Abstracts tagged "clinical trials"

Abstract Number: 1697 • 2019 ACR/ARP Annual Meeting
Efficacy of Apremilast for Oral Ulcers Associated with Active Behçet’s Syndrome over 64 Weeks: Long-term Results from the Japanese Subgroup in a Phase III Study
Mitsuhiro Takeno¹, Yoshiya Tanaka ², Hajime Kono ³, Shoji Sugii ⁴, Mitsumasa Kishimoto ⁵, Sue Cheng ⁶, Shannon McCue ⁷, Mindy Chen ⁸, Maria Paris ⁶ and Hiroaki Dobashi ⁹, ¹Nippon Medical School, Tokyo, Japan, ²University of Occupational and Environmental Health Japan, Kitakyushu, Japan, ³Teikyo University School of Medicine, Tokyo, Japan, ⁴Department of Rheumatic Diseases, Tokyo Metropoitan Tama Medica Center, Fuchu, Japan, ⁵Immuno-Rheumatology Center, St. Luke’s International Hospital, Tokyo, Japan, ⁶Celgene Corporation, Summit, ⁷Celgene Corporation, Summit, NJ, ⁸Celgene Corporation, Berkeley Heights, NJ, ⁹Kagawa University, Kagawa, Japan
Background/Purpose: Behçet’s syndrome is a chronic, multi-system, variable vessel vasculitis characterized by painful, recurrent oral ulcers (OU) that can be disabling and may impair quality…
Abstract Number: 940 • 2019 ACR/ARP Annual Meeting
Response to Placebo in Randomized Clinical Trials with Biologics in Non-renal, Non-neuropsychiatric Systemic Lupus Erythematosus: A Systematic Review and Pooled Analysis
Konstantinos Tselios¹, Laura Wakani ², Dafna Gladman ³, Jiandong Su ⁴ and Murray Urowitz ⁴, ¹University Health Network, University of Toronto, Toronto, Canada, ²University Health Network, Toronto, Canada, ³Toronto Western Hospital, Toronto, Canada, Toronto, ON, Canada, ⁴University Health Network, University of Toronto, Toronto, ON, Canada
Background/Purpose: Most randomized controlled trials (RCTs) with biologic medicines in systemic lupus erythematosus (SLE) failed to reach their respective end-points with the rates of the…
Abstract Number: 1760 • 2019 ACR/ARP Annual Meeting
Six-week Treatment with Low-dose Prednisolone in Patients with Painful Hand Osteoarthritis (HOPE): Results from a Randomised Double-blind Placebo-controlled Trial
Féline Kroon¹, Marion Kortekaas ¹, Annelies Boonen ², Stephan Böhringer ³, Monique Reijnierse ¹, Frits R Rosendaal ³, Naghmeh Riyazi ⁴, Mirian Starmans ⁵, Franktien Turkstra ⁶, Jende van Zeben ⁷, CF Allaart ⁸ and Margreet Kloppenburg ³, ¹Leiden University Medical Center, Leiden, Netherlands, ²Maastricht University Medical Center, Maastricht, Netherlands, ³Leiden University Medical Center, Leiden, Zuid-Holland, Netherlands, ⁴Haga Hospital, The Hague, Netherlands, ⁵Zuyderland Medical Center, Heerlen, Netherlands, ⁶Amsterdam Rheumatology and immunology Center | Reade, Amsterdam, Netherlands, ⁷Sint Franciscus Vlietland Groep, Rotterdam, Netherlands, ⁸Department of Rheumatology, Leiden University Medical Center, Leiden, The Netherlands, Leiden, Netherlands
Background/Purpose: Hand osteoarthritis (OA) is a prevalent joint disease with high disease-burden in need for effective therapeutic options. Studies have shown that synovial inflammation is…
Abstract Number: 941 • 2019 ACR/ARP Annual Meeting
Treatment of Lupus Nephritis with anti-CD20 Followed by Anti-BAFF: Impact on B Cell Reconstitution, B Cell Subsets, and Autoreactivity
Yemil Atisha Fregoso¹, Susan Malkiel ², Kristina Harris ³, Sai Kanaparthi ³, Margie Byron ⁴, Linna Ding ⁵, Dawn Smilek ⁶, David Wofsy ⁷, Maria Dall'Era ⁸, Cynthia Aranow ¹ and Betty Diamond ⁹, ¹Feinstein Institute for Medical Research, Manhasset, NY, ²Feinstein Institute for Medical Research, Manhasset, ³Immune Tolerance Network, Bethesda, ⁴Rho Federal Systems, Inc., Chapel Hill, NC, ⁵National Institute of Allergy and Infectious Diseases, Bethesda, MD, ⁶Immune Tolerance Network, San Francisco, CA, ⁷UCSF, San Francisco, ⁸University of California, San Francisco, San Francisco, CA, ⁹Feinstein Institutes for Medical Research, Manhasset
Background/Purpose: Despite the relevance of B cells in lupus, two clinical trials of anti-CD20 failed to meet primary endpoints in patients with lupus and lupus…
Abstract Number: 2174 • 2019 ACR/ARP Annual Meeting
Test-Retest Reliability and Validity of a Mobile Health Application to Automate the 30 Seconds Chair Stand Test – Preliminary Data to Create a Contemporary Instrument for Randomized Clinical Trials
Lucas Dantas¹, Matthew Harkey ², André Dantas ³, Lori Lyn Price ⁴, Jeffrey Driban ⁵ and Timothy McAlindon ¹, ¹Tufts Medical Center, Boston, MA, ²Tufts Medical Center, University of Massachusetts Medical School, Boston, MA, ³CI&T, Tokyo, Japan, ⁴Tufts Medical Center, Tufts University, Boston, MA, ⁵Tufts Medical Center, Boston
Background/Purpose: Contemporary technologies offer potential solutions to improve and automate data collection of randomized clinical trials by transitioning assessments from the clinic to the real-world.…
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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