Ireland Natalizumab (TYSABRI) Observational Program (iTOP)

Ireland Natalizumab (TYSABRI®) Observational Program (iTOP)

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.

Study Overview

• Status: Completed
• Conditions: Relapsing-Remitting Multiple Sclerosis
• Intervention / Treatment: Biological: natalizumab

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 Type: Observational
• Enrollment (Actual): 191

Contacts and Locations

Study Locations

• Ireland
  • County Cork
    • Cork, County Cork, Ireland
      • Research Site
  • County Dublin
    • Dublin, County Dublin, Ireland
      • Research Site
  • County Galway
    • Galway, County Galway, Ireland
      • Research Site
  • County Kerry
    • Tralee, County Kerry, Ireland
      • Research Site
  • County Sligo
    • Sligo, County Sligo, Ireland
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Other

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of participants experiencing Serious Adverse Events (SAEs)	up to 3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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	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
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

Collaborators and Investigators

• Sponsor: Biogen

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2011
• Primary Completion (Actual): December 31, 2017
• Study Completion (Actual): December 31, 2017

Study Registration Dates

• First Submitted: September 12, 2013
• First Submitted That Met QC Criteria: September 12, 2013
• First Posted (Estimate): September 17, 2013

Study Record Updates

• Last Update Posted (Actual): May 4, 2018
• Last Update Submitted That Met QC Criteria: May 3, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: Natalizumab; Ireland
• Additional Relevant MeSH Terms: Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Physiological Effects of Drugs; Immunologic Factors; Natalizumab
• Other Study ID Numbers: TYS-IRL-11-4