NCT00477113

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,207

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2007

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 21, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 22, 2007

Completed
7.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

June 22, 2015

Status Verified

June 1, 2015

Enrollment Period

8.3 years

First QC Date

May 21, 2007

Last Update Submit

June 18, 2015

Conditions

Multiple Sclerosis

Keywords

natalizumabMSTysabriMultiple SclerosisTYGRIS

Outcome Measures

Primary Outcomes (1)

  • Number of participants with serious infections, malignancies, and other SAEs

    5 years

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

MS patients treated with TYSABRI in North America

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

There may be mulitple sites in this clinical trial. Contact United BioSource Corporation

Kansas City, Missouri, 64111, United States

Location

Related Publications (1)

  • 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.

    PMID: 31901758DERIVED

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

whole blood, serum

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Medical Director

    Biogen

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 21, 2007

First Posted

May 22, 2007

Study Start

January 1, 2007

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

June 22, 2015

Record last verified: 2015-06

Locations

US(1)