Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2014-000917-30 | EudraCT Number |
Not provided
Not provided
Sponsor's decision.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| natalizumab | Experimental | natalizumab 300mg SC every 4 weeks for up to 12 treatment administrations (i.e. Day 1 through Week 44) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| natalizumab | Drug | Administered as specified in the treatment arm |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants with persistent anti-natalizumab antibodies | 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. | 48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants with transient anti-natalizumab antibodies | 48 weeks | |
| Proportion of participants with post-injection adverse events (AEs) | Including hypersensitivity reactions, anaphylactic reactions and other AEs occurring within 1 hour after SC natalizumab dosing. |
Not provided
Key Inclusion Criteria:
Key Exclusion Criteria:
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Biogen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Leuven | 3000 | Belgium | |||
| Research Site |
Not provided
| Label | URL |
|---|---|
| EudraCT Tabulated Result | View source |
Not provided
| ID | Term |
|---|---|
| D000069442 | Natalizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 48 weeks |
| Proportion of participants with clinical relapse | 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. | 48 weeks |
| 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 |
| Liège |
| 4000 |
| Belgium |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |