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)

Study identification

• EU PAS number:
  EUPAS9336
• Study ID:
  29107
• Official title and acronym:
  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)
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  The primary objective of the study is to retrospectively investigate changes in lymphocyte counts and lymphocyte subtypes, with a focus on CD4+ and CD8+ T cells, in participants on Tecfidera therapy for at least 6 months. The secondary objective is to investigate changes in lymphocyte subtypes other than CD4+ and CD8+ T cells.
• Study status:
  Finalised

Research institutions and networks

Institutions

Biogen

Multiple centres: 10 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned:27/03/2015

Actual:27/01/2015

Study start date

Planned:01/07/2015

Actual:21/07/2015

Data analysis start date

Actual:19/04/2016

Date of final study report

Planned:14/11/2016

Actual:25/01/2017

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Biogen

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)

Other study registration identification numbers and links

109MS419/NCT02519413: https://clinicaltrials.gov/ct2/show/NCT02519413