Abstracts tagged "clinical trials"

Abstract Number: 323 • 2016 ACR/ARHP Annual Meeting
Effect of 10 Years of Denosumab Treatment on Bone Histology and Histomorphometry in the Freedom Extension Study
David W Dempster^1,2, NS Daizadeh³, A Fahrleitner-Pammer⁴, Jens-Erik Beck Jensen⁵, DL Kendler⁶, Ivo Valter⁷, Rachel B Wagman³, Susan Yue³ and Jacques P Brown⁸, ¹Columbia University, New York, NY, ²Helen Hayes Hospital, West Haverstraw, NY, ³Amgen Inc., Thousand Oaks, CA, ⁴Medical University, Graz, Austria, ⁵Hvidovre University Hospital, Hvidovre, Denmark, ⁶University of British Columbia, Vancouver, BC, Canada, ⁷Center for Clinical and Basic Research, Tallinn, Estonia, ⁸Centre Hospitalier de l'Université Laval (CHUL), Quebec City, QC, Canada
Background/Purpose: Denosumab (DMAb) has been associated with low incidence of spine and non-spine, including hip, fractures through 10 years of treatment (Bone ASBMR 2015). Questions…
Abstract Number: 1653 • 2016 ACR/ARHP Annual Meeting
Delineating the Effects of Rheumatoid Arthritis Pharmacotherapies on Vascular Inflammation: Rationale and Design of a Clinical Trial
Jon T. Giles¹, Katherine Liao², Nina Paynter³, Alyssa Wohlfahrt⁴, Afshin Zartoshti⁵, Rachel Broderick⁶, Daniel H. Solomon⁷ and Joan Bathon⁶, ¹Division of Rheumatology, Columbia University, College of Physicians & Surgeons, New York, NY, ²Rheumatology, Immunology, and Allergy, Brigham and Women's Hospital, Boston, MA, ³Medicine, Harvard University, Boston, MA, ⁴Rheumatology, Immunology and Allergy, Brigham and Women's Hospital, Boston, MA, ⁵Rheumatology, Columbia University, College of Physicians & Surgeons, New York city, NY, ⁶Rheumatology, Columbia University, College of Physicians & Surgeons, New York, NY, ⁷Division of Rheumatology, Brigham and Women's Hospital and Harvard Medical School, Boston, MA
Background/Purpose: Rheumatoid arthritis is associated with an excess cardiovascular disease (CVD) burden. Fewer CVD events associated with specific DMARD therapies have been reported; however, causal…
Abstract Number: 642 • 2016 ACR/ARHP Annual Meeting
Quality of Life Outcomes Following Therapy with Chs-0214 and Etanercept (Enbrel): Randomized, Double-Blind Study in Subjects with Rheumatoid Arthritis
Alan J. Kivitz^1,2, James R. O'Dell³, Tsutomu Takeuchi⁴, Yoshiya Tanaka⁵, Satoshi Nakashima⁶, Cass Kelleher⁷, Jennifer Hodge⁸, Barbara Finck⁷ and RApsody Study Group, ¹Altoona Center for Clinical Research, Duncansville, PA, ²Altoona Arthritis & Osteoporosis Center, Duncansville, PA, ³Department of Internal Medicine, University of Nebraska Medical Center, Omaha, NE, ⁴Division of Rheumatology, Department of Internal Medicine,, Keio University School of Medicine, Tokyo, Japan, ⁵The First Department of Internal Medicine,, School of Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan, ⁶Daiishi Sankyo, Shinagawa-Ku Tokyo, Japan, ⁷Clinical Science, Coherus BioSciences, Redwood City, CA, ⁸Coherus BioSciences, Redwood City, CA
Background/Purpose: CHS-0214 is in development as a proposed biosimilar of etanercept. This Phase III confirmatory, safety and efficacy study randomized and dosed 644 subjects with…
Abstract Number: 1704 • 2016 ACR/ARHP Annual Meeting
Consistent Safety and Tolerability of Secukinumab over Long-Term Exposure in Patients with Active Psoriatic Arthritis and Moderate to Severe Plaque Psoriasis: Updated Pooled Safety Analyses
Philip J Mease¹, Iain B McInnes², Kristian Reich³, Mats Andersson⁴, Aiyang Tao⁵, Todd Fox⁴ and Chetan Karyekar⁵, ¹Swedish Medical Center and University of Washington, Seattle, WA, ²University of Glasgow, Glasgow, Great Britain, ³Dermatologikum Hamburg and Georg-August-University Göttingen, Hamburg, Germany, ⁴Novartis Pharma AG, Basel, Switzerland, ⁵Novartis Pharmaceuticals Corporation, East Hanover, NJ
Background/Purpose: Pooled safety data from the psoriasis (PsO) and psoriatic arthritis (PsA) clinical trial programs of secukinumab (SEC), through approximately 1 year, have been reported…
Abstract Number: 14L • 2015 ACR/ARHP Annual Meeting
Safety and Efficacy of ABT-494, a Novel Selective JAK1 Inhibitor, in Patients with Active Rheumatoid Arthritis and Inadequate Response or Intolerance to Anti-TNF Biologic Therapy
Joel M. Kremer¹, Edward C. Keystone², Paul Emery³, Heidi S. Camp⁴, Alan Friedman⁴, Li Wang⁴, Ahmed A. Othman⁴, Nasser Khan⁴ and Steven Jungerwirth⁴, ¹Albany Medical College, Albany, NY, ²Mount Sinai Hospital, University of Toronto, Toronto, ON, Canada, ³NIHR-Leeds Musculoskeletal Biomedical Research Unit, University of Leeds, Leeds, United Kingdom, ⁴AbbVie Inc., North Chicago, IL
Background/Purpose: The safety, efficacy, and dose response of ABT-494, a novel selective JAK1 inhibitor, were characterized vs placebo (PBO) in patients (pts) with moderately to…
Abstract Number: 1049 • 2015 ACR/ARHP Annual Meeting
Filgotinib (GLPG0634), an Oral JAK1 Selective Inhibitor Is Effective As Monotherapy in Patients with Active Rheumatoid Arthritis: Results from a Phase 2B Dose Ranging Study
Arthur Kavanaugh¹, Lucia Ponce², Regina Cseuz³, Olga Reshetko⁴, Mykola A Stanislavchuk⁵, Maria Greenwald⁶, Annegret Van der Aa⁷, Frédéric Vanhoutte⁷, Chantal Tasset⁷ and Pille Harrison⁷, ¹University of California San Diego, La Jolla, CA, ²Consulta Privada Dra. Lucia Ponce, Temuco, Chile, ³Revita Reumatologiai Rendelo, Budapest, Indonesia, ⁴Regional Clinical Hospital, Saratov, Russia, ⁵Vinnitsa Regional Clinical Hospital n.a. Pirogov, Vinnitsa, Ukraine, ⁶Desert Medical Advances, Palm Desert, CA, ⁷Galapagos NV, Mechelen, Belgium
Background/Purpose: Filgotinib (GLPG0634) is a novel oral, potent and selective JAK1 inhibitor that has previously demonstrated efficacy in combination with methotrexate (MTX) in treating rheumatoid…
Abstract Number: 1079 • 2015 ACR/ARHP Annual Meeting
The Potential Effect on Recruitment of Restricting Skin Scores Eligibility Criteria in Early Diffuse Scleroderma Trials
Robyn T. Domsic¹, Dinesh Khanna², Mary Lucas³, Virginia D. Steen⁴, Daniel E. Furst⁵, Robert Lafyatis⁶ and Thomas A. Medsger Jr.⁷, ¹Medicine - Rheumatology, University of Pittsburgh, Pittsburgh, PA, ²Division of Rheumatology, University of Michigan, Ann Arbor, MI, ³Medicine, University of Pittsburgh Scleroderma Center, Pittsburgh, PA, ⁴Rheumatology, Georgetown University Medical Center, Washington, DC, ⁵Medicine, University of California, Los Angeles, David Geffen School of Medicine, Los Angeles, CA, ⁶Boston University School of Medicine, Boston, MA, ⁷Department of Medicine/Rheumatology, University of Pittsburgh, Pittsburgh, PA
Background/Purpose: There is increasing interest in cohort enrichment for clinical trials of early diffuse SSc (dcSSc). Recent EUSTAR database analysis (Maurer et al. 2015)…
Abstract Number: 1080 • 2015 ACR/ARHP Annual Meeting
Modified Rodnan Skin Score Thresholds for the Optimization of Cohort Enrichment in Clinical Trials in Skin Fibrosis in Patients with Diffuse Cutaneous Systemic Sclerosis
Rucsandra Dobrota¹, Britta Maurer¹, Nicole Graf², Suzana Jordan³, Carmen Marina Mihai⁴, Otylia Kowal-Bielecka⁵, Yannick Allanore⁶, Oliver Distler¹ and EUSTAR co-authors, ¹Division of Rheumatology, University Hospital Zurich, Zurich, Switzerland, ²graf biostatistics, Winterthur, Switzerland, ³Department of Rheumatology, University Hospital Zurich, Zurich, Switzerland, ⁴Department of Internal Medicine and Rheumatology, Cantacuzino Hospital, Carol Davila University of Medicine and Pharmacy, Bucharest, Romania, ⁵Department of Rheumatology and Internal Medicine, Medical University of Bialystok, Bialystok, Poland, ⁶Department of Rheumatology, University Paris Descartes and Cochin Hospital, Paris, France
Background/Purpose: The modified Rodnan skin score (mRSS) is the major outcome measure for skin fibrosis in clinical trials (CT) in diffuse cutaneous scleroderma (dcSSc). Traditionally,…
Abstract Number: 1647 • 2015 ACR/ARHP Annual Meeting
A Randomized, Clinical Trial to Assess the Relative Efficacy and Tolerability of Two Doses of Etoricoxib in Patients with Rheumatoid Arthritis
Kara Bickham¹, Désirée van der Heijde², Narinder Rawal³, Joachim Sieper⁴, Boyd Scott⁵, Nancy Frontera¹, Sandhya Shah¹, Paul Stryszak¹, Dimitris Papanicolaou¹, Zoran Popmihajlov¹ and Paul Peloso¹, ¹Merck & Co., Inc., Kenilworth, NJ, ²University Hospital, Maastricht, Netherlands, ³Orebro University Hospital, Orebro, Sweden, ⁴Rheumatology, Charite - Campus Benjamin Franklin, Berlin, Germany, ⁵Merck Sharp & Dohme Corp., Whitehouse Station, NJ
Background/Purpose: Etoricoxib, a selective cyclooxygenase-2 (COX-2) inhibitor, provides symptom modification in RA patients. Previous dose-ranging studies in RA demonstrated the clinical efficacy of etoricoxib 90…
Abstract Number: 1782 • 2015 ACR/ARHP Annual Meeting
a Double-Blind, Randomized, Parallel-Group Study of Hydroxychloroquine on Cutaneous Lupus Erythematosus in Japan
Naoto Yokogawa¹, Toshiya Takahashi², Toshiaki Sato³ and Naohisa Yokota⁴, ¹on behalf of Japanese Hydroxychloroquine Study Group, Japan, Japan, ²Sanofi K.K., Tokyo, Japan, ³Sanofi.KK, Tokyo, Japan, ⁴Sanofi KK, Tokyo, Japan
Background/Purpose: In Japan hydroxychloroquine (HCQ) is still unavailable due to the banning of chloroquine in 1974 following allegations that it caused severe retinopathy. Therefore, a…
Abstract Number: 1786 • 2015 ACR/ARHP Annual Meeting
Improvements in Health-Related Quality of Life and Fatigue Following Administration of an IL-6 Monoclonal Antibody (PF-04236921) in an Enriched Population of Subjects with Active SLE
Vibeke Strand¹, Annette Diehl², Jared Christensen², Joseph Wajdula², Sudhakar Sridharan³ and Paul J Healey², ¹Biopharmaceutical Consultant, Portola Valley, CA, ²Pfizer Inc, New York City, NY, ³PPD Inc, Rockville, MA
Background/Purpose: The 10 mg dose of PF-04236921 showed evidence of efficacy in a phase 2 randomized controlled trial (RCT) in SLE.1,2 Here patient-reported outcomes (PROs)…
Abstract Number: 2144 • 2015 ACR/ARHP Annual Meeting
Efficacy and Safety of Different Dose Regimens of a Selective IL-23p19 Inhibitor (BI 655066) Compared with Ustekinumab in Patients with Moderate-to-Severe Plaque Psoriasis with and without Psoriatic Arthritis
Kim Papp¹, Alan Menter², Howard Sofen³, Stephen Tyring⁴, Jean-Philippe Lacour⁵, Beate Berner⁶, Nathan Bennett⁷, Stella Aslanyan⁷, Mary Flack⁷ and Paul Scholl⁷, ¹Probity Clinical Research, Waterloo, ON, Canada, ²Baylor Research Institute, Dallas, TX, ³Dermatology Research Associates, Los Angeles, CA, ⁴Center for Clinical Studies, Houston, TX, ⁵Dermatology Department, Hôpital de L’Archet, Nice, France, ⁶Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach, Germany, ⁷Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, CT
Background/Purpose: IL-23 is essential for the differentiation and maintenance of Th17 cells in psoriasis and psoriatic arthritis (PsA). We assessed the efficacy and safety of…
Abstract Number: 2313 • 2015 ACR/ARHP Annual Meeting
Responder Rates and Numbers Needed to Treat Based on Clinically Meaningful Improvements in Patient Reported Outcomes (PROs) Including Health-Related Quality of Life (HRQoL) after Sarilumab Treatment during a Phase III Randomized Controlled Trial (RCT)
Vibeke Strand¹, Regina Rendas-Baum², George J. Joseph³, Chieh-I Chen⁴, Hubert van Hoogstraten⁵, T. W. J. Huizinga⁶ and Mark C. Genovese⁷, ¹Biopharmaceutical Consultant, Portola Valley, CA, ²QualityMetric Inc, Lincoln, RI, ³Global Health Economics & Outcomes Research (HEOR), Sanofi, Bridgewater, NJ, ⁴Regeneron Pharmaceuticals, Inc., Tarrytown, NY, ⁵Sanofi, Bridgewater, NJ, ⁶Rheumatology, Leiden University Medical Center, Leiden, Netherlands, ⁷Division of Rheumatology, Stanford University Medical Center, Palo Alto, CA
Background/Purpose: Sarilumab is a human monoclonal antibody (mAb) directed against the soluble IL-6 receptor (sIL-6R), administered subcutaneously (SC) every 2 weeks (q2w). In the phase…
Abstract Number: 2363 • 2015 ACR/ARHP Annual Meeting
Efficacy and Safety of Adrenocorticotropic Hormone Gel (Acthar Gel ®) in Refractory Dermatomyositis or Polymyositis
Rohit Aggarwal¹, Galina Marder², Priyadarshini Loganathan³, Diane Koontz⁴, Preeya Nandkumar⁵, Zengbiao Qi⁶ and Chester V. Oddis⁷, ¹Rheumtology, University of Pittsburgh Medical Center, Pittsburgh, PA, ²Medicine, North Shore Long Island Health System, Great Neck, NY, ³University of Pittsburgh Medical Center, Pittsburgh, PA, ⁴University of Pittsburgh, Pittsburgh, PA, ⁵North Shore Long Island Health System, Great Neck, NY, ⁶Division of Rheumatology, University of Pittsburgh, Pittsburgh, PA, ⁷Rheum/Clinical Immunology, University of Pittsburgh, Pittsburgh, PA
Background/Purpose: Adrenocorticotropic hormone (ACTH) gel (repository corticotropin injection) is a long-acting full sequence ACTH that may include other pro-opiomelanocortin peptides thought to have anti-inflammatory and…
Abstract Number: 2727 • 2015 ACR/ARHP Annual Meeting
BI 695501, a Proposed Biosimilar for Adalimumab, Shows Bioequivalence to Adalimumab Reference Products in a Randomized, Double-Blind Phase I Trial in Healthy Subjects
Christopher Wynne¹, Magdalena Petkova², Ferdinand Rombout³, Niklas Czeloth³, Mario Altendorfer³, Benjamin Lang⁴, Francois-Xavier Frapaise³ and Rod Ellis-Pegler⁵, ¹Christchurch Clinical Studies Trust, Christchurch, New Zealand, ²SGS, CPU Antwerpen, Antwerp, Belgium, ³Boehringer Ingelheim, Ingelheim, Germany, ⁴Boehringer Ingelheim, Biberach an der Riss, Germany, ⁵Auckland Clinical Studies Limited, Auckland, New Zealand
Background/Purpose: BI 695501 is a proposed adalimumab biosimilar currently in development and was evaluated for pharmacokinetic (PK) similarity to both US-licensed and EU-approved reference products.…

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