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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NO_LONGER_AVAILABLE

Study Classification

EXPANDED_ACCESS

Study Start Date

2009-02-28

Study Completion Date

2010-10-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Juvenile Idiopathic Arthritis

Keywords

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juvenile idiopathic arthritis

Interventions

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Tocilizumab

8 mg/kg would be administered IV every 2 weeks for six weeks.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Not identified subject

Minimum Eligible Age

11 Years

Maximum Eligible Age

12 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kathleen O'Neil, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Oklahoma

Locations

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University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

Site Status

Countries

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United States

Other Identifiers

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14524

Identifier Type: -

Identifier Source: org_study_id