Natalizumab High Titer Immunogenicity and Safety

NCT ID: NCT00516893

Last Updated: 2014-05-15

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

113 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-10-31

Study Completion Date

2007-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Multiple Sclerosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type EXPERIMENTAL

BG00002-E (natalizumab high titer)

Intervention Type BIOLOGICAL

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

BG00002-E (natalizumab high titer)

Intervention Type BIOLOGICAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Tysabri

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* Prior treatment with natalizumab
* Considered by investigator to be immunocompromised
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Elan Pharmaceuticals

INDUSTRY

Sponsor Role collaborator

Biogen

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Biogen Idec

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Medical Director

Role: STUDY_DIRECTOR

Biogen

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Research Site

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

Site Status

Research Site

Maitland, Florida, United States

Site Status

Research Site

Miami, Florida, United States

Site Status

Research Site

Atlanta, Georgia, United States

Site Status

Research Site

Farmington Hills, Michigan, United States

Site Status

Research Site

Buffalo, New York, United States

Site Status

Research Site

New York, New York, United States

Site Status

Research Site

Charlotte, North Carolina, United States

Site Status

Research Site

Philadelphia, Pennsylvania, United States

Site Status

Research Site

Pittsburgh, Pennsylvania, United States

Site Status

Research Site

Dallas, Texas, United States

Site Status

Research site

Round Rock, Texas, United States

Site Status

Research Site

Milwaukee, Wisconsin, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

101MS201

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Rituximab in Systemic Sclerosis
NCT01748084 COMPLETED PHASE2/PHASE3