Longitudinal Pharmacokinetic, Pharmacodynamic, Immunological, and Biochemical
|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
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|