Tocilizumab for Relapsing Polychondritis

Relapsing Polychondritis Clinical Trial

Official title:

Efficacy of Tocilizumab in a Patient With Relapsing Polychondritis

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01104480
• Other study ID #: RP2010
• Status: Withdrawn
• Phase: Phase 2
• First received: April 13, 2010
• Last updated: May 12, 2014
• Start date: May 2010
• Est. completion date: May 2012

Study information

• Verified date: May 2014
• Source: McMaster Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Withdrawn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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Relapsing Polychondritis

Intervention

Drug:
• Tocilizumab
Tocilizumab 8mg/kg every 2 weeks given by IV infusion

Locations

Country	Name	City	State
Canada	McMaster Children's Hospital	Hamilton	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
McMaster Children's Hospital

Country where clinical trial is conducted

Canada, 

Outcome

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