Abstracts tagged "clinical trials"

Abstract Number: 1048 • 2015 ACR/ARHP Annual Meeting
Filgotinib (GLPG0634), an Oral JAK1 Selective Inhibitor Is Effective in Combination with Methotrexate in Patients with Active Rheumatoid Arthritis: Results from a Phase 2B Dose Ranging Study
R Westhovens¹, Rieke Alten², Dace Pavlova³, Favio Enríquez-Sosa⁴, Minodora Mazur⁵, Maria Greenwald⁶, Annegret Van der Aa⁷, Frédéric Vanhoutte⁷, Chantal Tasset⁷ and Pille Harrison⁷, ¹Skeletal Biology and Engineering Research Center, Department of Development and Regeneration, KU Leuven, Leuven, Belgium, KU Leuven, Leuven, Belgium, ²Internal Medicine, Rheumatology & Clinical Immunology, Schlosspark-Klinik, University Medicine Berlin, Berlin, Germany, ³LTD M & M Centrs, Carnikava, Latvia, ⁴CLINSTILE, S.A. DE C.V, Mexico, Mexico, ⁵IMSP Institul de Cardiologie, Chisinau, Moldova, 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: 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: 1522 • 2014 ACR/ARHP Annual Meeting
Impact of Sarilumab on Health Related Quality of Life (HRQoL), Fatigue, and Sleep in Rheumatoid Arthritis Patients at Week 24 – Results of a Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study
Vibeke Strand¹, George Joseph², Hubert van Hoogstraten², Chieh-I Chen³, Chungpeng Fan², Paulo Carita⁴, Neil Graham³, Tanya Momtahen² and Mark C Genovese⁵, ¹Biopharmaceutical Consultant, Portola Valley, CA, ²Sanofi, Bridgewater, NJ, ³Regeneron Pharmaceuticals, Inc., Tarrytown, NY, ⁴Sanofi, Chilly-Mazarin, France, ⁵Division of Immunology and Rheumatology, Stanford University Medical Center, Palo Alto, CA
Background/Purpose: Sarilumab, a fully human monoclonal antibody directed against the IL-6 receptor, demonstrated efficacy in the phase 3 part of the RA-MOBILITY study (NCT01061736) in…
Abstract Number: 1487 • 2014 ACR/ARHP Annual Meeting
A Phase 1 Dose-Ranging Repeated-Dose Trial of Parenteral Staphylococcal Protein A (PRTX-100) in Patients with Active Rheumatoid Arthritis on Methotrexate or Leflunamide Therapy
Craig Wiesenhutter^1,2, Rakesh Patel³, John Lavery⁴, Nighat Tahir^5,6, Lydie Hazan⁷, Alan Kivitz⁸, Elizabeth Bretton⁹ and Jeffrey Kaine¹⁰, ¹University of Washington School of Medicine, Seattle, WA, ²Coeur d’Alene Arthritis Clinic, Coeur d’Alene, ID, ³PMG Research of Salisbury, Salisbury, NC, ⁴Allen Arthritis and Allergy, Allen, TX, ⁵Community Hospital of Anderson and Madison County, Inc., Anderson, IN, ⁶Community Rheumatology of Anderson, Anderson, IN, ⁷Axis Clinical Trials, Los Angeles, CA, ⁸Altoona Center for Clinical Research, Duncansville, PA, ⁹Albuquerque Clinical Trials, Albuquerque, NM, ¹⁰Sarasota Arthritis Center, Sarasota, FL
Background/Purpose Staphylococcal protein A (SpA) binds with high affinity to the Fc region of human immunoglobulin G and also to the Fab framework region of…
Abstract Number: 977 • 2014 ACR/ARHP Annual Meeting
Randomized Clinical Trial of a Patient and Provider Intervention for Managing Osteoarthritis in Veterans
Kelli D. Allen^1,2, Hayden B. Bosworth^3,4, Amy Jeffreys¹, Cynthia Coffman^3,5, Santanu Datta^4,6, Jennifer McDuffie^1,7, Eugene Oddone^3,4, Jennifer Strauss^1,8 and William S. Yancy Jr.^1,4, ¹Health Services Research, Durham VA Medical Center, Durham, NC, ²Thurston Arthritis Research Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, ³Health Services Research, Durham VA Medical Center and Duke University Medical Center, Durham, NC, ⁴Department of Medicine, Division of General Internal Medicine, Duke University Medical Center, Durham, NC, ⁵Department of Biostatistics and Bioinformatics, Duke University Medical Center, Durham, NC, ⁶Health Services Reserach, Durham VA Medical Center and Duke University Medical Center, Durham, NC, ⁷Medicine, Duke University Medical Center, Durham, NC, ⁸Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC
Background/Purpose: Adequate management of osteoarthritis (OA) requires both medical and behavioral strategies. However, some recommended therapies are under-utilized in clinical settings, and there is low…
Abstract Number: 950 • 2014 ACR/ARHP Annual Meeting
Multiple Mechanisms of Tolerance Characterize the Immune Response to Autologous Modified Dendritic Cells Exposed to Citrullinated Peptides in Patients with Rheumatoid Arthritis
Soi-Cheng Law¹, Hendrik Nel², Ahmed Mehdi², Kim-Anh Le Cao² and Ranjeny Thomas³, ¹Diamantina Institute, Univ of Queensland, Brisbane, Australia, ²Diamantina Institute, University of Queensland, Brisbane, Australia, ³Diamantina Institute, Univ of Queensland, Brisbane, QLD, Australia
Background/Purpose We carried out a phase I clinical trial of tolerising autologous peripheral blood DCs exposed to 4 citrullinated self-peptides (“Rheumavax”) in 29 HLA-DR shared…
Abstract Number: 2503 • 2014 ACR/ARHP Annual Meeting
Early Response to Full-Dose Etanercept-Plus-Methotrexate Induction Therapy Predicts Sustained Remission with Reduced-Dose Combination Therapy in Early Rheumatoid Arthritis Patients
Paul Emery¹, Ronald Pedersen², Jack Bukowski³ and Lisa Marshall⁴, ¹NIHR-Leeds Musculoskeletal Biomedical Research Unit and Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds., United Kingdom, Leeds, United Kingdom, ²Specialty Care, Pfizer Inc, Collegeville, PA, ³Department of Specialty Care, Pfizer Inc, Collegeville, PA, ⁴Inflammation Immunology Disease Group, Pfizer Inc., Collegeville, PA
Background/Purpose: In early rheumatoid arthritis (RA), achievement of clinical remission and low disease activity (LDA) limits joint damage and disability.1 Anti-TNF agents are effective in…
Abstract Number: 891 • 2014 ACR/ARHP Annual Meeting
Randomized Clinical Trial of Group Vs. Individual Physical Therapy for Knee Osteoarthritis
Kelli D. Allen¹, Dennis Bongiorni², Hayden B. Bosworth³, Cynthia Coffman³, Santanu Datta⁴, David Edelman³, Jennifer H. Lindquist⁵, Eugene Oddone³ and Helen Hoenig⁶, ¹Health Services Research, Durham VA Medical Center and University of North Carolina at Chapel Hill, Durham, NC, ²Durham VA Medical Center, Durham, NC, ³Health Services Research, Durham VA Medical Center and Duke University Medical Center, Durham, NC, ⁴Health Services Reserach, Durham VA Medical Center and Duke University Medical Center, Durham, NC, ⁵Health Services Research, Durham VA Medical Center, Durham, NC, ⁶Durham VA Medical Center and Duke University Medical Center, Durham, NC
Background/Purpose: Physical therapy (PT) is a key component of treatment for knee osteoarthritis (OA). There is a high demand for PT services in many healthcare…
Abstract Number: 2420 • 2014 ACR/ARHP Annual Meeting
Quality Assessment of Controlled Trials Evaluating Chinese Herbal Medicine in Patients with Rheumatoid Arthritis: a Systematic Review
Xin Pan^1,2, Maria A. Lopez-Olivo², Pratibha Nayak³ and Maria E. Suarez-Almazor⁴, ¹Department of Rheumatology, Shuguang Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, China, ²Department of General Internal Medicine, The University of Texas, MD Anderson Cancer Center, Houston, TX, ³General Internal Medicine, The University of Texas, MD Anderson Cancer Center, Houston, TX, ⁴The Department of General Internal Medicine, The University of Texas, MD Anderson Cancer Center, Houston, TX
Background/Purpose: Chinese herbal medicine (CHM) is a mainstay in the treatment of rheumatoid arthritis (RA) in China. We conducted a systematic review to appraise the…
Abstract Number: 875 • 2014 ACR/ARHP Annual Meeting
Treatment-Related Outcomes in Connective Tissue Disease-Associated Pulmonary Arterial Hypertension: A Pooled Analysis of 12 Randomized Controlled Trials
Rennie L. Rhee¹, Nicole B. Gabler², Amy Praestgaard², Peter A. Merkel³ and Steven M. Kawut⁴, ¹Rheumatology, University of Pennsylvania, Philadelphia, PA, ²Department of Biostatistics and Epidemiology, University of Pennsylvania, Philadelphia, PA, ³University of Pennsylvania, Philadelphia, PA, ⁴Pulmonary and Critical Care, University of Pennsylvania, Philadelphia, PA
Background/Purpose: Recent studies have shown that therapies for pulmonary arterial hypertension (PAH) improve exercise capacity, but subgroup analyses suggest that these therapies may be less…
Abstract Number: 2254 • 2014 ACR/ARHP Annual Meeting
Changes in Subject Characteristics in the Denosumab Pivotal Fracture Trial and Its Extension for up to 8 Years
JD Adachi¹, CJF Lin², PR Ho², MA Bolognese³, HG Bone⁴, P Hadji⁵, S Papapoulos⁶, C Recknor⁷, NS Daizadeh², P Dakin², RB Wagman² and S Ferrari⁸, ¹McMaster University, Hamilton, ON, Canada, ²Amgen Inc., Thousand Oaks, CA, ³Bethesda Health Research Center, Bethesda, MD, ⁴Michigan Bone and Mineral Clinic, Detroit, MI, ⁵Philipps-University of Marburg, Marburg, Germany, ⁶Leiden University Medical Center, Leiden, Netherlands, ⁷United Osteoporosis Centers, Gainesville, GA, ⁸Geneva University Hospital, Geneva, Switzerland
Background/Purpose: Changes in demographics of study population enrolled in long-term osteoporosis clinical trials may affect interpretation of efficacy/safety outcomes. Denosumab is being evaluated for up…
Abstract Number: 581 • 2014 ACR/ARHP Annual Meeting
Evaluation of the Nonsteroidal Anti-Inflammatory Drug-Sparing Effect of Etanercept in Axial Spondyloarthritis: Results of a Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial
Maxime Dougados¹, Emily Wood², Bernard Combe³, Corinne Miceli-Richard⁴, Francis Berenbaum⁵, Nandan Koppiker⁶, Arnaud Dubanchet⁷ and Isabelle Logeart⁷, ¹Université Paris René Descartes and Hôpital Cochin, Paris, France, ²Biostatistics, Quanticate, Hitchin, England, ³Immuno-Rhumatologie, Hôpital Lapeyronie, Montpellier, France, ⁴Rheumatology Department, Université Paris-Sud 11, Bicêtre Hospital,, Kremlin Bicêtre, France, ⁵Service de Rhumatologie, Saint-Antoine Hospital, Paris, France, ⁶Pfizer PGRD, Sandwich, United Kingdom, ⁷Pfizer, Paris, France
Background/Purpose Nonsteroidal anti-inflammatory drugs (NSAIDs) are first-line pharmacotherapy in axial spondyloarthritis (axSpA) but are recommended for use at the lowest effective dose for the shortest…

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