Abstracts tagged "randomized trials"

Abstract Number: 028 • 2020 Pediatric Rheumatology Symposium
A Randomized, Double-blind, Placebo-controlled Study of Anakinra in Pediatric and Adult Patients with Still’s Disease
Laura Schanberg¹, Peter Nigrovic ², Ashley Cooper ³, Winn Chatham ⁴, Shoghik Akoghlanian ⁵, Namrata Singh ⁶, C. Egla Rabinovich ⁷, Akaluck Thatayatikom ⁸, Alysha Taxter ⁹, Jonathan Hausmann ¹⁰, Milan Zdravkovic ¹¹, Sven Ohlman ¹¹, Henrik Andersson ¹¹, Susanna Cederholm ¹², Gunilla Huledal ¹¹, Rayfel Schneider ¹³ and Fabrizio De Benedetti ¹⁴, ¹Duke Children's Hospital & Health Center, Durham, North Carolina, ²Boston Children's Hospital, Boston, Massachusetts, ³Children's Mercy Kansas City, Kansas City, ⁴University of Alabama at Birmingham, Birmingham, ⁵Nationwide Children's Hospital, Columbus, ⁶University of Iowa Hospitals and Clinics, Iowa, Iowa, ⁷Duke University Hospital, Durham, ⁸University of Florida, Gainesville, ⁹Wake Forest Baptist Medical Center, Winston-Salem, ¹⁰Division of Immunology, Boston Children's Hospital; Rheumatology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, ¹¹Sobi, Stockholm, Sweden, ¹²Stockholm, Sweden, ¹³The Hospital for Sick Children, Toronto, Canada, ¹⁴Division of Rheumatology, IRCCS Ospedale Pediatrico Bambino Gesu', Rome, Italy
Background/Purpose: Adult-onset Still’s disease (AOSD) and systemic juvenile idiopathic arthritis (SJIA) are rare systemic disorders of auto-inflammatory nature. There is a growing understanding that SJIA…
Abstract Number: 2412 • 2019 ACR/ARP Annual Meeting
Use of Minimal Important Difference (MID) in Randomized Clinical Trials of Pain in Osteoarthritis
Lavalley Michael¹, Matthew Parkes ², Daniel White ³, Stephan Reichebach ⁴, Timothy McAlindon ⁵ and David Felson ⁶, ¹Boston University, Boston, ²University of Manchester, Manchester, England, United Kingdom, ³University of Delaware, Newark, DE, ⁴University of Bern, Bern, Switzerland, ⁵Tufts Medical Center, Boston, MA, ⁶Boston University School of Medicine, Department of Rheumatology, Boston
Background/Purpose: Minimal important differences (MID), based on within-subject evaluation of attaining an improvement in a continuous outcome such as a pain scale, are important for…
Abstract Number: 2414 • 2019 ACR/ARP Annual Meeting
Efficacy and Safety of Abatacept in Patients with Early Active Primary Sjögren’s Syndrome – Open-label Extension Phase of a Randomized Controlled Phase III Trial
Jolien van Nimwegen¹, Esther Mossel ¹, Robin Wijnsma ¹, Greetje van Zuiden ¹, Konstantina Delli ¹, Alja Stel ¹, Bert van der vegt ¹, Erlin Haacke ¹, Lisette Olie ¹, Leonie Los ¹, Gwenny Verstappen ¹, Sarah Pringle ¹, Fred Spijkervet ¹, Frans Kroese ¹, Arjan Vissink ¹, Suzanne Arends ² and Hendrika Bootsma ³, ¹University Medical Center Groningen, University of Groningen, Groningen, Netherlands, ²Dept. of Rheumatology and Clinical Immunology - University Medical Center Groningen (UMCG), University of Groningen, Groningen, Netherlands, ³University of Groningen, Groningen, Netherlands
Background/Purpose: Abatacept (CTLA-4-Ig) targets the CD80/CD86:CD28 co-stimulatory pathway required for full T-cell activation and T-cell dependent activation of B-cells. The Abatacept Sjögren Active Patients phase…
Abstract Number: 2820 • 2018 ACR/ARHP Annual Meeting
Sustained Clinical Remission after Discontinuation of Infliximab with a Raising Dose Strategy in Patients with Rheumatoid Arthritis (RRRR study): A Randomized Controlled Trial
Yoshiya Tanaka¹, Koji Oba^2,3, Takao Koike^4,5, Nobuyuki Miyasaka⁶, Tsuneyo Mimori⁷, Tsutomu Takeuchi⁸, Shintaro Hirata⁹, Eiichi Tanaka¹⁰, Hidekata Yasuoka¹¹, Yuko Kaneko⁸, Kosaku Murakami⁷, Tomohiro Koga¹², Kazuhisa Nakano¹³, Koichi Amano¹⁴, Kazuyasu Ushio¹⁵, Tatsuya Atsumi¹⁶, Masayuki Inoo¹⁷, Kazuhiro Hatta¹⁸, Shinichi Mizuki¹⁹, Shohei Nagaoka²⁰, Shinichiro Tsunoda²¹, Hiroaki Dobashi²², Nao Horie³ and Norihiro Sato³, ¹University of Occupational and Environmental Health, Kitakyushu, Japan, ²Interfaculty Initiative in Information Studies, The University of Tokyo, Tokyo, Japan, ³Clinical Research and Medical Innovation Center, Hokkaido University Hospital, Sapporo, Japan, ⁴Hokkaido Medical Center for Rheumatic Diseases, Sapporo, Japan, ⁵NTT Sapporo Medical Center, Sapporo, Japan, ⁶Department of Medicine and Rheumatology, Tokyo Medical and Dental University, Tokyo, Japan, ⁷Department of Rheumatology and Clinical Immunology, Graduate School of Medicine, Kyoto University, Kyoto, Japan, ⁸Division of Rheumatology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan, ⁹Department of Clinical Immunology and Rheumatology, Hiroshima University Hospital, Hiroshima, Japan, ¹⁰Institute of Rheumatology, Tokyo Women's Medical University, Tokyo, Japan, ¹¹Division of Rheumatology, Department of Internal Medicine, Keio University School of Medicine, tokyo, Japan, ¹²Center for Bioinformatics and Molecular Medicine, Nagasaki University, Graduate School of Biomedical Sciences, Nagasaki, Japan, ¹³The First Department of Internal Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan, ¹⁴Department of Rheumatology and Clinical Immunology, Saitama Medical Center, Saitama Medical University, Saitama, Japan, ¹⁵Ushio Clinic, Osaka, Japan, ¹⁶Department of Rheumatology, Endocrinology and Nephrology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo, Japan, ¹⁷Utazu hospital, Utatsu-cho, Japan, ¹⁸Department of General Medicine, Tenri Hospital, Tenri, Japan, ¹⁹Center for Rheumatic Diseases, Matsuyama Red Cross Hospital, Matsuyama, Japan, ²⁰Department of Rheumatology, Yokohama Minami Kyosai Hospital, Yokohama, Japan, ²¹Division of Rheumatology Department of Internal Medicine, Hyogo College of Medicine, Nishinomiya, Japan, ²²Division of Endocrinology and Metabolism, Hematology, Rheumatology and Respiratory Medicine, Department of Internal Medicine, Kagawa University, Miki-cho, Japan
Background/Purpose: Infliximab (IFX), a TNF inhibitor, is one of the most widely used biological disease-modifying antirheumatic drugs. Recent studies indicated that baseline levels of serum…
Abstract Number: 1476 • 2017 ACR/ARHP Annual Meeting
Effect of Treat-to-Target Tocilizumab- and Methotrexate-Based Strategies on Health-Related Quality of Life in Newly Diagnosed Rheumatoid Arthritis Patients: Results of the U-Act-Early Trial
Xavier M Teitsma¹, Johannes WG Jacobs¹, Paco MJ Welsing², Attila Pethö-Schramm³, Michelle EA Borm⁴, Jacob M. van Laar⁵, Floris PJ Lafeber⁵ and Johannes W.J. Bijlsma², ¹Department of Rheumatology & Clinical Immunology, University Medical Center Utrecht, Utrecht, Netherlands, ²Rheumatology and Clinical Immunology, University Medical Center Utrecht, Utrecht, Netherlands, ³F. Hoffmann-La Roche, Basel, Switzerland, ⁴Beneluxlaan 2a, Roche Nederland BV, Woerden, Netherlands, ⁵Rheumatology & Clinical Immunology, University Medical Center Utrecht, Utrecht, Netherlands
Background/Purpose: Patient-reported outcomes are, in addition to other efficacy and safety related outcomes, important reflections of effectiveness and adverse effects of a therapy. The Outcomes…
Abstract Number: 2475 • 2017 ACR/ARHP Annual Meeting
Clinical Remission in Subjects with Rheumatoid Arthritis Treated with Subcutaneous Tocilizumab As Monotherapy or in Combination with Methotrexate or Other Synthetic Dmards: A Real-World Clinical Trial
Raimon Sanmartí¹, Emilio Martín-Mola², João E. Fonseca³, Douglas J. Veale⁴, Alejandro Escudero-Contreras⁵ and Carlos M Gonzalez⁶, ¹Rheumatology Service, Hospital Clínic de Barcelona, Barcelona, Spain, ²Hospital La Paz, Madrid, Spain, ³Rheumatology Research Unit, Instituto de Medicina Molecular, Faculdade de Medicina da Universidade de Lisboa, Lisbon, Portugal, Lisbon, Portugal, ⁴Rheumatology, St. Vincent's University Hospital, Dublin 4, Ireland, ⁵Rheumatology service, IMIBIC/Reina Sofia Hospital/University of Cordoba, Cordoba, Spain, ⁶Rheumatology, Hospital General Universitario Gregorio Marañón, Madrid, Spain
Background/Purpose: the primary objective of this study was to assess the 24-week efficacy and safety of subcutaneous (SC) tocilizumab (TCZ) 162 mg weekly (qw) as…
Abstract Number: 15 • 2017 Pediatric Rheumatology Symposium
An Internet-based Self-management Program for Adolescents with Juvenile Idiopathic Arthritis – A Randomized Controlled Trial
Jennifer N. Stinson¹, Sarah Campillo², Tania Cellucci³, Paul Dancey⁴, Ciarán M. Duffy⁵, Janet Ellsworth⁶, Brian Feldman⁷, Adam Huber⁸, Nicole Johnson⁹, Patrick McGrath⁸, Alan Rosenberg¹⁰, Natalie J. Shiff¹¹, Lynn R. Spiegel¹², Shirley M.L. Tse¹³, Lori Tucker¹⁴, J. Charles Victor¹⁵ and Stephanie Luca¹⁶, ¹Anesthesia and Pain Medicine, The Hospital for Sick Children, Toronto, ON, Canada, ²Montreal Children's Hospital, Montreal, QC, Canada, ³Pediatrics/Rheumatology, McMaster Children's Hospital, Hamilton, ON, Canada, ⁴Pediatrics, Janeway Children's Hospital, St. John's, NL, Canada, ⁵Children's Hospital of Eastern Ontario and University of Ottawa, Ottawa, ON, Canada, ⁶University of Alberta, Edmonton, AB, Canada, ⁷Department of Rheumatology, Hospital for Sick Children, Toronto, ON, Canada, ⁸IWK Health Centre, Halifax, NS, Canada, ⁹Pediatrics, University of Calgary, Alberta Children's Hospital, Calgary, AB, Canada, ¹⁰Pediatrics, University of Saskatchewan, Saskatoon, SK, Canada, ¹¹University of Florida, Gainesville, FL, ¹²Rheumatology/Pediatrics, The Hospital for Sick Children, Toronto, ON, Canada, ¹³Rheumatology, The Hospital for Sick Children and University of Toronto, Toronto, ON, Canada, ¹⁴Pediatric Rheum/Rm K4-120, BC Childrens Hospital, Vancouver, BC, Canada, ¹⁵University of Toronto, Toronto, ON, Canada, ¹⁶The Hospital for Sick Children, Toronto, ON, Canada
Background/Purpose: Juvenile Idiopathic Arthritis (JIA) is a common chronic childhood illness associated with physical and emotional symptoms that can negatively impact health-related quality of life…
Abstract Number: 18 • 2016 ACR/ARHP Annual Meeting
The Impact of Disease-Related and Contextual Factors on Work Outcomes in Chronic Inflammatory Arthritis Patients Treated with Biologics: A Systematic Review
Jenny Shu¹, Panos Lambiris² and Claire Bombardier³, ¹Department of Rheumatology, University of Toronto, Toronto, ON, Canada, ²University Health Network, Toronto, ON, Canada, ³Toronto General Hospital Research Institute, Toronto, ON, Canada
Background/Purpose: Biological therapy has been shown to have a positive effect on work outcomes, such as work participation and/or work disability in patients with chronic…
Abstract Number: 764 • 2016 ACR/ARHP Annual Meeting
Atacicept: Integrated Safety Profile from Phase II Randomized Placebo-Controlled Studies in Autoimmune Diseases
Patricia Fraser, Wai Chin and Amy Kao, EMD Serono, Billerica, MA
Background/Purpose: Atacicept, a recombinant fusion protein, targets both BLyS (B lymphocyte stimulator) and APRIL (a proliferation-inducing ligand), B cell activating factors involved in the pathogenesis…
Abstract Number: 867 • 2016 ACR/ARHP Annual Meeting
Termination of Tocilizumab-Treatment in Giant Cell Arteritis: Follow-up of Patients after the RCT (ClinicalTrials.gov registration number: NCT01450137)
Sabine Adler¹, Stephan Reichenbach², Stefan Kuchen³, Felix Wermelinger⁴, Diana Dan⁴, Michael Seitz⁴ and Peter M. Villiger⁴, ¹Rheumatology, Immunology, Allergology, University Hospital Bern, Bern, Switzerland, ²Institute of Social and Preventive Medicine, University of Bern, Bern, Switzerland, ³Rheumatology, Immunology, and Allergology, University of Bern, Bern, MD, Switzerland, ⁴Department of Rheumatology, Immunology and Allergology, University Hospital Bern, Bern, Switzerland
Background/Purpose:
Abstract Number: 9L • 2015 ACR/ARHP Annual Meeting
A Randomized Double-Blind Trial of Abatacept and Glucocorticoids for the Treatment of Giant Cell Arteritis
Carol A. Langford¹, David Cuthbertson², Steven R. Ytterberg³, Nader A. Khalidi⁴, Paul A. Monach⁵, Simon Carette⁶, Philip Seo⁷, Larry W. Moreland⁸, Michael Weisman⁹, Curry L. Koening¹⁰, Antoine G. Sreih¹¹, Robert F. Spiera¹², Carol McAlear¹³, Kenneth J. Warrington¹⁴, Christian Pagnoux⁶, Kathleen Maksimowicz-McKinnon¹⁵, Lindsy J. Forbess¹⁶, Gary S. Hoffman¹, Renee Borchin¹⁷, Jeffrey Krischer¹⁷ and Peter A. Merkel¹⁸, ¹Rheumatology, Cleveland Clinic, Cleveland, OH, ²Biostatistics and Informatics, Department of Pediatrics, University of South Florida, Tampa, FL, ³Rheumatology Division, Mayo Clinic, Rochester, MN, ⁴McMaster University, St Joseph's Healthcare Hamilton, Hamilton, ON, Canada, ⁵Rheumatology, Boston University School of Medicine, Boston, MA, ⁶Division of Rheumatology, Mount Sinai Hospital, University of Toronto, Toronto, ON, Canada, ⁷Division of Rheumatology, Johns Hopkins, Baltimore, MD, ⁸Rheumatology & Clinical Immunology, University of Pittsburgh, Pittsburgh, PA, ⁹Cedars-Sinai Medical Center, Los Angeles, CA, ¹⁰Division of rheumatology, George E. Wahlen Department of Veterans Affairs Medical Center Salt Lake City and University of Utah, University of Utah School of Medicine, Salt Lake City, UT, ¹¹Department of Rheumatology, University of Pennsylvania, Philadelphia, PA, ¹²Rheumatology, Hospital for Special Surgery, New York, NY, ¹³Penn Vasculitis Center, Division of Rheumatology, University of Pennsylvania, Philadelphia, PA, ¹⁴Rheumatology, Mayo Clinic, Rochester, MN, ¹⁵Rheumatology, University of Pittsburgh, Pittsburgh, PA, ¹⁶Rheumatology, Cedars-Sinai Medical Center, Los Angeles, CA, ¹⁷University of South Florida, Tampa, FL, ¹⁸Division of Rheumatology, University of Pennsylvania, Philadelphia, PA
Background/Purpose: Giant cell arteritis (GCA) is a large-vessel primary systemic vasculitis. Although glucocorticoids are effective in treating GCA, they are associated with substantial toxicity and…
Abstract Number: 972 • 2015 ACR/ARHP Annual Meeting
A Phase 2b Study Evaluating the Efficacy and Safety of Subcutaneously Administered Tregalizumab in Subjects with Active Rheumatoid Arthritis (RA) Despite Treatment with Methotrexate (MTX)
Ronald F. van Vollenhoven¹, Edward C. Keystone², Vibeke Strand³, Cesar Pacheco-Tena⁴, Jiri Vencovsky⁵, Frank Behrens⁶, Daniela Zipp⁷, Faiza Rharbaoui⁸, Ralf Wolter⁹, Rolf-Dietrich Tiemann¹⁰, Luise Knierim¹¹, Rainer Schmeidl¹¹, Xuefei Zhou¹², Silke Aigner^8,13, Benjamin Daelken¹⁴ and Andrea Wartenberg-Demand^8,12, ¹Department of Medicine, Unit for Clinical Therapy Research, Inflammatory Diseases (ClinTRID), The Karolinska Institute, Stockholm, Sweden, ²Mount Sinai Hospital, University of Toronto, Toronto, ON, Canada, ³Biopharmaceutical Consultant, Portola Valley, CA, ⁴Universidad Autónoma de Chihuahua, Chihuahua, Mexico, ⁵Institute of Rheumatology, Prague, Czech Republic, ⁶CIRI/Rheumatology & Fraunhofer TMP, Goethe University, Frankfurt, Germany, ⁷Landseinerstr 5, Biotest AG, Dreieich, Germany, ⁸Biotest AG, Dreieich, Germany, ⁹Corporate Clinical Research, L, Biotest AG, Dreieich, Germany, ¹⁰Data Management and Outsourcing, Biotest AG, Dreieich, Germany, ¹¹Cooperate Drug Safety, Biotest AG, Dreieich, Germany, ¹²Cooperate Clinical Research, Biotest AG, Dreieich, Germany, ¹³Landsteinerstrasse 5, Biotest AG, Dreieich, Germany, ¹⁴Project Managerment Office, Biotest Pharmaceuticals Corporation, Boca Raton, FL
Background/Purpose: In autoimmune diseases reduced numbers and functional impairment of regulatory T cells (Tregs) have been observed (1). Tregalizumab (BT-061) is a humanized, anti-CD4 mAb,…
Abstract Number: 1672 • 2015 ACR/ARHP Annual Meeting
One-Year Safety of Sirukumab Monotherapy: Results from a Randomized, Double-Blind, Parallel-Group, Multicenter Study in Japanese Subjects with Moderate to Severe Rheumatoid Arthritis
Tsutomu Takeuchi¹, Hisashi Yamanaka², Masayoshi Harigai³, Ryo Tamamura⁴, Yuchi Kato⁴, Yoshifumi Ukyo⁴, Toshikazu Nakano⁴, Takayuki Ota⁴, Benjamin Hsu⁵ and Yoshiya Tanaka⁶, ¹Keio University School of Medicine, Tokyo, Japan, ²Dept. of Rheumatology, Tokyo Women's Medical University, Tokyo, Japan, ³Dept of Pharmacovigilance, Tokyo Medical and Dental University, Tokyo, Japan, ⁴Janssen Pharmaceutical K.K., Tokyo, Japan, ⁵Janssen Research & Development, LLC, Spring House, PA, ⁶The First Dept. of Internal Medicine, University of Occupational & Environmental Health, Kitakyusyu, Japan
Background/Purpose: Interleukin-6 (IL-6) is a pleiotropic cytokine known for its proinflammatory functions. In rheumatoid arthritis (RA), increased concentrations of IL-6 may stimulate leukocyte recruitment to…
Abstract Number: 2541 • 2015 ACR/ARHP Annual Meeting
Improving Adherence with Treat to Target in Rheumatoid Arthritis through a Learning Collaborative: Rationale and Design of the Traction Trial
Daniel H. Solomon¹, Sara Lee², Agnes Zak², Jen Agosti³, Asaf Bitton⁴, Liana Fraenkel⁵, Leslie Harrold⁶, Elena Losina⁷, Bing Lu⁸, Theodore Pincus⁹, Josef S. Smolen¹⁰ and Jeffrey N. Katz¹¹, ¹Rheumatology, Brigham and Women's Hospital, Boston, MA, ²Brigham and Women's Hospital, Boston, MA, ³JRA Consulting, Andover, MA, ⁴Medicine, Brigham and Women's Hospital, Boston, MA, ⁵Medicine, Yale University School of Medicine, New Haven, CT, ⁶Dept of Medicine, UMass Medical School, Worcester, MA, ⁷Orthopedics, Brigham and Women's Hospital, BU School of Public Health and Harvard Medical School, Boston, MA, ⁸Rheumatology Immunology & Allergy, Brigham & Women's Hospital, Boston, MA, ⁹Medicine-Rheumatology, NYU Hospital for Joint Diseases, New York, NY, ¹⁰Medical University of Vienna, Vienna, Austria, ¹¹Brigham and Women's Hospital and Harvard Medical School, Boston, MA
Background/Purpose: Treat to target (TTT) is a recommended paradigm in the management of rheumatoid arthritis (RA). However, various data sources suggest that TTT is…
Abstract Number: 2854 • 2015 ACR/ARHP Annual Meeting
Long-Term Tolerability and Efficacy of Golimumab in Active Nonradiographic Axial Spondyloarthritis: Results from the Open-Label Extension of a Randomized, Double-Blind Study
Désirée van der Heijde¹, Maxime Dougados², Walter Maksymowych³, Gina Bergman⁴, Sean P. Curtis⁴, Anjela Tzontcheva⁴, George Philip⁴, Susan Huyck⁴ and Joachim Sieper⁵, ¹Leiden University Medical Center, Leiden, Netherlands, ²Paris-Descartes University, Paris, France, ³University of Alberta, Edmonton, AB, Canada, ⁴Merck & Co., Inc., Kenilworth, NJ, ⁵University Clinic Benjamin Franklin, Berlin, Germany
Background/Purpose: The tolerability and efficacy of golimumab (GLM) as a treatment for nonradiographic axial spondyloarthritis (nr-axSpA) were recently investigated in a randomized, double-blind (DB), placebo…

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