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.

@article{Genovese2008OcrelizumabAH,
  title={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.},
  author={Mark C Genovese and Jeffrey L Kaine and Mitchell B Lowenstein and Jos{\'e} Del Giudice and Andrew R Baldassare and Joy Schechtman and Edward J Fudman and Michael David Kohen and Sheila Gujrathi and Robert G Trapp and Nadera J. Sweiss and Greg Spaniolo and Wolfgang Dummer},
  journal={Arthritis and rheumatism},
  year={2008},
  volume={58 9},
  pages={2652-61}
}
OBJECTIVE Ocrelizumab, a humanized anti-CD20 monoclonal antibody, was studied in a first-in-human trial in rheumatoid arthritis (RA) patients receiving concomitant methotrexate (MTX). METHODS The ACTION trial was a combined phase I/II study of placebo plus MTX versus ocrelizumab plus MTX in 237 RA patients (intent-to-treat population). During phase I, 45 patients were treated with 1 of 5 escalating doses of study drug (infusions on days 1 and 15, 10-1,000 mg per each infusion). An additional… CONTINUE READING
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