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Completed

NCT Number: NCT01943526

Ireland Natalizumab (TYSABRI) Observational Program

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.

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Key information

Conditions

Relapsing-Remitting Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Multiple Sclerosis Multiple Sclerosis, Relapsing-Remitting Nervous System Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Research site, Cork, County Cork, Ireland

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Natalizumab

Biological

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

Primary outcomes

  1. Number of participants experiencing Serious Adverse Events (SAEs)

    Time frame: up to 3 years

Secondary outcomes

  1. Disability progression as determined by Expanded Disability Status Scale (EDSS)

    Time frame: 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.

  2. MS disease activity as determined by annualized relapse rate (ARR)

    Time frame: 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.

  3. MS disease activity as determined by distribution of the total number of relapses during the study

    Time frame: Up to 3 years

  4. MS disease activity as determined by time to first relapse

    Time frame: Up to 3 years

  5. MS disease activity as determined by number of participants with relapse

    Time frame: Up to 3 years

  6. MS disability progression and MS disease activity summarized for subpopulations according to baseline characteristics

    Time frame: 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

  7. MS disease activity as determined by MRI parameters

    Time frame: Up to 3 years

  8. Evaluation of short-term disease outcomes as assessed by EDSS progression

    Time frame: Up to 1 year

  9. Evaluation of short-term disease outcomes as assessed by occurrence of relapses

    Time frame: Up to 1 year

Sponsors and collaborators

Lead sponsor

Biogen

Industry

Registry information

Official study title

Ireland Natalizumab (TYSABRI®) Observational Program (iTOP)

Acronym: iTOP

Important dates

Study start
2011
Primary completion
2017
Study completion
2017
First posted
Sep 17, 2013
Registry last updated
May 4, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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