Pharmacokinetic, Immunological and Biochemical Sample Col... | NCT01070719

Studies
Pharmacokinetic, Immunological and Biochemical Sample Collection and Analysis of a Tysabri Patient Cohort

NCT01070719

Sponsor

John F. Foley, MD

Status

Completed

Last Update Posted

Mar 1, 2012Estimated

Enrollment

270Actual

Phase

Not provided

Conditions

Multiple Sclerosis
Relapse

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2010

Primary Completion Date

May 2010Actual

Completion Date

May 2010Actual

First Submitted Date

Feb 17, 2010

First Submission Date that Met QC Criteria

Feb 17, 2010

First Posted Date

Feb 18, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 28, 2012

Last Update Posted Date

Mar 1, 2012Estimated

Name	Class
Biogen	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This is an open-label study of patients with relapsing forms of Multiple Sclerosis designed to assess the biochemical, immunological and pharmacokinetic profiles of a large, actively infusing natalizumab patient population. A duration effect for progressive multifocal leukoencephalopathy (PML) risk associated with natalizumab therapy appears to exist. There is minimal data available to understand this effect at the biochemical and cellular level. The purpose of this study is to gather preliminary data on several parameters to guide in more focused research on the duration effect.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

270Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Relapsing form of MS treated with natalizumab		Only patients diagnosed with a relapsing form of Multiple Sclerosis (MS) and who are being treated with Tysabri (natalizumab) will be included in this Phase IV observational study.

Interventions

Not provided

Eligibility Module

Eligibility 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 75 years old, inclusive, at the time of informed consent.
Must be a patient with a relapsing form of Multiple Sclerosis 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 1 month.
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.
Fifteen patients who are 1 month to-12 months of natalizumab therapy, fifteen patients who are 24 months and over of natalizumab therapy will be asked to participate in the TNF alpha subset.

Exclusion Criteria:

Medical History:

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.
If subject answers 'Yes" to any question on the PML questionnaire that is not resolved prior to infusion as per standard operating procedure for natalizumab infusion.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Patients with relapsing forms of MS currently being treated with natalizumab.

Sampling Method

Non-Probability Sample

ID	Term
D009103	Multiple Sclerosis
D012008	Recurrence

ID	Term
D020278	Demyelinating Autoimmune Diseases, CNS
D020274	Autoimmune Diseases of the Nervous System
D009422	Nervous System Diseases
D003711	Demyelinating Diseases