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

NCT03284970 | Completed

• 1 other identifier: MS200136_0077
• Study Type: observational
• Target: 34
• Locations: 1 country
• Sites: 1

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).

Conditions

Relapsing-Remitting Multiple Sclerosis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Percentage of Subjects With One or More Infections

  Up to 12 months

Secondary Outcomes (10)

• 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

• 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

Study Arms (2)

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.

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• EMD Serono Research & Development Institute, Inc.: lead
• Merck KGaA, Darmstadt, Germany: collaborator

Study Sites (1)

Neurology Center of New England

Foxborough, Massachusetts, 02035, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting

Condition Hierarchy (Ancestors)

Multiple Sclerosis; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Medical Responsible

  EMD Serono Inc., a business of Merck KGaA, Darmstadt, Germany

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2017
• First Posted: September 15, 2017
• Study Start: August 23, 2017
• Primary Completion: May 11, 2018
• Study Completion: May 11, 2018
• Last Updated: August 6, 2018

Record last verified: 2018-08

Locations

US (1)