NCT00516893

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
113

participants targeted

Target at P50-P75 for phase_2 multiple-sclerosis

Timeline
Completed

Started Oct 2006

Shorter than P25 for phase_2 multiple-sclerosis

Geographic Reach
1 country

13 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2006

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

August 14, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 16, 2007

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

August 13, 2009

Completed
Last Updated

May 15, 2014

Status Verified

May 1, 2014

Enrollment Period

1 year

First QC Date

August 14, 2007

Results QC Date

June 30, 2009

Last Update Submit

May 1, 2014

Conditions

Multiple Sclerosis

Keywords

natalizumabTysabriMultiple SclerosisRelapsing Forms of Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Anti-Natalizumab Antibody Negative, Transient Positive, and Persistent Positive Status

    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.

    Assessed every 12 weeks from Week 0 (Baseline) to Week 36

Secondary Outcomes (3)

  • Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and Discontinuations Due to AEs

    AEs: collected from Baseline (Week 0) until Week 36 or premature withdrawal. SAEs: collected from informed consent until Week 36 or premature withdrawal.

  • Mean Change From Baseline in Expanded Disability Status Scale (EDSS) Scores at Week 36

    Baseline, Week 36

  • Annualized Relapse Rate

    Through Week 36

Study Arms (1)

Natalizumab High Titer

EXPERIMENTAL

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)

Interventions

BG00002-E (natalizumab high titer)BIOLOGICAL
Also known as: Tysabri
Natalizumab High Titer

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Diagnosis of a relapsing form of MS
  • Must fall within the therapeutic indications stated in the locally approved label for natalizumab

You may not qualify if:

  • Prior treatment with natalizumab
  • Considered by investigator to be immunocompromised

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Research Site

Washington D.C., District of Columbia, 20007, United States

Location

Research Site

Maitland, Florida, 32751, United States

Location

Research Site

Miami, Florida, 33136, United States

Location

Research Site

Atlanta, Georgia, 30327, United States

Location

Research Site

Farmington Hills, Michigan, 48334, United States

Location

Research Site

Buffalo, New York, 14203, United States

Location

Research Site

New York, New York, 10003, United States

Location

Research Site

Charlotte, North Carolina, 28207, United States

Location

Research Site

Philadelphia, Pennsylvania, 19104, United States

Location

Research Site

Pittsburgh, Pennsylvania, 15212, United States

Location

Research Site

Dallas, Texas, 75214, United States

Location

Research site

Round Rock, Texas, 78681, United States

Location

Research Site

Milwaukee, Wisconsin, 53215, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Natalizumab

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Results Point of Contact

Title
Biogen Idec Medical Director
Organization
Biogen Idec Inc.
clinicaltrials@biogenidec.com

Study Officials

  • Medical Director

    Biogen

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 14, 2007

First Posted

August 16, 2007

Study Start

October 1, 2006

Primary Completion

October 1, 2007

Study Completion

December 1, 2007

Last Updated

May 15, 2014

Results First Posted

August 13, 2009

Record last verified: 2014-05

Locations

US(13)