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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. Identifier: NCT00862758
Expanded Access Status : No longer available
First Posted : March 17, 2009
Last Update Posted : December 10, 2013
Hoffmann-La Roche
Information provided by (Responsible Party):
University of Oklahoma

Brief Summary:
Application for Compassionate Use of Tocilizumab in a Boy with Severe Polyarticular Juvenile Idiopathic Arthritis (JIA) Unresponsive to All Licensed Medications.

Condition or disease Intervention/treatment
Juvenile Idiopathic Arthritis Drug: Tocilizumab

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.

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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

Intervention Details:
  • Drug: Tocilizumab
    8 mg/kg would be administered IV every 2 weeks for six weeks.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   11 Years to 12 Years   (Child)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Subject X, polyarticular JIA, not responding to any other drug

Exclusion Criteria:

  • Not identified subject

Information from the National Library of Medicine

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 identifier (NCT number): NCT00862758

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United States, Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma CIty, Oklahoma, United States, 73104
Sponsors and Collaborators
University of Oklahoma
Hoffmann-La Roche
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Principal Investigator: Kathleen O'Neil, M.D. University of Oklahoma
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Responsible Party: University of Oklahoma Identifier: NCT00862758    
Other Study ID Numbers: 14524
First Posted: March 17, 2009    Key Record Dates
Last Update Posted: December 10, 2013
Last Verified: December 2013
Keywords provided by University of Oklahoma:
juvenile idiopathic arthritis
Additional relevant MeSH terms:
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Arthritis, Juvenile
Joint Diseases
Musculoskeletal Diseases
Disease Attributes
Pathologic Processes
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases