Abstracts tagged "clinical trials"

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…
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…

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