Ireland Natalizumab (TYSABRI®) Observational Program (iTOP)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Biogen
- Enrollment
- 191
- Locations
- 1
- Primary Endpoint
- Number of participants experiencing Serious Adverse Events (SAEs)
Study Overview
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.
Detailed Description
iTOP is a retrospective and prospective Irish observational study of participants receiving natalizumab, with each participant to be followed for 3 years. This study is designed to address the long-term safety profile and the long-term impact on disease activity and progression of natalizumab with marketed use. Collection of efficacy and safety data at 6- monthly intervals to coincide with regular clinic visits and routine clinical practice will therefore be undertaken during the iTOP observational period.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Other
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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).
- •NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Number of participants experiencing Serious Adverse Events (SAEs)
Time Frame: up to 3 years
Secondary Outcomes
- 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)
- MS disability progression and MS disease activity summarized for subpopulations according to baseline characteristics(Up to 3 years)
- MS disease activity as determined by MRI parameters(Up to 3 years)
- Evaluation of short-term disease outcomes as assessed by EDSS progression(Up to 1 year)
- Evaluation of short-term disease outcomes as assessed by occurrence of relapses(Up to 1 year)