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

Multiple Sclerosis Clinical Trial

— IIT12  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02965170
• Other study ID #: 001-012-TY
• Status: Completed
• Start date: October 2016
• Est. completion date: May 2018

Study information

• Verified date: April 2019
• Source: Rocky Mountain MS Research Group, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 109
• Est. completion date: May 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Locations

Country	Name	City	State
United States	Rocky Mountain MS Clinic	Salt Lake City	Utah

Sponsors (2)

Lead Sponsor	Collaborator
Rocky Mountain MS Research Group, LLC	Abreos Biosciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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