Retrospective Study to Determine Effect of Rebif and Tecfidera on Infections and Lymphocytes

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03284970

Enrollment

Registered

2017-09-15

Start date

2017-08-23

Completion date

2018-05-11

Last updated

2018-08-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Relapsing-Remitting Multiple Sclerosis

Keywords

Interferon beta-1a, Dimethyl fumarate, Rebif, Tecfidera, Relapsing-Remitting Multiple Sclerosis

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).

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

50 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Percentage of Subjects With One or More Infections	Up to 12 months

Secondary

Measure	Time frame
Percentage of Subjects With One or More Opportunistic Infections	Baseline, 6 Months, 12 Months
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
Percentage of Subjects With One or More Serious Infections	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
Total Lymphocyte Levels	Baseline, 6 Months, 12 Months

Countries

United States

Outcome results