Natalizumab Subcutaneous Immunogenicity and Safety Study
NCT02142192 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 2
Last updated 2024-06-03
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.
Conditions
Interventions
- DRUG
-
natalizumab
Administered as specified in the treatment arm
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Medical Director · Biogen
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2014-12-01
- Primary Completion
- 2015-06-04
- Completion
- 2015-06-04
Countries
- Belgium
Study Locations
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