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Validation of a Laboratory Test Measuring Natalizumab (Tysabri®) Serum Levels in MS — IIT12  

Multiple Sclerosis Clinical Trial

Official title:
Validation of a Laboratory Test Measuring Natalizumab (Tysabri®) Serum Levels in a Multiple Sclerosis Patient Cohort

Clinical Trial Summary

Validating a peptide-based laboratory test enabling the measurement of Tysabri® serum levels (pharmacokinetics, PK) in multiple sclerosis patients undergoing therapy. The results of this newly developed test will be compared to Tysabri® serum levels measured in parallel using an independent test. We will also simultaneously measure a pharmacodynamic marker of Tysabri®, receptor saturation levels on blood immune cells, which is thought to correlate with Tysabri® serum levels.

Clinical Trial Description

From a single site, consenting patients with relapsing forms of multiple sclerosis who are currently begin treated with Tysabri® (natalizumab) and meeting the eligibility criteria will be asked to provide blood samples on the same day, and prior to, a scheduled infusion of Tysabri® 300 mg IV. Up to 500 patients will be enrolled in this study. Each patient may be asked to donate blood up to 2 times (one blood draw per cycle) to obtain longitudinal data points. Each patient will also be asked to fill out a wellness patient reported outcome (PRO) questionnaire along with the blood draws ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02965170
Study type Observational
Source Rocky Mountain MS Research Group, LLC
Contact
Status Completed
Phase
Start date October 2016
Completion date May 2018
View Details
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