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Natalizumab Subcutaneous Immunogenicity and Safety Study

Information source: Biogen
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Relapsing Multiple Sclerosis

Intervention: natalizumab (Drug)

Phase: Phase 2

Status: Terminated

Sponsored by: Biogen

Official(s) and/or principal investigator(s):
Medical Director, Study Director, Affiliation: Biogen


The primary objective of this study is to evaluate the immunogenicity of natalizumab (BG00002) 300 mg subcutaneous (SC) administered to participants with relapsing multiple sclerosis (RMS). The secondary objectives of the study are to evaluate the safety of natalizumab SC injections and to evaluate the efficacy of natalizumab SC injections on relapses and on new magnetic resonance imaging (MRI) lesions.

Clinical Details

Official title: A Multicenter, Open-Label Immunogenicity and Safety Study of Subcutaneous Natalizumab 300 mg Administered to Subjects With Relapsing Multiple Sclerosis

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Proportion of participants with persistent anti-natalizumab antibodies

Secondary outcome:

Proportion of participants with transient anti-natalizumab antibodies

Proportion of participants with post-injection adverse events (AEs)

Proportion of participants with clinical relapse

Proportion of participants with gadolinium (Gd) enhancing lesion(s) as assessed by MRI.

Proportion of Participants that experience Adverse Events and Serious Adverse Events


Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.


Key Inclusion Criteria:

- Must have documented diagnosis of RMS at screening.

- Must fall within the therapeutic indications stated in the locally approved label for


- Must have an EDSS score from 0 to 6. 5, inclusive.

Key Exclusion Criteria:

- Any prior use of natalizumab.

- Positive for anti-natalizumab antibodies at screening.

- Treatment with immunomodulatory injections (including IFN-β and glatiramer acetate)

within 2 weeks prior to Screening. NOTE: Other protocol defined Inclusion/Exclusion criteria may apply

Locations and Contacts

Research Site, Leuven 3000, Belgium

Research Site, Liege 4000, Belgium

Additional Information

Starting date: December 2014
Last updated: July 2, 2015

Page last updated: August 23, 2015

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