TOP: IMA-06-02 Tysabri Observational Program
This study is currently recruiting participants.
Verified July 2012 by Biogen Idec
Sponsor:
Biogen Idec
Information provided by:
Biogen Idec
ClinicalTrials.gov Identifier:
NCT00493298
First received: June 27, 2007
Last updated: July 12, 2012
Last verified: July 2012
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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:
Genetics Home Reference related topics:
multiple sclerosis
MedlinePlus related topics:
Multiple Sclerosis
Drug Information available for:
Natalizumab
U.S. FDA Resources
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 May 23, 2013