Tecfidera Lymphocyte Chart Review

• Register: ClinicalTrials.gov
• Last refreshed on: 5 September 2016
• Main ID: NCT02519413
• Date of registration: 16/07/2015
• Prospective Registration: No
• Primary sponsor: Biogen
• Public title: Tecfidera Lymphocyte Chart Review REALIZE
• Scientific title: A Retrospective, Multi-Center, Observational Study to Assess the Effect of Tecfidera® Delayed-Release Capsules on Lymphocyte Subsets in Subjects With Relapsing Forms of Multiple Sclerosis (REALIZE)
• Date of first enrolment: July 2015
• Target sample size: 483
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02519413
• Study type: Observational
• Study design: Observational Model: Cohort, Time Perspective: Retrospective
• Phase: N/A

Countries of recruitment

United States

Contacts

• Name: Medical Director
• Affiliation: Biogen

Key inclusion & exclusion criteria

Key Inclusion Criteria:

- Initiated Tecfidera treatment for the first time on or after 27 March 2013 and
received at least 6 months of continuous treatment with Tecfidera

- Clinical diagnosis of a relapsing form of MS

- A baseline measurement for ALC and absolute CD4+ or CD8+ count within 6 months prior
to Tecfidera initiation

- At least 1 measurement for ALC and absolute CD4+ or CD8+ count while on Tecfidera
therapy for at least 6 months

Key Exclusion Criteria:

- Clinical diagnosis of human immunodeficiency virus (HIV) or acquired immunodeficiency
syndrome (AIDS) prior to Tecfidera initiation

- Participation in DEFINE 109MS301 (NCT00420212) or CONFIRM 109MS302 (NCT00451451)

NOTE: Other protocol-defined inclusion/exclusion criteria may apply.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Multiple Sclerosis

Intervention(s)

Drug: dimethyl fumarate

Primary Outcome(s)

Estimated absolute lymphocyte count (ALC) change from baseline following Tecfidera initiation [Time Frame: 6 and 12 months]

Estimated CD8+ count change from baseline following Tecfidera initiation [Time Frame: 6 and 12 months]

Estimated CD4+ count change from baseline following Tecfidera initiation [Time Frame: 6 and 12 months]

Secondary Outcome(s)

Percentage change from baseline for additional lymphocyte subsets (other than CD4+and CD8+) following Tecfidera initiation [Time Frame: 6 and 12 months]

Change from baseline for additional lymphocyte subsets (other than CD4+and CD8+) following Tecfidera initiation [Time Frame: 6 and 12 months]

Time to pre-determined lymphocyte counts following Tecfidera initiation [Time Frame: Up to 12 months]

Change from baseline for leukocyte, lymphocyte, CD4+/CD8+ ratio following Tecfidera initiation [Time Frame: 6 and 12 months]

Raw absolute counts for leukocyte, lymphocyte, CD4+/CD8+ ratio following Tecfidera initiation [Time Frame: 6 and 12 months]

Raw absolute counts for additional lymphocyte subsets (other than CD4+ and CD8+) [Time Frame: 6 and 12 months]

Potential predictors of low lymphocyte counts following Tecfidera initiation [Time Frame: 6 and 12 months]

Percentage change from baseline for leukocyte, lymphocyte, CD4+/CD8+ ratio following Tecfidera initiation [Time Frame: 6 and 12 months]

Secondary ID(s)

109MS419

Source(s) of Monetary Support

Please refer to primary and secondary sponsors