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This study has been withdrawn prior to enrollment.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:
Information provided by (Responsible Party):
Dr Maggie Larche, McMaster Children's Hospital
ClinicalTrials.gov Identifier:
NCT01104480
First received: April 13, 2010
Last updated: May 12, 2014
Last verified: May 2014
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 McMaster Children's Hospital:

Primary Outcome Measures:
  • Efficacy of Tocilizumab [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Inhibition of inflammatory markers Improvement in symptoms and signs


Secondary Outcome Measures:
  • Safety of Tocilizumab [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    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

Ages Eligible for Study:   12 Years to 15 Years
Genders 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Dr Maggie Larche, Associate professor, McMaster Children's Hospital
ClinicalTrials.gov Identifier: NCT01104480     History of Changes
Other Study ID Numbers: RP2010
Study First Received: April 13, 2010
Last Updated: May 12, 2014
Health Authority: Canada: Health Canada

Keywords provided by McMaster Children's Hospital:
Relapsing Polychondritis
Unremitting
Inflammation
IL6

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

ClinicalTrials.gov processed this record on July 23, 2014