Ireland Natalizumab (TYSABRI) Observational Program
iTOP
Ireland Natalizumab (TYSABRI®) Observational Program (iTOP)
1 other identifier
observational
191
1 country
5
Brief Summary
The objectives of this study are to assess the long-term safety and impact on disease activity and progression of natalizumab (Tysabri) in participants with relapsing remitting multiple sclerosis (RRMS) in a clinical practice setting.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Nov 2011
Longer than P75 for all trials
5 active sites
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
November 30, 2011
CompletedFirst Submitted
Initial submission to the registry
September 12, 2013
CompletedFirst Posted
Study publicly available on registry
September 17, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2017
CompletedMay 4, 2018
April 1, 2018
6.1 years
September 12, 2013
May 3, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of participants experiencing Serious Adverse Events (SAEs)
up to 3 years
Secondary Outcomes (9)
Disability progression as determined by Expanded Disability Status Scale (EDSS)
Up to 3 years
MS disease activity as determined by annualized relapse rate (ARR)
Up to 3 years
MS disease activity as determined by distribution of the total number of relapses during the study
Up to 3 years
MS disease activity as determined by time to first relapse
Up to 3 years
MS disease activity as determined by number of participants with relapse
Up to 3 years
- +4 more secondary outcomes
Interventions
Natalizumab will not be provided as a part of this study. Participants will receive natalizumab as prescribed by their treating physician.
Eligibility Criteria
Patients with RRMS who are being treated with natalizumab and patients who meet the criteria defined in the indication statement for prescription in Ireland. Existing patients will be enrolled retrospectively.
You may qualify if:
- Must give written informed consent and assent, as applicable.
- Decision to treat with natalizumab must precede enrollment.
- Patient characteristics and contraindications to treatment with natalizumab in accordance with prescribing information.
- Must be receiving natalizumab (Tysabri) for the treatment of RRMS in accordance with the natalizumab indication statement.
- Must have a documented diagnosis of Relapsing Remitting Multiple Sclerosis (RRMS).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Biogenlead
Study Sites (5)
Research site
Cork, County Cork, Ireland
Research site
Dublin, County Dublin, Ireland
Research site
Galway, County Galway, Ireland
Research site
Tralee, County Kerry, Ireland
Research site
Sligo, County Sligo, Ireland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Director
Biogen
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- OTHER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 12, 2013
First Posted
September 17, 2013
Study Start
November 30, 2011
Primary Completion
December 31, 2017
Study Completion
December 31, 2017
Last Updated
May 4, 2018
Record last verified: 2018-04