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Ocrelizumab, a humanized anti-CD20 monoclonal antibody, in the treatment of patients with rheumatoid arthritis: a phase I/II randomized, blinded, placebo-controlled, dose-ranging study.
Genovese MC, Kaine JL, Lowenstein MB, Del Giudice J, Baldassare A, Schechtman J, Fudman E, Kohen M, Gujrathi S, Trapp RG, Sweiss NJ, Spaniolo G, Dummer W; ACTION Study Group. Genovese MC, et al. Among authors: spaniolo g. Arthritis Rheum. 2008 Sep;58(9):2652-61. doi: 10.1002/art.23732. Arthritis Rheum. 2008. PMID: 18759293 Free article. Clinical Trial.
An industry statistician's perspective on PHC drug development.
Fridlyand J, Yeh RF, Mackey H, Bengtsson T, Delmar P, Spaniolo G, Lieberman G. Fridlyand J, et al. Among authors: spaniolo g. Contemp Clin Trials. 2013 Nov;36(2):624-35. doi: 10.1016/j.cct.2013.04.006. Epub 2013 May 3. Contemp Clin Trials. 2013. PMID: 23648396 Review.