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Completed

NCT Number: NCT03284970

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

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).

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Key information

Conditions

Relapsing-Remitting Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Multiple Sclerosis Multiple Sclerosis, Relapsing-Remitting Nervous System Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Neurology Center of New England

Foxborough, Massachusetts, 02035, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Percentage of Subjects With One or More Infections

    Time frame: Up to 12 months

Secondary outcomes

  1. Percentage of Subjects With One or More Serious Infections

    Time frame: Baseline, 6 Months, 12 Months

  2. Percentage of Subjects With One or More Opportunistic Infections

    Time frame: Baseline, 6 Months, 12 Months

  3. Number of Infections per Subject

    Time frame: Baseline, 6 Months, 12 Months

  4. Number of Serious Infections per Subject

    Time frame: Baseline, 6 Months, 12 Months

  5. Number of Opportunistic Infections per Subject

    Time frame: Baseline, 6 Months, 12 Months

  6. Total Lymphocyte Levels

    Time frame: Baseline, 6 Months, 12 Months

  7. Percentage of Subjects With Lymphopenia Grades I, II, III and IV

    Time frame: Baseline, 6 Months, 12 Months

  8. Cluster of Differentiation 4 (CD4) and Cluster of Differentiation 8 (CD8) Counts

    Time frame: Baseline, 6 Months, 12 Months

  9. Cluster of Differentiation 4 (CD4) and Cluster of Differentiation 8 (CD8) Ratio

    Time frame: Baseline, 6 Months, 12 Months

  10. Occurrence of Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Time frame: Baseline, 6 Months, 12 Months

Sponsors and collaborators

Lead sponsor

EMD Serono Research & Development Institute, Inc.

Industry

Collaborators

  • Merck KGaA, Darmstadt, Germany

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Sep 15, 2017
Registry last updated
Aug 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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