Validation of a Laboratory Test Measuring Natalizumab (Tysabri®) Serum Levels in MS
- Conditions
- Multiple Sclerosis
- Registration Number
- NCT02965170
- Lead Sponsor
- Rocky Mountain MS Research Group, LLC
- Brief 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 109
- Infusing with Tysabri at a single site, Rocky Mountain MS Clinic
- If subject donated or received blood, plasma, or any other blood products between the last Tysabri® infusion and the time of sample collection.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Natalizumab Concentrations in Serum 12 Months Validate a novel peptide-based laboratory test enabling the measurement of nadir natalizumab (Tysabri®) serum levels in multiple sclerosis patients undergoing therapy compared to the traditional ELISA assay
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Rocky Mountain MS Clinic
🇺🇸Salt Lake City, Utah, United States