Abstracts tagged "clinical trials"

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: 7L • 2017 ACR/ARHP Annual Meeting
A Phase 2 Study of Safety and Efficacy of Anabasum (JBT-101), a Cannabinoid Receptor Type 2 Agonist, in Refractory Skin-Predominant Dermatomyositis
Victoria P. Werth¹, Emily Hejazi², Sandra M. Pena¹, Jessica S. Haber³, Joyce Okawa¹, Rui Feng⁴, Kirubel Gabre², Josef Concha², Caitlin Cornwall⁵, Nancy Dgetluck⁶, Scott Constantine⁵ and Barbara White⁵, ¹Department of Dermatology, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, ²University of Pennsylvania, Philadelphia, PA, ³Department of Dermatology, University of Pennsylvania, Philadelphia, PA, ⁴Department of Biostatistics and Epidemiology at the Hospital of the University of Pennsylvania, Philadelphia, PA, ⁵Corbus Pharmaceuticals, Inc., Norwood, MA, ⁶Biostatistics, Corbus Pharmaceuticals, Inc., Norwood, MA

Background/Purpose: Effective treatment options are limited for refractory skin disease in dermatomyositis (DM). Anabasum is a non-immunosuppressive, synthetic, oral preferential CB2 agonist that triggers resolution…
Abstract Number: 13L • 2017 ACR/ARHP Annual Meeting
Significant, Sustained Improvement in Knee Function after Intra-Articular TPX-100: A Double-Blind, Randomized, Multi-Center, Placebo-Controlled Phase 2 Trial
Dawn McGuire¹, Nancy E Lane², Neil Segal³, Samy Metyas⁴, Hans Richard Barthel⁵, Meghan Miller¹, David Rosen¹ and Yoshi Kumagai¹, ¹OrthoTrophix, Inc, Oakland, CA, ²UC Davis Medical Center, Sacramento, CA, ³University of Kansas, Shawnee, KS, ⁴Medvin Clinical Research, Covina, CA, ⁵Barthel Clinic, Santa Barbara, CA

Background/Purpose: The current Phase 2 study was designed to evaluate safety, tolerability and preliminary efficacy of TPX-100 by IA administration in subjects with mild to…
Abstract Number: 885 • 2017 ACR/ARHP Annual Meeting
48-Week Complete Remission By Ethnic, Sex and Age Subgroups in Patients with Active Lupus Nephritis Treated with Voclosporin
David Wofsy¹, David A. Isenberg², Frédéric A. Houssiau³, Mary Anne Dooley⁴, Neil Solomons⁵ and Simrat Randhawa⁶, ¹Rheumatology, UCSF, San Francisco, CA, ²Centre for Rheumatology Research, Division of Medicine, University College London, London, United Kingdom, ³Rheumatology, Pôle de Maladies Rhumatismales, Université catholique de Louvain, Brussels, Belgium, ⁴UNC Kidney Centre, Chapel Hill, NC, ⁵Aurinia Pharmaceuticals Inc., Victoria, BC, Canada, ⁶Medical Affairs, Aurinia Pharmaceuticals, Victoria, BC, Canada
Background/Purpose: Voclosporin (VCS) is a novel CNI with a favorable metabolic profile, no observed effect on electrolytes, and a predictable dose response potentially eliminating the…
Abstract Number: 2884 • 2017 ACR/ARHP Annual Meeting
A Phase 2 Study of Safety and Efficacy of Anabasum (JBT-101), a Cannabinoid Receptor Type 2 Agonist, in Diffuse Cutaneous Systemic Sclerosis
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, Scott Constantine¹⁰ and Barbara White¹⁰, ¹Rheumatology, Hospital for Special Surgery, New York, NY, ²Medical and Rheumatology, Johns Hopkins University, Baltimore, MD, ³Rheumatology, Stanford University Medical Center, Palo Alto, CA, ⁴Division of Rheumatology, University of Utah, Salt Lake City, UT, ⁵Rheumatology, University of Pittsburgh, Pittsburgh, PA, ⁶Rheumatology, Robert Wood Johnson University Scleroderma Program, New Brunswick, NJ, ⁷David Geffen School of Medicine at UCLA, Los Angeles, CA, ⁸University of Texas McGovern Medical School, Houston, TX, ⁹Rheumatology, Boston University School of Medicine, Boston, MA, ¹⁰Corbus Pharmaceuticals, Inc., Norwood, MA
Background/Purpose: Systemic sclerosis (SSc) is characterized in part by chronic activation of the innate immune system with fibrosis. Anabasum is a non-immunosuppressive, synthetic, orally administered…
Abstract Number: 891 • 2017 ACR/ARHP Annual Meeting
Long-Term Efficacy and Safety of Tocilizumab in Patients with Refractory Takayasu Arteritis Treated Continuously over 52 Weeks: Results from Phase 3, Randomized, Double-Blind, Placebo-Controlled Trial and Open-Label Extension in Japan
Yoshikazu Nakaoka¹, Mitsuaki Isobe², Syuji Takei³, Yoshiya Tanaka⁴, Tomonori Ishii⁵, Shumpei Yokota⁶, Akira Nomura⁷, Seitaro Yoshida⁷ and Norihiro Nishimoto⁸, ¹Department of Vascular Physiology, National Cerebral and Cardiovascular Center Research Institute, Osaka, Japan, ²Sakakibara Heart Institute, Tokyo, Japan, ³Pediatrics of Developmental Medicine, Graduate School of Medical and Dental Sciences, Kagoshima University, Kagoshima, Japan, ⁴The First Department of Internal Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan, ⁵Clinical Research, Innovation and Education Center, Tohoku University Hospital, Sendai, Japan, ⁶Laboratory of Pediatric Research, Institute of Medical Science, Tokyo Medical University, Tokyo, Japan, ⁷Chugai Pharmaceutical Co., Ltd., Tokyo, Japan, ⁸Department of Molecular Regulation for Intractable Disease, Institute of Medical Science, Tokyo Medical University, Tokyo, Japan
Background/Purpose: Tocilizumab (TCZ), a humanized anti–IL-6 receptor antibody, showed a favorable trend toward relapse suppression in patients (pts) with refractory Takayasu arteritis (TAK) in a…
Abstract Number: 2981 • 2017 ACR/ARHP Annual Meeting
Evaluation of American College of Rheumatology Provisional Composite Response Index in Systemic Sclerosis (CRISS) in the Fasscinate Trial
Dinesh Khanna¹, Veronica J. Berrocal², Christopher Denton³, Angelika Jahreis⁴, Helen Spotswood⁵, Celia J. F. Lin⁴, Jeffrey Siegel⁶ and Daniel E. Furst⁷, ¹University of Michigan, Ann Arbor, MI, ²Div of Rheumatology, University of Michigan, Ann Arbor, MI, ³Department of Rheumatology, University College London, Royal Free Hospital, London, United Kingdom, ⁴Genentech, South San Francisco, CA, ⁵Roche Products Ltd., Welwyn Garden City, CA, United Kingdom, ⁶Roche Products Ltd., Welwyn Garden City, United Kingdom, ⁷University of California, Los Angeles, David Geffen School of Medicine, Los Angeles, CA
Background/Purpose: Treatment with Interleukin-6R inhibitor, tocilizumab (TCZ), in early progressive systemic sclerosis (SSc; the faSScinate trial) resulted in consistent, but not statistically significant, improvements in…
Abstract Number: 935 • 2017 ACR/ARHP Annual Meeting
Results from a 52 Week Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of a Novel, Intra-Articular, Wnt Pathway Inhibitor (SM04690) for the Treatment of Knee Osteoarthritis
Yusuf Yazici¹, Timothy E. McAlindon², Allan Gibofsky³, Nancy E. Lane⁴, Daniel J. Clauw⁵, Eddie Armas⁶, Nebojsa Skrepnik⁷, Christopher J. Swearingen¹, Anita DiFrancesco¹, Jeymi Tambiah¹ and Marc Hochberg⁸, ¹Samumed, LLC, San Diego, CA, ²Division of Rheumatology, Tufts Medical Center, Boston, MA, ³Rheumatology, Weill Cornell Medicine, and Hospital for Special Surgery, New York, NY, ⁴Center for Musculoskeletal Health, University of California at Davis, Hillsborough, CA, ⁵Chronic Pain & Fatigue Research Center, University of Michigan, Ann Arbor, MI, ⁶Well Pharma Medical Research, Miami, FL, ⁷Tuscon Orthopedics Institute, Tuscon, AZ, ⁸Head, Division of Rheumatology & Clinical Immunology; Vice Chair, Department of Medicine, University of Maryland School of Medicine, Baltimore, MD
Background/Purpose: Knee osteoarthritis (OA) is characterized by pain, disability and joint deformity due to articular cartilage degradation and bone remodeling. Wnt signaling is involved in…
Abstract Number: 2983 • 2017 ACR/ARHP Annual Meeting
Predictors for Disease Worsening Defined By Organ Failure in Diffuse Systemic Sclerosis: A European Scleroderma Trials and Research (EUSTAR) Analysis
Mike Oliver Becker¹, Nicole Graf², Rafael Sauter³, Yannick Allanore⁴, John Curram⁵, Christopher Denton⁶, Dinesh Khanna⁷, Marco Matucci-Cerinic⁸, Janethe Pena⁹, Janet E. Pope¹⁰ and Oliver Distler¹, ¹Department of Rheumatology, Center of Experimental Rheumatology, University Hospital Zurich, Zurich, Switzerland, ²Graf Biostatistics, Winterthur, Switzerland, ³Big Data Institute, Li Ka Shing Centre for Health Information and Discovery, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom, ⁴Department of Rheumatology, Cochin Hospital, Paris Descartes University, Paris, France, ⁵Bayer Plc, Newbury, United Kingdom, ⁶Department of Rheumatology, University College London, Royal Free Hospital, London, United Kingdom, ⁷University of Michigan, Ann Arbor, MI, ⁸Dept of Medicine/Div of Rheum, University of Florence, Florence, Italy, ⁹Bayer HealthCare Pharmaceuticals Inc, Whippany, NJ, ¹⁰Department of Medicine, Division of Rheumatology, University of Western Ontario, St Joseph's Health Care, London, ON, Canada
Background/Purpose: Mortality and worsening of organ function would be desirable endpoints for clinical trials in systemic sclerosis (SSc). However, these events are relatively rare, making…
Abstract Number: 1201 • 2017 ACR/ARHP Annual Meeting
Reducing Heterogeneity in OA Clinical Trials: Data from a Phase 2 Study of SM04690, a Novel, Intra-Articular, Wnt Pathway Inhibitor in Knee Osteoarthritis
Philip G. Conaghan¹, Anita DiFrancesco², Christopher J. Swearingen², Sarah Kennedy², Ismail Simsek², Jeymi Tambiah² and Yusuf Yazici², ¹Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, United Kingdom, ²Samumed, LLC, San Diego, CA
Background/Purpose: Kellgren-Lawrence [KL] radiographic grading is used to classify knee osteoarthritis (OA), but may not accurately reflect disease progression. Classifying subjects by baseline medial joint…
Abstract Number: 1204 • 2017 ACR/ARHP Annual Meeting
Radiographic Outcomes Were Associated with Pain and Function Responses: Post-Hoc Analysis of Results from a Phase 2 Study of a Small Molecule Wnt Pathway Inhibitor, SM04690, for Knee Osteoarthritis Treatment
Yusuf Yazici¹, Timothy E. McAlindon², Allan Gibofsky³, Nancy E. Lane⁴, Nebojsa Skrepnik⁵, Eddie Armas⁶, Christopher J. Swearingen¹, Anita DiFrancesco¹, Jeymi Tambiah¹ and Marc Hochberg⁷, ¹Samumed, LLC, San Diego, CA, ²Division of Rheumatology, Tufts Medical Center, Boston, MA, ³Rheumatology, Weill Cornell Medicine, and Hospital for Special Surgery, New York, NY, ⁴Center for Musculoskeletal Health, University of California, Davis School of Medicine, Sacramento, CA, ⁵Tuscon Orthopedics Institute, Tuscon, AZ, ⁶Well Pharma Medical Research, Miami, FL, ⁷Head, Division of Rheumatology & Clinical Immunology; Vice Chair, Department of Medicine, University of Maryland School of Medicine, Baltimore, MD
Background/Purpose: Knee osteoarthritis (OA) is characterized by pain, disability and joint deformity due to articular cartilage degradation and bone remodeling. Wnt signaling is involved in…
Abstract Number: 1676 • 2017 ACR/ARHP Annual Meeting
Improving Sensitivity to Change of the Modified Rodnan Skin Score over Time
Annel M. Fernandez¹, Robert F. Spiera², Jackie Szymonifka² and Jessica K. Gordon², ¹Medicine- Rheumatology/ Research, Hospital For Special Surgery, New York, NY, ²Rheumatology, Hospital for Special Surgery, New York, NY
Background/Purpose: The Modified Rodnan Skin Score (MRSS) assesses global dermal thickness through the examination of 17 body areas scored by clinical palpation using a 4…

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