Abstracts tagged "clinical trials"

Abstract Number: 1715 • 2018 ACR/ARHP Annual Meeting
Safety and Efficacy of Lenabasum in an Open-Label Extension of a Phase 2 Study in Diffuse Cutaneous Systemic Sclerosis Subjects
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, Elizabeth Lee¹⁰, Scott Constantine¹⁰ and Barbara White¹⁰, ¹Hospital for Special Surgery, New York, NY, ²Division of Rheumatology, Johns Hopkins University School of Medicine, Baltimore, MD, ³Immunology and Rheumatology, Stanford University School of Medicine, Palo Alto, CA, ⁴Division of Rheumatology, University of Utah, Salt Lake City, UT, ⁵Medicine - Rheumatology, University of Pittsburgh, Pittsburgh, PA, ⁶Rheumatology, Robert Wood Johnson Medical School, New Brunswick, NJ, ⁷Pacific Arthritis Associates, Los Angeles; University of California, Los Angeles; University of Washington, Seattle; University of Florence, Italy, Los Angeles, CA, ⁸Rheumatology, University of Texas McGovern Medical School, Houston, TX, ⁹Rheumatology, Boston University School of Medicine, Boston, MA, ¹⁰Corbus Pharmaceuticals, Inc., Norwood, MA
Background/Purpose: Lenabasum is a synthetic, non-immunosuppressive, selective cannabinoid receptor type 2 agonist that activates resolution of innate immune responses. Lenabasum had acceptable safety and tolerability,…
Abstract Number: 302 • 2018 ACR/ARHP Annual Meeting
Validity and Responsiveness of Inflammation and Joint Damage Scores Based on the Omeract Rheumatoid Arthritis MRI Scoring System
Ulf Sundin¹, Mikkel Østergaard², Daniel Glinatsi³, Anna-Birgitte Aga⁴, Kim Hørslev-Petersen⁵, Merete Lund Hetland⁶, Peter Junker⁷, Bo Jannik Ejbjerg⁸, Paul Bird⁹, Philip G. Conaghan¹⁰, Siri Lillegraven⁴ and Espen A. Haavardsholm⁴, ¹*Dept. of Rheumatology, Diakonhjemmet Hospital, Oslo, Norway, ²Center for Rheumatology and Spine Diseases, Rigshospitalet Glostrup Copenhagen Center for Arthritis Research, Copenhagen, Denmark, ³Copenhagen Center for Arthritis Research (COPECARE), Center for Rheumatology and Spine Diseases, Rigshospitalet, Centre for Head and Orthopaedics, Rigshospitalet, Glostrup, Denmark, ⁴Dept. of Rheumatology, Diakonhjemmet Hospital, Oslo, Norway, ⁵King Christian 10th Hospital for Rheumatic Diseases, University of Southern Denmark, Institute of Regional Health Research, Graasten, Denmark, ⁶Copenhagen Center for Arthritis Research, Center for Rheumatology and Spine Diseases, The DANBIO Registry, Glostrup, Denmark, ⁷Odense University Hospital, Odense, Denmark, ⁸Department of Rheumatology, Zealand University Hospital, Køge, Denmark, ⁹Medicine, University of New South Wales, Sydney, NSW, Australia, ¹⁰University of Leeds, Leeds, United Kingdom
Background/Purpose: The RAMRIS scoring system is used to quantify synovitis, tenosynovitis, bone marrow edema (BME), bone erosions and joint space narrowing (JSN) on MRI examinations…
Abstract Number: 1872 • 2018 ACR/ARHP Annual Meeting
Safety and Efficacy of Allogeneic Umbilical Cord-Derived Mesenchymal Stem Cells in Patients with Systemic Lupus Erythematosus: Results of an Open-Label Phase I Study
Diane L. Kamen¹, Paul J. Nietert², Hongjun Wang³, Tara Duke³, Colleen Cloud³, Angela Robinson³ and Gary S. Gilkeson⁴, ¹Medicine/Rheumatology & Immunology, Medical University of South Carolina, Charleston, SC, ²Public Health Sciences, Medical University of South Carolina, Charleston, SC, ³Medical University of South Carolina, Charleston, SC, ⁴Department of Medicine, Medical University of South Carolina, Charleston, SC
Background/Purpose: Mesenchymal stem cells (MSCs) are known to possess significant immunosuppressive and tissue protective properties, and their use in refractory systemic lupus erythematosus (SLE) is…
Abstract Number: 478 • 2018 ACR/ARHP Annual Meeting
Evidence Based Recommendations for Corticosteroid Tapering/Discontinuation in New Onset Juvenile Dermatomyositis Patients: Results from the Paediatric Rheumatology International Trials Organisation
Gabriella Giancane¹, Claudio Lavarello², Angela Pistorio², Francesco Zulian², Bo Magnusson³, Tadej Avcin², Fabrizia Corona², Valeria Gerloni², Serena Pastore², Roberto Marini², Silvana Martino², Anne Pagnier⁴, Michel Rodiere², Christine Soler², Valda Stanevicha², Rebecca ten Cate², Yosef Uziel², Jelena Vojinovic², Elena Fueri², Angelo Ravelli⁵, Alberto Martini⁶ and Nicola Ruperto⁷, ¹Clinica Pediatrica - Reumatologia, Istituto Giannina Gaslini, Genoa, Italy, ²Istituto Giannina Gaslini - Clinica Pediatrica e Reumatologia - PRINTO, Genoa, Italy, ³Karolinska University Hospital, Stockholm, Sweden, ⁴Istituto Giannina Gaslini - Clinica Pediatrica e Reumatologia - PRINTO, Genova, Italy, ⁵Clinica Pediatrica - Reumatologia, Istituto Giannina Gaslini, Genova, Italy, ⁶Universita di Genova Pediatria II, Genova, Italy, ⁷Istituto Giannina Gaslini - Clinica Pediatrica e Reumatologia, Genoa, Italy
Background/Purpose: At present no clear evidence based guidelines exist to standardize the tapering and discontinuation of corticosteroids (CS) in juvenile dermatomyositis (JDM). Aim of our…
Abstract Number: 2284 • 2018 ACR/ARHP Annual Meeting
Safety and Efficacy of Lenabasum in Refractory Skin-Predominant Dermatomyositis Subjects Treated on an Open-Label Extension of Trial JBT101-DM-001
Victoria P. Werth^1,2, David Pearson^1,2, Joyce Okawa^1,2, Rui Feng³, Josef Concha^1,2, Basil Patel^1,2, Emily Hejazi^1,2, Caitlin Cornwall⁴, Scott Constantine⁴ and Barbara White⁴, ¹University of Pennsylvania, Philadelphia, PA, ²Philadelphia Veterans Affairs Medical Center, Philadelphia, PA, ³University of Pennsylvania, Philadelphia', PA, ⁴Corbus Pharmaceuticals, Inc., Norwood, MA
Background/Purpose: Lenabasum is a synthetic, non-immunosuppressive, selective cannabinoid receptor type 2 agonist that activates resolution of innate immune responses. Lenabasum had acceptable safety and tolerability…
Abstract Number: 662 • 2018 ACR/ARHP Annual Meeting
Radiographic Progression of Structural Joint Damage in Patients with Active Psoriatic Arthritis Treated with Ixekizumab for up to 3 Years
Désirée van der Heijde¹, Vinod Chandran², Roy Fleischmann³, Olivier Benichou⁴, Suchitrita Rathmann⁴ and Catherine Shuler⁴, ¹Leiden University Medical Centre, Leiden, Netherlands, ²Krembil Research Institute & University of Toronto, Toronto, ON, Canada, ³University of Texas Southwestern Medical Center, Dallas, TX, ⁴Eli Lilly and Company, Indianapolis, IN
Background/Purpose: Ixekizumab (IXE), an IL-17A antagonist, was shown to be superior to placebo (PBO) in inhibiting the progression of structural joint damage in patients (pts)…
Abstract Number: 2356 • 2018 ACR/ARHP Annual Meeting
Perceptions, Incentives, and Barriers to Clinical Trial Participation: Qualitative Evaluation of Lupus Patients, Enriched for Minority Participants
Cristina Arriens¹, Fredonna Carthen², D'Angelo Grant², Paul Kamp¹, Stan Kamp¹, Katherine Thanou¹, Teresa Aberle¹, Eliza Chakravarty¹, Judith A. James³, Joan T. Merrill¹ and Motolani E. Ogunsanya⁴, ¹Arthritis and Clinical Immunology, Oklahoma Medical Research Foundation, Oklahoma City, OK, ²Arthritis & Clinical Immunology, Oklahoma Medical Research Foundation, OKLAHOMA CITY, OK, ³Arthritis and Clinical Immunology Program, Oklahoma Medical Research Foundation, Oklahoma City, OK, ⁴College of Pharmacy, University of Oklahoma Health Sciences Center, Oklahoma City, OK
Background/Purpose: Although SLE disproportionately affects minority racial groups, they are significantly under-represented in clinical trials. This may lead to false, underpowered conclusions in race-based sub-group…
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…

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