Ireland Natalizumab (TYSABRI) Observational Program
- Conditions
- Relapsing-Remitting Multiple Sclerosis
- Registration Number
- NCT01943526
- Lead Sponsor
- Biogen
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 191
- 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.
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number of participants experiencing Serious Adverse Events (SAEs) up to 3 years
- Secondary Outcome Measures
Name Time Method Disability progression as determined by Expanded Disability Status Scale (EDSS) Up to 3 years Disability progression is defined as at least a 1.0 point increase on the EDSS from Baseline that is sustained over 6 months. The EDSS measures disability status on a scale ranging from 0 to 10, with higher scores indicating more disability. Scoring is based on measures of impairment in eight functional systems on examination by a neurologist.
MS disease activity as determined by annualized relapse rate (ARR) Up to 3 years A clinical relapse is defined as new or recurrent neurological symptoms, not associated with fever, lasting for at least 24 hours, and followed by a period of 30 days of stability or improvement. New or recurrent neurological symptoms that occur less than 30 days following the onset of a protocol-defined relapse should be considered part of the same relapse.
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 Prognostic factors for disability progression and MS disease activity will be assessed in different participant cohorts stratified according to their baseline characteristics: Participant demographics including age, gender; Disease History, including diagnosis and duration at baseline; Baseline EDSS; Number of relapses within 1 and 2 years before baseline; MRI parameters at baseline; Prior use of disease modifying therapy, anti-neoplastic, immunosuppressant or immunomodulator therapy
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
Trial Locations
- Locations (1)
Research site
🇮🇪Sligo, County Sligo, Ireland