Abstracts tagged "clinical trials"

Abstract Number: 2771 • 2019 ACR/ARP Annual Meeting
A Phase I, Randomized, Double-blind, Placebo-controlled, Single Center, Single-dose Escalation to Investigate the Safety, Tolerability, and Pharmacodynamics of Subcutaneously Administered DEN-181 in Adult Patients with ACPA+ Rheumatoid Arthritis on Stable Methotrexate
Amee Sonigra ¹, Hendrik Nel ², Nishta Ramnoruth ², Meghna Talekar ², Joanne Tesiram ³, Frederik Stuurman ⁴, Lavinia Proctor ⁵, Helen Roberts ⁶, Robin Thurmond ⁷, Phillip Vecchio ³, Ian Gourley ⁸, Mark Rigby ⁹, Nathan Felix ¹⁰, Stephane Becart ¹¹, Kim Campbell ¹² and Ranjeny Thomas², ¹Princess Alexandra Hospital, Woolloongabba, Queensland, Australia, ²University of Queensland, Woolloongabba, Australia, ³Princess Alexandra Hospital, Woolloongabba, Australia, ⁴Centre for Human Drug Research, Leiden, Netherlands, ⁵Dendright, Woolloongabba, Australia, ⁶Dendright, Woolloongabba, Queensland, Australia, ⁷Janssen Research & Development, La Jolla, CA, ⁸Janssen Research & Development, Springhouse, ⁹Janssen Research & Development, La Jolla, ¹⁰Janssen R&D, Spring House, PA, ¹¹Janssen R&D, La Jolla, CA, ¹²Janssen Research & Development, LLC, Spring House, PA
Background/Purpose: Antigen-specific immunological tolerance strategies leverage the natural process of antigen presentation by dendritic cells (DCs) to regulate pathogenic T cells and B cells. We…
Abstract Number: 1217 • 2019 ACR/ARP Annual Meeting
Phase 2 Dose-ranging Study of SEL-212 in Symptomatic Gout Patients: Selection of Doses for Further Clinical Development
Rehan Azeem¹, Alan Kivitz ², Horacio Plotkin ¹, Lloyd Johnston ¹, Takashi K. Kishimoto ¹, Justin Park ¹, Stephen Smolinski ¹ and Wesley DeHaan ¹, ¹Selecta Biosciences, Watertown, MA, ²Altoona Center for Clinical Research, Duncansville, PA
Background/Purpose: Gout is caused by the deposition of monosodium urate (MSU) crystals in joints due to chronic hyperuricemia. Long-term treatment focuses on reducing serum uric…
Abstract Number: 2843 • 2019 ACR/ARP Annual Meeting
Safety and Efficacy of Lenabasum at Week 68 in an Open-Label Extension of a Phase 2 Study of Lenabasum in Refractory Skin-Predominant Dermatomyositis (DM) Subjects
Victoria Werth¹, David Pearson ², Joyce Okawa ², Rui Feng ³, Josef Concha ², Basil Patel ², Emily Hejazi ², Scott Constantine ⁴, Nancy Dgetluck ⁴ and Barbara White ⁴, ¹Corporal Michael J. Crescenz VAMC, Philadelphia, PA, USA and Department of Dermatology, University of Pennsylvania, Philadelphia, PA, USA, Philadelphia, PA, ²Philadelphia Veteran Affairs Medical Center, University of Pennsylvania, Philadelphia, PA, ³University of Pennsylvania, Philadelphia, ⁴Corbus Pharmaceuticals, Norwood, MA
Background/Purpose: Lenabasum is a rationally-designed preferential cannabinoid receptor type 2 agonist that activates resolution of innate immune responses to reduce tissue inflammation and fibrotic processes.…
Abstract Number: 1218 • 2019 ACR/ARP Annual Meeting
Monthly Dosing of ImmTOR Tolerogenic Nanoparticles Combined with Pegylated Uricase (Pegadricase) Enables Sustained Reduction of Acute Gout Flares in Symptomatic Gout Patients
Rehan Azeem¹, Justin Park ¹, Horacio Plotkin ¹, Alan Kivitz ², Lloyd Johnston ¹, Takashi K. Kishimoto ¹, Stephen Smolinski ¹ and Wesley DeHaan ¹, ¹Selecta Biosciences, Watertown, MA, ²Altoona Center for Clinical Research, Duncansville, PA
Background/Purpose: Long term gout treatment focuses on reducing sUA levels, thus allowing MSU crystals to dissolve. Rapid dissolution of MSU crystals during initial phase of…
Abstract Number: 2876 • 2019 ACR/ARP Annual Meeting
Go-Dact: A Phase 3b Randomized Double-Blind Placebo-Controled Proof-Of-Concept Trial, of Golimumab Plus Methotrexate (MTX) versus MTX Monotherapy, in Improving Dactylitis, in MTX Naïve Psoriatic Arthritis Patients
Elsa Vieira-Sousa¹, Pedro Alves ², Ana Maria Rodrigues ³, Filipa Teixeira ⁴, José Tavares-Costa ⁵, Alexandra Bernardo ⁶, Sofia Pimenta ⁶, Fernando Pimentel-Santos ⁷, João Lagoas Gomes ⁸, Renata Aguiar ⁹, Patrícia Pinto ¹⁰, Taciana Videira ¹⁰, Cristina Catita ¹¹, Helena Santos ¹², Joana Borges ¹³, Graça Sequeira ¹⁴, Célia Ribeiro ¹⁴, Lídia Teixeira ¹⁵, Pedro Ávila-Ribeiro ¹⁶, Fernando M Martins ¹⁷, Helena Canhão ¹⁸, Ruy M Ribeiro ¹⁹ and João Eurico Fonseca ¹⁶, ¹Rheumatology and Metabolic Bone Diseases, Hospital de Santa Maria - Centro Hospitalar Lisboa Norte, EPE | Rheumatology Research Unit, Instituto de Medicina Molecular - Faculty of Medicine, University of Lisbon, Lisbon Academic Medical Centre, Lisbon, Portugal,, Lisbon, Portugal, ²Radiology Department, CHLC, Lisbon, Portugal, ³Rheumatology Unit, , HSEIT, Ilha Terceira, Açores e FMUL, Centro Académico de Medicina de Lisboa, Lisbon, Portugal, ⁴Rheumatology Department, ULSAM, Ponte de Lima, Portugal, ⁵ULSAM, Ponte de Lima, Portugal, ⁶Rheumatology Department, CHSJ, Porto, Portugal, ⁷CEDOC, NOVA-Medical School | Hospital Egas Moniz, CHLO, Lisbon, Lisbon, Portugal, ⁸Rheumatology Department, Hospital de Egas Moniz, Centro Hospitalar de Lisboa Ocidental; CEDOC, NOVA Medical School, Faculdade de Ciências Médicas, Lisbon., Lisbon, Portugal, ⁹Rheumatology Department, CHBV, Aveiro, Portugal, ¹⁰Rheumatology Department, CHVNG, Vila Nova de Gaia, Portugal, ¹¹Hospital Particular do Algarve, Faro, Portugal, ¹²Instituto Português de Reumatologia (IPR), Lisbon, Portugal, ¹³Instituto Português de Reumatologia, Lisbon, Portugal, ¹⁴Rheumatology Unit, CHA, Faro, Portugal, ¹⁵Rheumatology Department, HGO, Almada, Portugal, ¹⁶Rheumatology and Bone Diseases Department, Hospital de Santa Maria, Centro Hospitalar Universitário Lisboa Norte; Unidade de Investigação em Reumatologia, Instituto de Medicina Molecular, Faculdade de Medicina, Universidade de Lisboa; Centro Académico de Medicina de Lisboa; Lisbon, Portugal., Lisbon, Portugal, ¹⁷Portuguese Society of Rheumatology, Lisbon, Portugal, ¹⁸CEDOC, EpiDoC Unit, NOVA Medical School, Lisbon, Lisbon, Portugal, ¹⁹Laboratório de Biomatemática, FMUL, Lisbon, Portugal
Background/Purpose: Psoriatic arthritis (PsA) dactylitis is associated with an increased risk of erosions and higher disease activity. Dactylitis treatment strategies are however controversial due to…
Abstract Number: 1383 • 2018 ACR/ARHP Annual Meeting
Examining Cutaneous Disease Activity As an Outcome Measure for Clinical Trials in Dermatomyositis
Rebecca Gaffney¹, Meera Tarazi², Rui Feng³, David Pearson⁴ and Victoria P. Werth⁵, ¹Dermatology, University of Pennsylvania, Philadelphia, PA, ²Department of Dermatology, University of Pennsylvania, Philadelphia, PA, ³Biostatistics, Epidemiology and Informatics, University of Pennsylvania, Philadelphia, PA, ⁴Philadelphia Veterans Affairs Medical Center, Philadelphia, PA, ⁵Department of Dermatology, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA
Background/Purpose: The FDA encourages clearance of skin findings as a primary outcome of clinical trials for inflammatory skin conditions. However, some DM patients retain signs…
Abstract Number: 2931 • 2018 ACR/ARHP Annual Meeting
Missing Outcomes in SLE Clinical Trials: Impact on Estimating Treatment Effects
Mimi Kim¹, Joan T. Merrill², Kenneth C. Kalunian³, Leslie Hanrahan⁴ and Peter M. Izmirly⁵, ¹Epidemiology and Population Health, Albert Einstein College of Medicine, Bronx, NY, ²University of Oklahoma Health Sciences Center, Oklahoma City, OK, ³Division of Rheumatology, Allergy and Immunology, UCSD School of Medicine, La Jolla, CA, ⁴Lupus Foundation of America, Washington DC, DC, ⁵NYU Langone Health, New York, NY
Background/Purpose: Missing data due to drop-out and loss to follow-up is a common problem in SLE trials. The usual approaches for handling this issue include…
Abstract Number: 1519 • 2018 ACR/ARHP Annual Meeting
Patient Characteristics Associated with Discontinuation of Tofacitinib for the Treatment of Rheumatoid Arthritis in Open-Label, Long-Term Extension Studies up to 9.5 Years
Jeffrey R. Curtis¹, Jürgen Wollenhaupt², Katerina Chatzidionysiou³, Sander W. Tas⁴, Lisy Wang⁵, Harry Shi⁶, María Montoro⁷, Petra Neregård⁸, Palle Dahl⁹ and Vassilis Tsekouras¹⁰, ¹University of Alabama at Birmingham, Birmingham, AL, ²Schön Klinik Hamburg-Eilbek Teaching Hospital of the University of Hamburg, Hamburg, Germany, ³Division of Rheumatology, Department of Medicine, Karolinska Institutet, Stockholm, Sweden, ⁴Amsterdam Rheumatology and Immunology Center, Academic Medical Center, Amsterdam, Netherlands, ⁵Pfizer Inc, Groton, CT, ⁶Pfizer Inc, Collegeville, PA, ⁷Pfizer Inc, Madrid, Spain, ⁸Pfizer Inc, Stochholm, Sweden, ⁹Pfizer Inc, Ballerup, Denmark, ¹⁰Pfizer Inc, Athens, Greece
Background/Purpose: Tofacitinib is an oral Janus kinase inhibitor for the treatment of RA. We explored characteristics of patients (pts) who discontinued (d/c) open-label, long-term extension…
Abstract Number: 2977 • 2018 ACR/ARHP Annual Meeting
Lenabasum, a Cannabinoid Type 2 Receptor Agonist, Reduces T-Cell Population and Downregulates Type 1 and 2 Interferon Activities in Lesional Dermatomyositis Skin
Nithin Reddy^1,2, Majid Zeidi^1,2, Barbara White³ and Victoria P. Werth^1,2, ¹University of Pennsylvania, Philadelphia, PA, ²Philadelphia Veterans Affairs Medical Center, Philadelphia, PA, ³Corbus Pharmaceuticals, Inc., Norwood, MA
Background/Purpose: Lenabasum is a synthetic, non-immunosuppressive, selective cannabinoid receptor type 2 (CB2) agonist that activates resolution of innate immune responses. CB2 is a G-protein coupled…
Abstract Number: 1552 • 2018 ACR/ARHP Annual Meeting
No Effect of Concomitant Glucocorticoid Therapy on Efficacy and Safety of Tocilizumab Monotherapy Found in Rheumatoid Arthritis Clinical Trials
Mary Safy¹, Johannes W. G. Jacobs¹, Michael Edwardes², Maria JH de Hair¹, Xavier M Teitsma¹, Paco MJ Welsing¹, Michelle EA Borm³, Yves Luder⁴, Jacob van Laar¹, Attila Pethö-Schramm⁴ and Johannes W. J. Bijlsma⁵, ¹Department of Rheumatology & Clinical Immunology, University Medical Center Utrecht, Utrecht, the Netherlands, Utrecht, Netherlands, ²Everest Clinical Research, Markham, ON, Canada, ³Roche Nederland BV, Woerden, Netherlands, ⁴F. Hoffmann-La Roche, Basel, Switzerland, ⁵Rheumatology & Clinical Immunology department University Medical Center Utrecht, Utrecht University, Utrecht, Netherlands
No effect of concomitant glucocorticoid therapy on efficacy and safety of tocilizumab monotherapy in rheumatoid arthritis clinical trialsM. Safy1, J.W.G. Jacobs1, M. Edwardes2, M.J.H. de…
Abstract Number: 1644 • 2018 ACR/ARHP Annual Meeting
Improvement in Morning Stiffness in Subjects with Psa Is Associated with Improvements in Pain, Physical Function, and Patient Global Response to Treatment
Ana-Maria Orbai¹, Jessica Walsh², Peter Nash³, Lichen Teng⁴, Benoit Guerette⁴ and Rieke Alten⁵, ¹Johns Hopkins University School of Medicine, Baltimore, MD, ²University of Utah School of Medicine, Salt Lake City, UT, USA, Salt Lake City, UT, ³University of Queensland, Brisbane, Australia, ⁴Celgene Corporation, Summit, NJ, ⁵Schlosspark-Klinik University Medicine, Berlin, Germany
Background/Purpose: Stiffness is an important component of inflammatory arthritis and plays a role in PsA flare. Patients with inflammatory arthritis report difficulty with activities, “slowing…
Abstract Number: 1715 • 2018 ACR/ARHP Annual Meeting
Safety and Efficacy of Lenabasum in an Open-Label Extension of a Phase 2 Study in Diffuse Cutaneous Systemic Sclerosis Subjects
Robert F. Spiera¹, Laura K. Hummers², Lorinda Chung³, Tracy M. Frech⁴, Robyn T. Domsic⁵, Vivien Hsu⁶, Daniel E. Furst⁷, Jessica K. Gordon¹, Maureen D. Mayes⁸, Robert W. Simms⁹, Elizabeth Lee¹⁰, Scott Constantine¹⁰ and Barbara White¹⁰, ¹Hospital for Special Surgery, New York, NY, ²Division of Rheumatology, Johns Hopkins University School of Medicine, Baltimore, MD, ³Immunology and Rheumatology, Stanford University School of Medicine, Palo Alto, CA, ⁴Division of Rheumatology, University of Utah, Salt Lake City, UT, ⁵Medicine - Rheumatology, University of Pittsburgh, Pittsburgh, PA, ⁶Rheumatology, Robert Wood Johnson Medical School, New Brunswick, NJ, ⁷Pacific Arthritis Associates, Los Angeles; University of California, Los Angeles; University of Washington, Seattle; University of Florence, Italy, Los Angeles, CA, ⁸Rheumatology, University of Texas McGovern Medical School, Houston, TX, ⁹Rheumatology, Boston University School of Medicine, Boston, MA, ¹⁰Corbus Pharmaceuticals, Inc., Norwood, MA
Background/Purpose: Lenabasum is a synthetic, non-immunosuppressive, selective cannabinoid receptor type 2 agonist that activates resolution of innate immune responses. Lenabasum had acceptable safety and tolerability,…
Abstract Number: 302 • 2018 ACR/ARHP Annual Meeting
Validity and Responsiveness of Inflammation and Joint Damage Scores Based on the Omeract Rheumatoid Arthritis MRI Scoring System
Ulf Sundin¹, Mikkel Østergaard², Daniel Glinatsi³, Anna-Birgitte Aga⁴, Kim Hørslev-Petersen⁵, Merete Lund Hetland⁶, Peter Junker⁷, Bo Jannik Ejbjerg⁸, Paul Bird⁹, Philip G. Conaghan¹⁰, Siri Lillegraven⁴ and Espen A. Haavardsholm⁴, ¹*Dept. of Rheumatology, Diakonhjemmet Hospital, Oslo, Norway, ²Center for Rheumatology and Spine Diseases, Rigshospitalet Glostrup Copenhagen Center for Arthritis Research, Copenhagen, Denmark, ³Copenhagen Center for Arthritis Research (COPECARE), Center for Rheumatology and Spine Diseases, Rigshospitalet, Centre for Head and Orthopaedics, Rigshospitalet, Glostrup, Denmark, ⁴Dept. of Rheumatology, Diakonhjemmet Hospital, Oslo, Norway, ⁵King Christian 10th Hospital for Rheumatic Diseases, University of Southern Denmark, Institute of Regional Health Research, Graasten, Denmark, ⁶Copenhagen Center for Arthritis Research, Center for Rheumatology and Spine Diseases, The DANBIO Registry, Glostrup, Denmark, ⁷Odense University Hospital, Odense, Denmark, ⁸Department of Rheumatology, Zealand University Hospital, Køge, Denmark, ⁹Medicine, University of New South Wales, Sydney, NSW, Australia, ¹⁰University of Leeds, Leeds, United Kingdom
Background/Purpose: The RAMRIS scoring system is used to quantify synovitis, tenosynovitis, bone marrow edema (BME), bone erosions and joint space narrowing (JSN) on MRI examinations…
Abstract Number: 1872 • 2018 ACR/ARHP Annual Meeting
Safety and Efficacy of Allogeneic Umbilical Cord-Derived Mesenchymal Stem Cells in Patients with Systemic Lupus Erythematosus: Results of an Open-Label Phase I Study
Diane L. Kamen¹, Paul J. Nietert², Hongjun Wang³, Tara Duke³, Colleen Cloud³, Angela Robinson³ and Gary S. Gilkeson⁴, ¹Medicine/Rheumatology & Immunology, Medical University of South Carolina, Charleston, SC, ²Public Health Sciences, Medical University of South Carolina, Charleston, SC, ³Medical University of South Carolina, Charleston, SC, ⁴Department of Medicine, Medical University of South Carolina, Charleston, SC
Background/Purpose: Mesenchymal stem cells (MSCs) are known to possess significant immunosuppressive and tissue protective properties, and their use in refractory systemic lupus erythematosus (SLE) is…
Abstract Number: 478 • 2018 ACR/ARHP Annual Meeting
Evidence Based Recommendations for Corticosteroid Tapering/Discontinuation in New Onset Juvenile Dermatomyositis Patients: Results from the Paediatric Rheumatology International Trials Organisation
Gabriella Giancane¹, Claudio Lavarello², Angela Pistorio², Francesco Zulian², Bo Magnusson³, Tadej Avcin², Fabrizia Corona², Valeria Gerloni², Serena Pastore², Roberto Marini², Silvana Martino², Anne Pagnier⁴, Michel Rodiere², Christine Soler², Valda Stanevicha², Rebecca ten Cate², Yosef Uziel², Jelena Vojinovic², Elena Fueri², Angelo Ravelli⁵, Alberto Martini⁶ and Nicola Ruperto⁷, ¹Clinica Pediatrica - Reumatologia, Istituto Giannina Gaslini, Genoa, Italy, ²Istituto Giannina Gaslini - Clinica Pediatrica e Reumatologia - PRINTO, Genoa, Italy, ³Karolinska University Hospital, Stockholm, Sweden, ⁴Istituto Giannina Gaslini - Clinica Pediatrica e Reumatologia - PRINTO, Genova, Italy, ⁵Clinica Pediatrica - Reumatologia, Istituto Giannina Gaslini, Genova, Italy, ⁶Universita di Genova Pediatria II, Genova, Italy, ⁷Istituto Giannina Gaslini - Clinica Pediatrica e Reumatologia, Genoa, Italy
Background/Purpose: At present no clear evidence based guidelines exist to standardize the tapering and discontinuation of corticosteroids (CS) in juvenile dermatomyositis (JDM). Aim of our…

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