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Request for Single Patient IND for Compassionate/Emergency Use of Tocilizumab

Expanded access is no longer available for this treatment.
Sponsor:
Collaborator:
Hoffmann-La Roche
Information provided by (Responsible Party):
University of Oklahoma
ClinicalTrials.gov Identifier:
NCT00862758
First received: March 16, 2009
Last updated: December 9, 2013
Last verified: December 2013
  Purpose

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


Condition Intervention
Juvenile Idiopathic Arthritis
Drug: Tocilizumab

Study Type: Expanded Access     What is Expanded Access?
Official Title: Emergency IND for Provision of Tocilizumab

Resource links provided by NLM:


Further study details as provided by University of Oklahoma:

Study Start Date: February 2009
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Tocilizumab
    8 mg/kg would be administered IV every 2 weeks for six weeks.
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.

  Eligibility

Ages Eligible for Study:   11 Years to 12 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Not identified subject
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00862758

Locations
United States, Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma CIty, Oklahoma, United States, 73104
Sponsors and Collaborators
University of Oklahoma
Hoffmann-La Roche
Investigators
Principal Investigator: Kathleen O'Neil, M.D. University of Oklahoma
  More Information

No publications provided

Responsible Party: University of Oklahoma
ClinicalTrials.gov Identifier: NCT00862758     History of Changes
Other Study ID Numbers: 14524
Study First Received: March 16, 2009
Last Updated: December 9, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Oklahoma:
juvenile idiopathic arthritis

Additional relevant MeSH terms:
Arthritis
Arthritis, Juvenile
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on November 20, 2014