Working… Menu

Tocilizumab for Relapsing Polychondritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01104480
Recruitment Status : Withdrawn (Tocilizumab was licenced in Canada for children, so the study was not necessary)
First Posted : April 15, 2010
Last Update Posted : May 13, 2014
Information provided by (Responsible Party):
Dr Maggie Larche, 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.

Condition or disease Intervention/treatment Phase
Relapsing Polychondritis Drug: Tocilizumab Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
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 2010
Estimated Primary Completion Date : July 2010
Estimated Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Tocilizumab

Intervention Details:
  • Drug: Tocilizumab
    Tocilizumab 8mg/kg every 2 weeks given by IV infusion
    Other Name: Actemra

Primary Outcome Measures :
  1. Efficacy of Tocilizumab [ Time Frame: 2 years ]
    Inhibition of inflammatory markers Improvement in symptoms and signs

Secondary Outcome Measures :
  1. Safety of Tocilizumab [ Time Frame: 2 years ]
    Monitoring of serum lipids and liver function tests

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   12 Years to 15 Years   (Child)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01104480

Layout table for location information
Canada, Ontario
McMaster Children's Hospital
Hamilton, Ontario, Canada, L8N 3YZ
Sponsors and Collaborators
McMaster Children's Hospital
Layout table for investigator information
Principal Investigator: Maggie Larché, MD, PhD McMaster University and Children's Hospital

Layout table for additonal information
Responsible Party: Dr Maggie Larche, Associate professor, McMaster Children's Hospital Identifier: NCT01104480     History of Changes
Other Study ID Numbers: RP2010
First Posted: April 15, 2010    Key Record Dates
Last Update Posted: May 13, 2014
Last Verified: May 2014
Keywords provided by Dr Maggie Larche, McMaster Children's Hospital:
Relapsing Polychondritis
Additional relevant MeSH terms:
Layout table for MeSH terms
Polychondritis, Relapsing
Cartilage Diseases
Musculoskeletal Diseases
Connective Tissue Diseases