Evidence of bioequivalence and positive patient user handling of a tocilizumab autoinjector

Autor: Navita L. Mallalieu, Christopher M Mela, Wendy Douglass, Christine Wells, Scott Fettner, Florian Wildenhahn, Monica Tavanti

Publikováno v: Expert opinion on drug delivery. 16(5)

Background: The anti–interleukin-6 receptor antibody tocilizumab is approved for subcutaneous injection using a prefilled syringe (PFS). We report results from a bioequivalence study in healthy subjects and a user-handling study in patients with rh

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::350d1a17dc012d9d8b6ace4f36c4cd19
https://pubmed.ncbi.nlm.nih.gov/31043095

Novel methodology to discern predictors of remission and patterns of disease activity over time using rheumatoid arthritis clinical trials data

Autor: A. Gilmour, S Schwank, Frederic Geissmann, Christopher M Mela, B Kola, B Harvey, I Vranic, Evan Tzanis, H-D Zucht, Peter C. Taylor, J Diboll, Alexandra Belson, G Molyneux, MA Sleeman, Rekha Parmar, E Vernon, Stephen P. Young, Iona Donnelly, C Cuff, P Schulz-Knappe, Heidi Lempp, Christopher D. Buckley, N Payne, John D. Isaacs, Coziana Ciurtin, H Noble, M Macoritto, A Parke, S Jelinsky, James N. Galloway, Ian C. Scott, Frederique Ponchel, Sarah Keidel, Denny Verbeeck, A Didierlaurent, MF McDermot, J Tarn, AT Virlan, T Lazarov, J Ellis, S Kaymakcalan, Anthony Rowe, Catharien M. U. Hilkens, G Altobelli, M Loza, P Jones, Ayako Wakatsuki Pedersen, Ian N. Bruce, Duncan Porter, A Cuza, D Ziemek, S Talbot, C Marshall, A Herath, D Finch, D Baker, Maya H Buch, Y Zhong, R Toward, Ludbrook, Mark Coles, Barnes, M Ho, M Page, J Casement, M Maciejewski, Claudio Carini, Sarah Brockbank, D Nguyen, H Tipney, A Filer, Christopher R. John, S Kelly, Andrew P. Cope, W Burny, M Curran, Catharina Lindholm, Benjamin A Fisher, Ray Harris, Jehan J. El-Jawhari, P Stocks, D Dastros-Pitel, Z Liu, Bdm Tom, Dennis Lendrem, Wayne Tsuji, F Stirling, J Worthington, Deborah P M Symmons, Matthew A. Sleeman, D Padhji, Fowzia Ibrahim, Smm Verstappen, P Budde, Ehrenstein, Marc C. Levesque, R Harry, B Allen, T Sabin, Michael Binks, Sally Hollis, Gerry Parker, S Lipsky, Georgina Thorborn, M Jenkins, A Hughes-Morley, Costantino Pitzalis, N Joseph, H Edwards, Jamie C. Sergeant, Paul Emery, H Ali, JA Butler, Liliane Fossati-Jimack, S Wright, Fiona Clarke, W Wu, Amy E. Anderson, Sharmila Rana, F Humby, F Hong, Myles Lewis, A Haynes, Katriona Goldmann, S Martins, CT Mela, S Hasan, David Scott, L Rowell, David Watson, Neil Gozzard, Karim Raza, Simon Read, M Hodge, Carl S. Goodyear, Farewell, George Davey Smith, Michele Bombardieri, Iain B. McInnes, C Larminie, G Simpson, N Ward, K Hicks, R Rao, Z Jia, FB Capdevila, A Long

Publikováno v: RA-MAP Consortium, Tom, B & Symmons, D 2018, ' Novel methodology to discern predictors of remission and patterns of disease activity over time using rheumatoid arthritis clinical trials data ', RMD Open, vol. 4, no. 2, pp. e000721 . https://doi.org/10.1136/rmdopen-2018-000721
RMD Open

ObjectivesTo identify predictors of remission and disease activity patterns in patients with rheumatoid arthritis (RA) using individual participant data (IPD) from clinical trials.MethodsPhase II and III clinical trials completed between 2002 and 201

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::5b48a096d68180fc5745f1e771c2710f
https://doi.org/10.1136/rmdopen-2018-000721

Glucocorticoid Effect on Radiographic Progression in Placebo Arms of Rheumatoid Arthritis Biologics Trials

Autor: Maarten Boers, Daniel Aletaha, Josef S Smolen, Christopher M Mela, Daniel Baker

Publikováno v: Journal of Rheumatology, 43(6), 1024-1026. Journal of Rheumatology
Boers, M, Aletaha, D, Mela, C M, Baker, D G & Smolen, J S 2016, ' Glucocorticoid Effect on Radiographic Progression in Placebo Arms of Rheumatoid Arthritis Biologics Trials ', Journal of Rheumatology, vol. 43, no. 6, pp. 1024-1026 . https://doi.org/10.3899/jrheum.150932

Objective.To assess the effect of glucocorticoids (GC) on damage progression in placebo-biologic arms of rheumatoid arthritis (RA) biologics trials.Methods.Posthoc metaanalysis of 2 infliximab (IFX) trials (established and early RA) and 1 tocilizumab

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::8ad2b8d4f578f43cfd71c7d45e18664f
https://research.vumc.nl/en/publications/1732ce89-b789-4df9-91cd-20c7878db24e

Erratum: The RA-MAP Consortium: a working model for academia–industry collaboration

Autor: Peter Schulze-Knappe, Alexandra Belson, Simon Read, Carl S. Goodyear, Sarah Keidel, Andrew P. Cope, Ravi Rao, Iain B. McInnes, Catharina Lindholm, Wayne Tsuji, Christopher M Mela, Marc C. Levesque, Brian D. M. Tom, Duncan Porter, Ray Harris, Michael R. Ehrenstein, Gerry Parker, Peter C. Taylor, Anthony Rowe, Sally Hollis, Matthew A. Sleeman, Frederique Ponchel, Denny Verbeeck, Neil Gozzard, Ayako Wakatsuki Pedersen, Deborah P M Symmons, Paul Emery, Claudio Carini, Michael Binks, Benjamin A Fisher, Michael F. McDermott, Francisco Bonachela-Capdevila, Sarah Brockbank, John D. Isaacs, Michael R. Barnes

Publikováno v: Nature Reviews Rheumatology. 14:119-119

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::48bc86a0d259c6cc566763437f4ff26e
https://doi.org/10.1038/nrrheum.2018.6

NKG2C + NK Cells Are Enriched in AIDS Patients with Advanced-Stage Kaposi's Sarcoma

Autor: Alan Steel, Christopher M Mela, Brian Gazzard, Mark Bower, F. Gotch, Martin R. Goodier

Publikováno v: Journal of Virology. 81:430-433

Kaposi's sarcoma (KS) is an AIDS-defining condition in individuals with human immunodeficiency virus type 1 infection. We investigated the phenotype and function of the NKG2C + NK cell population in individuals with AIDS and Kaposi's sarcoma. The sta

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::36615a23bdb08882058a4e182679d018
https://doi.org/10.1128/jvi.01567-06