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

Completed

Conditions studied: Multiple Sclerosis

In brief

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.

Key facts

Study ID

NCT02965170

Run by

Rocky Mountain MS Research Group, LLC

People needed

109

Starts

2016-10-01

Expected to finish

2018-05-01

Last updated by the study team

2019-04-24

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Infusing with Tysabri at a single site, Rocky Mountain MS Clinic

You may not qualify if…

• If subject donated or received blood, plasma, or any other blood products between the last Tysabri® infusion and the time of sample collection.

Where it is running

• Rocky Mountain MS Clinic — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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