A Pharmacokinetic (PK) Study of Natalizumab (Tysabri) at Steady State
The primary objective is to assess the pharmacokinetic (PK) profile of natalizumab (Tysabri) at steady state.
The secondary objective is to assess the pharmacodynamics (PD) profile (α4 integrin saturation) of Tysabri at steady state.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
|Official Title:||An Assessment of the Steady-State Pharmacokinetic and Pharmacodynamic Profile of Tysabri 300 mg Following at Least 12 Monthly Infusions|
- Pharmacokinetic (PK) Profile of Natalizumab [ Time Frame: Baseline (Day 0), 2 hours after infusion starts on Days 1 and on Days 2, 3, 4, 7, 14, 21 and 28 ] [ Designated as safety issue: No ]
- Natalizumab Binding Saturation Of α4 Integrin Sites On Peripheral Blood Mononuclear Cells (PBMC). [ Time Frame: Baseline (Day 0), 2 Hours after infusion starts on Days 1, and on Days 4, 7, 14, 21 and 28 ] [ Designated as safety issue: No ]The pharmacodynamic activity of natalizumab is assessed by measuring the degree of natalizumab saturation of the VLA-4 (α4β1 integrin) receptor on peripheral blood lymphocyte/monocyte populations.
|Study Start Date:||November 2008|
|Study Completion Date:||December 2008|
|Primary Completion Date:||December 2008 (Final data collection date for primary outcome measure)|
Experimental: Natalizumab 300 mg
Natalizumab infused at 300 mg every 28 days during the screening and assessment periods of the study which continues the therapy of the previous 12 months and maintains steady-state pharmacokinetics.
Drug: BG00002 (natalizumab)
Participants continue to receive regularly-scheduled doses of Tysabri (300 mg infusion every 28±7 days) through the Tysabri Outreach: United Commitment to Health Prescribing Program (TOUCH) throughout the screening and assessment periods. Participants must continue to be dosed every 28±7 days in order to maintain steady-state pharmacokinetics.
Other Name: Tysabri
Please refer to this study by its ClinicalTrials.gov identifier: NCT00744679
|Study Director:||Medical Director||Biogen Idec|