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
Summary
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 antibodiesProportion 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
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Key Inclusion Criteria:
- Must have documented diagnosis of RMS at screening.
- Must fall within the therapeutic indications stated in the locally approved label for
natalizumab.
- 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
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