Relapsing Polychondritis Clinical Trial
Official title:
Efficacy of Tocilizumab in a Patient With Relapsing Polychondritis
Verified date | May 2014 |
Source | McMaster Children's Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | Canada: Health Canada |
Study type | Interventional |
This is a study for one patient with severe relapsing polychondritis which has been unresponsive to other more conventional medications including prednisone, methotrexate, anakinra and TNF inhibitors. Tolerability, and efficacy of the drug, Tocilizumab will be monitored by clinical assessment and bloodwork.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | May 2012 |
Est. primary completion date | July 2010 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 12 Years to 15 Years |
Eligibility |
Inclusion Criteria: - A single patient with unremitting inflammatory relapsing polychondritis Exclusion Criteria: - As this is a study in a single patient, there are no exclusions |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | McMaster Children's Hospital | Hamilton | Ontario |
Lead Sponsor | Collaborator |
---|---|
McMaster Children's Hospital |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Efficacy of Tocilizumab | Inhibition of inflammatory markers Improvement in symptoms and signs | 2 years | No |
Secondary | Safety of Tocilizumab | Monitoring of serum lipids and liver function tests | 2 years | Yes |
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