Relapsing Multiple Sclerosis
Conditions
Brief 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.
Interventions
DRUGnatalizumab
Administered as specified in the treatment arm
Sponsors
Biogen
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion 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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of participants with persistent anti-natalizumab antibodies | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of participants with transient anti-natalizumab antibodies | 48 weeks | — |
| Proportion of participants with post-injection adverse events (AEs) | 48 weeks | Including hypersensitivity reactions, anaphylactic reactions and other AEs occurring within 1 hour after SC natalizumab dosing. |
| Proportion of participants with clinical relapse | 48 weeks | This may include new or enlarging T2 lesion(s), as determined by magnetic resonance imaging (MRI). Clinical relapse is defined as new or recurrent neurological symptoms not associated with fever or infection, lasting at least 24 hours, and accompanied by new objective neurological findings upon examination by the neurologist. |
| Proportion of participants with gadolinium (Gd) enhancing lesion(s) as assessed by MRI. | 48 weeks | — |
| Proportion of Participants that experience Adverse Events and Serious Adverse Events | up to 56 weeks | — |
Countries
Belgium
Outcome results
None listed