Clinical trial NCT01943526: Ireland Natalizumab (TYSABRI) Observational Program
Official title: Ireland Natalizumab (TYSABRI®) Observational Program (iTOP)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Relapsing-Remitting Multiple Sclerosis
Keywords: Ireland
Natalizumab
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2013-09-17
Enrollment: 191
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility 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.

Primary outcomes:
measure: Number of participants experiencing Serious Adverse Events (SAEs)
timeFrame: up to 3 years
Secondary outcomes:
measure: Disability progression as determined by Expanded Disability Status Scale (EDSS)
timeFrame: Up to 3 years
measure: MS disease activity as determined by annualized relapse rate (ARR)
timeFrame: Up to 3 years
measure: MS disease activity as determined by distribution of the total number of relapses during the study
timeFrame: Up to 3 years
measure: MS disease activity as determined by time to first relapse
timeFrame: Up to 3 years
measure: MS disease activity as determined by number of participants with relapse
timeFrame: Up to 3 years
measure: MS disability progression and MS disease activity summarized for subpopulations according to baseline characteristics
timeFrame: Up to 3 years
measure: MS disease activity as determined by MRI parameters
timeFrame: Up to 3 years
measure: Evaluation of short-term disease outcomes as assessed by EDSS progression
timeFrame: Up to 1 year
measure: Evaluation of short-term disease outcomes as assessed by occurrence of relapses
timeFrame: Up to 1 year
Other outcomes:
Locations:
city: Cork
country: Ireland
facility: Research site
state: County Cork
city: Dublin
country: Ireland
facility: Research site
state: County Dublin
city: Galway
country: Ireland
facility: Research site
state: County Galway
city: Tralee
country: Ireland
facility: Research site
state: County Kerry
city: Sligo
country: Ireland
facility: Research site
state: County Sligo
Study officials:
affiliation: Biogen
name: Medical Director
role: STUDY_DIRECTOR
References: