A Pharmacokinetic (PK) Study of Natalizumab (Tysabri) at Steady State

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00744679
Recruitment Status : Completed
First Posted : September 1, 2008
Last Update Posted : February 10, 2015
Elan Pharmaceuticals
Information provided by (Responsible Party):

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Drug: Natalizumab Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : November 2008
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Natalizumab
U.S. FDA Resources

Arm Intervention/treatment
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: 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 Names:
  • Tysabri
  • BG00002

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
    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.

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Key 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.
  • Must be a multiple sclerosis (MS) patient enrolled in the Tysabri Outreach: United Commitment to Health Prescribing Program (TOUCH) 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.

Key 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.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Information from the National Library of Medicine

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 identifier (NCT number): NCT00744679

United States, New York
Research Site
Latham, New York, United States
Sponsors and Collaborators
Elan Pharmaceuticals
Study Director: Medical Director Biogen

Responsible Party: Biogen Identifier: NCT00744679     History of Changes
Other Study ID Numbers: 101MS406
First Posted: September 1, 2008    Key Record Dates
Last Update Posted: February 10, 2015
Last Verified: February 2015

Keywords provided by Biogen:
Multiple Sclerosis

Additional relevant MeSH terms:
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Immunologic Factors
Physiological Effects of Drugs