Ireland TYSABRI® (Natalizumab) Observational Program (iTOP)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by Biogen Idec
Sponsor:
Information provided by (Responsible Party):
Biogen Idec
ClinicalTrials.gov Identifier:
NCT01943526
First received: September 12, 2013
Last updated: NA
Last verified: September 2013
History: No changes posted
  Purpose

This is a non-interventional observational study of patients receiving natalizumab (TYSABRI®) in Ireland. Time perspective of this study is both prospective and retrospective.

The primary objective of this study is to assess the long-term safety (incidence and pattern of SAEs including infections and discontinuations) in patients receiving natalizumab (TYSABRI®) in a clinical practice setting.

The secondary objectives are to assess the long-term disease activity and progression of patients with relapsing remitting multiple sclerosis (RRMS) who are receiving natalizumab (TYSABRI®) in a clinical practice setting.


Condition
Multiple Sclerosis, Relapsing-Remitting
Relapsing Remitting Multiple Sclerosis

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

Resource links provided by NLM:


Further study details as provided by Biogen Idec:

Primary Outcome Measures:
  • The number of participants that experience serious adverse events (SAEs) [ Time Frame: up to 3 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Proportion of Participants Whose Multiple Sclerosis Progresses at least 1 Point on the Expanded Disability Status Score (EDSS) and Sustained Over 6 Months [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
  • Proportion of Participants that Reach Expanded Disability Status Score (EDSS) Milestones Indicating Increasing Disability [ Time Frame: Up t o 3 years ] [ Designated as safety issue: No ]
  • 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 ]
  • Annualized Relapse Rate [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
  • Distribution of the Total Number of Relapses During the Study [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
  • Time to First Relapse [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
  • Proportions of Participants with relapse [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
  • 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 ]

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)
  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

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).
  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: Medical Director medinfo-uk@biogenidec.com

Locations
Ireland
Biogen Idec Investigative Site Recruiting
Tralee, Kerry, Ireland
Biogen Idec Investigative Site Recruiting
Cork, Ireland
Biogen Idec Investigative Site Recruiting
Dublin, Ireland
Sponsors and Collaborators
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 12, 2013
Health Authority: Ireland: Irish Medicines Board
Ireland: Research Ethics Committee

Keywords provided by Biogen Idec:
Ireland
Natalizumab

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on September 18, 2014