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

NCT02965170 | Completed

• 1 other identifier: 001-012-TY
• Study Type: observational
• Target: 109
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• Natalizumab Concentrations in Serum

  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

  12 Months

Study Arms (1)

MS Tysabri

Patients with relapsing forms of multiple sclerosis and who are currently undergoing Tysabri® therapy at Rocky Mountain Multiple Sclerosis Research Group.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Only patients with multiple sclerosis who have had one or more doses of Tysabri® (natalizumab) and are currently being treated with Tysabri® will be included in this study.

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.

Sponsors & Collaborators

• Rocky Mountain MS Research Group, LLC: lead
• Abreos Biosciences: collaborator

Study Sites (1)

Rocky Mountain MS Clinic

Salt Lake City, Utah, 84103, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• John F Foley, MD

  Rocky Mountain MS Research Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 8, 2016
• First Posted: November 16, 2016
• Study Start: October 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: May 1, 2018
• Last Updated: April 24, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)