Tocilizumab for Relapsing Polychondritis

Phase 2

Withdrawn

• Conditions: Relapsing Polychondritis

• Registration Number: NCT01104480
• Lead Sponsor: McMaster Children's Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-04-13
• Study First Submitted QC: 2010-04-13
• Study First Posted: 2010-04-15
• Study Start: 2010-05
• Primary Completion: 2010-07
• Study Completion: 2012-05
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-12
• Last Update Posted: 2014-05-13

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Male
• Target Recruitment: Not specified

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Efficacy of Tocilizumab	2 years	Inhibition of inflammatory markers Improvement in symptoms and signs

Secondary Outcome Measures

Name	Time	Method
Safety of Tocilizumab	2 years	Monitoring of serum lipids and liver function tests

Trial Locations

Locations (1)

McMaster Children's Hospital; 🇨🇦 Hamilton, Ontario, Canada