Clinical trial NCT00516893: Natalizumab High Titer Immunogenicity and Safety
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Multiple Sclerosis
Keywords: natalizumab
Tysabri
Multiple Sclerosis
Relapsing Forms of Multiple Sclerosis
Lead sponsor: Biogen
Sponsor class: INDUSTRY
Collaborators: name: Elan Pharmaceuticals
First posted: 2007-08-16
Enrollment: 113
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

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.


Eligibility 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

Primary outcomes:
measure: Number of Participants With Anti-Natalizumab Antibody Negative, Transient Positive, and Persistent Positive Status
timeFrame: Assessed every 12 weeks from Week 0 (Baseline) to Week 36
Secondary outcomes:
measure: Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and Discontinuations Due to AEs
timeFrame: AEs: collected from Baseline (Week 0) until Week 36 or premature withdrawal. SAEs: collected from informed consent until Week 36 or premature withdrawal.
measure: Mean Change From Baseline in Expanded Disability Status Scale (EDSS) Scores at Week 36
timeFrame: Baseline, Week 36
measure: Annualized Relapse Rate
timeFrame: Through Week 36
Other outcomes:
Locations:
city: Washington
country: United States
facility: Research Site
state: District of Columbia
city: Maitland
country: United States
facility: Research Site
state: Florida
city: Miami
country: United States
facility: Research Site
state: Florida
city: Atlanta
country: United States
facility: Research Site
state: Georgia
city: Farmington Hills
country: United States
facility: Research Site
state: Michigan
city: Buffalo
country: United States
facility: Research Site
state: New York
city: New York
country: United States
facility: Research Site
state: New York
city: Charlotte
country: United States
facility: Research Site
state: North Carolina
city: Philadelphia
country: United States
facility: Research Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Research Site
state: Pennsylvania
city: Dallas
country: United States
facility: Research Site
state: Texas
city: Round Rock
country: United States
facility: Research site
state: Texas
city: Milwaukee
country: United States
facility: Research Site
state: Wisconsin
Study officials:
affiliation: Biogen
name: Medical Director
role: STUDY_DIRECTOR
References: