Abstracts tagged "randomized trials"

Abstract Number: 3134 • 2015 ACR/ARHP Annual Meeting
Safety and Tolerability of Pirfenidone in Patients with Systemic Sclerosis Interstitial Lung Disease
Dinesh Khanna¹, Carlo Albera², Aryeh Fischer³, James R. Seibold⁴, Nader A. Khalidi⁵, Ganesh Raghu⁶, Lorinda Chung⁷, Elena Schiopu¹, Dan Chen⁸ and Eduard Gorina⁹, ¹University of Michigan, Ann Arbor, MI, ²University of Turin, Turin, Italy, ³National Jewish Health and University of Colorado, Denver, CO, ⁴Scleroderma Research Consultants LLC, Litchfield, CT, ⁵McMaster University, Hamilton, ON, Canada, ⁶University of Washington, Seattle, WA, ⁷Division of Immunology and Rheumatology, Stanford University School of Medicine, Stanford, CA, ⁸Jazz Pharmaceuticals (formerly of InterMune), Palo Alto, CA, ⁹Formerly of InterMune, Brisbane, CA
Background/Purpose: Interstitial lung disease (ILD) is a common and serious complication of systemic sclerosis (SSc). Pirfenidone, a novel antifibrotic agent, has been shown to be…
Abstract Number: 2525 • 2014 ACR/ARHP Annual Meeting
Infliximab Versus Conventional Combination Treatment and Work Loss in Early RA over 7 Years: A Randomized Trial
Jonas K Eriksson¹, Heather Miller², Johan A Karlsson³, Ingemar F Petersson⁴, Sofia Ernestam⁵, Pierre Geborek³, Ronald F van Vollenhoven² and Martin Neovius¹, ¹Clinical Epidemiology Unit, Department of Medicine, Karolinska Institutet, Stockholm, Sweden, ²ClinTRID, Department of Medicine, Karolinska Institutet, Stockholm, Sweden, ³Section of Rheumatology, Department of Clinical Sciences Lund, Lund University, Lund, Sweden, ⁴Section of Orthopedics, Department of Clinical Sciences Lund, Lund University, Lund, Sweden, ⁵Department of Learning, Informatics and Medical Education (LIME), Karolinska Institutet, Stockholm, Sweden
Background/Purpose: The introduction of TNF inhibitors has improved the treatment of RA, but at a substantial cost. The randomized Swefot trial compared the addition of…
Abstract Number: 2337 • 2014 ACR/ARHP Annual Meeting
The Cost and Effectiveness of Various Recruitment Strategies in a Mind Body Clinical Trial Among Older Adults with Knee Osteoarthritis
Jade V. Goldsmith¹, Lori Lyn Price², Jeffrey B. Driban³, William F. Harvey³ and Chenchen Wang³, ¹Center for Integrative Medicine and Division of Rheumatology, Tufts Medical Center, Boston, MA, ²Institute for Clinical Research and Health Policy Studies, Tufts Medical Center, Boston, MA, ³Rheumatology, Tufts Medical Center, Boston, MA
Background/Purpose : Recruitment and adherence are important and challenging factors that can determine the success of a clinical trial. Mind body therapies are an emerging and…
Abstract Number: 2139 • 2014 ACR/ARHP Annual Meeting
Predictors of Radiologic Disease Progression during the Rheumatoid Arthritis Comparison of Active Therapies Trial
Alan Erickson¹, Denis Rybin², Mary Brophy³, Robert Lew³, Ted R. Mikuls¹, Timothy Moore⁴, Keri Hannagan², Edward Keystone⁵ and James O' Dell¹, ¹Omaha VA Medical Center and University of Nebraska Medical Center, Omaha, NE, ²MAVERIC, VA Boston Heathcare System, Boston, MA, ³VA Boston Heathcare System, Boston, MA, ⁴Radiology, University of Nebraska Medical Center, Omaha, NE, ⁵University of Toronto and Mount Sinai Hospital, Toronto, ON, Canada
Background/Purpose Halting joint damage is a central goal in the treatment of rheumatoid arthritis. Much research has been conducted to identify factors associated with progressive…
Abstract Number: 2880 • 2013 ACR/ARHP Annual Meeting
Impact Of Different End Points On The Patient Cohort Size Needed To Demonstrate The Efficacy Of a Therapeutic Intervention In Pss. A Post Hoc Analysis Of The Tears Study (Tolerance and efficacy of Rituximab in primary Sjogren Syndrome study)
Valerie devauchelle-Pensec¹, Sandrine jousse-Joulin², Xavier Mariette³, Jean-Marie Berthelot⁴, Aleth Perdriger⁵, Eric Hachulla⁶, Xavier Puechal⁷, Véronique le Guern⁸, Jean Sibilia⁹, Jacques-Eric Gottenberg¹⁰, Laurent Chiche Sr.¹¹, Vincent Goeb¹², Gilles Hayem¹³, Jacques Morel¹⁴, Charles Zarnitsky¹⁵, Jean Jacques Dubost¹⁶, Jacques-Olivier Pers¹⁷, Divi Cornec¹⁸, Raphaèle Seror¹⁹, Emmanuel Nowak²⁰ and Alain Saraux²¹, ¹Department of rheumatology and unit of immunology (EA2216), Brest Occidentale university, Brest, France, ²Rheumatology/Immunology, CHU de la Cavale Blanche, Brest, France, ³Rheumatology Service, Bicêtre University Hospital, Le Kremlin Bicetre, France, ⁴Rheumatology Unit, Nantes University Hospital, Nantes, France, ⁵Rheumatology, Hôpital Sud, Rennes, France, ⁶Internal Medicine, Lille CEDEX, France, ⁷Department of Internal Medicine, Referral Center for Rare Autoimmune and Systemic Diseases, Hôpital Cochin, AP–HP, Université Paris Descartes, Paris, France, ⁸Department of Internal Medicine, Hôpital Cochin, Paris, France, ⁹Division of Rheumatology, University Hospital of Strasbourg, Strasbourg, France, ¹⁰Strasbourg University Hospital, Strasbourg, France, ¹¹Internal Medicine, CHU Marseille, Marseille, France, ¹²Rheumatology, Amiens University Hospital, Amiens, France, ¹³Rheumatology Unit, Bichat Hospital, Paris, France, ¹⁴Dpartment of Rheumatology, Lapeyronie Hospital, Montpellier, France, ¹⁵Rheumatology, Le Havre General Hospital, Le Havre, France, ¹⁶Rheumatology, CHU G.-Montpied, Clermont-Ferrand, France, ¹⁷Unit of immunology, EA 2216, Brest Occidentale University, Brest, France, ¹⁸Department of rheumatology, Brest Occidentale University, Brest, France, ¹⁹Rheumatology, Bicetre university hospital, LE Kremlin-Bicetre, France, ²⁰CIC, CHU Brest, Brest, France, ²¹Department of rheumatology and unit of immunology (EA 2216), Université Brest Occidentale, Brest, France
Background/Purpose: To calculate the sample sizes needed in future randomized controlled trials (RCTs) testing a therapeutic intervention in pSS, methodologists usually rely on data obtained…
Abstract Number: 2691 • 2013 ACR/ARHP Annual Meeting
Results Of The Strass Trial Regarding Impact Of Progressive Spacing Of Tnf-Blocker Injections In Rheumatoid Arthritis Patients In Das28 Remission: Is There a Difference Between Drugs – Adalimumab and Etanercept – Or Their Mode Of Use – Monotherapy Or Combination?
Bruno Fautrel¹, Thao Pham², Jacques Morel³, Toni Alfaiate⁴, Emmanuelle Dernis⁵, Philippe Gaudin⁶, Olivier Brocq⁷, Elisabeth Solau-Gervais⁸, Jean-Marie Berthelot⁹, Jean-Charles Balblanc¹⁰, Xavier Mariette¹¹ and Florence Tubach¹², ¹Paris 6 – Pierre et Marie Curie University; AP-HP, Rheumatology, Pitié-Salpêtrière Hospital, - GRC-UPMC 08 – EEMOIS, Paris, France, ²Rheumatology Department, Sainte Marguerite Hospital, Marseille, France, ³Department of Rheumatology, Hôpital Lapeyronie, Montpellier, France, ⁴Biostatistics, Bichat Hospital, AP-HP, Paris, France, ⁵Le Mans Hospital, Le Mans, France, ⁶Rheumatology Department, CHU Hôpital Sud, Grenoble Teaching Hospital, Echirolles, France, ⁷Hospital of Princesse Grâce de Monaco, Monaco, France, ⁸Rheumatology, University Hospital of Poitiers, Poitiers, France, ⁹Rheumatology Unit, Nantes University Hospital, Nantes, France, ¹⁰Rheumatology, Centre Hospitalier Général de Belfort, Belfort, France, ¹¹Rheumatology Service, Bicêtre University Hospital, Le Kremlin Bicetre, France, ¹²INSERM, Universite Paris Diderot, Paris, France
Background/Purpose: The STRASS trial was an 18-month randomized controlled trial, conducted in established RA patients in DAS28 remission with etanercept (ETA) or adalimumab (ADA), comparing…
Abstract Number: 2329 • 2013 ACR/ARHP Annual Meeting
Improvements In Physical Function Correlate With Improvements In Health Related Quality Of Life: Reported Outcomes In Rheumatoid Arthritis Patients Treated With Tofacitinib: Results From 3 Randomized Phase 3 Trials
V. Strand¹, R. E. Alten², C. I. Nduaka³, R. Riese³, D. Gruben³, S. H. Zwillich³, J. Andrews³ and G. Wallenstein³, ¹Adjunct, Division of Immunology / Rheumatology, Stanford University, Palo Alto, CA, ²Department of Internal Medicine II, Schlosspark-Klinik, University Medicine, Berlin, Germany, ³Pfizer Inc, Groton, CT
Background/Purpose: Tofacitinib is a novel, oral Janus kinase (JAK) inhibitor for the treatment of rheumatoid arthritis (RA). RA affects all domains of health-related quality of…
Abstract Number: 1977 • 2013 ACR/ARHP Annual Meeting
Remission At 3 Or 6 Months and Radiographic Non-Progression At 12 Months In Methotrexate-Naïve Rheumatoid Arthritis Patients Treated With Tofacitinib Or Methotrexate: A Post-Hoc Analysis Of The ORAL Start Trial
V. Strand¹, D. van der Heijde², R. Landewe³, E. B. Lee⁴, B. Wilkinson⁵, S. H. Zwillich⁵, J. Bradley⁵, C. Mebus⁵, B. Benda⁶ and D. Gruben⁵, ¹Adjunct, Division of Immunology / Rheumatology, Stanford University, Palo Alto, CA, ²Department of Rheumatology, Leiden University Medical Center, Leiden, Netherlands, ³Division of Clinical Immunology and Rheumatology, Academic Medical Center / University of Amsterdam, Amsterdam, Netherlands, ⁴Seoul National University, Seoul, South Korea, ⁵Pfizer Inc, Groton, CT, ⁶Pfizer Inc, Collegeville, PA
Background/Purpose: Tofacitinib is a novel, oral Janus kinase (JAK) inhibitor for the treatment of RA. The importance of “treat to target” in RA to attain…
Abstract Number: 1471 • 2013 ACR/ARHP Annual Meeting
Tofacitinib For Rheumatoid Arthritis: A Systematic Review and Meta-Analysis
Maria A. Lopez-Olivo¹, Maria E. Suarez-Almazor² and Mahesh Bavineni³, ¹General Internal Medicine, University of Texas. M.D Anderson Cancer Center, Houston, TX, ²The Department of General Internal Medicine, The University of Texas, MD Anderson Cancer Center, Houston, TX, ³Internal Medicine, Louisiana State University Lafayette, Lafayette, LA
Background/Purpose: Tofacitinib was developed as a small molecule inhibitor of the Janus kinase (JAK) pathways that are central to the maintenance of the inflammatory state…
Abstract Number: 1418 • 2013 ACR/ARHP Annual Meeting
Effects Of Smoking Status On Response To Treatment With Tofacitinib In Patients With Rheumatoid Arthritis
J. M. Kremer¹, J. D. Greenberg², C. Turesson³, D. Gruben⁴, C. A. Mebus⁴, E. Bananis⁵ and T. Robinson⁶, ¹Albany Medical College and The Center for Rheumatology, Albany, NY, ²Rheumatology, NYU Hospital for Joint Diseases, New York, NY, ³Lund University, Malmö, Sweden, ⁴Pfizer Inc, Groton, CT, ⁵Specialty Care, Pfizer Inc, Collegeville, PA, ⁶Pfizer Inc, Collegeville, PA
Background/Purpose: Cigarette smoking is a known risk factor for developing rheumatoid arthritis (RA).1 Several recent observational studies suggest that cigarette smoking may be associated with…
Abstract Number: 1419 • 2013 ACR/ARHP Annual Meeting
Mode Of Action Change Not Necessary After Failing The First Tumornecrosisfactor Inhibitor: Preliminary Results Of a Randomized Controlled Trial
Sofie H.M. Manders¹, Wietske Kievit², Herman L.M. Brus³, Hein J. Bernelot Moens⁴, Andre Hartkamp⁵, Reinhard Bos⁶, Elisabeth Brouwer⁷, Henk Visser⁸, Harald E. Vonkeman⁹, Rene Westhovens¹⁰, Mart A.F.J. van de Laar¹¹ and Piet LCM Van Riel¹, ¹Radboud University Nijmegen Medical Centre, Nijmegen, Netherlands, ²Department of Rheumatology and DREAM registry, Radboud University Nijmegen Medical Centre, Nijmegen, Netherlands, ³TweeSteden Ziekenhuis, Tilburg, Netherlands, ⁴Ziekenhuisgroep Twente, Almelo, Netherlands, ⁵Reumatology, Jeroen Bosch Hospital, 's-Hertogenbosch, Netherlands, ⁶Rheumatology, Medical Center Leeuwarden, Leeuwarden, Netherlands, ⁷Rheumatology and Clinical Immunology, University of Groningen, University Medical Center Groningen, Groningen, Netherlands, ⁸Rheumatology, Rijnstate, Arnhem, Netherlands, ⁹Medisch Spectrum Twente & University of Twente, Enschede, Netherlands, ¹⁰Rheumatology, University Hospital KU Leuven, Leuven, Belgium, ¹¹Rheumatology, Medisch Spectrum Twente & University of Twente, Enschede, Netherlands
Background/Purpose: The best treatment option after a patient has failed a first TNFi is still unknown. Therefore the objective of this randomized open label study…
Abstract Number: 441 • 2013 ACR/ARHP Annual Meeting
Tofacitinib, An Oral Janus Kinase Inhibitor: Safety Comparison In Patients With Rheumatoid Arthritis and An Inadequate Response To Nonbiologic Or Biologic Disease‑Modifying Anti-Rheumatic Drugs
G. R. Burmester¹, C Charles-Schoeman², J. D. Isaacs³, T. Hendrikx⁴, K. Kwok⁵, S. H. Zwillich⁶ and R. Riese⁶, ¹Department of Medicine/Rheumatology and Clinical Immunology and German Rheumatism Research Centre Berlin (DRFZ), Charité University Medicine Berlin, Berlin, Germany, ²University of California, Los Angeles, CA, ³Newcastle University, Newcastle-upon-Tyne, United Kingdom, ⁴Pfizer BV, Capelle aan den IJssel, Netherlands, ⁵Pfizer Inc, New York, NY, ⁶Pfizer Inc, Groton, CT
Background/Purpose: Tofacitinib is a novel, oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA). This analysis provides comparative safety data on the incidence…
Abstract Number: 443 • 2013 ACR/ARHP Annual Meeting
Efficacy and Safety Analyses Of Tofacitinib From Pooled Phase 2, Phase 3 and Long-Term Extension Rheumatoid Arthritis Studies: US Compared With Non-US Populations
S. B. Cohen¹, Roy Fleischmann¹, J. M. Kremer², A. Koenig³, K. Kwok⁴, L. Wang⁵, C. a. Mebus⁵, R. Riese⁵ and T. Robinson³, ¹Metroplex Clinical Research Center, Dallas, TX, ²Albany Medical College and The Center for Rheumatology, Albany, NY, ³Pfizer Inc, Collegeville, PA, ⁴Pfizer Inc, New York, NY, ⁵Pfizer Inc, Groton, CT
Background/Purpose: Tofacitinib is an oral Janus kinase inhibitor approved in the US for the treatment of rheumatoid arthritis at 5 mg BID. Phase (P) 3…
Abstract Number: 438 • 2013 ACR/ARHP Annual Meeting
Tofacitinib, An Oral Janus Kinase Inhibitor, In A Rheumatoid Arthritis Open-Label Extension Study Following Adalimumab Therapy In A Phase 3 Randomised Clinical Trial
M. C. Genovese¹, R. F. van Vollenhoven², B. Wilkinson³, L. Wang³, S. H. Zwillich³, D. Gruben³, B. Benda⁴ and T. V. Jones⁴, ¹Division of Rheumatology, Stanford University, Palo Alto, CA, ²Clinical Trials Unit Department of Rheumatology, The Karolinska Institute, Stockholm, Sweden, ³Pfizer Inc, Groton, CT, ⁴Pfizer Inc, Collegeville, PA
Background/Purpose: Tofacitinib is a novel, oral Janus kinase inhibitor for the treatment of rheumatoid arthritis. Here, we describe the efficacy and safety for adalimumab (ADA)…
Abstract Number: L9 • 2013 ACR/ARHP Annual Meeting
Tofacitinib Monotherapy Versus Methotrexate in Methotrexate-Naïve Patients with Rheumatoid Arthritis: Radiographic, Clinical and Functional Comparison
Roy Fleischmann¹, E. B. Lee², S Hall³, B. E. Wilkinson⁴, John D. Bradley⁵, D. Gruben⁴, T. Koncz⁶, S. Krishnaswami⁷, G. Wallenstein⁶, S. H. Zwillich⁴ and R.F. van Vollenhoven⁸, ¹Metroplex Clinical Research Center, Dallas, TX, ²Seoul National University, Seoul, South Korea, ³Cabrini Health and Monash University, Melbourne, Australia, ⁴Pfizer Inc, Groton, CT, ⁵Pfizer Inc., Groton, CT, ⁶Pfizer Inc, New York, NY, ⁷Clinical Pharmacology, Pfizer Inc, Groton, CT, ⁸The Karolinska Institute, Stockholm, Sweden
Background/Purpose: Tofacitinib is a novel, oral Janus kinase inhibitor for the treatment of RA. This Phase 3, 24-mo study (ORAL Start; NCT01039688) compared efficacy, including inhibition…

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