Request for Single Patient IND for Compassionate/Emergency Use of Tocilizumab
Primary Purpose
Juvenile Idiopathic Arthritis
Status
No longer available
Phase
Locations
United States
Study Type
Expanded Access
Intervention
Tocilizumab
Sponsored by
About this trial
This is an expanded access trial for Juvenile Idiopathic Arthritis focused on measuring juvenile idiopathic arthritis
Eligibility Criteria
Inclusion Criteria:
- Subject X, polyarticular JIA, not responding to any other drug
Exclusion Criteria:
- Not identified subject
Sites / Locations
- University of Oklahoma Health Sciences Center
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00862758
First Posted
March 16, 2009
Last Updated
December 9, 2013
Sponsor
University of Oklahoma
Collaborators
Hoffmann-La Roche
1. Study Identification
Unique Protocol Identification Number
NCT00862758
Brief Title
Request for Single Patient IND for Compassionate/Emergency Use of Tocilizumab
Official Title
Emergency IND for Provision of Tocilizumab
Study Type
Expanded Access
2. Study Status
Record Verification Date
December 2013
Overall Recruitment Status
No longer available
Study Start Date
February 2009 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
October 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Oklahoma
Collaborators
Hoffmann-La Roche
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Application for Compassionate Use of Tocilizumab in a Boy with Severe Polyarticular Juvenile Idiopathic Arthritis (JIA) Unresponsive to All Licensed Medications.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Juvenile Idiopathic Arthritis
Keywords
juvenile idiopathic arthritis
7. Study Design
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Tocilizumab
Intervention Description
8 mg/kg would be administered IV every 2 weeks for six weeks.
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subject X, polyarticular JIA, not responding to any other drug
Exclusion Criteria:
Not identified subject
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kathleen O'Neil, M.D.
Organizational Affiliation
University of Oklahoma
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Oklahoma Health Sciences Center
City
Oklahoma CIty
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Request for Single Patient IND for Compassionate/Emergency Use of Tocilizumab
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