for Sick Children, Toronto, ON, Canada, ⁶Child Health Evaluative Sciences, Hospital for Sick Children, Toronto, ON, Canada, ⁷Rheumatology, Johns Hopkins University School of Medicine, Baltimore, MD, ⁸University of Genova, Genova, Italy, ⁹Stanford University, Palo Alto, CA, ¹⁰Amsterdam Rheumatology and Immunology Center / Reade, Emma Children’s Hospital Amsterdam Medical Center, Amsterdam, Netherlands, ¹¹Scientific and Regulatory Management Department, European Medicines Agency, London, United Kingdom, ¹²Pediatric Rheumatology Collaborative Study Group (PRCSG), Cincinnati Children’s Hospital Medical Center, Cincinnati, OH, ¹³Rutgers Robert Wood Johnson Medical School, New Brunswick, NJ, ¹⁴Cincinnati Children's Hospital Medical Center, Cincinnati, OH, ¹⁵Pediatric Rheumatology, Seattle Children's Hospital, Seattle, WA, ¹⁶Universita di Genova Pediatria II, Genova, Italy, ¹⁷Arthritis Foundation, Saint Paul, MN, ¹⁸Pediatrics, University of Florida, Gainesville, FL, ¹⁹Children’s Hospital of Eastern Ontario Research Institute, Ottawa, ON, Canada, ²⁰Bruyere Research Institute, Ottawa, ON, Canada
Background/Purpose: The current JIA Core Set (ACR Pediatric 30) to assess efficacy of medications in randomized controlled trials (RCTs) was published in 1997 and developed…
Abstract Number: 2565 • 2018 ACR/ARHP Annual Meeting
Safety and Efficacy of Tofacitinib, an Oral Janus Kinase Inhibitor, up to 36 Months in Patients with Active Psoriatic Arthritis: Data from the Third Interim Analysis of OPAL Balance, an Open-Label, Long-Term Extension Study
Peter Nash¹, Laura C. Coates², Alan J. Kivitz³, Philip J. Mease⁴, Dafna D Gladman⁵, Jose A Covarrubias-Cobos⁶, Dona Fleishaker⁷, Cunshan Wang⁷, Elizabeth Kudlacz⁷, Sujatha Menon⁷, Lara Fallon⁸, Thijs Hendrikx⁹ and Keith S Kanik⁷, ¹University of Queensland, Brisbane, Australia, ²University of Oxford, Oxford, United Kingdom, ³Altoona Center for Clinical Research, Duncansville, PA, ⁴Swedish Medical Center and University of Washington, Seattle, WA, ⁵Krembil Research Institute, Toronto Western Hospital, Toronto, ON, Canada, ⁶Unidad Reumatologica Las Americas S.C.P, Mérida, Yucatan, Mexico, ⁷Pfizer Inc, Groton, CT, ⁸Pfizer Canada, Montreal, QC, Canada, ⁹Pfizer Inc, Collegeville, PA
Background/Purpose: Tofacitinib is an oral Janus kinase inhibitor for the treatment of psoriatic arthritis (PsA). We report the safety, tolerability, and efficacy of tofacitinib in…

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