Clinical trial NCT03284970: Retrospective Study to Determine Effect of Rebif and Tecfidera on Infections and Lymphocytes
Official title: Effect of Interferon Beta-1a SC 44 µg Three Times Weekly (Tiw) (Rebif) and Dimethyl Fumarate (DMF, Tecfidera) on Infections and Lymphocytes in Patients 50 Years or Older From a Single Center Chart Review
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Relapsing-Remitting Multiple Sclerosis
Keywords: Interferon beta-1a
Dimethyl fumarate
Rebif
Tecfidera
Relapsing-Remitting Multiple Sclerosis
Lead sponsor: EMD Serono
Sponsor class: INDUSTRY
Collaborators: name: Merck KGaA, Darmstadt, Germany
First posted: 2017-09-15
Enrollment: 34
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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).


Eligibility criteria: Inclusion Criteria:

* RRMS subjects who have been treated with interferon beta 1a SC 44 micro-gram thrice a week and dimethyl fumarate in inpatient or outpatient settings during the period from January 1, 2015 to December 31, 2015.
* Subjects with at least one year of laboratory values post-index date to analyze lymphocyte counts, and CD4 and CD8 counts. The date of first blood draw for laboratory tests after January 1, 2015 will be defined as the subject's index date.

Exclusion Criteria:

- Subjects who have been on treatment for less than 1 year after their index date.

Primary outcomes:
measure: Percentage of Subjects With One or More Infections
timeFrame: Up to 12 months
Secondary outcomes:
measure: Percentage of Subjects With One or More Serious Infections
timeFrame: Baseline, 6 Months, 12 Months
measure: Percentage of Subjects With One or More Opportunistic Infections
timeFrame: Baseline, 6 Months, 12 Months
measure: Number of Infections per Subject
timeFrame: Baseline, 6 Months, 12 Months
measure: Number of Serious Infections per Subject
timeFrame: Baseline, 6 Months, 12 Months
measure: Number of Opportunistic Infections per Subject
timeFrame: Baseline, 6 Months, 12 Months
measure: Total Lymphocyte Levels
timeFrame: Baseline, 6 Months, 12 Months
measure: Percentage of Subjects With Lymphopenia Grades I, II, III and IV
timeFrame: Baseline, 6 Months, 12 Months
measure: Cluster of Differentiation 4 (CD4) and Cluster of Differentiation 8 (CD8) Counts
timeFrame: Baseline, 6 Months, 12 Months
measure: Cluster of Differentiation 4 (CD4) and Cluster of Differentiation 8 (CD8) Ratio
timeFrame: Baseline, 6 Months, 12 Months
measure: Occurrence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Baseline, 6 Months, 12 Months
Other outcomes:
Locations:
city: Foxboro
country: United States
facility: Neurology Center of New England
state: Massachusetts
Study officials:
affiliation: EMD Serono Inc., a business of Merck KGaA, Darmstadt, Germany
name: Medical Responsible
role: STUDY_DIRECTOR
References: