- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01041248
Single Patient Study to Treat Relapsing Polychondritis With Tocilizumab
Efficacy of Tocilizumab in a Patient With Relapsing Polychondritis
Study Overview
Detailed Description
In this N = 1 study a single known patient with relapsing polychondritis who has failed methotrexate, various anti TNF medications, anti IL1 medication and prolongued glucocorticosteroids will be recruited to receive Tocilizumab 8 mg /kg q 2 weeks iv.
The objective is to assess efficacy of tociliuzmab in combination with stable ongoing therapy. Our patient received tocilizumab 8 mg/kg over 1 hour by intravenous infusion every 2 weeks throughout the course of the study. To assess tocilizumab efficacy, the primary objective is the change in physician global assessment on a 100-mm horizontal visual analogue scale (VAS) of disease activity.
The secondary objectives were the change in parent global assessment of disease activity on a 100 mm VAS and the glucocorticoid dose in mg per day. Frequency of adverse events was also measured at baseline and after each biweekly tocilizumab infusion.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Ontario
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Ottawa, Ontario, Canada, K1H 8L1
- Children's Hospital of Eastern Ontario
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Refractory relapsing polychondritis
- Failed glucocorticoid and methotrexate therapy
Exclusion Criteria:
- This is an N=1 clinical trial with a known patient, therefore, exclusion criteria are non-applicable.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Tocilizumab
Single arm open label study.
In this arm patient will receive 8mg/kg of Tocilizumab q 2 weeks iv.
|
8mg/kg every 2 weeks i.v.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Physician Global Assessment of Disease Activity
Time Frame: Baseline and then every 2 weeks prior to each infusion for total duration of 30 weeks
|
Physician global assessment of disease activity was assessed on a 100 mm Visual Analogue Scale where 0 would be no disease activity and 100 would be the maximum disease activity.
Higher values therefore indicate higher disease activity and therefore a worse outcome.
Change of this outcome measure over time was documented.
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Baseline and then every 2 weeks prior to each infusion for total duration of 30 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Prednisone Dose
Time Frame: 30 weeks
|
Prednisone dose administered to patient reduction through treatment course
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30 weeks
|
Parent/Patient Global Assessment of Overall Well Being
Time Frame: 30 weeks
|
A 100 mm visual analogue scale was used for the assessment of the parent/patient globale well being, maximum value is 100 and minimum value is 0 with lower values being better well being and therefore improved outcome and higher values worse well being and therefore worse outcome.
Changes in this score over time are being assessed with this measure.
|
30 weeks
|
Collaborators and Investigators
Investigators
- Principal Investigator: Johannes Roth, MD, Children's Hospital of Eastern Ontario
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ML 25245
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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