Tocilizumab for Relapsing Polychondritis

• Sponsor: McMaster Children's Hospital (Other)
• Overall Status: Withdrawn
• CT.gov ID: NCT01104480
• Collaborator: (none)
• Enrollment: 0
• Location: 1
• Duration (Months): 24
• Patients Per Site Per Month: 0

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Relapsing Polychondritis	Drug: Tocilizumab	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 0 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Efficacy of Tocilizumab in a Patient With Relapsing Polychondritis
• Study Start Date: May 1, 2010
• Anticipated Primary Completion Date: Jul 1, 2010
• Anticipated Study Completion Date: May 1, 2012

Outcome Measures

Primary Outcome Measures

1. Efficacy of Tocilizumab [2 years]

   Inhibition of inflammatory markers Improvement in symptoms and signs

Secondary Outcome Measures

1. Safety of Tocilizumab [2 years]

   Monitoring of serum lipids and liver function tests

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Years to 15 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	McMaster Children's Hospital	Hamilton	Ontario	Canada	L8N 3YZ

Sponsors and Collaborators

• McMaster Children's Hospital

Investigators

• Principal Investigator: Maggie Larché, MD, PhD, McMaster University and Children's Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dr Maggie Larche, Associate professor, McMaster Children's Hospital
• ClinicalTrials.gov Identifier: NCT01104480
• Other Study ID Numbers: RP2010
• First Posted: Apr 15, 2010
• Last Update Posted: May 13, 2014
• Last Verified: May 1, 2014

• Keywords provided by Dr Maggie Larche, Associate professor, McMaster Children's Hospital: Relapsing Polychondritis; Unremitting; Inflammation; IL6
• Additional relevant MeSH terms: Polychondritis, Relapsing

Study Results

No Results Posted as of May 13, 2014