Abstracts tagged "clinical trials"

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…
Abstract Number: 1364 • 2018 ACR/ARHP Annual Meeting
Treatment of Knee Osteoarthritis with SM04690 Improved WOMAC A1 “Pain on Walking” – Results from a 52-Week, Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of a Novel, Intra-Articular, Wnt Pathway Inhibitor
Jeyanesh Tambiah¹, Sarah Kennedy¹, Heli Ghandehari¹, Christopher Swearingen¹ and Marc C. Hochberg², ¹Samumed, LLC, San Diego, CA, ²University of Maryland School of Medicine, Baltimore, MD
Background/Purpose: Knee osteoarthritis (OA) is characterized by pain, functional limitation, and physical disability due to articular cartilage degradation and bone remodeling. Wnt signaling is involved…
Abstract Number: 2683 • 2018 ACR/ARHP Annual Meeting
Selective Expansion and Targeting of FoxP3+CD127lo Regulatory T Cells By Low-Dose IL-2 Therapy in Active SLE
Jens Humrich¹, Caroline von Spee-Mayer², Philipp Enghard³, Angelika Rose⁴, Elise Siegert⁵, Tobias Alexander⁵, Falk Hiepe⁶, Gerd R. Burmester⁷ and Gabriela Riemekasten⁸, ¹Department of Rheumatology, University Hospital Schleswig-Holstein - Campus Lübeck, Lübeck, Germany, ²Immunology, University Hospital Freiburg, Freiburg, Germany, ³Department of Nephrology, Charité – University Medicine Berlin, Berlin, Germany, ⁴Rheumatology and Clinical Immunology, Charité – University Medicine Berlin, Berlin, Germany, ⁵Rheumatology and Clinical Immunology, Charité - University Medicine Berlin, Berlin, Germany, ⁶Rheumatology, Charité – University Medicine Berlin, Berlin, Germany, ⁷Rheumatology and Clinical Immunology, Charité-University Medicine Berlin, Berlin, Germany, ⁸Rheumatology, University Hospital Schleswig-Holstein - Campus Lübeck, Lübeck, Germany
Background/Purpose: Interleukin-2 (IL-2) is crucial for the growth and survival of regulatory T cells (Treg), and thus for the control of autoimmunity. In previous studies…
Abstract Number: 1366 • 2018 ACR/ARHP Annual Meeting
Assessment of Health-Related Quality of Life in a 52-Week, Phase 2, Randomized, Controlled Trial of a Novel, Intra-Articular, Wnt Pathway Inhibitor (SM04690) for Treatment of Knee Osteoarthritis
Vibeke Strand¹, Heli Ghandehari², Christopher Swearingen² and Jeyanesh Tambiah², ¹Stanford University School of Medicine, Palo Alto, CA, ²Samumed, LLC, San Diego, CA
Background/Purpose: SM04690, a small molecule, intra-articular (IA) Wnt pathway inhibitor, is in development for knee OA treatment. A phase 2, 52-week, trial evaluated changes in…
Abstract Number: 2788 • 2018 ACR/ARHP Annual Meeting
The Effects of Plasma Exchange and Reduced-Dose Glucocorticoids during Remission-Induction for Treatment of Severe ANCA-Associated Vasculitis
Michael Walsh¹, Peter A. Merkel² and David Jayne³, ¹Nephrology, McMaster University, Hamilton, ON, Canada, ²Division of Rheumatology, Division of Rheumatology, University of Pennsylvania, Philadelphia, PA, ³Department of Medicine, University of Cambridge, Cambridge, United Kingdom
Background/Purpose: It is uncertain whether plasma exchange improves clinical outcomes in anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis. Also uncertain is whether, compared to standard therapy with…
Abstract Number: 1376 • 2018 ACR/ARHP Annual Meeting
The Omeract-Oarsi Core Set of Outcome Domains to Measure in Clinical Trials for People with Hip and/or Knee Osteoarthritis
Toby O Smith¹, Gillian Hawker², David J. Hunter³, Lyn March⁴, Beverly Shea⁵, Robin Christensen⁶, Francis Guillemin⁷, Caroline Terwee⁸, Paula Williamson⁹, Ewa M. Roos¹⁰, Richard Loeser¹¹, Thomas J. Schnitzer¹², Margreet Kloppenburg¹³, Tuhina Neogi¹⁴, Christoph Ladel¹⁵, Ulrike Kaiser¹⁶, Ali Mobasheri¹⁷, Nigel K Arden¹, Marc C. Hochberg¹⁸, Alan Tennant¹⁹, Maarten de Wit²⁰, Peter Tugwell²¹ and Philip G. Conaghan²², ¹Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, United Kingdom, ²University of Toronto, Toronto, ON, Canada, ³University of Sydney, Sydney, Australia, ⁴Department of Rheumatology, Northern Clinical School, Institute of Bone and Joint Research, Kolling Institute, University of Sydney & Department of Rheumatology, Royal North Shore Hospital, St Leonards, Sydney, Australia, ⁵Bruyere Research Institute, Ottawa, ON, Canada, ⁶Department of Rheumatology, Musculoskeletal Statistics Unit: The Parker Institute, Bispebjerg and Frederiksberg Hospital, & Department of Rheumatology, Odense University Hospital, Copenhagen, Denmark, ⁷University of Lorraine, Nancy, France, Nancy, France, ⁸Dep of Epidemiology and Biostatistics, EMGO Institute for Health and Care Research, VU University Medical Center, Amsterdam, Netherlands, ⁹University of Liverpool, Liverpool, United Kingdom, ¹⁰Inst Sports and Biomechanics, University of Southern Denmark, Odense, Denmark, ¹¹Thurston Arthritis Research Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, ¹²Northwestern University, Chicago, IL, ¹³Rheumatology and Clinical Epidemiology, Leiden University Medical Center, Leiden, Netherlands, ¹⁴Clinical Epidemiology Research and Training Unit, Boston University School of Medicine, Boston, MA, ¹⁵Merck KGaA, Darmstadt, Germany, ¹⁶Universitätsklinikum Carl Gustav Carus Dresden, Dresden, Germany, ¹⁷Rheumatology, School of Veterinary Medicine, University of Surrey, Guildford, United Kingdom, ¹⁸University of Maryland School of Medicine, Baltimore, MD, ¹⁹Swiss Paraplegic Research, Nottwil, Switzerland, ²⁰EULAR standing committee of PARE, Zurich, Switzerland, ²¹Center For Global Health, Institute of Population Hlth, Ottawa, ON, Canada, ²²Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds and National Institute for Health Research (NIHR) Leeds Biomedical Research Centre, Leeds, United Kingdom, Leeds, United Kingdom
Background/Purpose: It has been over 20 years since the OMERACT core outcome set (COS) to measure in clinical trials with people who have hip and/or…
Abstract Number: 2869 • 2018 ACR/ARHP Annual Meeting
Incorporation of Patient Reported Outcomes Data in the Care of US Veterans with Rheumatoid Arthritis: A Randomized, Controlled Trial
Michael R Bubb¹, Reuben Judd¹ and Ann D Chauffe², ¹Medicine, Malcom Randall VAMC, Gainesville, FL, ²Rheumatology Clinic of Opelousas, Opelousas, LA
Background/Purpose: Quantitative disease activity measures are required to implement a treat-to-target algorithm for the treatment of rheumatoid arthritis (RA). Available measures based on patient-derived data…
Abstract Number: 1383 • 2018 ACR/ARHP Annual Meeting
Examining Cutaneous Disease Activity As an Outcome Measure for Clinical Trials in Dermatomyositis
Rebecca Gaffney¹, Meera Tarazi², Rui Feng³, David Pearson⁴ and Victoria P. Werth⁵, ¹Dermatology, University of Pennsylvania, Philadelphia, PA, ²Department of Dermatology, University of Pennsylvania, Philadelphia, PA, ³Biostatistics, Epidemiology and Informatics, University of Pennsylvania, Philadelphia, PA, ⁴Philadelphia Veterans Affairs Medical Center, Philadelphia, PA, ⁵Department of Dermatology, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA
Background/Purpose: The FDA encourages clearance of skin findings as a primary outcome of clinical trials for inflammatory skin conditions. However, some DM patients retain signs…
Abstract Number: 2931 • 2018 ACR/ARHP Annual Meeting
Missing Outcomes in SLE Clinical Trials: Impact on Estimating Treatment Effects
Mimi Kim¹, Joan T. Merrill², Kenneth C. Kalunian³, Leslie Hanrahan⁴ and Peter M. Izmirly⁵, ¹Epidemiology and Population Health, Albert Einstein College of Medicine, Bronx, NY, ²University of Oklahoma Health Sciences Center, Oklahoma City, OK, ³Division of Rheumatology, Allergy and Immunology, UCSD School of Medicine, La Jolla, CA, ⁴Lupus Foundation of America, Washington DC, DC, ⁵NYU Langone Health, New York, NY
Background/Purpose: Missing data due to drop-out and loss to follow-up is a common problem in SLE trials. The usual approaches for handling this issue include…

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