Longitudinal Pharmacokinetic, Pharmacodynamic, Immunological, and Biochemical
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|ClinicalTrials.gov Identifier: NCT01330498|
Recruitment Status : Completed
First Posted : April 7, 2011
Last Update Posted : January 6, 2012
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||229 participants|
|Official Title:||Longitudinal Pharmacokinetic, Pharmacodynamic, Immunological, and Biochemical Sample Collection With MRI and Relapse Analysis of a Tysabri Patient Cohort|
|Study Start Date :||April 2011|
|Actual Primary Completion Date :||August 2011|
|Actual Study Completion Date :||August 2011|
Tysabri (natalizumab) infusing
Patients with relapsing forms of MS who participated in 001-001-TY and are currently still infusing with Tysabri (natalizumab).
- Duration Effect of natalizumab [ Time Frame: 18 months ]Primary: To further understand the duration effect of natalizumab at the biochemical, cellular, and pharmacokinetic levels in natalizumab patients; identify biomarkers which could aid in patient risk modification for (PML). Assess the stability of natalizumab concentration via pharmacokinetic measurement in ug/ml.
- Stability of cell trafficking inhibition [ Time Frame: 18 months ]Secondary endpoint: Assess the stability of cell trafficking inhibition produced through steady state Natalizumab administration through an infusion cycle. Cell trafficking is measured via sVCAM, measurement units ng/mL.
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01330498
|United States, Utah|
|Rocky Mountain Multiple Sclerosis Clinic|
|Salt Lake City, Utah, United States, 84103|
|Principal Investigator:||John F Foley, MD||Rocky Mountain MS Research Group, LLC|