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

NCT02965170 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 109

Last updated 2019-04-24

No results posted yet for this study

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.

Conditions

Sponsors & Collaborators

  • Abreos Biosciences

    collaborator OTHER

  • Rocky Mountain MS Research Group, LLC

    lead OTHER

Principal Investigators

  • John F Foley, MD · Rocky Mountain MS Research Group

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-10-31
Primary Completion
2017-12-31
Completion
2018-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02965170 on ClinicalTrials.gov