TOP: IMA-06-02 Tysabri Observational Program

This study is currently recruiting participants.
Verified July 2012 by Biogen Idec
Sponsor:
Information provided by:
Biogen Idec
ClinicalTrials.gov Identifier:
NCT00493298
First received: June 27, 2007
Last updated: July 12, 2012
Last verified: July 2012
  Purpose

A long term, post-marketing, observational safety and treatment impact study of Tysabri in patients with Relapsing Remitting Multiple Sclerosis


Condition Intervention
Relapsing Remitting Multiple Sclerosis
Drug: Natalizumab

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: TOP: IMA-06-02 Tysabri Observational Program

Resource links provided by NLM:


Further study details as provided by Biogen Idec:

Primary Outcome Measures:
  • Occurrence of SAE other than MS relapse [ Time Frame: continuously ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • occurrence of relapses [ Time Frame: yearly ] [ Designated as safety issue: No ]
  • EDSS progression [ Time Frame: yearly ] [ Designated as safety issue: No ]
  • assessment of baseline variables as a prognostic factor [ Time Frame: yearly ] [ Designated as safety issue: No ]
  • anti-JC virus (JCV) antibody prevalence [ Time Frame: yearly ] [ Designated as safety issue: No ]

Estimated Enrollment: 6000
Study Start Date: June 2007
Estimated Study Completion Date: December 2023
Estimated Primary Completion Date: December 2023 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
RRMS patients naïve to Tysabri
Drug: Natalizumab
Natalizumab, indication and dosing as per label
Other Name: Tysabri

Detailed Description:

Open label, multinational, multi-center, prospective, observational study of Tysabri. Endpoints include long term safety, Multiple Sclerosis disease activity as determined by occurrence and severity of clinical relapses, and disability progression (EDSS). Baseline disease characteristics will be evaluated as a prognostic indicators. The results will be compared to propensity matched external cohorts from an autonomous study. Additional endpoint includes evaluation of anti-JC virus (JVC) antibody prevalence for the duration of the study.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Multiple Sclerosis patients on (planned) therapy with Tysabri

Criteria

Inclusion Criteria:

  • Documented diagnosis of Relapsing Remitting Multiple Sclerosis
  • The decision to treat with Tysabri must precede enrollment
  • Patient must be a new Tysabri user, and must not have had more than 3 Tysabri infusions prior to enrollment
  • Must have had at least one relapse in the previous year, and must satisfy locally approved therapeutic indications for Tysabri

Exclusion Criteria:

  • History of Progressive Multifocal Leukoencephalopathy or other opportunistic infections, or and increased risk of opportunistic infections
  • History of positive anti-natalizumab antibodies
  • Concomitant Immunomodulatory or immunosuppressive therapy during therapy with Tysabri
  • Patient immunocompromised at the time of enrollment
  • Known active malignancy
  • Women must not be breast feeding or pregnant, or planning to become pregnant (must use birth control unless surgically sterile)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00493298

Contacts
Contact: Daniel Desgrandchamps, MD daniel.desgrandchamps@biogenidec.com
Contact: Ivan Balla ivan.balla@biogenidec.com

Locations
Switzerland
Biogen Idec International GmbH, Global Medical Affairs Recruiting
Zug, Switzerland, 6300
Contact: Daniel Desgrandchamps    +41 41 392 17 34    daniel.desgrandchamps@biogenidec.com   
Contact: Ivan Balla       ivan.balla@biogenidec.com   
Sponsors and Collaborators
Biogen Idec
  More Information

Additional Information:
No publications provided

Responsible Party: Ryan Arnold, MD, Biogen Idec
ClinicalTrials.gov Identifier: NCT00493298     History of Changes
Other Study ID Numbers: IMA-06-02
Study First Received: June 27, 2007
Last Updated: July 12, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Biogen Idec:
disease progression
Multiple Sclerosis
disease activity
natalizumab
long-term safety
Tysabri

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

ClinicalTrials.gov processed this record on April 17, 2014