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

NCT00744679 | Completed Phase 4

• 1 other identifier: 101MS406
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Keywords

MS; Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• Pharmacokinetic (PK) Profile of Natalizumab

  Baseline (Day 0), 2 hours after infusion starts on Days 1 and on Days 2, 3, 4, 7, 14, 21 and 28

Secondary Outcomes (1)

• Natalizumab Binding Saturation Of α4 Integrin Sites On Peripheral Blood Mononuclear Cells (PBMC).

  Baseline (Day 0), 2 Hours after infusion starts on Days 1, and on Days 4, 7, 14, 21 and 28

Study Arms (1)

Natalizumab 300 mg

EXPERIMENTAL

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

Interventions

Natalizumab DRUG

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.

Also known as: Tysabri, BG00002

Natalizumab 300 mg

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Biogen: lead
• Elan Pharmaceuticals: collaborator

Study Sites (1)

Research Site

Latham, New York, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Natalizumab

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Medical Director

  Biogen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2008
• First Posted: September 1, 2008
• Study Start: November 1, 2008
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: February 10, 2015

Record last verified: 2015-02

Locations

US (1)