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Tocilizumab for Relapsing Polychondritis

This study has been withdrawn prior to enrollment.
(Tocilizumab was licenced in Canada for children, so the study was not necessary)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01104480
First Posted: April 15, 2010
Last Update Posted: May 13, 2014
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.
Information provided by (Responsible Party):
Dr Maggie Larche, McMaster Children's Hospital
  Purpose
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 Intervention Phase
Relapsing Polychondritis Drug: Tocilizumab Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of Tocilizumab in a Patient With Relapsing Polychondritis

Resource links provided by NLM:


Further study details as provided by Dr Maggie Larche, McMaster Children's Hospital:

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


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


Enrollment: 0
Study Start Date: May 2010
Estimated Study Completion Date: May 2012
Estimated Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Tocilizumab
    Tocilizumab 8mg/kg every 2 weeks given by IV infusion
    Other Name: Actemra
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 15 Years   (Child)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
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 ClinicalTrials.gov identifier (NCT number): NCT01104480


Locations
Canada, Ontario
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
  More Information

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

Keywords provided by Dr Maggie Larche, McMaster Children's Hospital:
Relapsing Polychondritis
Unremitting
Inflammation
IL6

Additional relevant MeSH terms:
Polychondritis, Relapsing
Cartilage Diseases
Musculoskeletal Diseases
Connective Tissue Diseases