Request for Single Patient IND for Compassionate/Emergency Use of Tocilizumab
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00862758|
Recruitment Status : No longer available
First Posted : March 17, 2009
Last Update Posted : December 10, 2013
|Condition or disease||Intervention/treatment|
|Juvenile Idiopathic Arthritis||Drug: Tocilizumab|
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.
|Study Type :||Expanded Access|
|Official Title:||Emergency IND for Provision of Tocilizumab|
|Study Start Date :||February 2009|
|Actual Primary Completion Date :||October 2010|
|Actual Study Completion Date :||October 2010|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|