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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: May 1, 2014
Last verified: May 2014
  Purpose

The primary objective of the study was to evaluate the immunogenicity of natalizumab (Tysabri®) produced by a modified manufacturing process (natalizumab high titer; BG00002-E) administered intravenously (IV) to participants with relapsing forms of multiple sclerosis (MS). The secondary objective of this study was to evaluate the safety of natalizumab high titer.


Condition Intervention Phase
Multiple Sclerosis
Biological: BG00002-E (natalizumab high titer)
Phase 2

Study Type: Interventional
Study Design: 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:
  • Number of Participants With Anti-Natalizumab Antibody Negative, Transient Positive, and Persistent Positive Status [ Time Frame: Assessed every 12 weeks from Week 0 (Baseline) to Week 36 ] [ Designated as safety issue: No ]
    Negative: no detectable antibody at all post-baseline visits. Persistent positive: antibody positive at 2 or more post-baseline visits at least 42 days apart, or positive at the last post-baseline visit. Transient positive: antibody positive at only 1 post-baseline visit prior to the last visit.


Secondary Outcome Measures:
  • Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and Discontinuations Due to AEs [ Time Frame: AEs: collected from Baseline (Week 0) until Week 36 or premature withdrawal. SAEs: collected from informed consent until Week 36 or premature withdrawal. ] [ Designated as safety issue: Yes ]
    AE: any sign, symptom, or diagnosis/disease that was unfavorable or unintended, new, or if pre-existing, worsened in a participant administered a study treatment and that did not necessarily have a causal relationship with this treatment. SAE: an event that resulted in death; an event that, in the view of the investigator, placed the participant at immediate risk of death (life-threatening event); an outcome that resulted in a congenital anomaly/birth defect diagnosed in a child of a participant in this study; an event that required or prolonged inpatient hospitalization; an event that resulted in persistent or significant disability/incapacity; any other medically important event that, in the opinion of the investigator, may have jeopardized the participant or may have required intervention to prevent one of the other outcomes listed above. Events were classified as 'related' or 'not related' to study drug, and categorized as 'mild' moderate' or 'severe' per protocol.

  • Mean Change From Baseline in Expanded Disability Status Scale (EDSS) Scores at Week 36 [ Time Frame: Baseline, Week 36 ] [ Designated as safety issue: Yes ]
    EDSS assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to MS) was calculated. The change in EDSS at Month 36 was calculated as EDSS at Month 36 minus EDSS at baseline.

  • Annualized Relapse Rate [ Time Frame: Through Week 36 ] [ Designated as safety issue: Yes ]
    Annualized relapse rate was calculated as the total number of relapses that occurred during the study divided by the total number of years the participant was followed in the study. The annualized relapse rate was based only on those relapses that were determined to meet the definition of relapse per the investigator's clinical judgment. New or recurrent symptoms that occurred less than 30 days following the onset of a protocol-defined relapse were considered part of the same relapse.


Enrollment: 113
Study Start Date: October 2006
Study Completion Date: December 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Natalizumab High Titer
natalizumab high titer 300 mg administered as intravenous (IV) infusion over 60 minutes once every 4 weeks for up to 9 doses
Biological: BG00002-E (natalizumab high titer)
Other Name: Tysabri

  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 natalizumab
  • 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
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: 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
Research 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: Medical 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: May 1, 2014
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
Autoimmune Diseases
Autoimmune Diseases of the Nervous System
Demyelinating Autoimmune Diseases, CNS
Demyelinating Diseases
Immune System Diseases
Nervous System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on November 20, 2014