Ireland Natalizumab (TYSABRI) Observational Program

Relapsing-Remitting Multiple Sclerosis Clinical Trial

— iTOP  

Official title:

Ireland Natalizumab (TYSABRI®) Observational Program (iTOP)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01943526
• Other study ID #: TYS-IRL-11-4
• Status: Completed
• Start date: November 30, 2011
• Est. completion date: December 31, 2017

Study information

• Verified date: April 2018
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 191
• Est. completion date: December 31, 2017
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Relapsing-Remitting Multiple Sclerosis

Intervention

Biological:
• natalizumab
Natalizumab will not be provided as a part of this study. Participants will receive natalizumab as prescribed by their treating physician.

Locations

Country	Name	City	State
Ireland	Research site	Cork	County Cork
Ireland	Research site	Dublin	County Dublin
Ireland	Research site	Galway	County Galway
Ireland	Research site	Sligo	County Sligo
Ireland	Research site	Tralee	County Kerry

Sponsors (1)

Lead Sponsor	Collaborator
Biogen

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants experiencing Serious Adverse Events (SAEs)		up to 3 years
Secondary	Disability progression as determined by Expanded Disability Status Scale (EDSS)	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.	Up to 3 years
Secondary	MS disease activity as determined by annualized relapse rate (ARR)	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.	Up to 3 years
Secondary	MS disease activity as determined by distribution of the total number of relapses during the study		Up to 3 years
Secondary	MS disease activity as determined by time to first relapse		Up to 3 years
Secondary	MS disease activity as determined by number of participants with relapse		Up to 3 years
Secondary	MS disability progression and MS disease activity summarized for subpopulations according to baseline characteristics	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	Up to 3 years
Secondary	MS disease activity as determined by MRI parameters		Up to 3 years
Secondary	Evaluation of short-term disease outcomes as assessed by EDSS progression		Up to 1 year
Secondary	Evaluation of short-term disease outcomes as assessed by occurrence of relapses		Up to 1 year