Natalizumab High Titer Immunogenicity and Safety

Phase 2

Completed

• Conditions: Multiple Sclerosis
• Interventions: Biological: BG00002-E (natalizumab high titer)

• Registration Number: NCT00516893
• Lead Sponsor: Biogen

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-10
• Study First Submitted: 2007-08-14
• Study First Submitted QC: 2007-08-15
• Study First Posted: 2007-08-16
• Primary Completion: 2007-10
• Study Completion: 2007-12
• Results First Submitted: 2009-06-30
• Results First Submitted QC: 2009-06-30
• Results First Posted: 2009-08-13
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-01
• Last Update Posted: 2014-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 113

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Natalizumab High Titer	BG00002-E (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

Primary Outcome Measures

Name	Time	Method
Number of Participants With Anti-Natalizumab Antibody Negative, Transient Positive, and Persistent Positive Status	Assessed every 12 weeks from Week 0 (Baseline) to Week 36	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

Name	Time	Method
Annualized Relapse Rate	Through Week 36	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.
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.	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	Baseline, 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.

Trial Locations

Locations (2)

Research site; 🇺🇸 Round Rock, Texas, United States

Research Site; 🇺🇸 Milwaukee, Wisconsin, United States