TYSABRI Global Observational Program in Safety | NCT00477113

Studies
TYSABRI Global Observational Program in Safety

NCT00477113

Sponsor

Biogen

Status

Completed

Last Update Posted

Jun 22, 2015Estimated

Enrollment

2,207Actual

Phase

Not provided

Conditions

Multiple Sclerosis

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

Jun 2015

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

Jan 2007

Primary Completion Date

May 2015Actual

Completion Date

May 2015Actual

First Submitted Date

May 21, 2007

First Submission Date that Met QC Criteria

May 21, 2007

First Posted Date

May 22, 2007Estimated

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

Jun 18, 2015

Last Update Posted Date

Jun 22, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

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

The Primary objective of this study is to determine the incidence and pattern of serious infections, malignancies, and other serious adverse events (SAE) in participants with multiple sclerosis (MS) treated with Tysabri (natalizumab).

Detailed Description

The TYSABRI Global Observational Program in Safety (TYGRIS) is a safety observational cohort program designed to obtain long-term safety data in multiple sclerosis (MS) participants treated with natalizumab in a clinical practice setting in the United States or Canada.

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

2,207Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of participants with serious infections, malignancies, and other SAEs		5 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Key Inclusion Criteria:

MS patients in the US and Canada receiving TYSABRI under standard clinical care for less than or equal to 3 infusions are eligible to participate in TYGRIS.

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

MS patients treated with TYSABRI in North America

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Medical Director	Biogen	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
There may be mulitple sites in this clinical trial. Contact United BioSource Corporation		Kansas City	Missouri	64111	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
31901758	Derived	Foley J, Carrillo-Infante C, Smith J, Evans K, Ho PR, Lee L, Kasliwal R, Stangel M, Vermersch P, Hutchinson M, Marinelli F, Smirnakis K; TYGRIS investigators. The 5-year Tysabri global observational program in safety (TYGRIS) study confirms the long-term safety profile of natalizumab treatment in multiple sclerosis. Mult Scler Relat Disord. 2020 Apr;39:101863. doi: 10.1016/j.msard.2019.101863. Epub 2019 Nov 21.

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