Abstracts tagged "clinical trial"

Abstract Number: 2111 • ACR Convergence 2022
Long-term Efficacy of Guselkumab in Fatigue and Identification of Early Treatment Targets: Post Hoc Analysis Through 2 Years of a Phase 3, Randomized, Double-blind, Placebo-controlled Study Conducted in Biologic-naïve Patients with Active Psoriatic Arthritis
Dafna Gladman¹, Michael Starr², Roberto Ranza³, Ana-Maria Bravo Perdomo⁴, Marcie Strauss⁵, May Shawi⁶, Chenglong Han⁷, Emmanouil Rampakakis⁸, Andrew Ostor⁹ and Philip J Mease¹⁰, ¹Toronto Western Hospital, Schroeder Arthritis Institute, Toronto, ON, Canada, ²Montreal General Hospital, Montréal, QC, Canada, ³Serviço de Reumatología, Universidade Federal de Uberlândia, Uberlândia, Brazil, ⁴Immunology Medical Affairs, Janssen Latin America, Columbia, Colombia, ⁵Medasource, Indianapolis, IN, ⁶Immunology Global Medical Affairs, Janssen Pharmaceutical Companies of Johnson & Johnson, Horsham, PA, ⁷Immunology, Janssen Research & Development, LLC, Spring House, PA, ⁸McGill University, Department of Pediatrics and JSS Medical Research, Montréal, QC, Canada, ⁹Cabrini Medical Centre, Monash University & Emeritus Research, Melbourne, Australia, ¹⁰Swedish Medical Center/Providence St. Joseph Health, Seattle, WA
Background/Purpose: The IL-23p19-subunit inhibitor guselkumab (GUS) demonstrated clinically meaningful improvements in fatigue through one year of treatment1 independent of its effects on ACR20 and MDA…
Abstract Number: 0282 • ACR Convergence 2022
Efficacy and Safety of Upadacitinib in TNFi-IR Patients with Rheumatoid Arthritis from Three Phase 3 Clinical Trials
Roy Fleischmann¹, Louis Bessette², Jeffrey Sparks³, Stephen Hall⁴, Manish Jain⁵, Adriana Kakehasi⁶, Yanna Song⁷, Sebastian Meerwein⁸, Ryan DeMasi⁷, Jessica Suboticki⁹ and Andrea Rubbert-Roth¹⁰, ¹University of Texas Southwestern Medical Center and Metroplex Clinical Research Center, Dallas, TX, ²Centre de l'Ostoporose et de Rhumatologie de Québec, Québec, QC, Canada, ³Brigham and Women's Hospital and Harvard Medical School, Boston, MA, ⁴Emeritus Research and Monash University, Melbourne, Australia, ⁵Great Lakes Clinical Trials, Chicago, IL, ⁶Federal University of Minas Gerais, Hospital das Clínicas, Belo Horizonte, Brazil, ⁷AbbVie, Inc., North Chicago, IL, ⁸AbbVie Deutschland GmbH & Co KG, LUDWIGSHAFEN, Germany, ⁹AbbVie, Inc., Mettawa, IL, ¹⁰Division of Rheumatology, Cantonal Clinic St Gallen, St.Gallen, Switzerland
Background/Purpose: For patients with RA who are refractory to biologic disease-modifying antirheumatic drugs (bDMARDs), such as tumor necrosis factor inhibitors (TNFis), optimal disease control is…
Abstract Number: 0361 • ACR Convergence 2022
Gene Expression Pathways Modulated by Anifrolumab in Systemic Lupus Erythematosus
Tina Baker¹, Sharifian Hoda², Paul Newcombe¹, Mark Lazarus¹, Madhu Ramaswamy³, Nicola Ferrari¹, Daniel Muthas², Hussein Al-Mossawi¹, Raj Tummala³, Eric F. Morand⁴, Richard A. Furie⁵, Edward Vital⁶ and Philip Brohawn³, ¹AstraZeneca, Cambridge, United Kingdom, ²AstraZeneca, Gothenburg, Sweden, ³AstraZeneca, Gaithersburg, MD, ⁴Monash University, Melbourne, Australia, ⁵Northwell Health, Great Neck, NY, ⁶University of Leeds, Leeds, England, United Kingdom
Background/Purpose: Anifrolumab is a monoclonal antibody to IFN-α receptor 1 that inhibits type I IFN signaling. In the phase 3 TULIP-1 and TULIP-2 trials, anifrolumab…
Abstract Number: 0527 • ACR Convergence 2022
Rituximab as Maintenance Therapy for ANCA-associated Vasculitides: Pooled Analysis and Long-term Outcome of MAINRITSAN Trials
Florence Delestre¹, Pierre Charles², Loïc Guillevin³, Raphaël Porcher⁴ and Benjamin Terrier³, ¹cochin Hospital, Paris, France, ²Institut Mutualiste Montsouris, Paris, France, ³National Referral Center for Rare Systemic Autoimmune Diseases, Cochin Hospital, Paris, France, ⁴Université Paris Cité, Hôtel-Dieu, Paris, France
Background/Purpose: Maintenance therapy after induction of remission has been shown to reduce relapse rate and mortality in anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis. The three MAINRITSAN…
Abstract Number: 0997 • ACR Convergence 2022
Withdrawal of Maintenance Glucocorticoid versus Other Immunosuppressants Among Patients with Systemic Lupus Erythematosus in Long Term Clinical Remission: Interim Analysis of a Non-inferiority Randomised Controlled Trial
Aishwarya Gopal¹, Chengappa Kavadichanda², Devender Bairwa³, Molly Mary Thabah⁴ and Vir Singh Negi⁵, ¹Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Pondicherry, Puducherry, India, ²JIPMER, Pondicherry, Puducherry, India, ³Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry, Puducherry, India, ⁴JIPMER, Puducherry, Puducherry, India, ⁵AIIMS Bilaspur, Puducherry, Puducherry, India
Background/Purpose: Attempts to stop glucocorticoids among Systemic Lupus Erythematosus(SLE) patients in long term remission have been successful. Continuing other immunosuppressive (IS) agents indefinitely is currently…
Abstract Number: 1504 • ACR Convergence 2022
Efficacy of Risankizumab in the Treatment of PsA Patients with Limited and Extensive Joint Involvement
Alexis Ogdie¹, Christopher Ritchlin², Priscila Nakasato³, Ran Liu⁴, Christian Kaufmann⁴, Byron Padilla⁵ and Laure Gossec⁶, ¹Department of Medicine, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, ²Allergy, Immunology and Rheumatology Division, University of Rochester Medical School, Canandaigua, NY, ³AbbVie Inc, Toronto, ON, Canada, ⁴AbbVie, Inc., North Chicago, IL, ⁵AbbVie, Inc., Waukegan, IL, ⁶Sorbonne Université, Paris, France
Background/Purpose: PsA is a systemic disease involving multiple domains. Peripheral joints are frequently affected, and patients often initially present with asymmetrical oligoarthritis (2-4 swollen joints).…
Abstract Number: 1670 • ACR Convergence 2022
Phase II Clinical Trial to Assess the Safety and Efficacy of Tocilizumab in Combination with Ipilimumab and Nivolumab for Treatment-naïve Metastatic Melanoma
Noha Abdel-Wahab¹, Emma J. Montazari¹, Christine A. Spillson¹, Salah-Eddine Bentebibel¹, Jean H. Tayar¹, Maria Suarez-Almazor², Suhendan Ekmekcioglu¹, Daniel H. Johnson³ and Adi Diab¹, ¹UT MD Anderson Cancer Center, Houston, TX, ²MD Anderson Cancer Center, Houston, TX, ³Ochsner Health, New Orleans, LA
Background/Purpose: Immune checkpoint inhibitors (ICIs) led to impressive survival benefits in treatment of cancers. However, immune-related adverse events (irAEs) can cause treatment discontinuation and sometimes…
Abstract Number: 1904 • ACR Convergence 2022
Is Treating Painful Hand Osteoarthritis with Hormone Replacement Therapy Feasible? Primary Results from a Randomised Controlled Trial in Post-menopausal Women
Jennifer Williams¹, Mae Chester-Jones¹, Megan Goff², Anne Francis¹, Gretchen Brewer¹, Ioana Marian¹, Malvika Gulati¹, Charles Mackworth-Young³, Victoria Glover⁴, Sarah Lamb¹, Tonia Vincent⁵, Katy Vincent¹, Susan Dutton¹ and Fiona Watt⁶, ¹University of Oxford, Oxford, United Kingdom, ²University of Oxford, London, United Kingdom, ³Imperial College Healthcare NHS Trust, London, United Kingdom, ⁴White Horse Medical Practice, Faringdon, United Kingdom, ⁵Kennedy Institute of Rheumatology, University of Oxford, Oxford, United Kingdom, ⁶Imperial College London, London, United Kingdom
Background/Purpose: Hand osteoarthritis (OA) is more common in females and relative risk increases further around the age of menopause, potentially implicating sex hormone deficiency. There…
Abstract Number: 2112 • ACR Convergence 2022
Stringent Disease Activity Control at 2 Years Across Psoriatic Arthritis Domains Irrespective of Baseline Characteristics in Patients Treated with Guselkumab: Post Hoc Analysis of a Phase 3, Randomized, Double-blind, Placebo-controlled Study
Christopher Ritchlin¹, Philip J Mease², Wolf-Henning Boehncke³, John Tesser⁴, Soumya Chakravarty⁵, Emmanouil Rampakakis⁶, May Shawi⁷, Elena Schiopu⁸, Joseph Merola⁹, Iain B McInnes¹⁰ and Atul Deodhar¹¹, ¹Allergy, Immunology and Rheumatology Division, University of Rochester Medical School, Canandaigua, NY, ²Swedish Medical Center/Providence St. Joseph Health, Seattle, WA, ³Deptartment of Dermatology, Geneva University Hospitals, University of Geneva, Geneva, Switzerland, ⁴Arizona Arthritis & Rheumatology Associates, Phoenix, AZ, ⁵Janssen Scientific Affairs, LLC; Drexel University College of Medicine, Villanova, PA, ⁶McGill University, Department of Pediatrics and JSS Medical Research, Montréal, QC, Canada, ⁷Immunology Global Medical Affairs, Janssen Pharmaceutical Companies of Johnson & Johnson, Horsham, PA, ⁸Michigan Medicine Rheumatology Clinic – Taubman Center, Ann Arbor, MI, ⁹Brigham and Women's Hospital, Harvard Medical School, Boston, MA, ¹⁰Institute of Infection, Immunity and Inflammation, College of Medical, Veterinary and Life Sciences, University of Glasgow, Glasgow, Scotland, United Kingdom, ¹¹Oregon Health & Science University, Portland, OR, USA, Portland, OR
Background/Purpose: Guselkumab (GUS) is associated with robust and sustained improvement in PsA signs and symptoms in subgroups of patients (pts) pooled from the phase 3…
Abstract Number: 0292 • ACR Convergence 2022
Malignancy in the Upadacitinib Clinical Trial Programs for Rheumatoid Arthritis, Psoriatic Arthritis, and Ankylosing Spondylitis
Andrea Rubbert-Roth¹, Adriana Kakehasi², Tsutomu Takeuchi³, Marc Schmalzing⁴, Hannah Palac⁵, Jianzhong Liu⁵, Samuel Anyanwu⁵, Ralph Lippe⁶ and Jeffrey Curtis⁷, ¹Division of Rheumatology, Cantonal Clinic St Gallen, St.Gallen, Switzerland, ²Federal University of Minas Gerais, Hospital das Clínicas, Belo Horizonte, Brazil, ³Keio University and Saitama Medical University, Tokyo, Japan, ⁴University Hospital Wuerzburg, Wuerzburg, Germany, ⁵AbbVie, Inc., North Chicago, IL, ⁶AbbVie, Inc, Wiesbaden, Germany, ⁷University of Alabama at Birmingham, Birmingham, AL
Background/Purpose: Increased risk of malignancies has been associated with chronic inflammation, as well as immunosuppressive and immunomodulatory therapies. The objective of this analysis is to…
Abstract Number: 0364 • ACR Convergence 2022
Efficacy of BIIB059 on Joint and Skin Manifestations in Participants with Systemic Lupus Erythematosus (SLE): Exploratory Analyses of the Phase 2, Randomized, Double-Blind, Placebo-Controlled LILAC Study (Part A)
Richard Furie¹, Ronald van Vollenhoven², Victoria Werth³, Kenneth Kalunian⁴, Sandra Navarra⁵, Juanita Romero-Diaz⁶, Ting Wang⁷, Cristina Musselli⁷, Catherine Barbey⁸ and Nathalie Franchimont⁷, ¹Northwell Health, Great Neck, NY, ²Amsterdam University Medical Centers, Amsterdam, Netherlands, ³University of Pennsylvania and Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA, ⁴University of California San Diego, La Jolla, CA, ⁵University of Santo Tomas, Manila, Philippines, ⁶Instituto Nacional de Ciencias Medicas y Nutricion SZ, Ciudad de México, Mexico, ⁷Biogen, Cambridge, MA, ⁸Biogen, Baar, Switzerland
Background/Purpose: SLE is a heterogeneous illness that often manifests with skin and/or joint diseases.1 BIIB059 is a humanized monoclonal antibody that binds to BDCA2, a…
Abstract Number: 0530 • ACR Convergence 2022
Abatacept Significantly Reduces Subclinical Inflammation During Treatment (6 Months), This Persists After Discontinuation (12 Months), Resulting in a Delay in the Clinical Development of RA in Patients at Risk of RA (The ARIAA Study)
Juergen Rech¹, Arnd Kleyer², Mikkel Østergaard³, Melanie Hagen², Larissa Valor Mendez², Koray Tascilar², Gerhard Kroenke², Verena Schönau², David Simon², stefan Kleinert⁴, Xenofon Baraliakos⁵, Juergen Braun⁶, Axel Hueber⁷, Martin Fleck⁸, Andrea Rubbert-Roth⁹, Frank Behrens¹⁰, Martin Feuchtenberger¹¹, M. Zaenker¹², Reinhard Voll¹³, Cornelia Glaser¹⁴, Mária Filková¹⁵, Eugen Feist¹⁶, Gerd Burmester¹⁷, Kirsten Karberg¹⁸, Johannes Strunk¹⁹, Juan Canete²⁰, Ladislav Šenolt¹⁵, Esperanza Naredo²¹ and Georg Schett²², ¹University Clinic Erlangen, Erlangen, Germany, ²Department of Internal Medicine 3 – Rheumatology and Immunology, Friedrich-Alexander-University Erlangen-Nürnberg and Universitätsklinikum Erlangen, 91054 Erlangen, Germany; Deutsches Zentrum Immuntherapie, Friedrich-Alexander-UniversityErlangen-Nürnberg and Universitätsklinikum Erlangen, Erlangen, Germany, ³Rigshospitalet, University of Copenhagen, Glostrup, Denmark, ⁴Praxisgemeinschaft Rheumatologie - Nephrologie (PGRN), Erlangen, Germany, ⁵Ruhr University Bochum, Department of Rheumatology, Bochum, Germany; Rheumazentrum Ruhrgebiet, Rheumazentrum Ruhrgebiet, Herne, Germany, ⁶Rheumazentrum Ruhrgebiet, Herne, Germany, ⁷Klinikum Nuernberg Nord, Abteilung fuer Rheumatologie, Nuernberg, Germany, ⁸Asklepios Klinikum Bad Abbach, Klinik und Poliklinik für Rheumatologie/ Klin. Immunologie, Bad Abbach, Germany, ⁹Division of Rheumatology, Cantonal Clinic St Gallen, St.Gallen, Switzerland, ¹⁰Division of Rheumatology, University Hospital Frankfurt, Goethe University, Frankfurt am Main, Germany; Fraunhofer Institute for Translational Medicine & Pharmacology ITMP, Frankfurt, ¹¹MED | BAYERN OST GmbH, Fachbereich Rheumatologie, Burghausen, Germany, ¹²Immanuel Klinikum Bernau , Herzzentrum Brandenburg, Abteilung Innere Medizin, Bernau, Germany, ¹³Universitätsklinikum Freiburg, Klinik für Rheumatologie und Klinische Immunologie, Freiburg im Breisgau, Germany, ¹⁴Universitätsklinikum Freiburg, Klinik für Rheumatologie und Klinische Immunologie, Freiburg, Germany, ¹⁵Institute of Rheumatology and Department of Rheumatology, First Faculty of Medicine, Charles University, Prague, Czech Republic, ¹⁶Helios Clinic Vogelsang-Gommern, cooperation partner of the Otto von Guericke University Magdeburg, Magdeburg, Germany, ¹⁷Charité University Medicine Berlin, Berlin, Germany, ¹⁸Praxis für Rheumatologie und Innere Medizin, Rheumatologie, Berlin, Germany, ¹⁹Krankenhaus Porz am Rhein GmbH, Rheumaklinik, Köln (Porz), Germany, Koeln, Germany, ²⁰Unidad de Artritis Hospital Clinic, Barcelona, Spain, ²¹Hospital General Universitario Gregorio Marañón and Complutense University, Madrid, Spain, ²²Universitätsklinikum Erlangen, Erlangen, Germany
Background/Purpose: Development of the clinical phase of rheumatoid arthritis (RA) is preceded by an autoimmune phase, characterized by the presence of anti-citrullinated protein antibodies (ACPA),…
Abstract Number: 1001 • ACR Convergence 2022
Effect of Atacicept on Renal Function in Patients with Systemic Lupus Erythematosus (SLE)
David Isenberg¹, Celia Lin², Amy Kao³, Aida Aydemir⁴ and Caroline Gordon⁵, ¹University College London, London, United Kingdom, ²Vera Therapeutics, Inc, Burlingame, CA, ³EMD Serono, Billerica, MA, ⁴EMD Serono Research & Development Institute, Inc, Billerica, MA, ⁵Rheumatology Research Group, Institute of Inflammation and Ageing, College of Medical and Dental Sciences, University of Birmingham, Birmingham, United Kingdom
Background/Purpose: Atacicept is a fusion protein that blocks B-lymphocyte stimulator and a proliferation-inducing ligand, which are increased in patients with SLE. APRIL-SLE was a double-blind,…
Abstract Number: 1509 • ACR Convergence 2022
Patient Clusters Identified by Machine Learning from a Pooled Analysis of the Clinical Development Program of Secukinumab in Psoriatic Arthritis, Ankylosing Spondylitis and Psoriatic Arthritis with Axial Manifestations
Xenofon Baraliakos¹, Effie Pournara², Dafna Gladman³, Philip J Mease⁴, Samad S Jahandideh² and Laura Coates⁵, ¹Rheumazentrum Ruhrgebiet Herne, Herne, Germany, ²Novartis Pharma AG, Basel, Switzerland, ³Toronto Western Hospital, Schroeder Arthritis Institute, Toronto, ON, Canada, ⁴Swedish Medical Center/Providence St. Joseph Health, Seattle, WA, ⁵Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK, Oxford, England, United Kingdom
Background/Purpose: Universally acceptable clinical and imaging criteria to define axial psoriatic arthritis (PsA) is lacking.1 Machine learning (ML) algorithms can detect patterns from large clinical…
Abstract Number: 1675 • ACR Convergence 2022
Effectiveness of Intensive Diet and Exercise on Knee Pain Among Communities with Knee Osteoarthritis, Overweight, and Obesity: The WE-CAN Pragmatic Randomized Clinical Trial
Stephen Messier¹, Daniel Beavers², Kate Queen³, Shannon Mihalko¹, Gary Miller¹, Elena Losina⁴, Jeffrey Katz⁴, Richard Loeser⁵, Paul DeVita⁶, David Hunter⁷, Jovita Newman¹, Sara Quandt⁸, Mary Lyles², Joanne Jordan⁹ and Leigh Callahan¹⁰, ¹Wake Forest University, Winston-Salem, NC, ²Wake Forest University School of Medicine, Winston-Salem, NC, ³Haywood Regional Medical Center, Waynesville, NC, ⁴Brigham and Women's Hospital, Boston, MA, ⁵University of North Carolina, Chapel Hill, NC, ⁶East Carolina University, Greenville, NC, ⁷University of Sydney, Sydney, Australia, ⁸Wake Forest School of Medicine, Winston-Salem, NC, ⁹University of North Carolina School of Medicine, Chapel Hill, NC, ¹⁰University of North Carolina Thurston Arthritis Research Center, Chapel Hill, NC
Background/Purpose: Many health systems that treat people with knee osteoarthritis (OA) have no infrastructure in place to implement weight loss and exercise treatments. The policy…

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