A Pharmacokinetic (PK) Study of Tysabri at Steady State - Full Text View

Purpose

The pharmacokinetic (PK) profile of Tysabri in patients has been observed following 1 dose and after 6 consecutive doses. The primary purpose of this study is to observe the PK profile of Tysabri in patients who have been treated with Tysabri for at least 12 months (i.e., after achievement of steady state). To support this investigation, the pharmacodynamic (PD) profile will also be established in this population by assessing α4 integrin saturation.

The dosing regimen will be consistent with the current commercial prescribing information (Tysabri 300 mg IV infusion once a month).

The following participant population will be enrolled:

Have been treated monthly with Tysabri (natalizumab) for at least 12 months (with the 9 most recent doses received at uninterrupted intervals [i.e., every 28±7 days])
Currently enrolled in the Tysabri Outreach: United Commitment to Health (TOUCH) Prescribing Program
Tested negative at any prior evaluation for anti-Tysabri antibodies
Test negative for antibodies to Tysabri at the Screening Visit

Participants will be asked to provide blood samples over a 28-day period following a scheduled infusion of Tysabri.

The primary objective is to assess the PK profile of Tysabri at steady state. The secondary objective is to assess the PD profile (α4 integrin saturation) of Tysabri at steady state.

Condition	Intervention	Phase
Multiple Sclerosis	Drug: natalizumab	Phase IV

MedlinePlus related topics:

Multiple Sclerosis

Drug Information available for:

Natalizumab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Basic Science, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics/Dynamics Study

Official Title:	An Assessment of the Steady-State Pharmacokinetic and Pharmacodynamic Profile of Tysabri 300 mg Following at Least 12 Monthly Infusions

Further study details as provided by Biogen Idec:

Primary Outcome Measures:

To assess the PK profile of Tysabri at steady state. [ Time Frame: Baseline (Day 0), 2 hours after infusion starts, Days 1, 2, 3, 4, 7, 14, 21 and 28 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To assess the PD profile (α4 integrin saturation) of Tysabri at steady state. [ Time Frame: Baseline (Day 0), 2 Hours after infusion start, Days 4, 7, 14, 21 and 28 ] [ Designated as safety issue: No ]

Estimated Enrollment:	20
Study Start Date:	September 2008
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Intervention Details:

Natalizumab will be infused per the label at 300 mg every 4 weeks

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and local subject privacy regulations.
Aged 18 to 55 years old, inclusive, at the time of informed consent.
Must be an multiple sclerosis (MS) patient enrolled in the TOUCH Prescribing Program who is not expected to discontinue Tysabri therapy prior to completion of the requirements of this study.
Must have been treated with monthly IV infusions of Tysabri 300 mg for at least 12 months, with the 9 most recent doses having been administered at 28±7 day intervals.
Must test negative for antibodies to Tysabri at the Screening Visit.
Must have a magnetic resonance imaging (MRI) brain scan, performed prior to the initiation of treatment with Tysabri, on file.
Must weigh between 42 and 126 kg, inclusive.
All male subjects and female subjects of childbearing potential must practice effective contraception during the study.

Exclusion Criteria:

History of, or abnormal laboratory results indicative of, any clinically significant cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, gastrointestinal, dermatologic, psychiatric, and renal, or other major disease, as determined by the Investigator.
Positive result for antibodies to Tysabri at any prior evaluation.
Treatment with an investigational product or approved therapy for investigational use within 6 months prior to the start of PK sample collection or during the course of this study. Concurrent participation in an observational study (e.g., Tysabri Global Observational Program in Safety [TYGRIS]) is permitted.
Pre-scheduled for any elective procedure or medical treatment during the study period.
History of drug or alcohol abuse (as defined by the Investigator) within 2 years prior to the Screening Visit.
Female subjects who are breastfeeding, pregnant, or planning to become pregnant while on study.
Alcohol use within 24 hours prior to the Baseline Visit.
Inability or unwillingness to comply with study requirements, including the presence of any condition (e.g., physical, mental, social) that is likely to affect the subject's ability to comply with the study protocol.
Other unspecified reasons that, in the opinion of the Investigator or Biogen Idec, make the subject unsuitable for enrollment.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00744679

Contacts


Contact: Biogen Idec Medical Director		neurologyclinicaltrials@biogenidec.com

Locations


United States, Michigan
	Research Site
	Farmington Hills, Michigan, United States, 48334

United States, Utah
	Research Site
	Salt Lake City, Utah, United States, 84103

Sponsors and Collaborators

Biogen Idec

Elan Pharmaceuticals

More Information

Responsible Party:	Biogen Idec ( Biogen Idec Medical Director )
Study ID Numbers:	101MS406
First Received:	August 29, 2008
Last Updated:	August 29, 2008
ClinicalTrials.gov Identifier:	NCT00744679
Health Authority:	United States: Food and Drug Administration