Ireland Natalizumab (TYSABRI) Observational Program (iTOP)

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Biogen Identifier:
First received: September 12, 2013
Last updated: February 19, 2016
Last verified: February 2016
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.

Condition Intervention
Relapsing-Remitting Multiple Sclerosis
Biological: natalizumab

Study Type: Observational
Study Design: Observational Model: Case-Only
Official Title: Ireland Natalizumab (TYSABRI®) Observational Program (iTOP)

Resource links provided by NLM:

Further study details as provided by Biogen:

Primary Outcome Measures:
  • Number of participants experiencing Serious Adverse Events (SAEs) [ Time Frame: up to 3 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Disability progression as determined by Expanded Disability Status Scale (EDSS) [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
    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) [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
    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 [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
  • MS disease activity as determined by time to first relapse [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
  • MS disease activity as determined by number of participants with relapse [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
  • MS disability progression and MS disease activity summarized for subpopulations according to baseline characteristics [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
    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 [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
  • Evaluation of short-term disease outcomes as assessed by EDSS progression [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]
  • Evaluation of short-term disease outcomes as assessed by occurrence of relapses [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]

Enrollment: 191
Study Start Date: November 2011
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Intervention Details:
    Biological: natalizumab
    Natalizumab will not be provided as a part of this study. Participants will receive natalizumab as prescribed by their treating physician.
    Other Names:
    • Tysabri
    • BG00002
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.

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01943526

Research site
Cork, County Cork, Ireland
Research site
Dublin, County Dublin, Ireland
Research site
Galway, County Galway, Ireland
Research site
Tralee, County Kerry, Ireland
Research site
Sligo, County Sligo, Ireland
Sponsors and Collaborators
Study Director: Medical Director Biogen
  More Information

Responsible Party: Biogen Identifier: NCT01943526     History of Changes
Other Study ID Numbers: TYS-IRL-11-4 
Study First Received: September 12, 2013
Last Updated: February 19, 2016
Health Authority: Ireland: Health Products Regulatory Authority
Ireland: Research Ethics Committee

Keywords provided by Biogen:

Additional relevant MeSH terms:
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Autoimmune Diseases
Autoimmune Diseases of the Nervous System
Demyelinating Autoimmune Diseases, CNS
Demyelinating Diseases
Immune System Diseases
Nervous System Diseases processed this record on April 27, 2016