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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This study has been withdrawn prior to enrollment.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:
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

April 13, 2010
May 12, 2014
May 2010
July 2010   (final data collection date for primary outcome measure)
Efficacy of Tocilizumab [ Time Frame: 2 years ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: Yes ]
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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Withdrawn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
Male
12 Years to 15 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01104480
RP2010
No
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