Tocilizumab for Relapsing Polychondritis | NCT01104480

Studies
Tocilizumab for Relapsing Polychondritis

NCT01104480

Sponsor

McMaster Children's Hospital

Status

Withdrawn

Last Update Posted

May 13, 2014Estimated

Enrollment

0Actual

Phase

Phase 2

Conditions

Relapsing Polychondritis

Interventions

Tocilizumab

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2014

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Tocilizumab was licenced in Canada for children, so the study was not necessary

Expanded Access Info

Start Date

May 2010

Primary Completion Date

Jul 2010Estimated

Completion Date

May 2012Estimated

First Submitted Date

Apr 13, 2010

First Submission Date that Met QC Criteria

Apr 13, 2010

First Posted Date

Apr 15, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 12, 2014

Last Update Posted Date

May 13, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Name	Type	Description	Arm Group Labels	Other Names
Tocilizumab	Drug	Tocilizumab 8mg/kg every 2 weeks given by IV infusion		Actemra

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Efficacy of Tocilizumab	Inhibition of inflammatory markers Improvement in symptoms and signs	2 years

Secondary Outcomes

Measure	Description	Time Frame
Safety of Tocilizumab	Monitoring of serum lipids and liver function tests	2 years

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

15 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Maggie Larché, MD, PhD	McMaster University and Children's Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
McMaster Children's Hospital		Hamilton	Ontario	L8N 3YZ	Canada

Condition Browse Module

MeSH Terms

ID	Term
D011081	Polychondritis, Relapsing
D007249	Inflammation

Ancestor Terms

ID	Term
D002357	Cartilage Diseases
D009140	Musculoskeletal Diseases
D003240	Connective Tissue Diseases
D017437	Skin and Connective Tissue Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C502936	tocilizumab

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided