Abstracts tagged "clinical trial"

Abstract Number: 2337 • ACR Convergence 2023
Safety and Tolerability of NIM-1324, an Oral, Once-daily LANCL2 Agonist, in a Randomized, Double-Blind, Placebo-Controlled Phase 1 Study in Normal Healthy Volunteers
Andrew Leber, Raquel Hontecillas, Nuria Tubau Juni and Josep Bassaganya-Riera, NIMML Institute, Blacksburg, VA
Background/Purpose: Systemic lupus erythematosus is a complex disease in which the immune system is dysfunctional at multiple levels including impaired regulatory responses, altered self-antigen processing…
Abstract Number: 2597 • ACR Convergence 2023
Fecal Microbiota Transplantation in Patients with Systemic Sclerosis and Lower Gastrointestinal Tract Symptoms: Data from the ReSScue Phase 2 Randomized Clinical Trial
Anna-Maria Hoffmann-Vold¹, Havard Fretheim¹, Imon Barua¹, Maylen Nordgård Carstens¹, Henriette Didriksen², Vikas Sarna¹, Knut AE Lundin¹, Oliver Distler³, Dinesh Khanna⁴, Elizabeth Volkmann⁵, Oyvind Midtvedt¹, Tore Midtvedt⁶, Alvilde Dhainaut⁷, Anne-Kristine H Halse⁸, Gunnstein Bakland⁹, Inge Olsen¹, Maiju E Pesonen¹ and Oyvind Molberg¹⁰, ¹Oslo University Hospital, Oslo, Norway, ²Oslo University Hospital, Moss, Norway, ³Department of Rheumatology, University Hospital Zurich, University of Zurich, Zurich, Switzerland, ⁴University of Michigan, Ann Arbor, MI, ⁵University of California Los Angeles, Los Angeles, CA, ⁶Karolinska Institutet, Stockholm, Sweden, ⁷St. Olav, Trondheim, Norway, ⁸University Hospital Bergen, Bergen, Norway, ⁹University Hospital of North Norway, Tromsø, Norway, ¹⁰Dept of Rheumatology, University Hospital Oslo, Oslo, Norway
Background/Purpose: Lower gastrointestinal tract (GIT) complications are common in patients with systemic sclerosis (SSc), associate with a high disease burden, and current treatment alternatives are…
Abstract Number: 0271 • ACR Convergence 2023
Successful Treatment of Refractory IgG4-Related Disease with Tofacitinib: Experiences from 7 Patients
Huaqun Zhu, Sumei Tang, Yun Li, Feng Sun, Yuzhou Gan and Hua Ye, Peking University People’s Hospital, Beijing, China
Background/Purpose: Our observational cohort study aimed at assessing the effectiveness and safety of the Janus kinase (JAK) inhibitor tofacitinib in refractory IgG4-Related Disease (IgG4-RD).Methods: Seven…
Abstract Number: 0524 • ACR Convergence 2023
Efficacy of Certolizumab Pegol in Preventing Anterior Uveitis Flares Compared with Standard Non-Biologic Treatment: A Matched Control Study in High-Risk Patients with Axial Spondyloarthritis
Nigil Haroon¹, Zeynep Baskurt², Tina Chim³, Robert Inman⁴, Diana Paez⁵, Thomas Kumke⁶, Rachel Tham⁷, Mindy Kim⁸, Irene van der Horst-Bruinsma⁹ and Lianne Gensler¹⁰, ¹University of Toronto, University Health Network, Schroeder Arthritis Institute, Department of Medicine/Rheumatology, Toronto, ON, Canada, ²Department of Biostatistics, University Health Network, Toronto, ON, Canada, ³University Health Network, Schroeder Arthritis Institute, Department of Rheumatology, Toronto, ON, Canada, ⁴University Health Network, Toronto, ON, Canada, ⁵University of California San Francisco, Department of Medicine/Rheumatology, San Francisco, CA, ⁶UCB Pharma, Monheim am Rhein, Germany, ⁷UCB Pharma, Slough, United Kingdom, ⁸UCB Pharma, Atlanta, GA, ⁹Radboud University Medical Centre, Department of Rheumatology, Nijmegen, Netherlands, ¹⁰University of California San Francisco, Department of Medicine, Division of Rheumatology, San Francisco, CA
Background/Purpose: Acute anterior uveitis (AAU) is the most common extra-musculoskeletal manifestation in axial spondyloarthritis (axSpA), affecting more than a third of patients. However, long-term interventional…
Abstract Number: 0837 • ACR Convergence 2023
A Randomized, Double-Blind, Sham-Controlled, Clinical Trial of Auricular Vagus Nerve Stimulation for the Treatment of Active Rheumatoid Arthritis
Matthew Baker¹, Sarah Kavanagh², Stanley Cohen³, Alan Matsumoto⁴, Ara Dikranian⁵, John Tesser⁶, Alan Kivitz⁷, Konstantinos Alataris⁸ and Mark Genovese⁹, ¹Stanford University, Menlo Park, CA, ²Kavanagh Statistical Consulting, LLC, Apex, NC, ³Metroplex Clinical Research Center, Dallas, TX, ⁴Arthritis and Rheumatism Associates, Wheaton, MD, ⁵Cabrillo Center for Rheumatic Disease, San Diego, CA, ⁶Arizona Arthritis & Rheumatology Associates, Phoenix, AZ, ⁷Altoona Center for Clinical Research, Duncansville, PA, ⁸Nēsos, Menlo Park, CA, ⁹Stanford University, Sunnyvale, CA
Background/Purpose: Vagus nerve stimulation (VNS) has emerged in recent decades as a potential therapy for RA.We have previously shown that auricular VNS produced an average…
Abstract Number: 1326 • ACR Convergence 2023
Safety and Efficacy of Upadacitinib in Patients with Rheumatoid Arthritis Refractory to Biologic DMARDs: Results Through Week 204 from the SELECT-CHOICE Study
Andrea Rubbert-Roth¹, Koji Kato², Boulos Haraoui³, Maureen Rischmueller⁴, Yanxi Liu², Nasser Khan⁵, Heidi Camp² and Ricardo Xavier⁶, ¹Cantonal Hospital St. Gallen, St. Gallen, Switzerland, ²AbbVie, Inc., North Chicago, IL, ³Institut de Rhumatologie de Montréal, Montreal, QC, Canada, ⁴The Queen Elizabeth Hospital and Basil Hetzel Institute; Adelaide Medical School, University of Adelaide, Adelaide, Australia, ⁵Pharmacovigilance and Patient Safety, AbbVie, Inc., North Chicago, IL, ⁶Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil
Background/Purpose: To evaluate the long-term safety and efficacy of upadacitinib (UPA), an oral JAK inhibitor, through week 204 in patients with RA from the long-term…
Abstract Number: 1492 • ACR Convergence 2023
Pre-treatment Differentially Expressed Metagenes Characterize Systemic Lupus Patients Who Subsequently Achieve Clinical Response to Belimumab
Miles Smith¹, Kevin Thomas¹, Nicolas Dominguez¹, Susan Macwana¹, Wade DeJager¹, Stan Kamp¹, Carla Guthridge¹, Bridget Parrish¹, Cristina Arriens², Judith James¹, Joan Merrill¹ and Joel Guthridge¹, ¹Oklahoma Medical Research Foundation, Oklahoma City, OK, ²Oklahoma Medical Research Foundation and University of Oklahoma Health Sciences Center, Department of Arthritis & Clinical Immunology, Oklahoma City, OK
Background/Purpose: Belimumab, which targets the B Cell activator and survival factor BLyS, is an approved treatment for systemic lupus (SLE) and has demonstrated efficacy in…
Abstract Number: 1833 • ACR Convergence 2023
Development of a Polygenic Risk Model for Therapeutic Response to Bedtime Sublingual Cyclobenzaprine (TNX-102 SL*) in Fibromyalgia Based on Polygenic Single Nucleotide Polymorphism (SNP)-Count Scores
Jeffrey Rosenfeld¹, Greta Linse², Sally Slipher², Candace Flint³, Annie Iserson³, Herbert Harris⁴, Jean Engels³, Gregory Sullivan⁵ and Seth Lederman⁶, ¹Tonix Pharmaceuticals, Chatham, NJ, ²Montana State University, Bozeman, MT, ³Tonix Pharmaceuticals, New York, NY, ⁴Tonix Pharmaceuticals, Chapel Hill, NC, ⁵Tonix Pharmaceuticals Inc, Chatham, NJ, ⁶Tonix Pharmaceuticals, South Dartmouth, MA
Background/Purpose: Fibromyalgia (FM) is characterized by widespread pain, non-restorative sleep, fatigue, and cognitive dysfunction. TNX-102 SL is a sublingual cyclobenzaprine tablet designed for daily use…
Abstract Number: 2162 • ACR Convergence 2023
Safety and Efficacy of Filgotinib: An Update from the DARWIN 3 Phase 2 Long-term Extension with a Maximum of 8.2 Years of Exposure
René Westhovens¹, Rieke Alten², Lorenzo Dagna³, Arthur Kavanaugh⁴, Kevin Withrop⁵, Jane Barry⁶, Robin Besuyen⁷, Claudio Corallo⁸, Dick de Vries⁹, Nicolas Martin¹⁰, Chris Watson⁶, Mark C. Genovese¹¹, Alberto Spindler¹², Mykola Stanislavchuk¹³, Maria Greenwald¹⁴ and Paul Emery¹⁵, ¹Department of Rheumatology, KU Leuven, Skeletal Biology and Engineering Research Center, Leuven, Belgium, ²Department of Internal Medicine and Rheumatology, Schlosspark Klinik, University Medicine Berlin, Berlin, Germany, ³Department of Internal Medicine, IRCCS San Raffaele Hospital and Vita-Salute San Raffaele University, Milan, Italy, ⁴Division of Rheumatology, Allergy, and Immunology, University of California San Diego, La Jolla, CA, ⁵Oregon Health & Science University, Schools of Medicine and Public Health,, Portland, OR, ⁶Medical Affairs, Galapagos Biotech Ltd., Cambridge, United Kingdom, ⁷Clinical Development, Galapagos BV, Leiden, Netherlands, ⁸Medical Affairs, Galapagos Biopharma Italy S.R.L., Milan, Italy, ⁹Research and Development, Clinical Research, Galapagos BV, Leiden, Netherlands, ¹⁰Biostatistics, Galapagos NV, Mechelen, Belgium, ¹¹Clinical Development, Gilead Sciences Inc., Foster City, CA, ¹²Rheumatology Section, Centro Medico Privado de Reumatologia, San Miguel de Tucuman, Argentina, ¹³Rheumatology, National Pirogov Memorial Medical University, Vinnytsia, Ukraine, ¹⁴Rheumatology, Desert Medical Advances, Palm Desert, CA, ¹⁵Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, and NIHR Leeds Biomedical Research Centre, Leeds Teaching Hospitals NHS Trust, Leeds, United Kingdom
Background/Purpose: DARWIN 3 (NCT02065700) is a long-term extension (LTE) study assessing the safety and efficacy of filgotinib (FIL) in patients with rheumatoid arthritis (RA) and…
Abstract Number: 2339 • ACR Convergence 2023
Fragility of Randomized Clinical Trials of Systemic Lupus Erythematosus and Lupus Nephritis Therapies
Gabriel Figueroa-Parra¹, Mike Putman² and Ali Duarte-Garcia³, ¹Division of Rheumatology, Mayo Clinic, Rochester, MN, ²Division of Rheumatology, Medical College of Wisconsin, Milwaukee, WI, ³Mayo Clinic, Rochester, MN
Background/Purpose: Randomized controlled trials (RCTs) in systemic lupus erythematosus (SLE) for novel therapeutics have frequently failed to meet criteria for regulatory approval. Even among drugs…
Abstract Number: 0314 • ACR Convergence 2023
Lack of Systemic Effects from Intra-articular XT-150 for the Treatment of Moderate to Severe Pain Due to OA of the Knee: Safety Results from a Phase 2 Trial
Leonard Kapural¹, Stephen D. Collins², Eric Grigsby³, Mark McBride⁴, Jayson Rieger⁵, Morgan Stokes⁶, Howard Rutman⁶ and Flavia Cicuttini⁷, ¹Center for Clinical Research, Winston-Salem, NC, ²Xalud Therapeutics, Inc., Chicago, IL, ³Neurovations Clinical Research, Napa, CA, ⁴Instat Clinical Research, Chatham, NJ, ⁵PBM Capital, Charlottesville, VA, ⁶Xalud Therapeutics, Inc., Berkeley, CA, ⁷Monash University, Melbourne, Australia
Background/Purpose: This study (NCT04124042) was designed to assess the safety, tolerability, and efficacy of XT-150, a non-viral gene therapy, in adult participants with moderate to…
Abstract Number: 0530 • ACR Convergence 2023
Impact of Upadacitinib on Wearable Device-Measured Physical Activity in Patients with Ankylosing Spondylitis from the SELECT-AXIS 2 Trial
Jeffrey Curtis¹, Rebecca Grainger², Dan Webster³, Jie Shen⁴, Ana Biljan⁵, Anna Shmagel⁴, Peter Wung⁴ and Philip J. Mease⁶, ¹University of Alabama at Birmingham, Birmingham, AL, ²University of Otago, Wellington, New Zealand, ³AbbVie, Inc., Libertyville, IL, ⁴AbbVie, Inc., North Chicago, IL, ⁵AbbVie, Inc., Buffalo Grove, IL, ⁶Swedish Medical Center/Providence St. Joseph Health and University of Washington School of Medicine, Seattle, WA
Background/Purpose: Physical activity is associated with reduced pain, improved mobility and physical function in people with ankylosing spondylitis (AS) and plays a crucial role in…
Abstract Number: 0838 • ACR Convergence 2023
Infusion of Etanercept into the Peripheral Lymphatics Significantly Reduces Disease Activity in Rheumatoid Arthritis Patients with Inadequate Response to Subcutaneous Injections
Russell Ross¹, Vibeke Strand², Roel Querubin³, John Goldman⁴, Richard Leff⁵, Alexis Melson¹, Pei-Ling Roerig⁶ and Alan Smith⁷, ¹Sorrento Therapeutics, Atlanta, GA, ²Stanford University, Portola Valley, CA, ³Marietta Rheumatology Associates, Marietta, GA, ⁴Northside Hospital, Atlanta, GA, ⁵Kezar Life Sciences, Chadds Ford, PA, ⁶4P Therapeutics, Orlando, FL, ⁷4P Therapeutics, Atlanta, GA
Background/Purpose: The lymphatic system serves as a conduit for transporting immune cells and inflammatory molecules present in arthritic joints to lymph nodes (LN), playing a…
Abstract Number: 1327 • ACR Convergence 2023
Effects of Long-Term Low Dose Glucocorticoid Treatment for Rheumatoid Arthritis on Body Weight and Blood Pressure: A Pooled Analysis of Individual Patient Data from Five Randomised Trials
Andriko Palmowski¹, Sabrina Mai Nielsen², Zhivana Boyadzhieva³, Linda Hartman⁴, Judith Oldenkott⁵, Björn Svensson⁶, Ingiäld Hafström⁷, Siegfried Wassenberg⁸, Ernest Choy⁹, John Kirwan¹⁰, Robin Christensen¹¹, Maarten Boers¹² and Frank Buttgereit¹³, ¹Charité - Universitätsmedizin Berlin, Berlin, Germany, ²The Parker Institute, Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark, ³Charité Universitatsmedizine - Berlin, Berlin, Germany, ⁴Amsterdam University Medical Centers, Amsterdam, Netherlands, ⁵Charite - University Medicine Berlin, Berlin, Germany, ⁶Lund University, Lund, Sweden, ⁷Karolinska Institutet, Stockholm, Sweden, ⁸Rheumazentrum Ratingen, Ratingen, Germany, ⁹Section of Rheumatology, Cardiff University, Cardiff, United Kingdom, ¹⁰University of Bristol, Bristol, United Kingdom, ¹¹Musculoskeletal Statistics Unit, The Parker Institute, Copenhagen, Denmark, ¹²Amsterdam UMC, Vrije Universiteit, Amersfoort, Netherlands, ¹³Charité Universitätsmedizin, Dept. Rheumatology, Berlin, Germany
Background/Purpose: High-dose glucocorticoids (GCs) can cause weight gain and hypertension. It is unclear whether GCs at ≤7.5mg/day prednisone equivalent ("low dose"), administered for rheumatoid arthritis…
Abstract Number: 1496 • ACR Convergence 2023
Clinical Safety and Efficacy Results from EQUALISE Type B: A Phase 1b Open-label Clinical Study of Itolizumab, a Novel anti-CD6 Therapy, in Subjects with Active Proliferative Lupus Nephritis
Kenneth Kalunian¹, Robert Levin², Sreejith Parameswaran³, nelson kopyt⁴, Stephen Connelly⁵, Eugene Sun⁵, Katie Kim⁵, maple fung⁵ and Manish Rathi⁶, ¹University of California San Diego, La Jolla, CA, ²South Florida University, Tampa, FL, ³JIPMER, New Delhi, India, ⁴LeHigh University, LeHigh, PA, ⁵Equillium, La Jolla, CA, ⁶Postgraduate Institute of Medical education and Research, Chandigarh, India
Background/Purpose: Itolizumab is a first-in-class, non-depleting, monoclonal antibody against the co-stimulatory receptor CD6 that blocks its interaction with ALCAM, to inhibit Teff cell activity and…

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