Relapsing-Remitting Multiple Sclerosis
Conditions
Keywords
Ireland, Natalizumab
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.
Interventions
BIOLOGICALnatalizumab
Natalizumab will not be provided as a part of this study. Participants will receive natalizumab as prescribed by their treating physician.
Sponsors
Biogen
Study design
Observational model
CASE_ONLY
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
Key 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants experiencing Serious Adverse Events (SAEs) | up to 3 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| 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 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 | — |
| 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 |
Countries
Ireland
Outcome results
None listed