Request for Single Patient IND for Compassionate/Emergency Use of Tocilizumab
|Study Type:||Expanded Access What is Expanded Access?|
|Official Title:||Emergency IND for Provision of Tocilizumab|
|Study Start Date:||February 2009|
|Study Completion Date:||October 2010|
|Primary Completion Date:||October 2010 (Final data collection date for primary outcome measure)|
This trial is for a single subject with juvenile idiopathic arthritis unresponsive to all licensed treatments for JIA, and some licensed only for rheumatoid arthritis. He is currently wheelchair bound and completely dependent for activities of daily living and self-care. He is in constant pain, has abundant warmth and swelling of nearly all joints including TMJs, neck, shoulders, elbows, wrists, MCP and finger joints (even some DIP joints), hips, knees, ankles, subtalar and intertarsal joints, MTP and IP joints of the toes.
Drug at a dose of 8 mg/kg would be administered IV every 2 weeks, with close safety and monitoring studies.
Treatment would be monitored every 2 weeks. Efficacy will be measured using the ACR Pedi 30, 50 and 90 definitions as previously published, based on: 1) physician global assessment of disease activity; 2) parent/patient assessment of overall well-being; 3) functional ability; 4) number of joints with active arthritis; 5) number of joints with limited range of motion; and 6) erythrocyte sedimentation rate.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00862758
|United States, Oklahoma|
|University of Oklahoma Health Sciences Center|
|Oklahoma CIty, Oklahoma, United States, 73104|
|Principal Investigator:||Kathleen O'Neil, M.D.||University of Oklahoma|