Immunogenicity and Safety Study of Natalizumab (BG00002) administered to Participants with Relapsing Multiple Sclerosis
Phase 1
- Conditions
- Multiple Sclerosis (MS)MedDRA version: 17.0Level: PTClassification code 10048393Term: Multiple sclerosis relapseSystem Organ Class: 10029205 - Nervous system disordersTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2014-000917-30-DE
- Lead Sponsor
- Biogen Idec Research Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 113
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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 113
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- Any prior use of natalizumab.
- Positive for anti-natalizumab antibodies at screening.
- Treatment with immunomodulatory injections (including IFN-ß and glatiramer acetate) within 2 weeks prior to Screening.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective of this study is to evaluate the immunogenicity of natalizumab 300 mg SC administered to subjects with relapsing MS.;Secondary Objective: The secondary objectives are as follows:<br><br>• To evaluate the safety of natalizumab SC injections.<br><br>• To evaluate the efficacy of natalizumab SC injections on relapses and on new MRI lesions.;Primary end point(s): The proportion of subjects with persistent anti-natalizumab antibodies over 48 weeks. Persistent anti-natalizumab antibodies are defined as 2 positive anti-natalizumab test results separated by at least 6 weeks, with at least 1 positive test result occurring at or after the Week 24 Visit.;Timepoint(s) of evaluation of this end point: 48 weeks
- Secondary Outcome Measures
Name Time Method