Natalizumab High Titer Immunogenicity and Safety

This study has been completed.
Sponsor:
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
  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:


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 April 15, 2014