Abstracts tagged "Outcome measures"

Abstract Number: 438 • 2015 ACR/ARHP Annual Meeting
Comparison of the Stanford and Indian Health Assessment Questionnaires for Disability Outcomes in a Phase 3, Randomized, Double-Blind, Active Comparator Study of Infliximab and Biosimilar Infliximab BOW15 in Rheumatoid Arthritis
Arvind Chopra¹, Manjit Saluja², Alastair Knight³, Lucy Shneyer⁴, Cheryl Lassen⁵, Michael Wyand⁶ and Jonathan Kay⁷, ¹Rheumatology, Centre for Rheumatic Diseases, Pune 411001, India, ²Centre for Rheumatic Diseases, Pune 411001, India, ³Data Management, Evicom Ltd, Twickenham, United Kingdom, ⁴Shneyer Statistics, Denville, NJ, ⁵Epirus Biopharmaceuticals, Zug, Switzerland, ⁶Epirus Biopharmaceuticals, Boston, MA, ⁷University of Massachussets Medical School, Worcester, MA
Background/Purpose: The Stanford Health Assessment Questionnaire (HAQ) includes several questions that are more relevant to rheumatoid arthritis (RA) patients in Western countries than to those…
Abstract Number: 2646 • 2015 ACR/ARHP Annual Meeting
Different Wording of the Patient Global Assessment Scale Leads to Different Rating of Disease Activity
Helga Radner¹, Paul Studenic², Stanley B. Cohen³, N Shadick⁴, C Iannaccone⁵, Elisabeth Lie⁶, Maria Dahl Mjaavatten⁶, Meredith Leigh Cohen³, Josef S. Smolen⁷ and Daniel Aletaha⁸, ¹Department of Internal Medicine III; Division of Rheumatology, Medical University of Vienna, Vienna, Austria, ²Department of Internal Medicine 3, Division of Rheumatology, Medical University Vienna, Vienna, Austria, ³Metroplex Clinical Research Center, Dallas, TX, ⁴Division of Rheumatology, Immunology & Allergy, Brigham and Women's Hosp, Boston, MA, ⁵Division of Rheumatology, Immunology and Allergy, Brigham and Women’s Hospital, Boston, MA, ⁶Dept. of Rheumatology, Diakonhjemmet Hospital, Oslo, Norway, ⁷Dept of Medicine 3, Division of Rheumatology, Medical Univ Vienna, Vienna, Austria, ⁸Rheumatology, Medical University Vienna, Vienna, Austria
Background/Purpose: The patient global assessment of disease activity (PtGA) is a key variable in assessing RA disease activity and remission (REM). Typically assessed on a…
Abstract Number: 649 • 2015 ACR/ARHP Annual Meeting
Measures of Health-Related Quality of Life in Psoriatic Arthritis: Are They Sensitive to Both Joint and Skin Aspects?
Mwidimi Ndosi¹, Ming-Anne Hsu², J. Cappelleri³, Amit Chhabra⁴, Heather Jones⁵ and Philip S. Helliwell⁶, ¹School of Healthcare, University of Leeds, Leeds, United Kingdom, ²445 Eastern Point Road, Pfizer Inc, Groton, CT, ³Statistics, Pfizer Inc, New London, CT, ⁴Pfizer Inc, Collegeville, PA, ⁵Inflammation Global Medical Affairs, Pfizer, Collegeville, PA, ⁶Section of Musculoskeletal Disease, University of Leeds, Leeds, United Kingdom

Background/Purpose: Psoriatic Arthritis Quality of Life (PsAQol), Ankylosing Spondylitis Quality of Life (ASQoL), and Dermatology Life Quality Index (DLQI) are tools that assess different aspects of health-related…
Abstract Number: 2666 • 2015 ACR/ARHP Annual Meeting
Trajectories of EQ-5D in RA Patients Treated with Biologics Using the IORRA Cohort
Daisuke Hoshi, Eiichi Tanaka, Eisuke Inoue, Yoko Shimizu, Naoki Sugimoto, Kumi Shidara, Ayako Nakajima, Shigeki Momohara, Atsuo Taniguchi and Hisashi Yamanaka, Institute of Rheumatology, Tokyo Women’s Medical University, Tokyo, Japan
Background/Purpose: Patient-reported outcomes are recognized as important for evaluating the disease status of rheumatoid arthritis (RA). The EuroQol 5-dimensional descriptive system (EQ-5D) has been used…
Abstract Number: 701 • 2015 ACR/ARHP Annual Meeting
Is Skin Disease More Important to Women or Men in the Assessment of Disease Activity in Psoriatic Arthritis?
Maqbool Sheriff¹, Michel Zummer², J Antonio Avina-Zubieta³, Proton Rahman⁴, Wojciech Olszynski⁵, Michael Starr⁶, Philip Baer⁷, Emmanouil Rampakakis⁸, Eliofotisti Psaradellis⁹, Cathy Tkaczyk¹⁰, Brendan Osborne¹⁰, Karina Maslova¹¹, Francois Nantel¹² and Allen J Lehman¹¹, ¹Nanaimo Regional General Hospital, Nanaimo, BC, Canada, ²Rheumatology, Hôpital Maisonneuve-Rosemont and University of Montreal, Montreal, QC, Canada, ³Medicine, University of British Columbia, Department of Medicine, Division of Rheumatology, Vancouver, BC, Canada, ⁴Rheumatology, St. Clare's Mercy Hospital, St. John's, NF, Canada, ⁵University of Saskatchewan, Saskatoon, SK, Canada, ⁶Rheumatology, McGill University, Montreal, QC, Canada, ⁷Section on Rheumatology, Ontario Medical Association/Journal of the Canadian Rheumatology Association, Toronto, ON, Canada, ⁸JSS Medical Research, St-Laurent, QC, Canada, ⁹JSS Medical Research, Montreal, QC, Canada, ¹⁰Medical Affairs, Janssen Inc., Toronto, ON, Canada, ¹¹Janssen Inc., Toronto, ON, Canada, ¹²19 Green belt Dr, Janssen Inc., Toronto, ON, Canada
Background/Purpose: Patient global assessment of disease activity (PtGA) is a standard outcome measure used both in randomized controlled trials and in clinical practice to ascertain…
Abstract Number: 2669 • 2015 ACR/ARHP Annual Meeting
Persistency of Patient Reported Morning (AM) Stiffness in a Large US Registry Cohort of Rheumatoid Arthritis (RA) Patients Initiating New DMARD Therapy
Vibeke Strand¹, Robert J. Holt², Heather J. Litman³, Jeffrey D. Kent⁴, Hristina Pashova⁵, John T. Nguyen³ and Carol J. Etzel^6,7, ¹Division of Immunology/Rheumatology, Stanford University School of Medicine, Portola Valley, CA, ²University of Illinois - Chicago, Chicago, IL, ³Corrona, LLC., Southborough, MA, ⁴Horizon Pharma USA, Inc., Deerfield, IL, ⁵Axio Research, LLC., Seattle, WA, ⁶The University of Texas MD Anderson Cancer Center, Houston, TX, ⁷Corrona, LLC, Southborough, MA
Background/Purpose: AM stiffness is a common yet under-appreciated symptom in RA. The longitudinal impact of AM stiffness has not been previously investigated. This study evaluated…
Abstract Number: 702 • 2015 ACR/ARHP Annual Meeting
Is Skin Disease More Important to Patients or Physicians in the Assessment of Disease Activity in Psoriatic Arthritis?
Dalton Sholter¹, Proton Rahman², J Antonio Avina-Zubieta³, John Kelsall⁴, Regan Arendse⁵, Majed M. Khraishi⁶, S Shaikh⁷, William G. Bensen⁸, Emmanouil Rampakakis⁹, John S. Sampalis¹⁰, Francois Nantel¹¹, May Shawi¹², Susan Otawa¹³, Cathy Tkaczyk¹³ and Allen J Lehman¹², ¹Rheumatology Associates, Edmonton, AB, Canada, ²Rheumatology, St. Clare's Mercy Hospital, St. John's, NF, Canada, ³Medicine, University of British Columbia, Department of Medicine, Division of Rheumatology, Vancouver, BC, Canada, ⁴Mary Pack Arthritis Centre, Vancouver, Vancouver, BC, Canada, ⁵University of Saskatchewan, Saskatoon, SK, Canada, ⁶Nexus Clinical Research, St Johns, NF, Canada, ⁷Niagara Peninsula Arthritis Centre, Hamilton, ON, Canada, ⁸St Joseph's Healthcare Hamilton, Hamilton, ON, Canada, ⁹JSS Medical Research, St-Laurent, QC, Canada, ¹⁰McGill University, Montreal, QC, Canada, ¹¹19 Green belt Dr, Janssen Inc., Toronto, ON, Canada, ¹²Janssen Inc., Toronto, ON, Canada, ¹³Medical Affairs, Janssen Inc., Toronto, ON, Canada
Background/Purpose: Patient (PtGA) and physician (MDGA) global assessment of disease activity are standard outcome measures used in clinical practice and research to ascertain patient and…
Abstract Number: 2691 • 2015 ACR/ARHP Annual Meeting
Musculoskeletal Ultrasound in Multi-Center Rheumatoid Arthritis Clinical Trials: Methodology for Optimizing Reliability of Acquisition and Real-Time Scoring
Veena K. Ranganath¹, Yossra Suliman^1,2, Jenny Brook³, David Elashoff³, Ami Ben-Artzi⁴, Cesar Olmos¹, Nabeel Borazan³, Thasia Woodworth¹ and Gurjit S. Kaeley⁵, ¹Medicine, Division of Rheumatology, David Geffen School of Medicine, Los Angeles, CA, ²Rheumatology and Rehabilitation department, Assiut university, Faculty of Medicine,, Assiut, Egypt, ³Medicine, David Geffen School of Medicine, Los Angeles, CA, ⁴David Geffen School of Medicine, Los Angeles, CA, ⁵University of Florida, Jacksonville, FL
Background/Purpose: Rheumatoid arthritis (RA) musculoskeletal ultrasound (MSUS) literature reports good reliability of scoring still images with training, but inconsistent reliability of scoring during acquisition, likely…
Abstract Number: 851 • 2015 ACR/ARHP Annual Meeting
Does the Clinical Context Improve the Reliability of Rheumatologists Grading Digital Ulcers in Systemic Sclerosis?
Michael Hughes¹, Chris Roberts², Andrew Tracey¹, Graham Dinsdale¹, Andrea Murray¹ and Ariane L. Herrick¹, ¹Centre for Musculoskeletal Research, University of Manchester, Manchester Academic Health Science Centre, Manchester, United Kingdom, ²Centre for Biostatistics, Institute of Population Health, University of Manchester, Manchester, United Kingdom
Background/Purpose: Digital ulcers (DUs) are often a primary end point in SSc clinical trials, although the reliability of rheumatologists grading DUs is poor to moderate…
Abstract Number: 2961 • 2015 ACR/ARHP Annual Meeting
Reliability and Validity of the Total Joint Count and Swollen Joint Count in Early Diffuse Systemic Sclerosis
Jessica K. Gordon¹, Veronica J. Berrocal², Gandikota Girish³, Meng Zhang⁴, Chris Hatzis¹, Shervin Assassi⁵, Elana J. Bernstein⁶, Robyn T. Domsic⁷, Faye N. Hant⁸, Monique E. Hinchcliff⁹, Elena Schiopu¹⁰, Virginia D. Steen¹¹, Tracy M. Frech¹² and Dinesh Khanna¹³, ¹Rheumatology, Hospital for Special Surgery, New York, NY, ²Div of Rheumatology, University of Michigan, Ann Arbor, MI, ³Radiology, University of Michigan, Ann Arbor, MI, ⁴Epidemiology and Biostatistics, Hospital for Special Surgery, New York, NY, ⁵Rheumatology, University of Texas Medical School at Houston, Houston, TX, ⁶Rheumatology, Columbia University College of Physicians & Surgeons, New York, NY, ⁷Medicine - Rheumatology, University of Pittsburgh, Pittsburgh, PA, ⁸Dept of Medicine, Medical University of South Carolina, Charleston, SC, ⁹Division of Rheumatology, Division of Rheumatology, Northwestern University, Feinberg School of Medicine, Chicago, IL, ¹⁰University of Michigan, Ann Arbor, MI, ¹¹Rheumatology, Georgetown University Medical Center, Washington, DC, ¹²Div of Rheumatology, University of Utah, Salt Lake City, UT, ¹³Division of Rheumatology, University of Michigan, Ann Arbor, MI
Background/Purpose: Arthropathy and tendinopathy in Systemic Sclerosis (SSc) contribute to disability and are associated with disease progression. Clinical trials in SSc sometimes include the tender…
Abstract Number: 1227 • 2015 ACR/ARHP Annual Meeting
Discrepancies Between Registered and Published Primary Outcomes in Randomized Controlled Trials of Rheumatoid Arthritis
Sheila Lezcano¹, Saha Sajib², Ashley Fan³, Mohini Pathria³, Karina Marianne D. Torralba⁴ and Nasim A. Khan⁵, ¹Internal Medicine, Loma Linda University, Loma Linda, CA, ²Internal Medicine, University of California-Riverside, Riverside, CA, ³Loma Linda University, Loma Linda, CA, ⁴Division of Rheumatology, Department of Internal Medicine, Loma Linda University, Loma Linda, CA, ⁵Rheumatology, University of Arkansas for Medical Sciences and Central Arkansas Veterans Healthcare System, Little Rock, AR
Background/Purpose: Selective outcome reporting may bias treatment effect estimates of clinical trials. Registration of clinical trials was established to improve transparency in their conduct and…
Abstract Number: 3208 • 2015 ACR/ARHP Annual Meeting
Spinal Radiographic Progression in Early Axial Spondyloarthritis: Data from the DESIR Cohort
Sofia Ramiro¹, Désirée van der Heijde¹, Rosaline van den Berg², Victoria Navarro-Compán³, Antoine Feydy⁴, Maria-Antonietta d'Agostino⁵, Damien Loeuille⁶, Maxime Dougados⁷, Monique Reijnierse⁸ and Pascal Claudepierre⁹, ¹Rheumatology, Leiden University Medical Center, Leiden, Netherlands, ²Leiden University Medical Center, Leiden, Netherlands, ³Rheumatology, University Hospital La Paz, Madrid, Spain, ⁴Paris Descartes University, Radiology B department, Cochin Hospital, Paris, France, ⁵Rheumatology, Versailles-Saint Quentin en Yvelines University, Boulogne-Billancourt, France, ⁶Rheumatology, Nancy University Hospital, Nancy, France, ⁷Rheumatology Department, Cochin hospital, Paris-Descartes University, Paris, France, ⁸Radiology, Leiden University Medical Center, Leiden, Netherlands, ⁹Rheumatology, Université Paris Est Créteil, Créteil, France
Background/Purpose: The development of radiographic damage over time has been investigated in patients with AS, but not yet in early axial spondyloarthritis (axSpA). We have…
Abstract Number: 1284 • 2014 ACR/ARHP Annual Meeting
Sensitivity to Change of Patient Preference Outcome Measures for Pain in Trials of Patients with Knee Osteoarthritis
Matthew J. Parkes¹, Michael J. Callaghan¹, Terence W. O'Neill¹ and David T. Felson^1,2, ¹Arthritis Research UK Centre for Epidemiology, Institute of Inflammation and Repair, University of Manchester, Manchester, United Kingdom, ²Clinical Epidemiology Unit, Boston University School of Medicine, Boston, MA
Background/Purpose A variety of pain and function instruments are often measured in osteoarthritis (OA) clinical trials. Instruments with maximal sensitivity to change are preferred as the…
Abstract Number: 821 • 2014 ACR/ARHP Annual Meeting
Pregnancy Outcome in Women Treated with Adalimumab for the Treatment of Rheumatoid Arthritis: An Update
Christina D Chambers^1,2, Diana L Johnson¹, Yunjun Luo¹, Ronghui Xu^2,3 and Kenneth L Jones¹, ¹University of California San Diego Department of Pediatrics, La Jolla, CA, ²University of California San Diego Department of Family and Preventive Medicine, La Jolla, CA, ³University of California San Diego Department of Mathematics, La Jolla, CA
Background/Purpose Adalimumab is a fully human monoclonal antibody to tumor necrosis factor alpha and is approved for several indications including rheumatoid arthritis (RA). Methods The…
Abstract Number: 572 • 2014 ACR/ARHP Annual Meeting
Objective Evaluation of Physical Functioning after TNFi Therapy in Ankylosing Spondylitis Patients; A Selection of Three Feasible Performance-Based Tests
Salima F.E. van Weely¹, Joost Dekker^1,2, Martijn P.M. Steultjens³, Christiaan J. Van Denderen¹, Mike T. Nurmohamed¹, Ben A.C. Dijkmans⁴ and Irene E. van der Horst-Bruinsma⁴, ¹Reade, centre for Rehabilitation and Rheumatology, Amsterdam, Netherlands, ²Rehabilitation Medicine, Psychiatry and EMGO Institute for Health and Care Research, VU University Medical Center, Amsterdam, Netherlands, ³Institute for Applied Health Research and School of Health and Life Sciences, Glasgow Caledonian University, Glasgow, Scotland, ⁴Rheumatology, VU University Medical Centre, Amsterdam, Netherlands
Background/Purpose: Physical functioning is considered an important outcome domain for the evaluation of the effectiveness of therapy and the course of the disease. In an effort…

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