Validation of a Laboratory Test Measuring Natalizumab (Tysabri®) Serum Levels in MS
| Status: | Recruiting |
|---|---|
| Conditions: | Neurology, Neurology, Multiple Sclerosis |
| Therapuetic Areas: | Neurology, Other |
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 3/24/2017 |
| Start Date: | October 2016 |
| End Date: | May 2017 |
| Contact: | John F Foley, MD |
| Phone: | 801-408-5700 |
Validation of a Laboratory Test Measuring Natalizumab (Tysabri®) Serum Levels in a Multiple Sclerosis Patient Cohort
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.
(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.
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
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
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.
We found this trial at
1
site
Salt Lake City, Utah 84103
Principal Investigator: John F Foley, MD
Phone: 801-408-4584
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