Natalizumab High Titer Immunogenicity and Safety

Multiple Sclerosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00516893
• Other study ID #: 101MS201
• Status: Completed
• Phase: Phase 2
• First received: August 14, 2007
• Last updated: May 1, 2014
• Start date: October 2006
• Est. completion date: December 2007

Study information

• Verified date: May 2014
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 113
• Est. completion date: December 2007
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Biological:
• BG00002-E (natalizumab high titer)

Locations

Country	Name	City	State
United States	Research Site	Atlanta	Georgia
United States	Research Site	Buffalo	New York
United States	Research Site	Charlotte	North Carolina
United States	Research Site	Dallas	Texas
United States	Research Site	Farmington Hills	Michigan
United States	Research Site	Maitland	Florida
United States	Research Site	Miami	Florida
United States	Research Site	Milwaukee	Wisconsin
United States	Research Site	New York	New York
United States	Research Site	Philadelphia	Pennsylvania
United States	Research Site	Pittsburgh	Pennsylvania
United States	Research site	Round Rock	Texas
United States	Research Site	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Biogen	Elan Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and Discontinuations Due to AEs	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.	AEs: collected from Baseline (Week 0) until Week 36 or premature withdrawal. SAEs: collected from informed consent until Week 36 or premature withdrawal.	Yes
Secondary	Mean Change From Baseline in Expanded Disability Status Scale (EDSS) Scores at Week 36	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.	Baseline, Week 36	Yes
Secondary	Annualized Relapse Rate	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.	Through Week 36	Yes