Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Merck KGaA, Darmstadt, Germany | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study will be a single center, retrospective, pilot study to determine the effect of Rebif (interferon beta-1a) and Tecfidera (dimethyl fumarate) on infections on total lymphocyte counts, grade of lymphopenia, Cluster of Differentiation 4 (CD4) and Cluster of Differentiation 8 (CD8) counts and ratios in subjects aged 50 years and above with Relapsing-Remitting Multiple Sclerosis (RRMS).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rebif (interferon beta 1a) | This study will retrospectively collect the data from the subjects who had been treated with Rebif subcutaneously (SC) at a dose of 44 micro-grams three times a week. | ||
| Tecfidera (dimethyl fumarate) | This study will retrospectively collect the data from the subjects who had been treated with Tecfidera. |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects With One or More Infections | Up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects With One or More Serious Infections | Baseline, 6 Months, 12 Months | |
| Percentage of Subjects With One or More Opportunistic Infections | Baseline, 6 Months, 12 Months | |
Not provided
Inclusion Criteria:
Exclusion Criteria:
- Subjects who have been on treatment for less than 1 year after their index date.
Not provided
Not provided
Not provided
The study will include subjects aged 50 years or older with relapsing RRMS, identified from a feasibility assessment conducted at a single center in United States, who were treated with either interferon beta-1a SC 44 micro-gram or dimethyl fumarate between January 1, 2015 to December 31, 2015.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Responsible | EMD Serono Inc., a business of Merck KGaA, Darmstadt, Germany | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Neurology Center of New England | Foxborough | Massachusetts | 02035 | United States |
Not provided
| ID | Term |
|---|---|
| D020529 | Multiple Sclerosis, Relapsing-Remitting |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
| Number of Infections per Subject |
| Baseline, 6 Months, 12 Months |
| Number of Serious Infections per Subject | Baseline, 6 Months, 12 Months |
| Number of Opportunistic Infections per Subject | Baseline, 6 Months, 12 Months |
| Total Lymphocyte Levels | Baseline, 6 Months, 12 Months |
| Percentage of Subjects With Lymphopenia Grades I, II, III and IV | Baseline, 6 Months, 12 Months |
| Cluster of Differentiation 4 (CD4) and Cluster of Differentiation 8 (CD8) Counts | Baseline, 6 Months, 12 Months |
| Cluster of Differentiation 4 (CD4) and Cluster of Differentiation 8 (CD8) Ratio | Baseline, 6 Months, 12 Months |
| Occurrence of Adverse Events (AEs) and Serious Adverse Events (SAEs) | Baseline, 6 Months, 12 Months |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |