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| Name | Class |
|---|---|
| Abreos Biosciences | OTHER |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MS Tysabri | Patients with relapsing forms of multiple sclerosis and who are currently undergoing Tysabri® therapy at Rocky Mountain Multiple Sclerosis Research Group. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| John F Foley, MD | Rocky Mountain MS Research Group | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rocky Mountain MS Clinic | Salt Lake City | Utah | 84103 | United States |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |