NCT02965170

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 109 (actual)
• Sponsor: Rocky Mountain MS Research Group, LLC · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed 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

Conditions

• Multiple Sclerosis

Timeline

• Start date: 2016-10-01
• Primary completion: 2017-12-01
• Completion: 2018-05-01
• First posted: 2016-11-16
• Last updated: 2019-04-24

Locations

1 site across 1 country: United States