Ireland Natalizumab (TYSABRI®) Observational Program (iTOP)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Biogen Idec
Sponsor:
Information provided by (Responsible Party):
Biogen Idec
ClinicalTrials.gov Identifier:
NCT01943526
First received: September 12, 2013
Last updated: September 19, 2014
Last verified: September 2014
  Purpose

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
Relapsing-Remitting Multiple Sclerosis

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 Idec:

Primary Outcome Measures:
  • The Number of Participants Experiencing Serious Adverse Events (SAEs) [ Time Frame: up to 3 years ] [ Designated as safety issue: Yes ]
    An SAE is any event which: • results in death • is an immediate threat to life • requires inpatient hospitalization or prolongation of existing hospitalization • results in persistent or significant disability/incapacity • is a congenital anomaly or birth defect, or • any other event which requires intervention to prevent death or hospitalization.


Secondary Outcome Measures:
  • Proportion of Participants that progress at least 1 point on EDSS sustained after 6 months [ 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 Expanded Disability Status Scale (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,

  • Proportion of Participants that Reach Expanded Disability Status Score (EDSS) Milestones Indicating Increasing Disability [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
    The percentage of participants that reach EDSS milestones such as 4.0, 6.0, and 7.0 sustained after 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,

  • Proportion of Participants Whose Expanded Disability Status Score (EDSS) Worsened, Stabilized or Improved and Sustained over 6 Months [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
    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,

  • Annualized Relapse Rate [ 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.

  • Distribution of the Total Number of Relapses During the Study [ 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.

  • Time to First Relapse [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
  • Proportion of Participants with relapse [ 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.

  • Multiple Sclerosis (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: • EDSS • Disease duration • Number of relapses in previous 1 and 2 years • Previous use of disease modifying therapies • Age, gender

  • Freedom from disease activity [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
    Freedom from disease activity will be assessed and defined as no activity on clinical measures, radiological measures or a composite of the two


Estimated Enrollment: 1000
Study Start Date: November 2011
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Detailed Description:

iTOP is a retrospective and prospective Irish observational study of patients receiving natalizumab (TYSABRI®), with each patient 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 (TYSABRI®) 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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with Relapsing Remitting Multiple Sclerosis (RRMS) who are being treated with natalizumab (TYSABRI®) and patients who meet the criteria defined in the indication statement for prescription in Ireland. Existing patients will be enrolled retrospectively. New patients will be enrolled after the decision to treat with natalizumab (TYSABRI®) has been made.

Criteria

Key Inclusion Criteria:

  1. Must give written informed consent and provide all authorizations required by local law
  2. Decision to treat with natalizumab (TYSABRI®) must precede enrollment

Patient characteristics and contraindications to treatment with natalizumab (TYSABRI®) in accordance with prescribing information

  1. Patients must be receiving natalizumab (Tysabri®) for the treatment of Relapsing Remitting Multiple Sclerosis (RRMS) in accordance with the natalizumab (Tysabri®) indication statement
  2. Patient 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 ClinicalTrials.gov identifier: NCT01943526

Contacts
Contact: Biogen Idec clinicaltrials@biogenidec.com

Locations
Ireland
Biogen Idec Investigative Site Completed
Tralee, Kerry, Ireland
Biogen Idec Investigative Site Recruiting
Cork, Ireland
Biogen Idec Investigative Site Recruiting
Dublin, Ireland
Sponsors and Collaborators
Biogen Idec
Investigators
Study Director: Medical Director Biogen Idec
  More Information

No publications provided

Responsible Party: Biogen Idec
ClinicalTrials.gov Identifier: NCT01943526     History of Changes
Other Study ID Numbers: TYS-IRL-11-4
Study First Received: September 12, 2013
Last Updated: September 19, 2014
Health Authority: Ireland: Irish Medicines Board
Ireland: Research Ethics Committee

Keywords provided by Biogen Idec:
Ireland
Natalizumab

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

ClinicalTrials.gov processed this record on October 23, 2014