Immunogenicity and Safety Study of Natalizumab (BG00002) administered to Participants with Relapsing Multiple Sclerosis

Conditions: Multiple Sclerosis (MS)
MedDRA version: 17.0Level: PTClassification code 10048393Term: Multiple sclerosis relapseSystem Organ Class: 10029205 - Nervous system disorders
Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Registration Number: EUCTR2014-000917-30-DK

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