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

Overview

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).

Full Title of Study: “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

  • Study Type: Observational
  • Study Design
    • Time Perspective: Retrospective
  • Study Primary Completion Date: May 11, 2018

Arms, Groups and Cohorts

  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Percentage of Subjects With One or More Infections
    • Time Frame: Up to 12 months

Secondary Measures

  • Percentage of Subjects With One or More Serious Infections
    • Time Frame: Baseline, 6 Months, 12 Months
  • Percentage of Subjects With One or More Opportunistic Infections
    • Time Frame: Baseline, 6 Months, 12 Months
  • Number of Infections per Subject
    • Time Frame: Baseline, 6 Months, 12 Months
  • Number of Serious Infections per Subject
    • Time Frame: Baseline, 6 Months, 12 Months
  • Number of Opportunistic Infections per Subject
    • Time Frame: Baseline, 6 Months, 12 Months
  • Total Lymphocyte Levels
    • Time Frame: Baseline, 6 Months, 12 Months
  • Percentage of Subjects With Lymphopenia Grades I, II, III and IV
    • Time Frame: Baseline, 6 Months, 12 Months
  • Cluster of Differentiation 4 (CD4) and Cluster of Differentiation 8 (CD8) Counts
    • Time Frame: Baseline, 6 Months, 12 Months
  • Cluster of Differentiation 4 (CD4) and Cluster of Differentiation 8 (CD8) Ratio
    • Time Frame: Baseline, 6 Months, 12 Months
  • Occurrence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
    • Time Frame: Baseline, 6 Months, 12 Months

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 50 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • EMD Serono Research & Development Institute, Inc.
  • Collaborator
    • Merck KGaA, Darmstadt, Germany
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Medical Responsible, Study Director, EMD Serono Inc., a business of Merck KGaA, Darmstadt, Germany

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.