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

Relapsing-Remitting Multiple Sclerosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03284970
• Other study ID #: MS200136_0077
• Status: Completed
• Start date: August 23, 2017
• Est. completion date: May 11, 2018

Study information

• Verified date: August 2018
• Source: EMD Serono
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: May 11, 2018
• Est. primary completion date: May 11, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Relapsing-Remitting Multiple Sclerosis
• Sclerosis

Locations

Country	Name	City	State
United States	Neurology Center of New England	Foxboro	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
EMD Serono Research & Development Institute, Inc.	Merck KGaA

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Subjects With One or More Infections		Up to 12 months
Secondary	Percentage of Subjects With One or More Serious Infections		Baseline, 6 Months, 12 Months
Secondary	Percentage of Subjects With One or More Opportunistic Infections		Baseline, 6 Months, 12 Months
Secondary	Number of Infections per Subject		Baseline, 6 Months, 12 Months
Secondary	Number of Serious Infections per Subject		Baseline, 6 Months, 12 Months
Secondary	Number of Opportunistic Infections per Subject		Baseline, 6 Months, 12 Months
Secondary	Total Lymphocyte Levels		Baseline, 6 Months, 12 Months
Secondary	Percentage of Subjects With Lymphopenia Grades I, II, III and IV		Baseline, 6 Months, 12 Months
Secondary	Cluster of Differentiation 4 (CD4) and Cluster of Differentiation 8 (CD8) Counts		Baseline, 6 Months, 12 Months
Secondary	Cluster of Differentiation 4 (CD4) and Cluster of Differentiation 8 (CD8) Ratio		Baseline, 6 Months, 12 Months
Secondary	Occurrence of Adverse Events (AEs) and Serious Adverse Events (SAEs)		Baseline, 6 Months, 12 Months