CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 1 enrolled
Drug / intervention
Tocilizumabdrug
Likely dose
Tocilizumab 8mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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Search/NCT01041248
NCT01041248N/ACompleted

Efficacy of Tocilizumab in a Patient With Relapsing Polychondritis

Children's Hospital of Eastern Ontario·interventional·Posted Dec 31, 2009·Updated Mar 3, 2021

In Brief

A clinical study evaluating Tocilizumab for Relapsing Polychondritis. Completed, enrolled 1 participant across 1 site.

Detailed Summary

Relapsing polychondritis (RP) is a rare, immune-mediated disease associated with inflammation in cartilaginous structures and other tissues throughout the body. Prognosis can be poor, especially in cases where there is acute involvement of the laryngotracheal cartilages leading to airway destruction, which are resistant to treatments such as corticosteroids, immunosuppressive or cytotoxic drugs. The pathogenesis remains unclear although it is thought that autoimmune reactions to antigens present in cartilages, such as type II collagen and matrilin may evoke symptoms. There are no known clinical or laboratory measures that predict the expression of specific disease manifestations or the overall disease course. Two recently published case reports have shown an association with elevated serum IL-6 levels and relapsing polychondritis. In these case reports, both patients with refractory relapsing polychondritis were treated with tocilizumab, a humanized monoclonal antibody to the Interleukin 6 receptor, and achieved sustained response to the drug. This single patient trial aims to evaluate the response to Tocilizumab in an eight year old boy with relapsing polychondritis who has been shown to have elevated serum IL-6 levels and who has responded poorly to conventional therapies. The study hypothesis is that Tocilizumab will be able to control the disease in this patient.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada
Collaborators--

Timeline

N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedDec 31, 2009
Enrollment StartJan 1, 2010
Primary CompletionJan 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 16.5 years ago

Interventions

Tocilizumabdrug

8mg/kg every 2 weeks i.v.