Abstracts tagged "clinical trials"

Abstract Number: 1519 • 2018 ACR/ARHP Annual Meeting
Patient Characteristics Associated with Discontinuation of Tofacitinib for the Treatment of Rheumatoid Arthritis in Open-Label, Long-Term Extension Studies up to 9.5 Years
Jeffrey R. Curtis¹, Jürgen Wollenhaupt², Katerina Chatzidionysiou³, Sander W. Tas⁴, Lisy Wang⁵, Harry Shi⁶, María Montoro⁷, Petra Neregård⁸, Palle Dahl⁹ and Vassilis Tsekouras¹⁰, ¹University of Alabama at Birmingham, Birmingham, AL, ²Schön Klinik Hamburg-Eilbek Teaching Hospital of the University of Hamburg, Hamburg, Germany, ³Division of Rheumatology, Department of Medicine, Karolinska Institutet, Stockholm, Sweden, ⁴Amsterdam Rheumatology and Immunology Center, Academic Medical Center, Amsterdam, Netherlands, ⁵Pfizer Inc, Groton, CT, ⁶Pfizer Inc, Collegeville, PA, ⁷Pfizer Inc, Madrid, Spain, ⁸Pfizer Inc, Stochholm, Sweden, ⁹Pfizer Inc, Ballerup, Denmark, ¹⁰Pfizer Inc, Athens, Greece
Background/Purpose: Tofacitinib is an oral Janus kinase inhibitor for the treatment of RA. We explored characteristics of patients (pts) who discontinued (d/c) open-label, long-term extension…
Abstract Number: 2977 • 2018 ACR/ARHP Annual Meeting
Lenabasum, a Cannabinoid Type 2 Receptor Agonist, Reduces T-Cell Population and Downregulates Type 1 and 2 Interferon Activities in Lesional Dermatomyositis Skin
Nithin Reddy^1,2, Majid Zeidi^1,2, Barbara White³ and Victoria P. Werth^1,2, ¹University of Pennsylvania, Philadelphia, PA, ²Philadelphia Veterans Affairs Medical Center, Philadelphia, PA, ³Corbus Pharmaceuticals, Inc., Norwood, MA
Background/Purpose: Lenabasum is a synthetic, non-immunosuppressive, selective cannabinoid receptor type 2 (CB2) agonist that activates resolution of innate immune responses. CB2 is a G-protein coupled…
Abstract Number: 1552 • 2018 ACR/ARHP Annual Meeting
No Effect of Concomitant Glucocorticoid Therapy on Efficacy and Safety of Tocilizumab Monotherapy Found in Rheumatoid Arthritis Clinical Trials
Mary Safy¹, Johannes W. G. Jacobs¹, Michael Edwardes², Maria JH de Hair¹, Xavier M Teitsma¹, Paco MJ Welsing¹, Michelle EA Borm³, Yves Luder⁴, Jacob van Laar¹, Attila Pethö-Schramm⁴ and Johannes W. J. Bijlsma⁵, ¹Department of Rheumatology & Clinical Immunology, University Medical Center Utrecht, Utrecht, the Netherlands, Utrecht, Netherlands, ²Everest Clinical Research, Markham, ON, Canada, ³Roche Nederland BV, Woerden, Netherlands, ⁴F. Hoffmann-La Roche, Basel, Switzerland, ⁵Rheumatology & Clinical Immunology department University Medical Center Utrecht, Utrecht University, Utrecht, Netherlands
No effect of concomitant glucocorticoid therapy on efficacy and safety of tocilizumab monotherapy in rheumatoid arthritis clinical trialsM. Safy1, J.W.G. Jacobs1, M. Edwardes2, M.J.H. de…
Abstract Number: 1644 • 2018 ACR/ARHP Annual Meeting
Improvement in Morning Stiffness in Subjects with Psa Is Associated with Improvements in Pain, Physical Function, and Patient Global Response to Treatment
Ana-Maria Orbai¹, Jessica Walsh², Peter Nash³, Lichen Teng⁴, Benoit Guerette⁴ and Rieke Alten⁵, ¹Johns Hopkins University School of Medicine, Baltimore, MD, ²University of Utah School of Medicine, Salt Lake City, UT, USA, Salt Lake City, UT, ³University of Queensland, Brisbane, Australia, ⁴Celgene Corporation, Summit, NJ, ⁵Schlosspark-Klinik University Medicine, Berlin, Germany
Background/Purpose: Stiffness is an important component of inflammatory arthritis and plays a role in PsA flare. Patients with inflammatory arthritis report difficulty with activities, “slowing…
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…

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