Arvind Chopra, S Chandrashekara, Rajgopalan Iyer, Liza Rajasekhar, Naresh Shetty, Sarathchandra Mouli Veeravalli, Alakendu Ghosh, Mrugank Merchant, Jyotsna Oak, Vikram Londhey, Abhijit Barve, M S Ramakrishnan, Enrique Montero
The objective of this study was to assess the safety and efficacy of itolizumab with methotrexate in active rheumatoid arthritis (RA) patients who had inadequate response to methotrexate. In this open-label, phase 2 study, 70 patients fulfilling American College of Rheumatology (ACR) criteria and negative for latent tuberculosis were randomized to four arms: 0.2, 0.4, or 0.8 mg/kg itolizumab weekly combined with oral methotrexate, and methotrexate alone (2:2:2:1). Patients were treated for 12 weeks, followed by 12 weeks of methotrexate alone during follow-up...
April 2016: Clinical Rheumatology