Trial record 8 of 279 for:
biogen | biogen
Natalizumab High Titer Immunogenicity and Safety
This study has been completed.
Sponsor:
Biogen Idec
Collaborator:
Elan Pharmaceuticals
Information provided by:
Biogen Idec
ClinicalTrials.gov Identifier:
NCT00516893
First received: August 14, 2007
Last updated: October 14, 2009
Last verified: October 2009
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Purpose
Biogen Idec is studying natalizumab (TYSABRI®) produced by a modified manufacturing process (natalizumab high titer).
| Condition | Intervention | Phase |
|---|---|---|
|
Multiple Sclerosis |
Drug: natalizumab |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label |
| Official Title: | A Multicenter, Open-Label Immunogenicity and Safety Study of Natalizumab High Titer Material (BG00002-E) in Subjects With Relapsing Forms of Multiple Sclerosis |
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:
- Incidence of Antibodies to Natalizumab [ Time Frame: Up to Week 36 ] [ Designated as safety issue: Yes ]
| Enrollment: | 113 |
| Study Start Date: | October 2006 |
| Study Completion Date: | December 2007 |
| Primary Completion Date: | November 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Natalizumab
Natalizumab High Titer 300 mg
|
Drug: natalizumab
Natalizumab high titer 300 mg administered IV infusion over 60 minutes once every 4 weeks for up to 9 doses.
Other Name: Tysabri
|
Detailed Description:
This study is a multicenter, single-arm, open-label study in subjects with relapsing forms of MS. The population will include subjects who have never received natalizumab and who are appropriate for natalizumab treatment in that the inclusion criteria are in accordance with local labeling. Subjects may receive up to 9 doses of natalizumab high titer 300 mg IV every 4 weeks.
Clinical and laboratory safety assessments will be performed throughout the study for up to 44 weeks.
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Diagnosis of a relapsing form of MS
- Must fall within the therapeutic indications stated in the locally approved label for TYSABRI
- Other protocol-defined inclusion criteria may apply
Exclusion Criteria:
- Prior treatment with natalizumab
- Considered by Investigator to be immunocompromised
- Other protocol-defined exclusion criteria may apply
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00516893
Locations
| United States, District of Columbia | |
| Research Site | |
| Washington, District of Columbia, United States, 20007 | |
| United States, Florida | |
| Research Site | |
| Maitland, Florida, United States, 32751 | |
| Research Site | |
| Miami, Florida, United States, 33136 | |
| United States, Georgia | |
| Research Site | |
| Atlanta, Georgia, United States, 30327 | |
| United States, Michigan | |
| Research Site | |
| Farmington Hills, Michigan, United States, 48334 | |
| United States, New York | |
| Research Site | |
| Buffalo, New York, United States, 14203 | |
| Research Site | |
| New York, New York, United States, 10003 | |
| United States, North Carolina | |
| Research Site | |
| Charlotte, North Carolina, United States, 28207 | |
| United States, Pennsylvania | |
| Reseach Site | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Research Site | |
| Pittsburgh, Pennsylvania, United States, 15212 | |
| United States, Texas | |
| Research Site | |
| Dallas, Texas, United States, 75214 | |
| Research site | |
| Round Rock, Texas, United States, 78681 | |
| United States, Wisconsin | |
| Research Site | |
| Milwaukee, Wisconsin, United States, 53215 | |
Sponsors and Collaborators
Biogen Idec
Elan Pharmaceuticals
Investigators
| Study Director: | Study Director | Biogen Idec |
More Information
No publications provided
| Responsible Party: | Biogen Idec Medical Director, Biogen Idec |
| ClinicalTrials.gov Identifier: | NCT00516893 History of Changes |
| Other Study ID Numbers: | 101MS201 |
| Study First Received: | August 14, 2007 |
| Results First Received: | June 30, 2009 |
| Last Updated: | October 14, 2009 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Biogen Idec:
|
natalizumab TYSABRI Multiple Sclerosis Relapsing Forms of Multiple Sclerosis |
Additional relevant MeSH terms:
|
Multiple Sclerosis Sclerosis 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 June 18, 2013