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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This study has been withdrawn prior to enrollment.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
April 13, 2010
April 15, 2010
May 13, 2014
May 2010
July 2010   (Final data collection date for primary outcome measure)
Efficacy of Tocilizumab [ Time Frame: 2 years ]
Inhibition of inflammatory markers Improvement in symptoms and signs
Same as current
Complete list of historical versions of study NCT01104480 on ClinicalTrials.gov Archive Site
Safety of Tocilizumab [ Time Frame: 2 years ]
Monitoring of serum lipids and liver function tests
Same as current
Not Provided
Not Provided
 
Tocilizumab for Relapsing Polychondritis
Efficacy of Tocilizumab in a Patient With Relapsing Polychondritis
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.
Not Provided
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Relapsing Polychondritis
Drug: Tocilizumab
Tocilizumab 8mg/kg every 2 weeks given by IV infusion
Other Name: Actemra
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
May 2012
July 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Male
12 Years to 15 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
 
NCT01104480
RP2010
No
Not Provided
Not Provided
Dr Maggie Larche, McMaster Children's Hospital
McMaster Children's Hospital
Not Provided
Principal Investigator: Maggie Larché, MD, PhD McMaster University and Children's Hospital
McMaster Children's Hospital
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP