Natalizumab High Titer Immunogenicity and Safety

Biogen

Status and phase: Completed; Phase 2

Conditions: Multiple Sclerosis

Treatments: Biological: BG00002-E (natalizumab high titer)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00516893

101MS201

Details and patient eligibility

About

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.

Enrollment: 113 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

113 participants in 1 patient group

Natalizumab High Titer

Experimental group

Description:

natalizumab high titer 300 mg administered as intravenous (IV) infusion over 60 minutes once every 4 weeks for up to 9 doses

Treatment:

Biological: BG00002-E (natalizumab high titer)