Abstracts tagged "clinical trials"

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: 7L • 2017 ACR/ARHP Annual Meeting
A Phase 2 Study of Safety and Efficacy of Anabasum (JBT-101), a Cannabinoid Receptor Type 2 Agonist, in Refractory Skin-Predominant Dermatomyositis
Victoria P. Werth¹, Emily Hejazi², Sandra M. Pena¹, Jessica S. Haber³, Joyce Okawa¹, Rui Feng⁴, Kirubel Gabre², Josef Concha², Caitlin Cornwall⁵, Nancy Dgetluck⁶, Scott Constantine⁵ and Barbara White⁵, ¹Department of Dermatology, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, ²University of Pennsylvania, Philadelphia, PA, ³Department of Dermatology, University of Pennsylvania, Philadelphia, PA, ⁴Department of Biostatistics and Epidemiology at the Hospital of the University of Pennsylvania, Philadelphia, PA, ⁵Corbus Pharmaceuticals, Inc., Norwood, MA, ⁶Biostatistics, Corbus Pharmaceuticals, Inc., Norwood, MA

Background/Purpose: Effective treatment options are limited for refractory skin disease in dermatomyositis (DM). Anabasum is a non-immunosuppressive, synthetic, oral preferential CB2 agonist that triggers resolution…
Abstract Number: 13L • 2017 ACR/ARHP Annual Meeting
Significant, Sustained Improvement in Knee Function after Intra-Articular TPX-100: A Double-Blind, Randomized, Multi-Center, Placebo-Controlled Phase 2 Trial
Dawn McGuire¹, Nancy E Lane², Neil Segal³, Samy Metyas⁴, Hans Richard Barthel⁵, Meghan Miller¹, David Rosen¹ and Yoshi Kumagai¹, ¹OrthoTrophix, Inc, Oakland, CA, ²UC Davis Medical Center, Sacramento, CA, ³University of Kansas, Shawnee, KS, ⁴Medvin Clinical Research, Covina, CA, ⁵Barthel Clinic, Santa Barbara, CA

Background/Purpose: The current Phase 2 study was designed to evaluate safety, tolerability and preliminary efficacy of TPX-100 by IA administration in subjects with mild to…
Abstract Number: 725 • 2017 ACR/ARHP Annual Meeting
Safety and Efficacy of Anabasum (JBT-101) in Diffuse Cutaneous Systemic Sclerosis (dcSSc) Subjects Treated in an Open-Label Extension of Trial JBT101-SSc-001
Robert F. Spiera¹, Laura K. Hummers², Lorinda Chung³, Tracy M. Frech⁴, Robyn T. Domsic⁵, Vivien Hsu⁶, Daniel E. Furst⁷, Jessica K. Gordon¹, Maureen D. Mayes⁸, Robert W. Simms⁹, Scott Constantine¹⁰ and Barbara White¹⁰, ¹Rheumatology, Hospital for Special Surgery, New York, NY, ²Medical and Rheumatology, Johns Hopkins University, Baltimore, MD, ³Rheumatology, Stanford University Medical Center, Palo Alto, CA, ⁴Division of Rheumatology, University of Utah, Salt Lake City, UT, ⁵Medicine - Rheumatology, University of Pittsburgh, Pittsburgh, PA, ⁶Rheumatology, Robert Wood Johnson University Scleroderma Program, New Brunswick, NJ, ⁷David Geffen School of Medicine at UCLA, Los Angeles, CA, ⁸Internal Medicine/Rheumatology, University of Texas Health Science Center at Houston, Houston, TX, ⁹Rheumatology, Boston University School of Medicine, Boston, MA, ¹⁰Corbus Pharmaceuticals, Inc., Norwood, MA
Background/Purpose: Anabasum (JBT-101) is a selective cannabinoid receptor type 2 agonist that activates resolution of innate immune responses and limits fibrosis in animal models of…
Abstract Number: 2092 • 2017 ACR/ARHP Annual Meeting
Pilot Clinical Study of a Novel Unobtrusive Carpal Tunnel Tissue Manipulation Device in Reducing Symptoms of Carpal Tunnel Syndrome
Pauline Luong^1,2, Frank King³, Zong-Ming Li^2,4, Matt Dickason⁵, Matthew Diamond⁶ and Jae Son^1,2, ¹Pressure Profile Systems, Los Angeles, CA, ²Sohn Inc, Los Angeles, CA, ³Mission Pain and Spine Institute, Mission Viejo, CA, ⁴Biomedical Engineering, Orthopaedic Surgery, and Physical Medicine & Rehabilitatio, Cleveland Clinic, Cleveland, OH, ⁵Renaissance Associates, Newport Beach, CA, ⁶Rusk Institute of Rehabilitation Medicine, NYU School of Medicine, San Francisco, CA
Background/Purpose: Carpal tunnel syndrome (CTS) is the most common peripheral entrapment neuropathy and has been associated with systemic conditions such as rheumatoid arthritis, hypothyroidism, and…
Abstract Number: 726 • 2017 ACR/ARHP Annual Meeting
Performance of the American College of Rheumatology Provisional Composite Response Index in Systemic Sclerosis (CRISS) in the Scleroderma Lung Study-I
Dinesh Khanna¹, Donald P. Tashkin², Holly Wilhalme² and Chi-hong Tseng³, ¹University of Michigan, Ann Arbor, MI, ²University of California, Los Angeles, David Geffen School of Medicine, Los Angeles, CA, ³Medicine, University of California, Los Angeles, David Geffen School of Medicine, Los Angeles, CA
Background/Purpose: The CRISS has been proposed as a composite outcome measure for trials in systemic sclerosis1. CRISS is a 2-step process that assigns a probability…
Abstract Number: 2156 • 2017 ACR/ARHP Annual Meeting
Comparison of Patients with Dermatomyositis in a Specialty Clinic Versus Clinical Trial with Anabasum (JBT-101), a Cannabinoid Receptor Type 2 Agonist
Victoria P Werth¹, Emily Hejazi², Sandra M. Pena³, Jessica S. Haber⁴, Joyce Okawa³, Rui Feng⁵, Kirubel Gabre², Josef Concha², Scott Constantine⁶ and Barbara White⁶, ¹University of Pennsylvania and the VA Medical Center, Philadelphia, PA, ²University of Pennsylvania, Philadelphia, PA, ³Department of Dermatology, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, ⁴Department of Dermatology, University of Pennsylvania, Philadelphia, PA, ⁵Department of Biostatistics and Epidemiology at the Hospital of the University of Pennsylvania, Philadelphia, PA, ⁶Corbus Pharmaceuticals, Inc., Norwood, MA
Background/Purpose: There are limited treatment options and no published double-blind randomized placebo-controlled trials for the treatment of skin manifestations of dermatomyositis (DM). There is no…
Abstract Number: 738 • 2017 ACR/ARHP Annual Meeting
Prospective Validation of the Systemic Sclerosis Skin Symptoms Patient-Reported Outcome (SSPRO) in a Phase 2 Trial of Anabasum (JBT-101) in Diffuse Cutaneous Systemic Sclerosis (dcSSc)
Ada Man¹, Nancy Dgetluck² and Barbara White³, ¹Rheumatology, University of Manitoba, Winnipeg, MB, Canada, ²Biostatistics, Corbus Pharmaceuticals, Norwood, MA, ³Corbus Pharmaceuticals, Inc., Norwood, MA
Background/Purpose: Skin thickening is the defining manifestation of dcSSc. A dcSSc patient’s assessment of their skin involvement can provide information about how that patient feels…
Abstract Number: 2610 • 2017 ACR/ARHP Annual Meeting
Quantiferon Testing in a Clinical Trial of Systemic Lupus Erythematosus
Niti Goel¹, Stephen Wax², Amy Kao², Russell Reeve³ and Marsha Mackey⁴, ¹QuintilesIMS, Duke University School of Medicine, Durham, NC, ²EMD Serono Research & Development Institute, Inc. (a business of Merck KGaA), Billerica, MA, ³QuintilesIMS, Durham, NC, ⁴QuintilesIMS, Rockville, MD
Background/Purpose: Tuberculosis (TB) has been reported to occur at a higher rate in SLE patients than in the general population. As a result, most clinical…
Abstract Number: 874 • 2017 ACR/ARHP Annual Meeting
Effect of Rituximab on a Salivary Gland Ultrasound Score in Primary Sjögren’s Syndrome: Results of Multicentre Double-Blind Randomised Controlled Trial Sub-Study
Benjamin Fisher¹, Colin Everett², John Rout³, John O'Dwyer², Paul Emery⁴, Costantino Pitzalis⁵, Wan-Fai Ng⁶, Andrew Carr⁷, Colin Pease², Elizabeth Price⁸, Nurhan Sutcliffe⁹, Jimmy Makdissi¹⁰, Anwar Tappuni¹⁰, Nagui Gendi¹¹, Frances Hall¹², Sharon Ruddock², Catherine Fernandez², Claire Hulme², Kevin Davies¹³, Christopher J. Edwards¹⁴, Peter Lanyon¹⁵, Robert J. Moots¹⁶, Euthalia Roussou¹⁷, Linda Sharples¹⁸, Michele Bombardieri¹⁹ and Simon Bowman²⁰, ¹Rheumatology Research Group, University of Birmingham, Birmingham, United Kingdom, ²University of Leeds, Leeds, United Kingdom, ³Birmingham Dental Hospital, Birmingham, United Kingdom, ⁴NIHR Leeds Biomedical Research Centre, Leeds Teaching Hospitals NHS Trust, Leeds, United Kingdom, ⁵Centre for Experimental Medicine and Rheumatology, William Harvey Research Institute, Barts and The London, School of Medicine and Dentistry, Queen Mary University of London, London, United Kingdom, ⁶Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, United Kingdom, ⁷Newcastle Dental Hospital, Newcastle, United Kingdom, ⁸Great Western Hospital, Swindon, United Kingdom, ⁹Royal London Hospital, London, UK, London, United Kingdom, ¹⁰Barts Health NHS Trust, London, United Kingdom, ¹¹Basildon and Thurrock University Hospital, Basildon, UK, Basildon, United Kingdom, ¹²School of Clinical Medicine, University of Cambridge, Cambridge, United Kingdom, ¹³University of Sussex, Brighton, United Kingdom, ¹⁴University of Southampton, Southampton, United Kingdom, ¹⁵University of Nottingham, Nottingham, United Kingdom, ¹⁶University of Liverpool, Liverpool, United Kingdom, ¹⁷Barking Havering and Redbridge University hospitals NHS Trust, London, United Kingdom, ¹⁸London School of Hygiene and Tropical Medicine, London, United Kingdom, ¹⁹Centre for Experimental Medicine and Rheumatology, William Harvey Research Institute, Queen Mary University of London, UK, London, United Kingdom, ²⁰Department of Rheumatology, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK, Birmingham, United Kingdom
Background/Purpose: B lymphocytes are important in the pathogenesis of primary Sjögren’s syndrome (PSS), but two phase III trials (TEARS and TRACTISS) of the B cell…
Abstract Number: 2766 • 2017 ACR/ARHP Annual Meeting
Physical Therapy Vs. Internet-Based Exercise Training for Patients with Knee Osteoarthritis: Results of a Randomized Controlled Trial
Kelli Allen¹, Liubov Arbeeva², Leigh F. Callahan³, Yvonne M. Golightly⁴, Adam P. Goode⁵, Bryan Heiderscheit⁶, Carla Hill⁷, Kim Huffman⁸, Herbert Seversen⁹ and Todd A. Schwartz¹⁰, ¹Rheumatology, University of North Carolina at Chapel Hill and Durham VA Medical Center, Durham, NC, ²Thurston Arthritis Research Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, ³Thurston Arthritis Research Center, University of North Carolina, Chapel Hill, NC, ⁴Epidemiology, University of North Carolina at Chapel Hill, Chapel Hill, NC, ⁵O, Duke University, Durham, NC, ⁶Department of Orthopedics and Rehabilitation, University of Wisconsin, Madison, WI, ⁷University of North Carolina at Chapel Hill, Chapel Hill, NC, ⁸School of Medicine, Division of Rheumatology, Immunology and Molecular Physiology and Durham VA Medical Center, Duke University, Durham, NC, ⁹Oregon Research Institute, Durham, OR, ¹⁰Biostatistics, University of North Carolina at Chapel Hill, Chapel Hill, NC
Background/Purpose: The majority of adults with osteoarthritis (OA) are inactive, highlighting the need for continued efforts to promote regular engagement in exercise. Few studies have…
Abstract Number: 885 • 2017 ACR/ARHP Annual Meeting
48-Week Complete Remission By Ethnic, Sex and Age Subgroups in Patients with Active Lupus Nephritis Treated with Voclosporin
David Wofsy¹, David A. Isenberg², Frédéric A. Houssiau³, Mary Anne Dooley⁴, Neil Solomons⁵ and Simrat Randhawa⁶, ¹Rheumatology, UCSF, San Francisco, CA, ²Centre for Rheumatology Research, Division of Medicine, University College London, London, United Kingdom, ³Rheumatology, Pôle de Maladies Rhumatismales, Université catholique de Louvain, Brussels, Belgium, ⁴UNC Kidney Centre, Chapel Hill, NC, ⁵Aurinia Pharmaceuticals Inc., Victoria, BC, Canada, ⁶Medical Affairs, Aurinia Pharmaceuticals, Victoria, BC, Canada
Background/Purpose: Voclosporin (VCS) is a novel CNI with a favorable metabolic profile, no observed effect on electrolytes, and a predictable dose response potentially eliminating the…

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