A Pharmacokinetic (PK) Study of Natalizumab (Tysabri) at Steady State
This study has been completed.
Information provided by (Responsible Party):
First received: August 29, 2008
Last updated: February 6, 2015
Last verified: February 2015
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.
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
||An Assessment of the Steady-State Pharmacokinetic and Pharmacodynamic Profile of Tysabri 300 mg Following at Least 12 Monthly Infusions
Primary Outcome Measures:
- 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 ]
Secondary Outcome Measures:
| Study Start Date:
| Study Completion Date:
| 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.
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.
|Ages Eligible for Study:
||18 Years to 55 Years (Adult)
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00744679
|Latham, New York, United States |
History of Changes
|Other Study ID Numbers:
|Study First Received:
||August 29, 2008
||February 6, 2015
||United States: Food and Drug Administration
Keywords provided by Biogen:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on December 08, 2016
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Immune System Diseases
Physiological Effects of Drugs